2013 Product Catalog

Transcription

Pharmacies
McKesson Plasma and Biologics
2013 Product Catalog
877.MCK.BLOOD (877.625.2566)
With Alphanate® you have a choice!
Packaged with Mix2Vial® Filter Transfer Set
VWF:RCo and FVIII potency on vial labels and folding cartons
Potency
Diluent Size
250 IU FVIII Range
5 mL
500 IU FVIII Range
5 mL
1000 IU FVIII Range
10 mL
1500 IU FVIII Range
10 mL
For further information call: Grifols USA, LLC Professional Service: 888-GRIFOLS (888 474 3657)
Customer Service: 888 325 8579; Fax: 323 441 7968 www.grifols.com
Grifols Biologicals Inc.
5555 Valley Boulevard, Los Angeles, California 90032, USA
A8L10-22-US-10
Available in the following potencies and color coded assay ranges
is dedicated to bringing a wide
selection of plasma-derivative
products to your pharmacy.
Three simple steps to get started:
1
Call 877.MCK.BLOOD.
You will be connected to a dedicated
Plasma Service Representative.
2
Activate your McKesson
Account for plasma purchases.
Your plasma customer representative
will ask you to confirm which
account number(s) you would like
to use, or help you establish a new
account for your plasma purchases.
You will also be asked for an email
address to receive plasma order
acknowledgements.
3
If applicable, share your current
GPO or manufacturer allocations.
McKesson will work directly with
your GPO and/or plasma manufacturers to shift your allocations
to McKesson within a target of 30
days. Your GPO must validate that
transfer. Non-contract purchases
can be ordered immediately.
Multiple Ordering Options
Online:
connect.mckesson.com
Call:
877.MCK.BLOOD
(877.625.2566)
Email:
[email protected]
Fax:
888.752.7626
Welcome to the first 2013 issue of
the McKesson Plasma and Biologics
Product Catalog.
We have made some improvements within our organization that are designed to
better support your needs. Specifically, we’ve reorganized our division into two
teams, customer service and sales, to better meet your needs more timely and
effectively. Also, these teams are now divided by region to be more aligned with
your operating hour time zones. In addition to these organizational improvements,
there are exciting changes to our portfolio and services that you’ll be interested
to learn about in this issue:
New Products
Over the past year, we’ve added 13 new biological drugs to our expanding portfolio;
Inside:
How to Order
4
Consignment Program
6
Product Guide
Return Goods Policy
serving our customers with a comprehensive portfolio. We maintain the exclusive
distribution for Nplate®, and we’ve recently added exclusive distribution for Xtandi®.
We will continue to expand these types of offerings over the coming years — creating
convenience for you, and remaining your single source for all your plasma and
specialty products.
Faster Access
Now you can view MPB’s portfolio of products online and place orders via McKesson
Connect SM . By streamlining the ordering process, we have also become the first
plasma and biologics distributor with the ability to display available IU sizes of
factor products online. We continue to refine and enhance our online ordering
process to simplify your ordering experience. Newly added features this year include
the new item alert for non-returnable and refrigerated items at the time you place
the order; a “Quicklink” to immediately create a plasma biologics order online
within McKesson Connect; and by popular demand, the ability to place orders for
free products like administration kits. To find out more about these enhancements,
contact your MPB customer service specialist.
Improved Customer Service
With two dedicated teams, we can provide you with immediate service for the types
of questions you may have. For instance, if you have basic questions about account
setup, billing or troubleshooting your order, you’ll have an expert customer service
representative to quickly assist you. On the other hand, if you want to place on order
or find out about a new product, you’ll have a dedicated sales team focused solely
on order taking. Now when you call 877.MCK.BLOOD, you’ll hear a prompt that will
direct you to the right team based on your needs.
None of these improvements could be possible without your continued support
and feedback. We thank you for your business and will continue to maintain the
relationships we have sincerely enjoyed building, provide exceptional customer service,
We promise to keep getting better … one order at a time. We’re looking forward
to another successful year and partnership, and with your support, many more.
14
Plasma and Biologics Team 15
however, our continued success and dedication is to our plasma products and
and keep a steadfast focus on the main reason we do what we do — the patients.
9–13
Travis Poe
Vice President of Sales
[email protected]
Consignment Program
Peace of mind. Factor products
on-site, on-hand, ready when
you are.
The high cost of blood factor products makes stocking them cost-prohibitive for many
providers. With McKesson’s Plasma and Biologics Consignment Program, you have
the convenience of purchasing only what you need, when you need it, for a minimal
convenience fee. Once products are purchased, they are replenished upon use and
guaranteed never to expire.
More convenience for you.
The McKesson Plasma and Biologics
Consignment Program is customized to
deliver convenience. Not only are products
available on demand; products and billing
are tailored to meet your needs.
With on-demand factor products, you
have peace of mind that products are:
• There when you need them
• Billed when you use them
• Guaranteed fresh
• Competitively priced
Let us help ensure you have the
products you need in the safest and
most cost-effective way.
Call a Plasma Service
Representative today at
877.MCK.BLOOD (877.625.2566)
to design your customized
Consignment Program.
After 2 prior lines of MBC chemotherapy,
DISCOVER OVERALL SURVIVAL
HALAVEN: The FIRST and ONLY single-agent
therapy proven to significantly extend OVERALL
SURVIVAL after 2 prior lines of MBC therapy1-9
UPDATED OVERALL SURVIVAL (OS) ANALYSIS (UNPLANNED): MEDIAN OS, MONTHS (95% CI)1,10,a
P R O P O R T I O N O F PAT I E N T S A L I V E
1.0
The updated OS analysis was consistent with the
primary analysis1
The primary analysis, conducted when ~50% of events (deaths) had been
observed, demonstrated a median OS for Halaven vs TPC of 13.1 months
(95% CI: 11.8, 14.3) vs 10.6 months (95% CI: 9.3, 12.5), HR*=0.81 (95% CI: 0.66,
0.99) (P=0.041)1,10
Results from an updated, unplanned survival analysis of the Phase III, randomized,
open-label, multicenter, multinational EMBRACE† trial of Halaven versus TPC in patients
with metastatic breast cancer (MBC) (N=762), conducted when 77% of events (deaths)
had been observed. The primary endpoint was OS. Patients were randomized (2:1)
to receive either Halaven 1.4 mg/m2 IV for 2 to 5 minutes on Days 1 and 8 of a 21-day
cycle, or any single-agent therapy, selected prior to randomization. At baseline, all
patients had received ≥2 prior chemotherapeutic regimens for metastatic disease
and demonstrated disease progression within 6 months of their last chemotherapeutic
regimen. All patients received prior anthracycline- and taxane-based chemotherapy,
unless contraindicated. Therapies in the TPC arm consisted of 97% chemotherapy
(26% vinorelbine, 18% gemcitabine, 18% capecitabine, 16% taxanes [included
paclitaxel, docetaxel, nab-paclitaxel, and ixabepilone], 9% anthracyclines, 10% other
chemotherapy), and 3% hormonal therapy.
Indication
Halaven is indicated for the treatment of patients with metastatic breast cancer
who have previously received at least two chemotherapeutic regimens for
the treatment of metastatic disease. Prior therapy should have included an
anthracycline and a taxane in either the adjuvant or metastatic setting.
Important Safety Information
Neutropenia
• Monitor complete blood counts prior to each dose, and increase the frequency of
monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration
and reduce subsequent doses in patients who experience febrile neutropenia or
Grade 4 neutropenia lasting longer than 7 days
• Severe neutropenia (ANC <500/mm3) lasting more than 1 week occurred in 12%
(62/503) of patients. Patients with elevated liver enzymes >3 × ULN and bilirubin
>1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile
neutropenia than patients with normal levels
• Grade 3 and Grade 4 neutropenia occurred in 28% and 29%, respectively, of
patients who received Halaven. Febrile neutropenia occurred in 5% of patients
and two patients (0.4%) died from complications
Peripheral Neuropathy
• Patients should be monitored closely for signs of peripheral motor and
sensory neuropathy
• Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4%
of patients who received Halaven. Delay administration of Halaven until
resolution to Grade 2 or less
• Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two
percent of patients developed a new or worsening neuropathy that had not
recovered within a median follow-up duration of 269 days (range 25-662 days)
• Peripheral neuropathy (5%) was the most common adverse reaction resulting
in discontinuation
Please see accompanying brief summary of Halaven full Prescribing Information.
To learn more about Halaven, visit www.halaven.com
HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
© 2012 Eisai Inc.
All rights reserved.
Printed in USA/August 2012
HALA0039 R1
0.9
0.8
Halaven
25%
(2.6 month)
(n=508)
13.2
0.7
INCREASE
(12.1, 14.4)
0.6
IN MEDIAN OS
Deaths=386
0.5
Treatment of
Physician’s Choice
0.4
(n=254)
0.3
10.6
0.2
(9.2, 12.0)
0.1
Deaths=203
0.0
0
6
12
18
24
30
36
54
26
11
5
0 Halaven
0 TPC
TIME (MONTHS)
Number of
patients at risk
a
508
254
406
178
274
106
142
61
CI=confidence interval; Treatment of Physician’s Choice (Control arm)=TPC.
Conducted in the intent-to-treat (ITT) population.
Pregnancy Category D
• Halaven is expected to cause fetal harm when administered to a pregnant
woman and patients should be advised of these risks
QT Prolongation
• In an uncontrolled ECG study in 26 patients, QT prolongation was observed
on Day 8, independent of eribulin concentration, with no prolongation on Day 1.
ECG monitoring is recommended for patients with congestive heart failure;
bradyarrhythmias; concomitant use of drugs that prolong QT interval,
including Class Ia and III antiarrhythmics; and electrolyte abnormalities
• Correct hypokalemia or hypomagnesemia prior to initiating Halaven and
monitor electrolytes periodically during therapy. Avoid in patients with
congenital long QT syndrome
Hepatic and Renal Impairment
• For patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic
and/or moderate (CrCl 30-50 mL/min) renal impairment, a reduction in starting
dose is recommended
Most Common Adverse Reactions
• Most common adverse reactions (≥25%) reported in patients receiving Halaven
were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%),
peripheral neuropathy (35%), nausea (35%), and constipation (25%)
• The most common serious adverse reactions reported in patients receiving
Halaven were febrile neutropenia (4%) and neutropenia (2%)
References: 1. Halaven [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2012. 2. Saad ED et al. J Clin Oncol.
2010;28(11):1958-1962. 3. Slamon DJ et al. N Engl J Med. 2001;344(11):783-792. 4. Geyer CE et al.
N Engl J Med. 2006;355(26):2733-2743. 5. von Minckwitz G et al. J Clin Oncol. 2009;27(12):1999-2006.
6. Miller K et al. N Engl J Med. 2007;357(26):2666-2676. 7. Robert NJ et al. J Clin Oncol. 2011;29(10):1252-1260.
8. Sparano JA et al. J Clin Oncol. 2010;28(20):3256-3263. 9. Jones SE et al. J Clin Oncol. 2005;23(24):55425551. 10. Cortes J et al. Lancet. 2011;377(9769):914-923.
*HR=hazard ratio.
† EMBRACE=Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice versus E7389 (Eribulin).
HALAVEN® (eribulin mesylate) Injection BRIEF SUMMARY – See package insert for full prescribing information.
2.2
Dose Modification
Assess for peripheral neuropathy and obtain complete blood cell counts prior to each dose.
Recommended dose delays
• Do not administer HALAVEN on Day 1 or Day 8 for any of the following:
– ANC <1,000/mm3
– Platelets <75,000/mm 3
– Grade 3 or 4 non-hematological toxicities.
• The Day 8 dose may be delayed for a maximum of 1 week.
– If toxicities do not resolve or improve to ≤ Grade 2 severity by Day 15, omit the dose.
– If toxicities resolve or improve to ≤ Grade 2 severity by Day 15, administer HALAVEN at a reduced dose and initiate
the next cycle no sooner than 2 weeks later.
Recommended dose reductions
• If a dose has been delayed for toxicity and toxicities have recovered to Grade 2 severity or less, resume HALAVEN at a
reduced dose as set out in Table 1.
• Do not re-escalate HALAVEN dose after it has been reduced.
Table 1 Recommended Dose Reductions
Recommended
Event Description
HALAVEN Dose
Permanently reduce the 1.4 mg/m2 HALAVEN dose for any of the following:
ANC <500/mm3 for >7 days
ANC <1,000 /mm3 with fever or infection
Platelets <25,000/mm3
1.1 mg/m2
Platelets <50,000/mm3 requiring transfusion
Non-hematologic Grade 3 or 4 toxicities
Omission or delay of Day 8 HALAVEN dose in previous cycle for toxicity
Occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m2
0.7 mg/m2
Occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m2
Discontinue HALAVEN
ANC = absolute neutrophil count.
Toxicities graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
5
WARNINGS AND PRECAUTIONS
5.1
Neutropenia
Severe neutropenia (ANC <500/mm3) lasting more than one week occurred in 12% (62/503) of patients in Study 1, leading to
discontinuation in <1% of patients. Patients with alanine aminotransferase or aspartate aminotransferase >3 × ULN (upper limit of
normal) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal aminotransferase
levels. Patients with bilirubin >1.5 × ULN also had a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Monitor complete blood counts prior to each dose; increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias.
Delay administration of HALAVEN and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia
lasting longer than 7 days. Clinical studies of HALAVEN did not include patients with baseline neutrophil counts below 1,500/mm3.
5.2
Peripheral Neuropathy
Grade 3 peripheral neuropathy occurred in 8% (40/503) of patients, and Grade 4 in 0.4% (2/503) of patients in Study 1. Peripheral
neuropathy was the most common toxicity leading to discontinuation of HALAVEN (5% of patients; 24/503). Neuropathy lasting
more than one year occurred in 5% (26/503) of patients. Twenty-two percent (109/503) of patients developed a new or worsening
neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Monitor patients closely for
signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy
until resolution to Grade 2 or less.
5.3
Embryo-Fetal Toxicity
There are no adequate and well-controlled studies of HALAVEN in pregnant women. HALAVEN is a microtubule inhibitor; therefore,
it is expected to cause fetal harm when administered to a pregnant woman. Embryo-fetal toxicity and teratogenicity occurred in rats
that received eribulin mesylate at approximately half of the recommended human dose based on body surface area. If this drug is used
during pregnancy, or if a patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus.
5.4
QT Prolongation
In an uncontrolled open-label ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration,
with no QT prolongation observed on Day 1. ECG monitoring is recommended if therapy is initiated in patients with congestive
heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte
abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically
during therapy. Avoid HALAVEN in patients with congenital long QT syndrome.
6
ADVERSE REACTIONS
The following adverse reactions are discussed in detail in other sections of the labeling:
•Neutropenia•Peripheralneuropathy•QTintervalprolongation
The most common adverse reactions (≥25%) reported in patients receiving HALAVEN were neutropenia, anemia, asthenia/fatigue,
alopecia, peripheral neuropathy, nausea, and constipation. The most common serious adverse reactions reported in patients receiving
HALAVEN were febrile neutropenia (4%) and neutropenia (2%). The most common adverse reaction resulting in discontinuation of
HALAVEN was peripheral neuropathy (5%).
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
In clinical trials, HALAVEN has been administered to 1,222 patients with multiple tumor types, including 240 patients exposed to
HALAVEN for 6 months or longer. The majority of the 1,222 patients were women (82%) with a median age of 58 years (range: 26 to
91 years). The racial and ethnic distribution was Caucasian (83%), Black (5%), Asian (2%), and other (5%).
The adverse reactions described in Table 2 were identified in 750 patients treated in Study 1. In Study 1, patients were randomized (2:1)
to receive either HALAVEN (1.4 mg/m2 on Days 1 and 8 of a 21-day cycle) or single agent treatment chosen by their physician (control
group). A total of 503 patients received HALAVEN, and 247 patients in the control group received therapy consisting of chemotherapy
[total 97% (anthracyclines 10%, capecitabine 18%, gemcitabine 19%, taxanes 15%, vinorelbine 25%, other chemotherapies 10%)]
or hormonal therapy (3%). The median duration of exposure was 118 days for patients receiving HALAVEN and 63 days for patients
receiving control therapy. Table 2 reports the most common adverse reactions occurring in at least 10% of patients in either group.
Table 2 Adverse Reactions with a Per-Patient Incidence of at Least 10% in Study 1
MedDRA ver 10.0
HALAVEN (n=503)
Control Group (n=247)
All Grades
≥ Grade 3
All Grades
≥ Grade 3
Blood and Lymphatic System Disordersa
Neutropenia
82%
57%
53%
23%
Anemia
58%
2%
55%
4%
Nervous system disorders
35%
8%
16%
2%
Peripheral neuropathyb
Headache
19%
<1%
12%
<1%
General disorders and administrative site conditions
Asthenia/Fatigue
54%
10%
40%
11%
Mucosal inflammation
9%
1%
10%
2%
Pyrexia
21%
<1%
13%
<1%
Gastrointestinal disorders
Constipation
25%
1%
21%
1%
Diarrhea
18%
0
18%
0
Nausea
35%
1%
28%
3%
Vomiting
18%
1%
18%
1%
Musculoskeletal and connective tissue disorders
Arthralgia/Myalgia
22%
<1%
12%
1%
Back pain
16%
1%
7%
2%
Bone pain
12%
2%
9%
2%
Pain in extremity
11%
1%
10%
1%
Investigations
Weight decreased
21%
1%
14%
<1%
Metabolism and nutrition disorders
Anorexia
20%
1%
13%
1%
Respiratory, thoracic, and mediastinal disorders
Cough
14%
0
9%
0
Dyspnea
16%
4%
13%
4%
Skin and subcutaneous tissue disorders
10%
NAc
Alopecia
45%
NAc
Table 2 (cont'd)
MedDRA ver 10.0
HALAVEN (n=503)
Control Group (n=247)
All Grades
≥ Grade 3
All Grades
≥ Grade 3
Infections and Infestations
Urinary Tract Infection
10%
1%
5%
0
a
Based upon laboratory data.
b
Includes neuropathy peripheral, neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia.
c
Not applicable; (grading system does not specify > Grade 2 for alopecia).
Cytopenias: Grade 3 neutropenia occurred in 28% (143/503) of patients who received HALAVEN in Study 1, and 29% (144/503)
of patients experienced Grade 4 neutropenia. Febrile neutropenia occurred in 5% (23/503) of patients; two patients (0.4%) died
from complications of febrile neutropenia. Dose reduction due to neutropenia was required in 12% (62/503) of patients and
discontinuation was required in <1% of patients. The mean time to nadir was 13 days and the mean time to recovery from severe
neutropenia (<500/mm3) was 8 days. Grade 3 or greater thrombocytopenia occurred in 1% (7/503) of patients. G-CSF (granulocyte
colony-stimulating factor) or GM-CSF (granulocyte–macrophage colony-stimulating factor) was used in 19% of patients who
received HALAVEN.
Peripheral Neuropathy: In Study 1, 17% of enrolled patients had Grade 1 peripheral neuropathy and 3% of patients had Grade 2
peripheral neuropathy at baseline. Dose reduction due to peripheral neuropathy was required by 3% (14/503) of patients who received
HALAVEN. Four percent (20/503) of patients experienced peripheral motor neuropathy of any grade and 2% (8/503) of patients
developed Grade 3 peripheral motor neuropathy.
Liver Function Test Abnormalities: Among patients with Grade 0 or 1 ALT levels at baseline, 18% of HALAVEN-treated patients
experienced Grade 2 or greater ALT elevation. One HALAVEN-treated patient without documented liver metastases had concomitant
Grade 2 elevations in bilirubin and ALT; these abnormalities resolved and did not recur with re-exposure to HALAVEN.
Less Common Adverse Reactions: The following additional adverse reactions were reported in ≥5% to <10% of the HALAVENtreated group:
• Eye Disorders: increased lacrimation
• Gastrointestinal Disorders: dyspepsia, abdominal pain, stomatitis, dry mouth
• General Disorders and Administration Site Conditions: peripheral edema
• Infections and Infestations: upper respiratory tract infection
• Metabolism and Nutrition Disorders: hypokalemia
• Musculoskeletal and Connective Tissue Disorders: muscle spasms, muscular weakness
• Nervous System Disorders: dysgeusia, dizziness
• Psychiatric Disorders: insomnia, depression
• Skin and Subcutaneous Tissue Disorders: rash
8
USE IN SPECIFIC POPULATIONS
8.1
Pregnancy Category D
There are no adequate and well-controlled studies with HALAVEN in pregnant women. HALAVEN is a microtubule inhibitor; therefore,
it is expected to cause fetal harm when administered to a pregnant woman. Embryo-fetal toxicity and teratogenicity occurred in rats
that received eribulin mesylate at approximately half of the recommended human dose based on body surface area. If this drug is
used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential
hazard to the fetus.
In a developmental toxicity study, pregnant rats received intravenous infusion of eribulin mesylate during organogenesis (Gestation
Days 8, 10, and 12) at doses approximately 0.04, 0.13, 0.43 and 0.64 times the recommended human dose, based on body surface
area (mg/m2). Increased abortion and severe external or soft tissue malformations were observed in offspring at doses 0.64 times the
recommended human dose based on body surface area (mg/m2), including the absence of a lower jaw, tongue, stomach and spleen.
Increased embryo-fetal death/resorption, reduced fetal weights, and minor skeletal anomalies consistent with developmental delay
were also reported at or above doses of 0.43 times the recommended human dose.
Maternal toxicity of eribulin mesylate was reported in rats at or above doses of 0.43 times the recommended human dose (mg/m²),
and included enlarged spleen, reduced maternal weight gain and decreased food consumption.
8.3
Nursing Mothers
It is not known whether HALAVEN is excreted into human milk. No studies in humans or animals were conducted to determine if
HALAVEN is excreted into milk. Because many drugs are excreted into human milk and because of the potential for serious adverse
reactions in human milk fed infants from HALAVEN, a decision should be made whether to discontinue nursing or to discontinue
HALAVEN taking into account the importance of the drug to the mother.
8.4
Pediatric Use
The safety and effectiveness of HALAVEN in pediatric patients below the age of 18 years have not been established.
8.6
Hepatic Impairment
Administration of HALAVEN at a dose of 1.1 mg/m2 to patients with mild hepatic impairment and 0.7 mg/m2 to patients with moderate
hepatic impairment resulted in similar exposure to eribulin as a dose of 1.4 mg/m2 to patients with normal hepatic function. Therefore,
a lower starting dose of 1.1 mg/m2 is recommended for patients with mild hepatic impairment (Child-Pugh A) and of 0.7 mg/m2 is
recommended for patients with moderate hepatic impairment (Child-Pugh B). HALAVEN was not studied in patients with severe hepatic
impairment (Child-Pugh C).
8.7
Renal Impairment
For patients with moderate renal impairment (CrCl 30-50 mL/min), the geometric mean dose-normalized systemic exposure increased
2-fold compared to patients with normal renal function. A lower starting dose of 1.1 mg/m2 is recommended for patients with moderate
renal impairment. The safety of HALAVEN was not studied in patients with severe renal impairment (CrCl <30 mL/min).
10
OVERDOSAGE
Overdosage of HALAVEN has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia
lasting seven days and a Grade 3 hypersensitivity reaction lasting one day.
There is no known antidote for HALAVEN overdose.
12
CLINICAL PHARMACOLOGY
12.3
Pharmacokinetics
Specific Populations
Hepatic Impairment
A study evaluated the PK of eribulin in patients with mild (Child-Pugh A; n=7) and moderate (Child-Pugh B; n=5) hepatic impairment.
Compared to patients with normal hepatic function (n=6), eribulin exposure increased 1.8-fold and 2.5-fold in patients with mild
and moderate hepatic impairment, respectively. Administration of HALAVEN at a dose of 1.1 mg/m2 to patients with mild hepatic
impairment and 0.7 mg/m2 to patients with moderate hepatic impairment resulted in similar exposure to eribulin as a dose of
1.4 mg/m2 to patients with normal hepatic function.
Renal Impairment
No formal PK trials were conducted with HALAVEN in patients with renal impairment. Available data suggests that geometric
mean dose-normalized systemic exposure is similar for patients with mild renal impairment (CrCl 50-80 mL/min) relative to patients
with normal renal function. However, for patients with moderate renal impairment (CrCl 30-50 mL/min), the geometric mean dosenormalized systemic exposure increased 2-fold compared to patients with normal renal function.
12.6
Cardiac Electrophysiology
The effect of HALAVEN on the QTc interval was assessed in an open-label, uncontrolled, multicenter, single-arm dedicated QT
trial. A total of 26 patients with solid tumors received 1.4 mg/m2 of HALAVEN on Days 1 and 8 of a 21-day cycle. A delayed QTc
prolongation was observed on Day 8, with no prolongation observed on Day 1. The maximum mean QTcF change from baseline (95%
upper confidence interval) was 11.4 (19.5) ms.
13
NONCLINICAL TOXICOLOGY
13.1
Carcinogenesis, mutagenesis, impairment of fertility
Carcinogenicity studies have not been conducted with eribulin mesylate.
Eribulin mesylate was not mutagenic in in vitro bacterial reverse mutation assays (Ames test). Eribulin mesylate was positive in mouse
lymphoma mutagenesis assays, and was clastogenic in an in vivo rat bone marrow micronucleus assay.
The effects of HALAVEN on human fertility are unknown. Fertility studies have not been conducted with eribulin mesylate in
humans or animals. However, nonclinical findings in repeated-dose dog and rat toxicology studies suggest that male fertility may be
compromised by treatment with eribulin mesylate. Rats exhibited testicular toxicity (hypocellularity of seminiferous epithelium with
hypospermia/aspermia) following dosing with eribulin mesylate at or above 0.43 times the recommended human dose (mg/m2) given
once weekly for 3 weeks, or at or above 0.21 times the recommended human dose (mg/m2) given once weekly for 3 out of 5 weeks,
repeated for 6 cycles. Testicular toxicity was also observed in dogs given 0.64 times the recommended human dose (mg/m2) weekly
for 3 out of 5 weeks, repeated for 6 cycles.
17
PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling
• Advise patients to contact their health care provider for a fever of 100.5°F or greater or other signs or symptoms of infection
such as chills, cough, or burning or pain on urination.
• Advise women of childbearing potential to avoid pregnancy and to use effective contraception during treatment with HALAVEN.
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
© 2012 Eisai Inc. All rights reserved. Printed in USA / March 2012 ERI 346
Call: 877.625.2566 | Email: [email protected] | Fax: 888.752.7626
Product Description
Material
Manufacturer
NDC
Size/Form
Code
Albuked® 25% 50 mL
Albuked® 25% 100 mL
Albuked® 5% 50 mL
Albuked® 5% 250 mL
Albumin 25% 50 mL
Albumin 25% 50 mL
Albumin 25% 100 mL
Albumin 25% 100 mL
Albumin 5% 250 mL
Albumin 5% 500 mL
Albumin Admin IV Set
Albuminar® 25% 50 mL
AlbuRx® 25% 50 mL
AlbuRx® 25% 100 mL
AlbuRx® 5% 250 mL
AlbuRx® 5% 500 mL
Albutein® 25% 50 mL
Buminate 25% 20 mL
Buminate 25% 50 mL
Buminate 25% 100 mL
Buminate 5% 250 mL
Buminate 5% 500 mL
Buminate Admin IV Set
Buminate Admin IV Set
Flexbumin 25% 50 mL
Flexbumin 25% 100 mL
Flexbumin 50 mL Admin IV Set
Flexbumin 50 mL Admin IV Set
Flexbumin 100mL Admin IV Set
Flexbumin 100mL Admin IV Set
Kedbumin 25% 50 mL
Plasbumin® 25% 20 mL
Plasbumin®-5 L/A 50 mL
1356385
1356526
1355684
1355791
1250679
1129717
1131374
1251057
1250547
1250646
1222116
2286318
2286763
2536233
2536241
2291540
2291664
2292530
2292746
1248376
1248392
1248137
1248285
1325950
1326313
1327659
1328277
1329747
1722701
1725837
1332253
1332709
1722586
1725688
1722669
1725704
3915998
3221405
3221454
3221397
3221470
3221496
3224797
3224813
3224839
3224854
3224870
Kedrion
Kedrion
Kedrion
Kedrion
Octapharma
Grifols
Grifols
Octapharma
Octapharma
Octapharma
CSL Behring
CSL Behring
CSL Behring
CSL Behring
CSL Behring
CSL Behring
CSL Behring
CSL Behring
CSL Behring
Grifols
Grifols
Grifols
Grifols
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Kedrion
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
76125-0784-25
76125-0784-10
76125-0785-05
76125-0785-25
67467-0643-01
61953-0002-01
61953-0002-02
67467-0643-02
67467-0623-02
67467-0623-03
00053-7970-04
00053-7680-32
00053-7680-33
00053-7670-31
00053-7670-32
44206-0251-05
44206-0251-10
44206-0310-25
44206-0310-50
68516-5216-01
68516-5216-02
68516-5214-01
68516-5214-02
00944-0490-01
00944-0490-02
00944-0900-03
00944-0491-01
00944-0491-02
N/A
N/A
00944-0493-01
00944-0493-02
N/A
N/A
N/A
N/A
76179-0025-01
13533-0684-16
13533-0684-20
13533-0684-71
13533-0685-20
13533-0685-25
13533-0690-20
13533-0690-25
13533-0692-16
13533-0692-20
13533-0692-71
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Each
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
10/CS
10/CS
10/CS
6/CS
6/CS
Each
6/CS
24/CS
12/CS
Each
24/CS
Each
12/CS
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
P9047
P9047
P9045
P9045
P9047
Q0157
Q0157
P9047
P9045
P9045
Factors
Advate® 200-400 IU*
Advate® 1201-1800 IU*
Advate® rAHF 200-400 IU*
Advate®+Baxject 200-400 IU*
3920642
3920659
3920667
3920675
1216027
1216282
1216506
1216589
1216605
1216639
1216670
1216993
1217025
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
00944-2921-02
00944-2922-02
00944-2923-02
00944-2924-02
00944-2940-01
00944-2940-02
00944-2940-03
00944-2940-04
00944-2940-10
00944-2941-10
00944-2942-10
00944-2943-10
00944-2944-10
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Albumin
Note: order quantities are based on the size/form indicated per item
* Refrigerated
** Frozen
† Available only for in-patient hospital pharmacies
Q0157
Q0157
P9047
P9047
Q0157
Q0157
P9041
P9041
Q0157
Q0157
P9041
P9041
Q0157
P9047
P9047
P9045
P9041
P9046
P9046
Q0157
Q0157
Q0157
P9041
P9041
J7192
J7192
J7192
J7192
J7192
J7192
J7192
J7192
J7192
J7192
J7192
J7192
J7192
‡ Dropship
Product Description
Material
Manufacturer
NDC
Size/Form
Code
Factors (continued)
Alphanate® 250-499 IU*
Alphanate® 1300+ IU*
AlphaNine® 500-1500 IU*
AlphaNine® 1000-1499 IU*
AlphaNine® 1500+ IU*
BEBULIN 500-700 IU*
BeneFIX® 250-499 IU*
BeneFIX® 500-999 IU*
BeneFIX® RT 250-499 IU*
BeneFIX® RT 2000+ IU*
BeneFIX® RT 3000+ IU*
FEIBA® NF 400-650 IU*
FEIBA® NF 1750-3250 IU*
FEIBA® NF 1750-3250 IU*
Helixate® FS 200-399 IU*
Helixate® FS 2000+ IU*
Helixate® FS 3000+ IU*
Hemofil® M 220-400 IU*
Humate-P 500-999 IU*
Koate® 250-399 IU*
Koate® 400-799 IU*
Koate® 800-1250 IU*
Koate® DVI 250-399 IU*
Kogenate® FS CLS 500-999 IU*
Kogenate® FS CLS 2000 IU+*
Kogenate® FS with BIO-SET 250-499 IU*
Kogenate® FS with BIO-SET 2000 IU*
Kogenate® FS with BIO-SET 3000 IU*
Monoclate-P 720-1199 IU*
Monoclate-P 1200-1800 IU*
Mononine® 500-719 IU*
Mononine® 720-1300 IU*
Novoseven® RT 1 mg*
Profilnine® 450-999 IU*
Recombinate®+Baxject 220-400 IU*
1217033
1217058
1182914
1179670
1186469
1101872
2115871
2115897
2115939
2124691
1248442
1248624
3915071
3915089
3915105
3915113
1125905
2136331
1217959
2136349
1217967
2136372
1217991
1236686
1237254
1237296
1237304
1237841
1215789
1215870
1215888
1215912
2266120
2266203
2266856
3221330
3221355
3221363
3914710
3914728
3914736
1757327
1756865
1754894
1754928
1755057
1755305
1723618
2271401
2272052
2279297
2281335
2538635
2538650
2538668
1255256
2115863
2115764
2115798
1215656
1215706
Baxter
Baxter
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Baxter
Pfizer
Pfizer
Pfizer
Pfizer
Pfizer
Pfizer
Pfizer
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
CSL Behring
CSL Behring
CSL Behring
CSL Behring
CSL Behring
Baxter
Baxter
Baxter
Baxter
CSL Behring
CSL Behring
CSL Behring
Kedrion
Kedrion
Kedrion
Kedrion
Kedrion
Kedrion
Bayer
Bayer
Bayer
Bayer
Bayer
Bayer
Bayer
CSL Behring
CSL Behring
CSL Behring
CSL Behring
Novo Nordisk
Novo Nordisk
Novo Nordisk
Novo Nordisk
Grifols
Grifols
Grifols
Baxter
Baxter
00944-2945-10
00944-2946-10
68516-4601-01
68516-4602-01
68516-4603-02
68516-4604-02
68516-3601-02
68516-3602-02
68516-3603-02
64193-0445-02
58394-0003-06
58394-0002-06
58394-0633-03
58394-0634-03
58394-0635-03
58394-0636-03
58394-0637-03
64193-0222-03
64193-0222-03
64193-0224-02
64193-0222-04
64193-0222-05
64193-0222-05
00053-8131-02
00053-8132-02
00053-8133-02
00053-8134-02
00053-8135-02
00944-2930-01
00944-2931-01
00944-2932-01
00944-2933-01
00053-7615-05
00053-7615-10
00053-7615-20
13533-0665-20
13533-0665-30
13533-0665-50
76125-0250-20
76125-0500-30
76125-0667-50
00026-3783-30
00026-3786-60
00026-3792-20
00026-3793-30
00026-3795-50
00026-3796-60
00026-3797-70
00053-7656-04
00053-7656-05
00053-7668-02
00053-7668-04
00169-7010-01
00169-7020-01
00169-7050-01
00169-7040-01
68516-3201-01
68516-3202-02
68516-3203-02
00944-2831-10
00944-2832-10
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
J7192
J7192
J7186
J7186
J7186
J7186
J7193
J7193
J7193
J7194
* Refrigerated
** Frozen
J7195
J7195
J7195
J7195
J7198
J7198
J7198
J7198
J7192
J7192
J7192
J7192
J7192
J7190
J7190
J7190
J7190
J7187
J7187
J7187
J7190
J7190
J7190
J7192
J7192
J7192
J7192
J7192
J7192
J7192
J7190
J7190
J7193
J7193
J7189
J7189
J7189
J7189
J7194
J7194
J7194
J7192
J7192
‡ Dropship
Product Description
Material
Manufacturer
NDC
Size/Form
Code
Recombinate® RAHF 220-400 IU*
wilate® 450-899 IU*
wilate® 500-999 IU*
wilate® 900 IU*
Xyntha® 250-499 IU*
Xyntha® 500-999 IU*
Xyntha® 1000-1999 IU*
Xyntha® 2000+ IU*
Xyntha® SOLOFUSE® 3000 IU+*
1215763
2144715
3913233
3913241
3913258
3913266
3913274
2116432
1690114
2116457
1249309
1249838
1250042
1250075
3915626
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Octapharma
Octapharma
Octapharma
Pfizer
Pfizer
Pfizer
Pfizer
Pfizer
00944-2833-10
00944-2834-10
00944-2841-10
00944-2842-10
00944-2843-10
00944-2844-10
00944-2845-10
67467-0181-01
67467-0182-01
67467-0181-02
58394-0012-01
58394-0013-01
58394-0014-01
58394-0015-01
58394-0016-03
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
J7192
J7192
J7192
J7192
Hyperimmunes
GamaSTAN® S/D 2 mL*
GamaSTAN® S/D 10 mL*
HyperHEP B® S/D 0.5 mL Pre-filled Syringe*
HyperHEP B® S/D 1 mL Pre-filled Syringe*
HyperHEP B® S/D 1 mL*
HyperHEP B® S/D 5 mL*
HyperRAB® S/D 2 mL*
HyperRAB® S/D 10 mL*
HyperRHO® S/D MiniDose Syringe*
HyperRHO® S/D 250 mL Syringe*
HyperTET® 250 mL Syringe*
RhoGAM® MICRH 50 mcg 1mL Syringe*
RhoGAM® Ultra-Filtered PLUS Syringe*
Rhophylac® RHO Pre-filled Syringe*
Rhophylac® RHO Pre-filled Syringe*
WinRho® SDV 1500 IU 1.3 mL*
WinRho® SDV 15000 IU 13 mL*
WinRho® SDV 15000 IU 13 mL*
3224664
3224672
3224763
3224730
3224714
3224771
3224573
3221280
3224623
3224581
3224649
1186113
1245299
1249937
1266493
1273333
1280494
2291870
2292423
2116507
2118024
2118008
2116655
2116945
2118040
2116994
2118057
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
JOM
JOM
JOM
JOM
JOM
JOM
CSL Behring
CSL Behring
Baxter
Cangene
Cangene
Baxter
Baxter
Cangene
Baxter
Cangene
13533-0635-04
13533-0635-12
13533-0636-03
13533-0636-02
13533-0636-01
13533-0636-05
13533-0618-02
13533-0618-10
13533-0631-06
13533-0631-02
13533-0634-02
00562-7806-01
00562-7806-05
00562-7806-25
00562-7805-01
00562-7805-05
00562-7805-25
44206-0300-01
44206-0300-10
00944-2967-03
53270-3500-01
53270-3300-01
00944-2967-07
00944-2967-05
53270-3100-01
00944-2967-09
53270-3000-01
Single Vial
Single Vial
Each
Each
Single Vial
Single Vial
Single Vial
Single Vial
Each
Each
Single Vial
Each
5/CS
25/CS
Each
5/CS
25/CS
Each
10/CS
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
J1470
J1550
90371
90371
CPT-90371
CPT-90371
CPT-90375
CPT-90375
J2788
J2790
J1670
IVIG
Carimune® NF 3 gm
Carimune® NF 6 gm
Carimune® NF 12 gm
Flebogamma® 0.5 gm 10mL
Flebogamma® 2.5 gm 50 mL
Flebogamma® 5 gm 100 mL
Flebogamma® 10 gm 200 mL
Flebogamma® DIF 5% 0.5 gm
Flebogamma® DIF 5% 2.5 gm
Flebogamma® DIF 5% 5 gm
Gammagard 1 gm Liquid*
2292761
2293181
2293421
1143916
1145739
1147826
1151018
1133883
1135540
1137280
1139138
1141357
1281872
1245380
1243575
1215581
CSL Behring
CSL Behring
CSL Behring
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Baxter
44206-0416-03
44206-0417-06
44206-0418-12
61953-0003-01
61953-0003-02
61953-0003-03
61953-0003-04
61953-0004-01
61953-0004-02
61953-0004-03
61953-0004-04
61953-0004-05
61953-0005-01
61953-0005-03
61953-0005-02
00944-2700-02
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
J1566
J1566
J1566
Factors (continued)
* Refrigerated
** Frozen
J7192
J7192
J3590
J3590
J7185
J7185
J7185
J7185
J7185
J2790
J2790
J2790
J2792
J2792
J2792
J2792
J2792
J2792
J2792
J2792
J1567
J1567
J1567
J1567
J1567
J1572
J1572
J1572
J1569
‡ Dropship
Product Description
Material
Manufacturer
NDC
Size/Form
Code
IVIG (continued)
Gammagard 2.5 gm Liquid*
Gammagard SD 0.5 gm*
Gammagard SD 2.5 gm*
Gammagard SD 5 gm*
Gammagard SD 5 gm IgA<1 ug/mL*
Gammagard SD 10 gm*
Gammagard SD 10 gm IgA<1 ug/mL*
Gammagard Admin IV Set Gammaked™ 1 gm Liquid*
Gammaked™ 2.5 gm Liquid*
Gammaked™ 5 gm Liquid*
Gammaplex® 5 gm, 100 mL*
Gammaplex® 10 gm, 200 mL*
Gamunex-C® 1 gm, 10 mL*
Gamunex-C® 2.5 gm, 25 mL*
Gamunex® 10% 1 gm, 10 mL*
Gamunex® 2.5 gm, 25 mL*
Gamunex® 10%, 5 gm*
Gamunex® 10% 10 gm, 100 mL*
Gamunex® 20 gm*
Hizentra® 5 mL 1 gm
Octagam® 5% 1 gm
Octagam® 5% 2.5 gm
Octagam® 5% 5 gm
Octagam® 5% 10 gm
Octagam® S/D 1 gm
Octagam® S/D 2.5 gm
Octagam® S/D 5 gm
Octagam® S/D 10 gm
Privigen® 5 gm
Privigen® 10 gm
Privigen® 20 gm
1215599
1215607
1215615
1215631
3913993
1215243
1215490
1215524
1256056
1215573
1256502
2144558
1356567
1356971
1357649
3914694
3914702
3919206
3919214
1245398
1247055
1248020
1250810
1254986
3221249
3221264
3217833
3221223
3221272
1731702
1731728
1731744
1251131
1251206
1251271
1251537
1251636
1251644
1251685
1251776
2293470
2293488
2293538
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Kedrion
Kedrion
Kedrion
Kedrion
Kedrion
BPL
BPL
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
Grifols
CSL Behring
CSL Behring
CSL Behring
Octapharma
Octapharma
Octapharma
Octapharma
Octapharma
Octapharma
Octapharma
Octapharma
CSL Behring
CSL Behring
CSL Behring
00944-2700-03
00944-2700-04
00944-2700-05
00944-2700-06
00944-2700-07
00944-2620-01
00944-2620-02
00944-2620-03
00944-2655-03
00944-2620-04
00944-2655-04
N/A
76125-0900-01
76125-0900-25
76125-0900-50
76125-0900-10
76125-0900-20
64208-8234-02
64208-8234-03
13533-0800-12
13533-0800-15
13533-0800-20
13533-0800-71
13533-0800-24
13533-0645-12
13533-0645-15
13533-0645-20
13533-0645-71
13533-0645-24
44206-0451-01
44206-0451-02
44206-0454-04
67467-0843-01
67467-0843-02
67467-0843-03
67467-0843-04
68209-0843-01
68209-0843-02
68209-0843-03
68209-0843-04
44206-0436-05
44206-0437-10
44206-0438-20
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Each
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
Single Vial
J1569
J1569
J1569
J1569
Nasals
Stimate® Nasal Spray 1.5 mg, 2.5 mL
2117018
CSL Behring
00053-6871-00
Each
Plasma Protein Fraction
Plasmanate® 5% 50 mL
Plasmanate® 5% 250 mL
3224524
3224565
Grifols
Grifols
13533-0613-20
13533-0613-25
Single Vial
Single Vial
P9043
P9043
Vaccines
RabAvert® 1 mL*
1926948
Novartis
63851-0501-01
Single Vial
90675
Specialty Products
ADCETRIS® 50 mg*‡
Altera Exhalation Filter/Valve Set
Altera Nebulizer System
Altera Nebulizer Handset
BOSULIF® 100 mg 120 tablets
BOSULIF® 500 mg 30 tablets
Cayston 75 mg 28-Day Kit†
Erivedge 150 mg, 30 doses*‡
1837335
1267426
1264308
1264985
1690072
1690064
1259464
1129097
Seattle Genetics
PARI
PARI
PARI
Pfizer
Pfizer
Gilead
Genentech
51144-0050-01
83490-0410-03
N/A
N/A
00069-0135-01
00069-0136-01
61958-0901-01
50242-0140-01
Single Vial
Each
Each
Each
Each
Each
Each
Each
* Refrigerated
** Frozen
J1566
J1566
J1566
J1566
J1566
J1566
J1561
J1561
J1561
J1561
J1561
J1557
J1557
J1561
J1561
J1561
J1561
J1561
J1561
J1561
J1561
J1561
J1561
J1559
J1559
J1559
J1568
J1568
J1568
J1568
J1568
J1568
J1459
J1459
J1459
‡ Dropship
Product Description
Material
Manufacturer
NDC
Size/Form
EYLEA® 2 mg 0.5 mL*
Halaven® Injection 1 mg, 2mL*
Jakafi® 5 mg 60 tablets
Kyprolis® 60 mg SDV Lyophilized Powder*
Makena® Injection 250 mg/mL, 5 mL*
Nexavar® 200 mg 120 tablets
Nplate® SDV 250 mcg 0.5 mL*‡
Nplate® SDV 500 mcg 1 mL*‡
Panhematin® 313 mg 100 mL*
PERJETA™ 420mg, 14mL*
Smartmask Kids Pediatric
Solesta® Injection 50 mg, 15mL†
STIVARGA® 40 mg, 28 tablets/bottle
Thyrogen 2-vial Kit*
Voraxaze 1000 IU†
XTANDI® 40 mg 120 capsules
YERVOY™ 50 mg 10 mL*
YERVOY™ 200 mg 40 mL*
ZALTRAP® 100 mg*‡
ZALTRAP® 200 mg*‡
ZELBORAF® 240 mg 120 tablets*‡
3915519
1192624
3920865
3920873
3920881
3920899
3921004
3921129
1760933
2040160
3916012
3916004
2117133
1180942
1266287
2038719
2039683
1620921
2038743
1609296
2143535
2144046
2038727
2038735
1129907
REGENERON
EISAI
Incyte
Incyte
Incyte
Incyte
Incyte
Onyx
Ther-Rx
BAYER
Amgen
Amgen
Lundbeck
Genentech
PARI
Salix
Bayer
Genzyme
BTG
Astellas
Bristol Myers
Bristol Myers
Sanofi
Sanofi
Genentech
61755-0005-02
62856-0389-01
50881-0050-60
50881-0100-60
50881-0150-60
50881-0200-60
50881-0250-60
76075-0101-01
64011-0243-01
50419-0488-58
55513-0221-01
55513-0222-01
67386-0701-54
50242-0145-01
74422-9789-00
89114-0850-03
50419-0171-03
58468-1849-04
50633-0210-11
00469-0125-99
00003-2327-11
00003-2328-22
00024-5840-01
00024-5841-01
50242-0090-01
Single Vial
Single Vial
Each
Each
Each
Each
Each
Single Vial
Single Vial
Each
Single Vial
Single Vial
Single Vial
Single Vial
Each
4/CS
3 Each
2 Vial Kit
Single Vial
Each
Single Vial
Single Vial
Single Vial
Single Vial
Each
Other
ARTISS Pre-filled Syringe Set 2 mL
ATryn® 1700-1799 IU*
Berinert Kit 500 IU*†
COSEAL® Surg Sealant 2 mL
COSEAL® 22 cm Ext App
CytoGAM® 2.5 gm 50 mL*
DUPLOSPRAY 30 cm
FibriJet® 0600036 DUPLOTIP
FibriJet® 0600038 DUPLOTIP
FLOSEAL Seal 5 mL
FLOSEAL Seal 10 mL
FLOSEAL Reuse Endo App
Novoseven® RT Infusion Kit*
Riastap® 900-1300 IU*
Thrombate III® 450-750 IU*
Thrombate III® 1000 IU*
Tisseel 2 mL Kit*
Tisseel 2 mL**
Tisseel 2 mL EZ PREP*
Tisseel 2 mL VALUPAK*
Tisseel 4 mL Kit**
Tisseel 4 mL Kit w/DUP FREE*
Tisseel 4 mL Kit+DUPLOJECT*
Tisseel 4 mL EZ PREP*
Tisseel 10 mL Kit**
Tisseel 10 mL Kit+DUPLOJECT*
Tisseel 10mL EZ PREP*
Tisseel EasySpray Pressure Regulator
3914785
3914017
3914793
1180926
1725605
1734169
1734409
1734425
1355924
2141943
3914850
3914835
3914843
1343227
1354893
2115541
1728765
2115509
3221504
3221512
1217116
3914751
1725290
1323492
3914769
3914553
1217629
1725316
1324649
3914777
1217934
1725324
1325232
3914025
Baxter
Baxter
Baxter
GTC
CSL Behring
Baxter
Baxter
Baxter
Baxter
CSL Behring
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Novo Nordisk
CSL Behring
Grifols
Grifols
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
Baxter
00944-8503-02
00944-8503-04
00944-8503-10
42976-0121-02
63833-0825-02
N/A
N/A
N/A
N/A
44206-0532-11
N/A
N/A
N/A
N/A
N/A
99992-1155-41
00169-7080-06
63833-8915-10
13533-0603-20
13533-0603-30
00944-4201-04
00944-8402-02
N/A
00944-4201-03
00944-8402-04
00944-4201-08
00944-4201-08
N/A
00944-4201-07
00944-8402-10
00944-4201-12
N/A
00944-4201-11
N/A
Each
Each
Each
Single Vial
Single Vial
Each
Each
Each
10/CS
Single Vial
5/CS
10/CS
10/CS
6/CS
6/CS
6/CS
Each
Single Vial
Single Vial
Single Vial
Each
Each
Each
6/CS
Each
Each
Each
Each
6/CS
Each
Each
Each
6/CS
10/CS
Code
Specialty Products (continued)
* Refrigerated
** Frozen
J9179
J1640
J9228
J9228
J0598
934070
934071
934072
J0850
J1680
J7197
921028
921051VP
921029
‡ Dropship
Return Goods Policy
1. Items Eligible for Return
• Refrigerated product that is received in damaged condition must be reported within
two business days of receipt. Ambient (room temperature) product that is received in
damaged condition must be reported within five business days of receipt.
• Product that is purchased on a non-returnable basis, including refrigerated
products, is not eligible for credit.
• Due to the unique manufacturing process of certain products and limitations
on usage, McKesson follows all manufacturer policies regarding acceptance
of returns. McKesson sells products as non-returnable only when the
manufacturer policy does not allow returns. McKesson allows returns on
products when the manufacturer policy deems the product fit.
2. Return Authorization (RA)
• All customers must obtain an RA number from an MPB customer service
representative prior to returning a product.
• An RA provides the right to return product; it does not guarantee credit.
Credit will be provided when product is received and all return requirements
have been met.
• RA request must be made within 30 days of product delivery.
• An RA is valid for 30 days from the date of RA approval.
• Any returned product without an RA will not be provided credit.
3. Product Re-Processing (PRP) Fee
• A PRP fee will be waived for any product that arrives at customer in damaged
condition or any product delivered in error. All other returns are subject to a
PRP fee.
• The PRP fee will be 10% of the purchase price, with a maximum of $1,000 and
a minimum of $50.
4. Required Procedures for Returning
ALL Items
• All returns MUST follow the Return Goods Care and Shipping Procedures, which
can be located on the McKesson Connect Plasma and Biologics program page.
• Detailed care for refrigerated and ambient product is provided.
5. Disclaimers
• McKesson Plasma and Biologics reserves the right to change conditions of the
Return Goods Policy without notice.
• McKesson Plasma and Biologics is not responsible for merchandise returned
without prior authorization and reserves the right to reject said shipment and
charge the customer for any incurred costs.
• RA requests must be made within 30 days of receiving shipment.
• Product not returned within 30 days of receipt of an RA will not be provided credit.
6. Additional Notes
• All returns must comply with all applicable rules, regulations, policies
and procedures.
• The credit amount for returned products is based on the original purchase price.
Territory Map
Plasma Service
Representatives
WA
ME
MT
ND
VT
MN
OR
NY
WY
MI
AK
PA
IA
NE
NV
IL
UT
CA
CT
DE
MD, DC
WV
MO
VA
KY
AZ
NC
TN
OK
NM
RI
NJ
OH
IN
CO
KS
NH
MA
WI
SD
ID
SC
AR
HI
MS
GA
AL
LA
TX
FL
Angie Calvert
Phone: 615.287.5543
[email protected]
Josh Hammers
Phone: 615.287.5546
[email protected]
Leslee Leach
Phone: 615.287.5540
[email protected]
Bennett Corley
Phone: 615.287.5512
[email protected]
Keith Layden
Phone: 615.287.5469
[email protected]
Craig Turner
Phone: 615.287.5435
[email protected]
Plasma Sales Managers
WA
MT
Leslee Leach
VT NH
ND
MN
OR
ID
WI
SD
NV
Stacey Knowles
Phone: 402.213.8379
[email protected]
CO
PA
IA
NE
UT
IL
KS
MO
OK
NM
WV
KY
SC
AR
AL
GA
LA
FL
HI
Shane Withers
Phone: 972.898.3501
[email protected]
VA
NC
TN
MS
TX
OH
IN
AK
AZ
NY
MI
WY
CA
ME
MA
RI
CT
DE
MD, DC
Kogenate® FS:
The brand you know with
Kogenate® FS with BIO-SET® offers:
Grab & Go packaging contains materials
necessary for safe and fast reconstitution
BIO-SET® reconstitution system with user-friendly features
Wide range of vial sizes for flexibility in preparing your dose
Small diluent volumes make reconstitution fast and easy
250 IU
500 IU
1000 IU
2000 IU
2.5-mL Diluent
3000 IU
5.0-mL Diluent
Ask your doctor if Kogenate® FS is right for you.
INDICATIONS
Kogenate® FS, antihemophilic factor (recombinant), is a recombinant factor VIII
treatment indicated for the control and prevention of bleeding episodes and
peri-operative management in adults and children (0-16 years) with hemophilia A.
Kogenate® FS is also indicated for routine prophylaxis to reduce the frequency of
bleeding episodes and the risk of joint damage in children with hemophilia A with
no preexisting joint damage.
BAYER, the Bayer Cross, and KOGENATE are registered trademarks of Bayer.
BIO-SET is a registered trademark of Biodome SAS.
©2011 Bayer HealthCare Pharmaceuticals Inc.
All rights reserved
06/11
KN10000211
the convenience you need
Kogenate® FS can be stored at room temperature
(up to 77oF) for up to 1 year*
*Store Kogenate® FS at 36°F to
46°F for up to 30 months from
the date of manufacture. Within
this period, Kogenate® FS may be
stored for a period of up to
12 months at temperatures up
to 77°F. The starting date of room
temperature storage should be
clearly recorded on the unopened
product carton. Once stored at
room temperature, the product
must not be returned to the
refrigerator. The shelf-life then
expires after the storage at room
temperature (up to 12 months)
or the expiration date on the
product vial, whichever is earlier.
For more information, visit kogenatefs.com.
IMPORTANT SAFETY INFORMATION
The most serious adverse reactions are systemic hypersensitivity reactions and the
development of high-titer inhibitors necessitating alternative treatments to AHF. The most
common adverse reactions observed in clinical trials were inhibitor formation in previously
untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion
site reactions, and central venous access device (CVAD) line-associated infections.
Kogenate® FS is contraindicated in patients who have manifested
life-threatening immediate hypersensitivity reactions, including
anaphylaxis, to the product or its components, including mouse
or hamster proteins.
For important risk and use information, please see brief
summary of Prescribing Information on the following page
or visit kogenatefs.com/prescribing-information.jsp.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
Albumin-free 1
Demonstrated bleed control 2
Zero transfer step 2
It’s the factor VIII with state-of-the-art purification.1,3
It comes with all-in-one reconstitution.2
When your patients turn to you, consider XYNTHA.
XYNTHA® Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free is indicated for the control
and prevention of bleeding episodes in patients with
hemophilia A (congenital factor VIII deficiency or classic
hemophilia) and for surgical prophylaxis in patients with
hemophilia A.
XYNTHA does not contain von Willebrand factor and,
therefore, is not indicated in von Willebrand’s disease.
Important Safety Information for XYNTHA
• Donotuseinpatientswhohavemanifestedlifethreatening immediate hypersensitivity reactions,
including anaphylaxis, to the product or its components,
including hamster proteins.
Save on XYNTHA
*
*
Terms and conditions can be found
at XYNTHA.com.
• Allergictypehypersensitivityreactionsare
possible. Inform patients of the early signs or
symptoms (including hives, generalized urticaria,
chest tight-ness, wheezing, and hypotension) and
anaphylaxis. If these symptoms occur, advise
patients to discontinue use of the product and
contact their physician. XYNTHA contains trace
amounts of hamster proteins. Patients may develop
hypersensitivity to these proteins.
• PatientsusingcoagulationfactorVIIIproducts
should be monitored for inhibitors, which have been
reported in patients receiving XYNTHA.
Need help accessing Pfizer medicines? Pfizer’s RSVP
program may be able to help. Call 1-888-327-RSVP
(7787) or visit www.HemophiliaVillage.com/RSVP.
FREE TRIAL Help your eligible patients get a
1-month supply up to 20,000 IU* One-time offer.
FreeTrialPfizerFactor.com
See your local hemophilia representative today to request a form.
If you are unable to reach your representative, please try 888-999-2349.
*Offer applies to patients covered by a private commercial insurance plan only.
*Terms and conditions apply.
• ClinicalresponsetoXYNTHAmayvary.Ifbleedingis
not controlled with the recommended dose of factor,
determine the plasma level and administer a dose of
XYNTHA sufficient to achieve clinical response. If the
factor level does not increase or there is no response,
suspect an inhibitor and perform appropriate testing.
• Themostcommonadversereactioninthesafetyand
efficacy study is headache (24% of subjects) and in the
surgery study is fever (43% of subjects). Overall, the
most common adverse reactions (≥5% of subjects) in
clinical studies were headache, fever, nausea, vomiting,
diarrhea, and weakness.
• XYNTHAisaninjectablemedicineadministeredby
intravenous (IV) infusion. Patients should be advised
that local irritation may occur when infusing XYNTHA
after reconstitution in XYNTHA® SOLOFUSE®.
Please see accompanying full Prescribing Information on next page.
1. Kelley B, Jankowski M, Booth J. An improved manufacturing process for XYNTHA/
ReFacto AF. Haemophilia. 2009;1-9.doi:10.1111/j.1365-2516.2009.02160.x. 2. XYNTHA®
SOLOFUSE® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Prescribing
Information, Wyeth Pharmaceuticals Inc. 3. XYNTHA® Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free Prescribing Information, Wyeth Pharmaceuticals Inc.
*Terms and conditions apply. Your patients must be currently covered by a private
[commercial] insurance plan. For questions about the XYNTHA Trial Prescription Program,
please call 1.800.710.1379 or write us at XYNTHA Trial Prescription Program Administrator,
MedVantx, PO Box 5736, Sioux Falls, SD 57117-5736 If your patients are not eligible for
the trial prescription program, they may find help accessing Pfizer medicines by contacting
Pfizer’s RSVP program at 1-888-327-RSVP (7787).
Manufactured by Wyeth Pharmaceuticals Inc.
RUS473303-01
© 2012 Pfizer Inc.
Marketed by Pfizer Inc.
All rights reserved.
Printed in the USA/July 2012
Brief Summary
See package insert for full Prescribing Information. For further product information and current
package insert, please visit XYNTHA.com or call Wyeth Pharmaceuticals toll-free at 1-800-438-1985.
INDICATIONS AND USAGE
Control and Prevention of Bleeding Episodes in Patients with Hemophilia A
XYNTHA is indicated for the control and prevention of bleeding episodes in patients with
hemophilia A (congenital factor VIII deficiency or classic hemophilia).
Surgical Prophylaxis in Patients with Hemophilia A
XYNTHA is indicated for surgical prophylaxis in patients with hemophilia A.
XYNTHA does not contain von Willebrand factor, and therefore is not indicated in patients with
von Willebrand’s disease.
DOSAGE FORMS AND STRENGTHS
XYNTHA is available as a white to off-white lyophilized powder in the following nominal dosages:
- 250 International Units
Each XYNTHA vial has the actual recombinant factor VIII (rFVIII) potency in International Units
stated on the label.
CONTRAINDICATIONS
Do not use in patients who have manifested life-threatening immediate hypersensitivity
reactions, including anaphylaxis, to the product or its components, including hamster proteins.
WARNINGS AND PRECAUTIONS
Anaphylaxis and Hypersensitivity Reactions—Allergic type hypersensitivity reactions are
possible. Inform patients of the early signs or symptoms of hypersensitivity reactions (including
hives [rash with itching], generalized urticaria, chest tightness, wheezing, and hypotension) and
anaphylaxis. Advise patients to discontinue use of the product and to contact their physician if
these symptoms occur.
XYNTHA contains trace amounts of hamster proteins. Patients treated with this product may
develop hypersensitivity to these non-human mammalian proteins.
Neutralizing Antibodies—Patients using coagulation factor VIII products, including XYNTHA,
should be monitored for the development of factor VIII inhibitors by appropriate clinical observations
and laboratory tests. Inhibitors have been reported following administration of XYNTHA. If
expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an
appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present.
Monitoring: Laboratory Tests—The clinical response to XYNTHA may vary. If bleeding is not
controlled with the recommended dose, determine the plasma level of factor VIII and administer
a sufficient dose of XYNTHA to achieve a satisfactory clinical response. If the patient’s plasma
factor VIII level fails to increase as expected or if bleeding is not controlled after the expected dose,
suspect the presence of an inhibitor (neutralizing antibodies) and perform appropriate testing
as follows:
• UseindividualfactorVIIIvaluesforrecoveryand,ifclinicallyindicated,other
pharmacokinetic characteristics to guide dosing and administration.
• MonitorplasmafactorVIIIactivitylevelsbytheone-stageclottingassaytoconfirmthat
adequate factor VIII levels have been achieved and are maintained, when clinically indicated.
• MonitorfordevelopmentoffactorVIIIinhibitors.PerformassaytodetermineiffactorVIII
inhibitor is present when expected factor VIII activity plasma levels are not attained, or when
bleeding is not controlled with the expected dose of XYNTHA. Use Bethesda Units (BU) to
titer inhibitors.
ADVERSE REACTIONS
Overall, the most common adverse reactions (≥ 5%) with XYNTHA were headache, pyrexia,
nausea, vomiting, diarrhea, and asthenia.
Clinical Trials Experience—Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly
compared to rates in the clinical trials of another drug and may not reflect the rates observed
in clinical practice.
XYNTHA was evaluated in two clinical studies (N=124). In the first study (n=94), safety and
efficacy were examined in previously treated patients (PTPs) with hemophilia A (factor VIII activity
in plasma [FVIII:C] ≤ 2%] who received XYNTHA for routine prophylaxis and on-demand treatment.
Ninety-four patients received at least one dose of XYNTHA, resulting in a total of 6,775 infusions.
The second study (n=30) examined the use of XYNTHA for surgical prophylaxis in previously
treated patients with severe or moderately severe hemophilia A ( [FVIII:C] ≤ 2%) who required
elective major surgery and were expected to receive XYNTHA replacement therapy for at least
6 days post-surgery. All patients received at least one dose of XYNTHA, resulting in 1161 infusions.
One patient received XYNTHA for a pre-surgery pharmacokinetic assessment only and did not
undergo surgery.
The most frequently reported adverse reaction in PTP patients was headache (24% of subjects).
Other adverse reactions reported in ≥ 5% of patients were: nausea (6%), diarrhea (5%), asthenia
(5%), and pyrexia (5%).
The most frequently reported adverse reaction in surgical patients was pyrexia (43%). Other
adverse reactions reported in ≥ 5% of patients were: headache (13%), nausea (13%), and
vomiting (7%).
Immunogenicity Information—There is a potential for immunogenicity with therapeutic proteins.
The clinical studies for XYNTHA examined 94 patients who had previously been treated with
factor VIII (PTPs) and 30 surgical patients. In the safety and efficacy study, two subjects with inhibitors
were observed in 89 subjects (2.2%) who completed ≥ 50 exposure days. In a Bayesian statistical
analysis, results from this study were used to update PTP results from a prior supporting study
using XYNTHA manufactured at the initial facility (with one de novo and two recurrent inhibitors
observed in 110 patients) and the experience with predecessor product (with one inhibitor
observed in 113 subjects). The Bayesian analysis indicated that the population inhibitor rate for
Manufactured by Wyeth Pharmaceuticals Inc.
RUS483904-01 © 2012 Pfizer Inc. All rights reserved.
XYNTHA, an estimate of the 95% upper limit of the true inhibitor rate, was 4.17%.
None of the PTPs developed anti-CHO (Chinese hamster ovary) or anti-TN8.2 antibodies. One PTP
developed anti-FVIII antibodies; but, this patient did not develop an inhibitor.
In the surgery study, one low titer persistent inhibitor and one transient false-positive inhibitor
were reported. In this study, one surgical patient developed anti-CHO cell antibodies with no
associated allergic reaction. One patient developed anti-FVIII antibodies; but, this patient did not
develop an inhibitor.
Overall, no allergic manifestation to any immune response was observed during the study.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the
assay. Additionally, the observed incidence of antibody, including neutralizing antibody, positivity
in an assay may be influenced by several factors, including assay methodology, sample handling,
timing of sample collection, concomitant medications, and underlying disease. For these reasons,
comparisons of the incidence of antibodies to XYNTHA with the incidence of antibodies to other
products may be misleading.
Postmarketing Experience—Because these reactions are reported voluntarily from a population
of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
The following postmarketing adverse reactions have been reported for XYNTHA:
Hypersensitivity Reactions
Anaphylaxis
Inhibitor Development
Inadequate Therapeutic Response
DRUG INTERACTIONS
None known.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C - Animal reproduction studies have not been conducted with XYNTHA.
It is not known whether XYNTHA can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. XYNTHA should be given to a pregnant woman only
if clinically indicated.
Labor and Delivery—There is no information available on the effect of factor VIII replacement
therapy on labor and delivery. XYNTHA should be used only if clinically indicated.
Nursing Mothers—It is not known whether this drug is excreted into human milk. Because many
drugs are excreted into human milk, caution should be exercised if XYNTHA is administered to
nursing mothers. XYNTHA should be given to nursing mothers only if clinically indicated.
Pediatric Use—Pharmacokinetics of XYNTHA was studied in 7 previously treated patients 12-16
years of age. Pharmacokinetic parameters in these patients were similar to those obtained for
adults after a dose of 50 IU/kg. For these 7 patients, the mean (± SD) Cmax and AUC∞ were 1.09 ±
0.21 IU/mL and 11.5 ± 5.2 IU·h/mL, respectively. The mean clearance and plasma half-life values
were 5.23 ± 2.36 mL/h/kg and 8.03 ± 2.44 hours (range 3.52 – 10.6 hours), respectively. The mean
K-value and in vivo recoveries were 2.18 ± 0.41 IU/dL per IU/kg and 112 ± 23%, respectively.
Geriatric Use—Clinical studies of XYNTHA did not include subjects aged 65 and over. In general,
dose selection for an elderly patient should be individualized.
STORAGE AND HANDLING
XYNTHA Vials
Product as Packaged for Sale:
• StoreXYNTHAunderrefrigerationatatemperatureof2°to8°C(36°to46°F)forupto
36 months from the date of manufacture until the expiration date stated on the label. Within
theexpirationdate,XYNTHAalsomaybestoredatroomtemperaturenottoexceed25°C
(77°F)forupto3months.After room temperature storage, XYNTHA can be returned to the
refrigerator until the expiration date. Do not store XYNTHA at room temperature and return it
to the refrigerator more than once.
• Clearlyrecordthestartingdateatroomtemperaturestorageinthespaceprovidedontheouter
carton. At the end of the 3-month period, immediately use, discard, or return the product to
refrigeratedstorage.Thediluentsyringemaybestoredat2°to25°C(36°to77°F).
• DonotuseXYNTHAaftertheexpirationdate.
• Donotfreeze.(Freezingmaydamagetheprefilleddiluentsyringe.)
• Duringstorage,avoidprolongedexposureofXYNTHAvialtolight.
Product After Reconstitution:
• Storethereconstitutedsolutionatroomtemperaturepriortoadministration.Rememberto
administer XYNTHA within 3 hours after reconstitution.
XYNTHA SOLOFUSE
Product as Packaged for Sale:
• StoreXYNTHASOLOFUSEunderrefrigerationatatemperatureof2°to8°C(36°to46°F)for
up to 36 months from the date of manufacture until the expiration date stated on the label.
Within the expiration date, XYNTHA SOLOFUSE also may be stored at room temperature not
toexceed25°C(77°F)forupto3months.
• Clearlyrecordthestartingdateatroomtemperaturestorageinthespaceprovidedontheouter
carton. At the end of the 3-month period, immediately use or discard the product. Do not put
the product back into the refrigerator.
• DonotuseXYNTHASOLOFUSEaftertheexpirationdatestatedonthelabelorafter3months
when stored at room temperature, whichever is earlier.
• Donotfreeze.(FreezingmaydamagetheXYNTHASOLOFUSE.)
• Duringstorage,avoidprolongedexposureofXYNTHASOLOFUSEtolight.
Product After Reconstitution:
• Storethereconstitutedsolutionatroomtemperaturepriortoadministration.Rememberto
administer XYNTHA SOLOFUSE within 3 hours after reconstitution or after removal of the grey
rubber tip cap from the product.
This brief summary is based on the Xyntha® [Antihemophilic Factor (Recombinant), Plasma/AlbuminFree] Prescribing Information LAB-0516-3.0, revised 01/12, and LAB-0500-7.0, revised 01/12.
Marketed by Pfizer Inc.
Printed in USA/September 2012
Packaged with Mix2Vial® Filter Transfer Set
Potency
Diluent Size
500 IU FIX Range
10 mL
1000 IU FIX Range
10 mL
1500 IU FIX Range
10 mL
For further information call: Grifols USA, LLC Professional Service: 888-GRIFOLS (888 474 3657)
Customer Service: 888 325 8579; Fax: 323 441 7968 www.grifols.com
Grifols Biologicals Inc.
5555 Valley Boulevard, Los Angeles, California 90032, USA
A9L14-14-US-10
Available in the following potencies and color coded assay ranges
Continued confidence partnering with the
industry’s distribution leader
With more than 175 years in the distribution business and a proven
track record within the pharmaceutical industry, McKesson
will provide the same world-class distribution service for your
plasma products. McKesson has direct relationships with plasma
manufacturers, ensuring pedigree compliance so that you receive
direct-from-manufacturer products.
McKesson is committed to better health — the health of patients,
the health of customers’ businesses and the health of the nation’s
healthcare system. As a partner to all stakeholders in the industry,
we improve the business of healthcare so everyone can focus on
what matters most: the health of the patient.
Stacey Knowles
402.213.8379
[email protected]
Shane Withers
972.898.3501
[email protected]
Find out the latest news and updates
facebook.com/mckessonplasma
@McKessonPlasma
McKesson Plasma and Biologics, LLC
401 Mason Road
La Vergne, TN 37086
mckesson.com/plasmabiologics
email: [email protected]
877.625.2566 (877.MCK.BLOOD)
©2013 McKesson Corporation. All rights reserved.
MFCT-07084-03-13

2013 Product Catalog

Transcription

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