July 24, 2016
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Alphanate




Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

Anaphylaxis and severe hypersensitivity reactions are possible with ALPHANATE. Early signs of allergic reactions, which can progress to anaphylaxis, may include angioedema, chest tightness, hypotension, rash, nausea, vomiting, paresthesia, restlessness, wheezing and dyspnea. Discontinue use of ALPHANTE if hypersensitivity symptoms occur, and initiate appropriate treatment.

Neutralizing Antibodies

Development of procoagulant activity-neutralizing antibodies (inhibitors) has been detected in patients receiving FVIII-containing products. Carefully monitor patients treated with AHF products for the development of FVIII inhibitors by appropriate clinical observations and laboratory tests. No specific studies have been conducted with ALPHANATE to evaluate inhibitor formation. If expected plasma FVIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an appropriate assay that measures FVIII inhibitor concentration.

Thromboembolic Events

Thromboembolic events have been reported in von Willebrand Disease patients receiving replacement therapy with Antihemophilic Factor/von Willebrand Factor Complexes, especially in those with known risk factors for thrombosis including but not limited to elderly age, previous thrombosis, metabolic syndrome, cancer, surgery, oral contraceptive and hormone therapy, diabetes, hypertension, hyperlipidemia, smoking, and pregnancy.9 Monitor plasma levels of VWF:RCo and FVIII activities to avoid sustained excessive VWF and FVIII activity levels (greater than 150 IU/dL), which may increase the risk of thrombotic events, during continued treatment of replacement therapy with Antihemophilic Factor/von Willebrand Factor Complexes. Consider antithrombotic measures in VWD patients at risk for thrombosis [see ADVERSE REACTIONS].

Intravascular Hemolysis

ALPHANATE contains blood group specific isoagglutinins. Monitor the patient for signs of intravascular hemolysis and decreasing hematocrit when large and/or frequent doses of Antihemophilic Factor/von Willebrand Factor Complexes are required in patients of blood groups A, B, or AB, as cases of acute hemolytic anemia, increased bleeding tendency or hyperfibrinogenemia have been reported. These events typically subside after cessation of the factor concentrate infusion.10 Consider alternative therapy should this condition worsen despite discontinuation of ALPHANATE.

Vasomotor Reactions

Rapid administration of a FVIII concentrate may result in vasomotor reactions. Do not administer ALPHANATE at a rate exceeding 10 mL/minute.

Transmissible Infectious Agents

Because ALPHANATE is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob Disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain virus infections, and by inactivating and/or removing certain viruses during manufacturing. [see DESCRIPTION].

Monitoring Laboratory Tests

Monitor for development of FVIII and VWF inhibitors. Perform appropriate assays to determine if FVIII and/or VWF inhibitor(s) are present if bleeding is not controlled with expected dose of ALPHANATE.

Monitor plasma levels of VWF:RCo and FVIII activities to avoid sustained excessive VWF and FVIII activity levels (greater than 150 IU/dL), which may increase the risk of thrombotic events, particularly in patients with known risk factors.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with ALPHANATE. It is also not known whether ALPHANATE can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. ALPHANATE should be given to a pregnant woman only if clearly needed.

Labor And Delivery

No human or animal data. Use only if clearly needed.

Nursing Mothers

No human or animal data. Use only if clearly needed.

Pediatric Use

Hemophilia A

A total of 21 children (ages 7-16) were included in clinical trials with ALPHANATE. Subjects received ALPHANATE weekly for prophylaxis or suspected bleeds. They were successfully treated for 1499 bleeding episodes or as prophylaxis to prevent them (e.g., pain in the joint). The median number of units needed to treat the bleeds was 420 IU, with a range of 210 to 1620 IU. Adult and pediatric subjects did not differ in their response to treatment.

Von Willebrand Disease

The hemostatic efficacy of ALPHANATE has been studied in 20 pediatric subjects (ages 7-18) with VWD. Based on the data from a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo. Adult and pediatric subjects did not differ in their response to treatment.

Geriatric Use

No human or animal data. Use only if clearly needed.

REFERENCES

9. Coppola, A., Franchini, M., Makris M. Santagostino, E. Minno, G.DI, Mannucci, P.M. Thrombotic adverse events to coagulation factor concentrates for treatment of patients with haemophilia and von Willebrand disease: a systematic review of prospective studies. Haemophilia 2012; 18, e173-e187.

10. Soni, N.S., Patel A.R., Vohra, R.M., Shah P.C. Hemophiliac with Hemolytic Anemia resulting from Factor VIII Concentrate. Acta Haemato 1977; 58:294-297.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/2/2016

Warnings
Precautions

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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