"The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes"...
- Clinician Information:
Atryn Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Atryn FDA Prescribing Information: Side Effects
The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis and post procedural). The most common adverse events reported in clinical trials at a frequency of 5% are hemorrhage and infusion site reaction.
Clinical Trial 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 practice.
Adverse reactions that occurred in clinical trials with hereditary AT deficient patients are shown in Table 3 by System Organ Class.
Table 3: Adverse Reactions in Hereditary AT Deficient Patients
(one event per patient, 2% of total population, n=47)
General Disorders and Administration Site Disorders
Application Site Pruritus Feeling Hot Non-cardiac Chest Pain
Hepatic Enzyme Abnormal
Musculoskeletal and Connective Tissue Disorders
Renal and Urinary Disorders
For ATryn (recombinant lyophilized powder) , a potential safety issue is the development of an immunological reaction to the recombinant protein or any of the potential contaminating proteins. Assays were developed and used to detect antibodies directed against antithrombin (Recombinant), goat AT, or goat-milk proteins. No confirmed specific immunological reaction was seen in any of the patients tested, nor were there any clinical adverse events that might indicate such a response.
A post-marketing patient registry has been established to collect additional data on the immunogenic potential of ATryn (recombinant lyophilized powder) in patients treated with ATryn (recombinant lyophilized powder) on more than one occasion. Physicians are encouraged to participate in the registry by collecting pre- and post-treatment serum samples from patients according to instructions provided by Ovation Pharmaceuticals, Inc. and submitting them to Ovation for analysis for the development of antibodies to antithrombin (Recombinant). Serum samples should be collected within one week before initiation of treatment and on days 1, 7 and 28 days from initiation of treatment. Physicians wanting to participate in this program are encouraged to contact Ovation Pharmaceuticals, Inc. at 1-800-455-1141. Ovation will provide detailed instructions for the collection, processing and shipping of samples, as well as all tubes and labels that are necessary for the collection and processing of samples.
Read the entire FDA prescribing information for Atryn (Recombinant Lyophilized Powder) »
Additional Atryn Information
- Atryn Drug Interactions Center: antithrombin iii, hum recom iv
- Atryn Side Effects Center
- Atryn FDA Approved Prescribing Information including Dosage
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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