ATryn Side Effects

Please note - some side effects for ATryn may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of ATryn - for the Consumer

ATryn

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using ATryn:

Mild bleeding, redness, swelling, or itching at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; chest pain; dizziness; fainting; fatigue; unusual bruising or bleeding; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

ATryn Side Effects - for the Professional

ATryn

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.

Immunogenicity

For ATryn, 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 in patients treated with ATryn 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 Lundbeck Inc. and submitting them to Lundbeck Inc. 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 Lundbeck Inc. at 1-800-455-1141. Lundbeck Inc. 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.

Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included hemorrhage and hematoma.

General

General side effects have included hot feelings and noncardiac chest pain.

Gastrointestinal

Gastrointestinal side effects have included intraabdominal hemorrhage.

Genitourinary

Genitourinary side effects have included hematuria.

Hepatic

Hepatic side effects have included hepatic enzyme abnormalities.

Local

Local side effects have included infusion site reaction and application site pruritus.

Musculoskeletal

Musculoskeletal side effects have included hemarthrosis.

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