Xyntha Side Effects

Generic Name: antihemophilic factor,antihemophilic factor (human),antihemophilic factor (recombinant)

Please note - some side effects for Xyntha 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 Xyntha - for the Consumer

Xyntha

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 Xyntha:

Diarrhea; headache; mild fever; nausea; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue lips, gums, or nail beds; fainting; fast heartbeat; severe or persistent dizziness; wheezing.

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.

Xyntha Side Effects - for the Professional

Xyntha

The most common adverse reaction in study 1 is headache (24% of subjects) and in study 2 is pyrexia (41% of subjects).

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.

Study 1 is a pivotal phase 3 (safety and efficacy) study in which previously treated patients (PTPs) with hemophilia A received Xyntha for routine prophylaxis and on-demand treatment, 94 subjects received at least one dose of Xyntha, resulting in a total of 6,775 infusions [see Clinical Studies (14)]. In Study 1, the most frequently reported treatment-emergent adverse reaction was headache (24% of subjects). Other adverse reactions reported in ≥ 5% of subjects were: nausea (6%), diarrhea (5%), asthenia (5%) and pyrexia (5%). No subject developed anti-CHO or anti-TN8.2 antibodies.

Study 2 (surgery) is an on-going open-label, single-arm study of at least 25 evaluable PTPs with severe or moderately severe hemophilia A (factor VIII activity in plasma [FVIII:C] ≤ 2%) who required elective major surgery and were planned to receive Xyntha replacement therapy for at least 6 days post-surgery. Twenty-two subjects received at least one dose of Xyntha, resulting in 766 infusions [see Clinical Studies (14)].

In Study 2, the most frequently reported treatment-emergent adverse reaction was pyrexia (41% of subjects). Other adverse reactions reported in ≥ 5% of subjects were: headache (9%), nausea (9%), diarrhea (5%), vomiting (5%) and asthenia (5%). The adverse reactions reported in either study were considered mild or moderate in severity.

In Study 1, the incidence of FVIII inhibitors to Xyntha was the primary safety endpoint. Two subjects with inhibitors were observed in 89 subjects (2.2%) who completed ≥ 50 exposure days. These results were consistent with the pre-specified endpoint that no more than 2 inhibitors may be observed in at least 81 subjects.

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, where one de novo and two recurrent inhibitors were observed in 110 subjects, and the experience with predecessor product (1 inhibitor in 113 subjects). This Bayesian analysis indicates that the population (true) inhibitor rate for Xyntha, the estimate of the 95% upper limit of the true inhibitor rate, was 4.17%.

Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have included headache, dizziness, somnolence, and asthenia.

Respiratory

Respiratory side effects have included dyspnea and rhinitis.

Musculoskeletal

Musculoskeletal side effects have included arthralgia.

Local

Local side effects have included injection site pain.

General

General side effects have included pyrexia and chills.

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea, and vomiting.

Dermatologic

Dermatologic side effects have include pruritus, rash, and urticaria.

Cardiovascular

Cardiovascular side effects have included hemorrhage, hypotension, and vasodilatation.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.