Benefix Side Effects

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

BeneFix

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 BeneFix:

Mild chills; nausea; stinging at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur when using BeneFix:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; faintness; fever; flushing; headache; lethargy; lightheadedness, especially upon standing; nausea; rapid heart rate; vomiting.

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.

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Benefix Side Effects - for the Professional

BeneFIX

The most serious adverse reactions are systemic hypersensitivity reactions, including bronchospastic reactions and/or hypotension and anaphylaxis and the development of high-titer inhibitors necessitating alternative treatments to factor IX replacement therapy.

The most common adverse reactions observed in clinical trials (frequency > 5% of PTPs or PUPs) were headaches, dizziness, nausea, injections site reaction, injection site pain and skin-related hypersensitivity reactions (e.g., rash, hives).

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.

During uncontrolled open-label clinical studies with BeneFIX, Coagulation Factor IX (Recombinant), conducted in previously treated patients (PTPs), 113 adverse reactions with known or unknown relation to BeneFIX therapy were reported among 38.5% (25 of 65) of subjects (with some subjects reporting more than one event) who received a total of 7,573 infusions. These adverse reactions are summarized in Table 5.

Table 5: Adverse Reactions Reported for PTPs*

Body System	Adverse Reaction	Number of patients (%)
*Adverse reactions reported within 72 hours of an infusion of BeneFIX. 1 Low-titer transient inhibitor formation. 2 The renal infarct developed in a hepatitis C antibody-positive patient 12 days after a dose of BeneFIX for a bleeding episode. The relationship of the infarct to the prior administration of BeneFIX is uncertain.
Blood and lymphatic system disorders	Factor IX inhibition1	1 (1.5%)
Eye disorders	Blurred vision	1 (1.5%)
Gastrointestinal disorders	Nausea	4 (6.2%)
	Vomiting	1 (1.5%)
General disorders and administration site conditions	Injection site reaction	5 (7.7%)
	Injection site pain	4 (6.2%)
	Fever	2 (3.1%)
Infections and infestations	Cellulitis at IV site	1 (1.5%)
	Phlebitis at IV site	1 (1.5%)
Nervous system disorders	Headache	7 (10.8%)
	Dizziness	5 (7.7%)
	Taste perversion (altered taste)	3 (4.6%)
	Shaking	1 (1.5%)
	Drowsiness	1 (1.5%)
Renal and urinary disorders	Renal infarct2	1 (1.5%)
Respiratory, thoracic and mediastinal disorders	Dry cough	1 (1.5%)
	Hypoxia	1 (1.5%)
	Chest tightness	1 (1.5%)
Skin and subcutaneous disorders	Rash	4 (6.2%)
	Hives	2 (3.1%)
Vascular disorders	Flushing	2 (3.1%)

In the 63 previously untreated patients (PUPs), who received a total of 5,538 infusions, 10 adverse reactions were reported among 9.5% of the patients (6 out of 63) having known or unknown relationship to BeneFIX. These events are summarized in Table 6.

Table 6: Adverse Reactions Reported for PUPs*

Body System	Adverse Reaction	Number of Patients (%)
*Adverse reactions reported within 72 hours of an infusion of BeneFIX. 1 Two subjects developed high-titer inhibitor formation during treatment with BeneFIX.
Blood and lymphatic system disorders	Factor IX inhibition1	2 (3.2%)
General disorders and administration site conditions	Injection site reaction	1 (1.6%)
	Chills	1 (1.6%)
Respiratory, thoracic and mediastinal disorders	Dyspnea (respiratory distress)	2 (3.2%)
Skin and subcutaneous disorders	Hives	3 (4.8%)
	Rash	1 (1.6%)

For adverse reactions thought to be related to the administration of BeneFIX, the rate of infusion should be decreased or the infusion stopped.

Immunogenicity

In clinical studies with 65 PTPs (defined as having more than 50 exposure days), a low-titer inhibitor was observed in one patient. The inhibitor was transient, the patient continued on study and had normal factor IX recovery pharmacokinetics at study completion (approximately 15 months after inhibitor detection).

In clinical studies with pediatric PUPs, inhibitor development was observed in 2 out of 63 patients (3.2%), both were high-titer (> 5 BU) inhibitors detected after 7 and 15 exposure days, respectively. Both patients were withdrawn from the study.

Post-marketing Experience

The following post-marketing adverse reactions have been reported for BeneFIX: inadequate factor IX recovery, inadequate therapeutic response, inhibitor development [see Clinical Pharmacology (12)], anaphylaxis [see Warnings and Precautions (5.2)], angioedema, dyspnea, hypotension, and thrombosis.

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 safety and efficacy of BeneFIX administration by continuous infusion have not been established [see Warnings and Precautions (5.3)]. There have been post-marketing reports of thrombotic events, including life-threatening SVC syndrome in critically ill neonates, while receiving continuous-infusion BeneFIX through a central venous catheter. Cases of peripheral thrombophlebitis and DVT have also been reported. In some, BeneFIX was administered via continuous infusion, which is not an approved method of administration [see Dosage and Administration (2)].

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Side Effects by Body System - for Healthcare Professionals

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity reactions, including bronchospastic reactions and/or hypotension and anaphylaxis.

Hematologic

Hematologic side effects have included and the development of high-titer inhibitors necessitating alternative treatments to factor IX replacement therapy.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.

Dermatologic

Dermatologic side effects have included hives, rash, and flushing.

Local

Local side effects have included Injection site reaction, Injection site pain, cellulitis at IV site, and phlebitis at IV site.

Nervous system

Nervous system side effects have included headache, dizziness, taste perversion (altered taste), shaking, and drowsiness.

Respiratory

Respiratory side effects have included dry cough, hypoxia, chest tightness, and dyspnea (respiratory distress)

General

General side effects have included fever.

Ocular

Ocular side effects have included blurred vision.

Renal

Renal side effects have e included renal infarction.

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