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Benefix

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Benefix

Side Effects
Interactions

SIDE EFFECTS

See also CLINICAL PHARMACOLOGY: Clinical Studies.

As with the intravenous administration of any protein product, the following reactions may be observed after administration: headache, fever, chills, flushing, nausea, vomiting, lethargy, or manifestations of allergic reactions. Should evidence of an acute hypersensitivity reaction be observed, the infusion should be stopped promptly and appropriate counter measures and supportive therapy should be administered.

During uncontrolled open-label clinical studies with BeneFIXR, Coagulation Factor IX (Recombinant), conducted in previously treated patients (PTPs), 131 adverse reactions with definite, probable, possible or unknown relation to BeneFIX (coagulation factor ix recombinant) R therapy were reported among 27 of 65 subjects (with some subjects reporting more than one event) who received a total of 7573 infusions. These adverse reactions are summarized in Table 1 below.

Table 1: Adverse Events Reported for PTPs*

Reaction Total number of events with definite, probable, possible or unknown relation to therapy
(n=129)
Number and (%) of patients from which the reports originated
(n=65)
Number and (%) of infusions temporally associated with thereaction1
(n=7573)
Nausea 27 4 (6.2 %) 27 (0.36 %)
Taste perversion (Altered taste) 14 3 (4.6 %) 19 (0.25 %)
Hypoxia (Urge to cough with hypoxemia) 11 1 (1.5 %) 11 (0.15 %)
Injection site reaction 11 5 (7.7 %) 12 (0.16 %)
Injection site pain 10 4 (6.2 %) 16 (0.21 %)
Headache 10 7 (10.8 %) 13 (0.17 %)
Dizziness 7 5 (7.7 %) 8 (0.11 %)
Allergic rhinitis 7 3 (4.6 %) 9 (0.12 %)
Pain (Burning sensation in the jaw and skull) 6 1 (1.5 %) 7 (0.09 %)
Rash 6 5 (7.7 %) 7 (0.09 %)
Hives 3 2 (3.1 %) 3 (0.04 %)
Flushing 3 2 (3.1 %) 4 (0.05 %)
Fever 2 2 (3.1 %) 2 (0.03 %)
Shaking 2 2 (3.1%) 1 (0.01%)
Factor IX inhibitor 2 1 1 (1.5 %) 2 (0.03 %)
Chest tightness 1 1 (1.5 %) 4 (0.05 %)
Drowsiness 1 1 (1.5 %) 1 (0.01 %)
Visual disturbance 1 1 (1.5 %) 1 (0.01 %)
Cellulitis at the IV site 1 1 (1.5 %) 7 (0.09 %)
Phlebitis at the IV site 1 1 (1.5 %) 7 (0.09 %)
Dry cough 1 1 (1.5 %) 0 (0.00 %)
Allergic reaction 1 1 (1.5 %) 1 (0.01 %)
Diarrhea 1 1 (1.5 %) 1 (0.01 %)
Lung disorder 1 1 (1.5 %) 1 (0.01 %)
Vomiting 1 1 (1.5 %) 1 (0.01 %)
Renal infarct3 1 1 (1.5 %) 1 (0.01 %)
Total 131 27/65 (41.5 %) 148/7573 (2.2 %)
*More than one event in the table could have been assoc. with an infusion; however, the total represents the actual number of infusions given.
1 Reaction occurring within 72 hours after infusion.
2 Low titer transient inhibitor formation.
3 The renal infarct developed in a hepatitis C antibody positive patient 12 days after a dose of BeneFIX® (coagulation factor ix recombinant) for a bleeding episode. The relationship of the infarct to the prior administration of BeneFIX® (coagulation factor ix recombinant) is uncertain.

One subject discontinued BeneFIX® (coagulation factor ix recombinant) due to pulmonary allergic-type symptoms.

In the 63 treated PUPS, who received a total of 5538 infusions, 22 adverse reactions were reported as having definite, probable, possible or unknown relationship to BeneFIX® (coagulation factor ix recombinant) . These events are summarized in Table 2 below.

Table 2: Adverse Events reported for PUPs*

Reaction Total number of events with definite, probable, possible or unknown relation to therapy
(n=22)
Number and (%) of patients from which the reports originated
(n=63)
Number and (%) of infusions temporally associated with there action1
(n=5538)
Diarrhea 5 1 (1.6 %) 11 (0.20%)
Urticaria (hives) 3 3 (4.8 %) 3 (0.05%)
Factor IX inhibitor2 2 2 (3.2%) 4 (0.07%)
Dyspnea (Respiratory distress) 2 2 (3.2 %) 2 (0.04%)
Increased alkaline phosphatase 1 1 (1.6 %) 3 (0.05%)
Elevated ALT 1 1 (1.6 %) 0 (0.00 %)
Rash (Body rash) 1 1 (1.6 %) 1 (0.02%)
Elevated AST 1 1 (1.6 %) 0 (0.00 %)
Chills (Rigors) 1 1 (1.6 %) 3 (0.05%)
Photosensitivity reaction 1 1 (1.6 %) 0 (0.00 %)
Injection site reaction 1 1 (1.6%) 2 (0.04%)
HAV seroconversion3 1 1 (1.6 %) 2 (0.04%)
Parvovirus B19 seroconversion4 1 1 (1.6%) 1 (0.02%)
Asthma 1 1 (1.6 %) 1 (0.02%)
Total 22 11/63 (17.5%) 27/5538 (0.60%)
*More than one event in the table could have been assoc. with an infusion; however, the total represents the actual number of infusions given.
1Reaction occurring within 72 hours after infusion.
2Two subjects developed high titer inhibitor formation during treatment with BeneFIX® (coagulation factor ix recombinant) .
3 Relationship of HAV seroconversion to BeneFIX® (coagulation factor ix recombinant) is unknown. HAV seroconversion was noted on 2 occasions in a single patient but was negative at final visit. The patient had no laboratory or clinical findings associated with active infection.
4Relationship of Parvovirus B19 seroconversion to BeneFIX® (coagulation factor ix recombinant) is unknown. It was unlikely that seroconversion was related to BeneFIX® (coagulation factor ix recombinant) due to the frequency of community acquired infection and viral safeguards built into the manufacturing process (See DESCRIPTION).

If any adverse reaction takes place that is thought to be related to the administration of BeneFIX® (coagulation factor ix recombinant) , the rate of infusion should be decreased or the infusion stopped.

Post-marketing Experience

The following post-marketing adverse reactions have been reported for BeneFIX® (coagulation factor ix recombinant) , as well as for plasma-derived factor IX products: inadequate factor IX recovery, inadequate therapeutic response, inhibitor development (see CLINICAL PHARMACOLOGY), anaphylaxis (see WARNINGS), laryngeal edema, angioedema, cyanosis, 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® (coagulation factor ix recombinant) administration by continuous infusion have not been established (see WARNINGS). There have been post-marketing reports of thrombotic events including life-threatening SVC syndrome in critically ill neonates, while receiving continuousinfusion BeneFIX® (coagulation factor ix recombinant) through a central venous catheter. Cases of peripheral thrombophlebitis and DVT have also been reported. In some, BeneFIX (coagulation factor ix recombinant) was administered via continuous infusion, which is not an approved method of administration (See Instruction For Use, Administration).

Read the Benefix (coagulation factor ix recombinant) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

Read the Benefix Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.

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