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Benefix

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Benefix

Benefix

Benefix Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

BeneFIX, Coagulation Factor IX (recombinant) is used to treat or prevent bleeding in people with hemophilia B. It is not for treating people with hemophilia A factor VII deficiency. It is a man-made protein similar to a natural protein in the body that helps the blood to clot. Common side effects include fever, pain at injection site, chills, headache, flushing, weakness, nausea, or vomiting.

Dosage and duration of treatment for all factor IX products depends on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX. Other drugs may interact with BeneFIX. Tell your doctor all medications and supplements you use. During pregnancy, BeneFIX should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our BeneFIX, Coagulation Factor IX (recombinant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Benefix in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever or chills;
  • continued bleeding after treatment;
  • feeling like you might pass out;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance; or
  • swelling in your feet or ankles, weight gain, loss of appetite.

Less serious side effects may be more likely to occur, such as:

  • headache;
  • warmth, redness, or tingly feeling under your skin;
  • nausea, vomiting;
  • dizziness; or
  • pain, redness, or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Benefix (Coagulation Factor IX Recombinant) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Benefix Overview - Patient Information: Side Effects

SIDE EFFECTS: Fever, pain at injection site, chills, headache, flushing, weakness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling at injection site, shortness of breath, fast heartbeat, change in the amount of urine, swelling of the ankles/feet, pain/redness/swelling of arms or legs, new or increased bleeding/bruising.

Get medical help right away if any of these rare but very serious side effects occur: bluish fingers, chest pain, trouble breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Benefix (Coagulation Factor IX Recombinant)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Benefix FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Benefix (Coagulation Factor IX Recombinant) »

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Benefix - User Reviews

Benefix User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Benefix sorted by most helpful. Patient Discussions FAQs

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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