Medical Editor: John P. Cunha, DO, FACOEP
Helixate FS Antihemophilic Factor (Recombinant) is a naturally occurring protein in the blood used to treat or prevent bleeding episodes in adults and children with hemophilia A. Helixate FS Antihemophilic Factor is also used to control bleeding related to surgery or dentistry in a person with hemophilia, and to prevent joint damage in people age 16 or older with severe hemophilia A and no prior joint damage. Helixate FS Antihemophilic Factor is not for use in people with von Willebrand disease. Common side effects of Helixate FS Antihemophilic Factor include flushing of the face (warmth, redness, itching, or tingling under your skin), headache, nausea, vomiting, and fast heartbeat that may be lessened by giving this medication more slowly. Other side effects of Helixate FS Antihemophilic Factor include:
- injection site reactions
- sore throat
- runny nose
- unusual or unpleasant taste in your mouth
- skin itching or rash
- joint pain or swelling, or
Dosage of Helixate FS is based on the patient's body weight. Helixate FS may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Helixate FS should be taken only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Helixate FS Antihemophilic Factor (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.
Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, numbness, tingling; fever, dizziness, nausea; fast heartbeats, chest tightness, wheezing, difficult breathing; pale skin, cold sweat, feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- increased bleeding episodes;
- any bleeding that will not stop;
- chest pain; or
- a light-headed feeling, like you might pass out.
Common side effects may include:
- nose bleeds;
- nausea, vomiting, diarrhea;
- headache, dizziness;
- muscle or joint pain;
- flushing (sudden warmth, redness, or tingly feeling);
- fever, chills;
- weakness; or
- pain, swelling, itching, or redness where the injection was given.
Read the entire detailed patient monograph for Helixate FS (Antihemophilic Factor (Recombinant))
During the clinical studies conducted in previously treated patients (PTPs), 109 adverse events were reported in the course of 4160 infusions (2.6%). Only 13 events were reported by the investigator as at least remotely related to study drug. Another 7 events were nonassessable. Thus 20 events in 11 patients were considered to be either nonassessable or at least remotely related to Helixate FS (antihemophilic factor (recombinant)) administration, for an incidence of 0.5% relative to the number of infusions administered. Events that were at least remotely drug-related included: local injection site reactions (2), dizziness (2), rash (2), unusual taste in the mouth (1), mild increase in blood pressure (1), pruritus (1), depersonalization (1), nausea (1), and rhinitis (1). No FVIII inhibitors have developed in the 72 PTPs with severe hemophilia A who have received Helixate FS (antihemophilic factor (recombinant)) for a mean of 54 exposure days.
In clinical studies with previously untreated patients (PUPs) and minimally treated (MTP) pediatric patients, 18 adverse events were reported by the clinical investigators as at least possibly related to the study drug including the expected complication of inhibitor development in 8 patients (included in the 10 patients discussed under CLINICAL PHARMACOLOGY), a forearm bleed following venipuncture, constipation, adenopathy, rash, anemia and pallor in one inhibitor patient with gastroenteritis, and serous otitis media.
The following events are principally derived from post-marketing experience and publications,14 and accurate rate estimates are generally not possible. Among patients treated with its predecessor product HELIXATE, very rare cases of serious allergic reactions and anaphylactic reactions have been reported, particularly in very young patients or patients who had previously reacted to other FVIII concentrates. Individual cases of hypotension have been very rarely reported. Rare cases of urticaria have also been reported. Although such serious reactions have not been reported with the use of Helixate FS (antihemophilic factor (recombinant)) , it is likely that these may also occur. Rare cases of dyspnea have been reported with Helixate FS (antihemophilic factor (recombinant)) .
Read the entire FDA prescribing information for Helixate FS (Antihemophilic Factor (Recombinant))