Recommended Topic Related To:

Helixate FS

"The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape B"...

Helixate FS

Side Effects
Interactions

SIDE EFFECTS

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.

Post-marketing experience

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 Helixate FS (antihemophilic factor (recombinant)) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

REFERENCES

14. Pernod G, Armari C, Barro C, et al: Anaphylaxis following the use of a plasma-derived immunopurified Monoclate-P®, and the recombinant Recombinate® and Kogenate® factor VIII: a therapeutic challenge. Haemophilia 5(2):143-4, 1999.

Last reviewed on RxList: 1/30/2009
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
A A A

Helixate FS - User Reviews

Helixate FS 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 Helixate FS 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.


Women's Health

Find out what women really need.