Recombinate (Antihemophilic Factor) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

During the clinical studies conducted in the previously treated patient group, there were 13 infusion related minor adverse reactions reported out of 10,446 infusions (0.12%). One patient experienced flushing and nausea during his first infusion which abated on decreasing the infusion rate. A second patient experienced mild fatigue during and following one infusion and a third patient had a series of eleven nose bleeds with a periodicity associated with the infusions.

The protein in greatest concentration in RECOMBINATE rAHF is Albumin (Human). Reactions associated with intravenous administration of albumin are extremely rare, although nausea, fever, chills or urticaria have been reported. Other allergic reactions could theoretically be encountered in the use of this Antihemophilic Factor preparation. See Information for Patients.

REPORTS OF SUSPECTED RECOMBINATE SIDE EFFECTS / ADVERSE REACTIONS

Possible Recombinate side effects / adverse reactions in 49 year old male

Reported by a consumer/non-health professional from United States on 2012-02-09

Patient: 49 year old male

Reactions: Septic Shock, Organ Failure

Adverse event resulted in: death

Suspect drug(s):
Recombinate

Possible Recombinate side effects / adverse reactions in 46 year old male

Reported by a pharmacist from United States on 2012-02-17

Patient: 46 year old male weighing 82.8 kg (182.2 pounds)

Reactions: Dyspnoea, Chest Pain, Infusion Related Reaction

Suspect drug(s):
Recombinate

Recombinate
    Dosage: 2000 tiw iv
    Indication: Factor Viii Deficiency
    Start date: 2008-05-08
    End date: 2012-02-08