DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Recombinate (Antihemophilic Factor) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse Reactions from Clinical Trials

During controlled clinical studies with RECOMBINATE enrolling 210 subjects, the most commonly reported adverse drug reactions were chills, flushing, rash and epistaxis..

System Organ Class
(SOC)
Preferred MedDRA
Term
Number of Subjects Percent of Evaluable Subjects 1
GASTROINTESTINAL DISORDERS Nausea 1 0.48
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

Chills

Fatigue

Pyrexia

3

1

1

1.43

0.48

0.48

INFECTIONS AND INFESTATIONS Ear infections 1 0.48
INVESTIGATIONS Acoustic stimulation tests abnormal 1 0.48
MUSCULOSKELETAL AND CONNECTIVE TISSUES DISORDERS Pain in extremity 1 0.48
NERVOUS SYSTEM DISORDERS

Dizziness

Tremors

1

1

0.48

0.48

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Pharyngolaryngeal pain 1 0.48
SKIN AND SUBCUTANEOUS TISSUE DISORDERS

Hyperhidrosis

Pruritus

Rash

Rash maculopapular

1

1

2

1

0.48

0.48

0.95

0.48

VASCULAR DISORDERS

Epistaxis

Flushing

Hematoma

Hypotension

Pallor

Peripheral coldness

1 2

2

1

1

1

1

0.48

0.95

0.48

0.48

0.48

0.48

1 Number of evaluable subjects experiencing the event/total number of evaluable subjects [% relative to 210, the total number of unique subjects who received at least 1 infusion of RECOMBINATE].
2 One subject experienced 11 events of epistaxis

During the Previously Treated Patients (PTP) study, none of the 71 subjects developed de novo evidence of Factor VIII inhibitor. However, during the phase II/III portion of the study, 1 subject with a history of inhibitors exhibited inhibitor activity at 6 months (0.8 Bethesda Units [BU]), which resolved by 9 months. One other subject in this study had detectable Factor VIII inhibitor at baseline (1.26 BU) and exhibited an anamnestic response at 6 months (10.3 BU). During a prospective pharmaco-surveillance study of subjects who received batches of RECOMBINATE containing modestly increased Chinese Hamster Ovary (CHO) cell protein levels, none of the 34 treated subjects developed a Factor VIII inhibitor.

During the Previously Untreated Patients (PUP) study, 22 of the 73 evaluable subjects developed inhibitors to Factor VIII. Of these, 13 subjects displayed no detectable Factor VIII inhibitors at study exit.

Post-Marketing Adverse Reactions

In addition to the adverse reactions noted in clinical trials, the following adverse reactions have been reported in the post-marketing experience. These adverse reactions are listed by MedDRA (version 12.1) System Organ Class (SOC), then by MedDRA coding system Preferred Term in order of severity.

BLOOD AND LYMPHATIC SYSTEM DISORDERS: Factor VIII inhibition

CARDIAC DISORDERS: Tachycardia, Cyanosis

GASTROINTESTINAL DISORDERS: Vomiting, Abdominal pain

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Malaise, Injection site reactions, Chest pain, Chest discomfort

IMMUNE SYSTEM DISORDERS: Anaphylactic reaction, Hypersensitivity

NERVOUS SYSTEM DISORDERS: Loss of consciousness, Headache, Paresthesia

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: Dyspnea, Cough, Laryngeal edema

SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Angioedema, Urticaria, Erythema



REPORTS OF SUSPECTED RECOMBINATE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Recombinate. The information is not vetted and should not be considered as verified clinical evidence.

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



See index of all Recombinate side effect reports >>

Drug label data at the top of this Page last updated: 2010-05-26

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015