Recommended Topic Related To:

Refacto

"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.

Dotarem is a gadolinium-based"...

Refacto

Refacto

SIDE EFFECTS

In phase 3 clinical studies of ReFacto (antihemophilic factor) involving a total of 218 study subjects (113 PTPs, 101 PUPs, and 4 PTPs who participated in the surgery study only), more than 138 million IU were administered during a total of 75,757 exposure days. The 113 PTPs in the long-term PTP study were given a median of 327 injections (range 4-1769 injections) over a median of 313 exposure days (range 4-1312 days). The 101 PUPs in the long-term PUP study were given a median of 218 injections (range 1-1476 injections) over a median of 197 exposure days (range 1-1466 days).

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. During phase 3 clinical studies with ReFacto® Antihemophilic Factor (Recombinant), 278 adverse reactions were probably or possibly related or of unknown relation to therapy with 80,370 infusions (0.35% of infusions) in 109 of 218 study subjects (50%).

Adverse reactions reported by ≥ 1% of study subjects are presented in Tables 2 and 3 for PTPs and PUPs, respectively. One of 218 subjects experienced hypotension that was mild in severity and considered probably related to the administration of ReFacto (antihemophilic factor) as noted in Table 3.

TABLE 2. SUMMARY OF STUDY-DRUG RELATED ADVERSE EVENTS IN ≥ 1% OF PTPS

Body system No. of Events No. of Subjects
Eventa n=145 n=113
n (%) n (%)
Body as a whole
  Asthenia 2 (1.4) 2 (1.8)
  Chills 2 (1.4) 2 (1.8)
  Headache 5 (3.4) 4 (3.5)
  Injection site pain 5 (3.4) 2 (1.8)
Cardiovascular system
  Hemorrhage 2 (1.4) 2 (1.8)
Digestive system
  Nausea 25 (17.2) 5 (4.4)
Hemic and lymphatic system
  FVIII AB lab increase (ELISA) 4 (2.8) 4 (3.5)
  CHO AB lab increase (ELISA) 19 (13.1) 16 (14.2)
  Mouse IgG AB lab increase (ELISA) 4 (2.8) 4 (3.5)
Nervous system
  Dizziness 4 (2.8) 4 (3.5)
Respiratory system
  Dyspnea 6 (4.1) 2 (1.8)
Skin and appendages
  Pruritus 34 (23.4) 2 (1.8)
Special senses
  Taste perversion 3 (2.1) 3 (2.7)
a: Includes events for 113 PTPs during their participation in the long-term study and surgery study. The 4 PTPs who participated in the surgery study only had no adverse events that were study-drug related.

TABLE 3. SUMMARY OF STUDY-DRUG RELATED ADVERSE EVENTS IN ≥ 1% OF PUPS

Body system No. of Events No. of Subjects
Eventa n=133 n=101
n (%) n (%)
Body as a whole
  Abdominal pain 1 (0.8) 1 (1.0)
  Anaphylactoid reaction 1 (0.8) 1 (1.0)
  Asthenia 1 (0.8) 1 (1.0)
  Catheter infection 1 (0.8) 1 (1.0)
  Catheter misc 1 (0.8) 1 (1.0)
  Catheter thrombosis 2 (1.5) 2 (2.0)
  Edema 1 (0.8) 1 (1.0)
  Fever 6 (4.5) 6 (5.9)
  Infection 1 (0.8) 1 (1.0)
  Injection site reaction 1 (0.8) 1 (1.0)
  Pain 2 (1.5) 2 (2.0)
Cardiovascular system
  Hemorrhage 1 (0.8) 1 (1.0)
  Hypotension 1 (0.8) 1 (1.0)
  Vasodilatation 1 (0.8) 1 (1.0)
Digestive system
  Anorexia 1 (0.8) 1 (1.0)
  Diarrhea 1 (0.8) 1 (1.0)
  Gastrointestinal hemorrhage 1 (0.8) 1 (1.0)
  Nausea 1 (0.8) 1 (1.0)
Hemic and lymphatic system
  FVIII inhibitor 32 (24.1) 32 (31.7)
  FVIII AB lab increase (ELISA) 31 (23.3) 26 (25.7)
  CHO AB lab increase (ELISA) 20 (15.0) 17 (16.8)
  Mouse IgG AB lab increase (ELISA) 17 (12.8) 12 (11.9)
Metabolic and nutritional disorders
  SGOT increased 1 (0.8) 1 (1.0)
Musculoskeletal system
  Arthralgia 1 (0.8) 1 (1.0)
Nervous system
  Somnolence 1 (0.8) 1 (1.0)
Respiratory system
  Rhinitis 1 (0.8) 1 (1.0)
Skin and appendages
  Rash 1 (0.8) 1 (1.0)
  Urticaria 1 (0.8) 1 (1.0)
Urogenital system
  Urinary tract infection 2 (1.5) 1 (1.0)
a: Includes events for 101 PUPs during their participation in the long-term study and surgery study.

If any adverse reaction takes place that is thought to be related to administration of ReFacto (antihemophilic factor) , the rate of infusion should be decreased or stopped.

Inhibitor development is a known adverse event associated with the treatment of patients with hemophilia A. In addition to the one report of a high-titer inhibitor in the clinical study of PTPs (see CLINICAL PHARMACOLOGY), there have been reports of high-titer inhibitors in PTPs in the post-marketing setting. High- and low-titer inhibitors have been reported in PUPs in both clinical trials and the post-marketing setting (see PRECAUTIONS, General).

Other adverse experiences that were reported during the clinical trials, but which were assessed by both the investigator and the sponsor as “unlikely” to be related to ReFacto (antihemophilic factor) administration included: dyspnea (3), rash (2), pruritus (1), neuropathy (1), arm weakness (1), and thrombophlebitis of upper arm (1).

Read the Refacto (antihemophilic factor) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 2/19/2009
This monograph has been modified to include the generic and brand name in many instances.

A A A

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.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations