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Refacto

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Refacto

Refacto Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

ReFacto (antihemophilic factor, recombinant) is a protein used to treat or prevent bleeding episodes in adults and children with hemophilia A. It 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. It is not for use in people with von Willebrand disease. This medication is available in generic form. Common side effects include sore throat, cough, runny nose; fever or chills; mild nausea, vomiting; unusual or unpleasant taste in your mouth; skin itching or rash; warmth, redness, itching, or tingling under your skin; joint pain or swelling; dizziness; headache; or swelling, stinging, or irritation where the injection was given.

Dosage and duration of treatment with ReFacto depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. ReFacto may interact with other drugs. Tell your doctor all medications and supplements you use. It is unknown if ReFacto will harm a fetus. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our ReFacto (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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Refacto in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or chills;
  • mild nausea, vomiting;
  • unusual or unpleasant taste in your mouth;
  • skin itching or rash;
  • warmth, redness, itching, or tingling under your skin;
  • joint pain or swelling;
  • dizziness;
  • headache; or
  • swelling, stinging, or irritation where the injection was given.

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.

Read the entire detailed patient monograph for Refacto (Antihemophilic Factor) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Refacto FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Refacto (Antihemophilic Factor) »

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