Refacto
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Refacto
Refacto Side Effects Center
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) »
Additional Refacto Information
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.
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