Refacto
- Generic Name: antihemophilic factor
- Brand Name: Refacto
Refacto (Antihemophilic Factor) side effects drug center
- Related Drugs
- 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; weakness; shortness of breath; changes in taste; or swelling
- stinging
- pain,or
- irritation where the injection was given
- increased bleeding episodes;
- any bleeding that will not stop;
- chest pain; or
- a light-headed feeling, like you might pass out.
- nose bleeds;
- nausea, vomiting, diarrhea;
- headache, dizziness;
- muscle or joint pain;
- rash;
- flushing (sudden warmth, redness, or tingly feeling);
- fever, chills;
- cough;
- weakness; or
- pain, swelling, itching, or redness where the injection was given.
What Is Refacto?
ReFacto (antihemophilic factor, recombinant) is a protein used to treat or prevent bleeding episodes in adults and children with hemophilia A. ReFacto 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. ReFacto is not for use in people with von Willebrand disease. ReFacto is available in generic form.
What Are Side Effects of Refacto?
Common side effects of ReFacto include:
Dosage for Refacto
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.
What Drugs, Substances, or Supplements Interact with Refacto?
ReFacto may interact with other drugs. Tell your doctor all medications and supplements you use.
Refacto During Pregnancy or Breastfeeding
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.
Additional Information
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.
Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, numbness, tingling; fever, dizziness, nausea; fast heartbeats, chest tightness, wheezing, difficult breathing; pale skin, cold sweat, feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
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)
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)
© Refacto Patient Information is supplied by Cerner Multum, Inc. and Refacto Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.