Common adverse reactions are: nausea, abdominal pain, dyspepsia, stomatitis/mouth sores, rash, nasopharyngitis, diarrhea, liver function test abnormalities, vomiting, headache, bronchitis, thrombocytopenia, alopecia, leukopenia, pancytopenia, dizziness, photosensitivity, and "burning of skin lesions". The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse reactions are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection.
- Aspirin, NSAIDs, and Steroids: Concomitant use may elevate and prolong serum methotrexate levels, resulting in deaths from severe hematologic and gastrointestinal toxicity.
- Proton Pump Inhibitors (PPIs): Concomitant use of some PPIs may elevate and prolong serum levels of methotrexate and cause increased toxicity.
- Oral Antibiotics: Certain oral antibiotics may decrease intestinal absorption of methotrexate or interfere with enterohepatic circulation by inhibiting bowel flora and suppressing metabolism of the drug by bacteria. Use of Rasuvo with penicillins should be carefully monitored.
- Hepatotoxins: Patients receiving concomitant therapy with Rasuvo and other potential hepatotoxins should be closely monitored for possible increased risk of hepatotoxicity.
- Theophylline: Methotrexate may decrease the clearance of theophylline, therefore theophylline levels should be monitored.
- Folic Acid and Antifolates: Vitamin preparations containing folic acid or its derivatives may decrease responses to systemically administered methotrexate. Folate deficiency states may increase methotrexate toxicity.
- Mercaptopurine: Methotrexate increases the plasma levels of mercaptopurine, therefore dose adjustment may be required.
- Other Drugs: Toxicity may be increased because of displacement of certain drugs. Use of Rasuvo with probenecid should be carefully monitored.
- Pregnancy: Methotrexate has been reported to cause embryotoxicity, fetal death, congenital anomalies, and abortion in humans and is contraindicated in pregnant women.
- Nursing Mothers: Because of the potential for serious adverse reactions from methotrexate in breast fed infants, Rasuvo is contraindicated in nursing mothers.
Females and Males of Reproductive Potential: Contraception should be used by both females and males while taking Rasuvo. Pregnancy should be avoided if either partner is receiving Rasuvo:
- for a minimum of 3 months after treatment with Rasuvo for males.
- during and for at least 1 menstrual cycle after treatment with Rasuvo for females.
- Pediatric Use: Safety and efficacy of Rasuvo have not been established in pediatric patients with psoriasis or neoplastic disease.
- Geriatric Use: Use caution in dose selection. Elderly patients should be closely monitored for early signs of hepatic, bone marrow and renal toxicity.
- Renal Impairment: Elimination is reduced. Patients require careful monitoring for toxicity and require dose reduction or discontinuation of Rasuvo.
- Hepatic Impairment: Contraindicated in patients with alcoholic liver disease or other chronic liver disease.
Rasuvo is for once weekly subcutaneous use only.
Administer Rasuvo in the abdomen or thigh.