Recovery has been reported with discontinuation of therapy. Reactions have occurred within days of oral, intramuscular, intravenous, or intrathecal methotrexate administration. Severe, occasionally fatal, skin reactions have been reported following single or multiple doses of methotrexate.Like other cytotoxic drugs, methotrexate may induce “tumor lysis syndrome” in patients with rapidly growing tumors.Discontinue Rasuvo first and, if the lymphoma does not regress, appropriate treatment should be instituted. Malignant lymphomas, which may regress following withdrawal of methotrexate, may occur in patients receiving low-dose methotrexate and, thus, may not require cytotoxic treatment.Diarrhea and ulcerative stomatitis require interruption of therapy: otherwise, hemorrhagic enteritis and death from intestinal perforation may occur.Pulmonary symptoms (especially a dry, nonproductive cough) may require interruption of treatment and careful investigation. It is not always fully reversible and fatalities have been reported. Methotrexate-induced lung disease, including acute or chronic interstitial pneumonitis, is a potentially dangerous lesion, which may occur acutely at any time during therapy and has been reported at low doses.Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the rheumatoid arthritis population. For this reason, periodic liver biopsies are usually recommended for psoriatic patients who are under long-term treatment. Liver biopsy after sustained use often shows histologic changes, and fibrosis and cirrhosis have been reported these latter lesions may not be preceded by symptoms or abnormal liver function tests in the psoriasis population. These are usually transient and asymptomatic, and also do not appear predictive of subsequent hepatic disease. Acutely, liver enzyme elevations are frequently seen. Methotrexate causes hepatotoxicity, fibrosis and cirrhosis, but generally only after prolonged use.Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs).Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of Rasuvo administration. Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions.Rasuvo is contraindicated in pregnant women. Therefore, Rasuvo is not recommended for females of childbearing potential unless there is clear medical evidence that the benefits can be expected to outweigh the considered risks. Methotrexate has been reported to cause fetal death and/or congenital anomalies.Patients should be informed by their physician of the risks involved and be under a physician's care throughout therapy. Patients should be closely monitored for bone marrow, liver, lung, skin, and kidney toxicities. Deaths have been reported with the use of methotrexate in the treatment of malignancy, psoriasis, and rheumatoid arthritis. Because of the possibility of serious toxic reactions (which can be fatal), Rasuvo should be used only in patients with psoriasis or rheumatoid arthritis with severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy. Rasuvo should be used only by physicians whose knowledge and experience include the use of antimetabolite therapy. WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY AND DEATH
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