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Medac Pharma, Inc. Secures FDA Approval of Rasuvo (methotrexate) injection for Rheumatoid Arthritis, Poly-Articular-Course Juvenile Idiopathic Arthritis and Psoriasis
Date:7/14/2014

suvo. Advise males to avoid pregnancy for a minimum of three months after therapy and females to avoid pregnancy for at least one ovulatory cycle after therapy.
  • Effects on Reproduction: Methotrexate has been reported to cause impairment of fertility, oligospermia and menstrual dysfunction in humans, during and for a short period after cessation of therapy.
  • Laboratory Tests: Patients undergoing Rasuvo therapy should be closely monitored so that toxic effects are detected promptly.  Baseline assessment should include a complete blood count with differential and platelet counts, hepatic enzymes, renal function tests and a chest X-ray.
  • Risks from Improper Dosing: The physician and/or pharmacist should emphasize to the patient that Rasuvo is administered once weekly and mistaken daily use has led to fatal toxicity.
  • Patients with Impaired Renal Function, Ascites, or Pleural Effusions: Elimination is reduced. Such patients require especially careful monitoring for toxicity and require dose reduction or, in some cases, discontinuation of Rasuvo administration.
  • Dizziness and Fatigue: May impair ability to drive or operate machinery.
  • Malignant Lymphomas: Non-Hodgkin's lymphoma and other tumors have been reported in patients receiving low-dose oral methotrexate.  However, there have been instances of malignant lymphoma arising during treatment with low-dose methotrexate, which have regressed completely following withdrawal of methotrexate, without requiring active anti-lymphoma treatment.  Discontinue Rasuvo first and, if the lymphoma does not regress, appropriate treatment should be instituted.
  • Tumor Lysis Syndrome: Like other cytotoxic drugs, methotrexate may induce "tumor lysis syndrome" in patients with rapidly growing tumors.
  • Concomitant Radiation Therapy: Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.
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