Rasuvo (methotrexate) - What You Need to Know

Once-Weekly Subcutaneous Autoinjector

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Rasuvo (methotrexate), a single‑dose autoinjector containing the prescription drug methotrexate, was approved by the U.S. Food and Drug Administration (FDA) on July 11, 2014. Rasuvo, manufactured by Medac, Pharma, Inc. is an easy-to-use alternative to oral methotrexate or the vial-and-syringe injectable form.

Indications for Rasuvo

Rasuvo is approved for the management of patients with severe, active rheumatoid arthritis and polyarticular juvenile idiopathic arthritis who had an inadequate response to first-line therapy or were intolerant.

Rasuvo is also indicated for control of symptoms associated with severe, recalcitrant, disabling psoriasis in adults who failed to achieve a satisfactory response with other treatment options. (Note: Rasuvo should not be used to treat neoplastic diseases.)

Administration of Rasuvo

Rasuvo is administered once weekly as a subcutaneous injection only. Rasuvo is available in 10 dosage strengths from 7.5 mg to 30 mg (in 2.5 mg increments). The autoinjector is triggered manually and should be injected in the abdomen or thigh. Other formulations of methotrexate should be used if dosage below 7.5 mg or above 30 mg are prescribed -- or if adjustments below 2.5 mg are needed.

The typical starting dosage of methotrexate for rheumatoid arthritis is 7.5 mg once weekly for oral or subcutaneous injection. For psoriasis, the usual starting dose is 10-25 mg once weekly via oral, intramuscular, subcutaneous, or intravenous administration.

For polyarticular juvenile idiopathic arthritis, the starting dose is 10mg/m2 once weekly (m2 is square meter of body surface area).

Who Should Not Use Rasuvo?

Rheumatoid arthritis patients who are pregnant should not use Rasuvo. It should also be avoided by nursing mothers, as well as patients dealing with: alcoholism or liver disease, immunodeficiency syndromes, or preexisting blood dyscrasias.

Patients with a known hypersensitivity to methotrexate should also avoid Rasuvo.

Common Adverse Reactions

There are common adverse reactions associated with Rasuvo including, nausea, abdominal pain, dyspepsia, stomach or mouth sores, nasopharyngitis, diarrhea, liver test abnormalities, vomiting, headache, bronchitis, thrombocytopenia (low platelets), alopecia, leukopenia (low white blood cell count), pancytopenia (low counts for all types of blood cells), dizziness, and sensitivity to ultraviolet light. If you have an adverse reaction, you can report it to the drug manufacturer at 1-855-336-3322, to the FDA at 1-800-FDA-1088, or Medwatch at http://www.fda.gov/medwatch.

Drug Interactions

Your doctor should have a list of all the medications and supplements that you currently take. Be aware that by taking aspirin, a NSAID, or corticosteroid medication together with Rasuvo, serum methotrexate levels may be prolonged (i.e., it may remain in your bloodstream longer) and potentially increase the risk of toxicity.

Taking proton pump inhibitors (e.g., Nexium or omeprazole) with Rasuvo can also prolong serum methotrexate levels and increase the risk of toxicity. 

Warnings and Precautions

Rasuvo includes a Boxed Warning (the most serious type of warning issued). The paraphrased highlights of the Boxed Warning are:

  • Rasuvo should only be used by doctors with knowledge and experience of antimetabolite therapy. Rasuvo is a folate analog metabolic inhibitor.
  • Because of the potential for serious toxic reactions, possibly fatal, Rasuvo should be prescribed only for those with rheumatoid arthritis, psoriasis, or polyarticular juvenile idiopathic arthritis who have not responded to other treatments.
  • Methotrexate has reportedly caused fetal death or congenital abnormalities.
  • Methotrexate elimination is decreased in those with impaired kidney function, ascites, or pleural effusion.
  • Bone marrow suppression, aplastic anemia, and gastrointestinal toxicity may occur unexpectedly and be potentially fatal if methotrexate is taken with NSAIDs.
  • Prolonged use of methotrexate can cause hepatotoxicity, fibrosis, and cirrhosis. Periodic liver biopsy tests may be indicated.
  • Methotrexate-induced lung disease (e.g., acute and chronic interstitial pneumonitis) can occur, even at lower doses.
  • Diarrhea and ulcerative stomatitis require that treatment with methotrexate be stopped to prevent intestinal perforation or hemorrhagic enteritis.
  • Malignant lymphoma may develop even with low dose methotrexate. The drug should be discontinued to see if lymphoma regresses.
  • Methotrexate may induce "tumor lysis syndrome" in patients who have rapidly growing tumors.
  • Severe, sometimes fatal, skin reactions can occur with methotrexate use.
  • Potentially fatal opportunistic infections may occur with methotrexate use.
  • If methotrexate is given together with radiotherapy, there may be an increased risk of soft tissue necrosis and osteonecrosis

The Bottom Line

Rasuvo is a convenient formulation of methotrexate. Rasuvo carries all of the potential adverse effects and boxed warnings associated with other formulations of methotrexate.


Rasuvo. Full Prescribing Information. Revised 11/2014.

Rasuvo Approval History. drugs.com.

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