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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

ble absorption rates and inconsistent bioavailability among patients. 

Medac Pharma, Inc. developed Rasuvo to optimize MTX therapy.  The subcutaneous mode of delivery of Rasuvo, with its wide range of dosing options, has been designed to improve bioavailability.

Rheumatologist Eric Ruderman, MD, Professor of Medicine, Northwestern University Feinberg School of Medicine, stated, "As a rheumatologist, I believe Rasuvo will offer patients the opportunity to maximize the benefit they get from methotrexate.  Rasuvo's dosing flexibility, in particular, will be very helpful, as RA patients do not all respond equally to methotrexate, making it important to select a treatment regimen that is appropriate for the patient's condition."

For complete prescribing information, including Boxed Warning, please visit www.Rasuvo.com.

Indications and Important Safety Information Including Boxed Warning

INDICATIONS:

Rasuvo is a folate analog metabolic inhibitor indicated for the:

  • Management of patients with severe, active rheumatoid arthritis (RA) and active polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy.
  • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

Limitations of Use
Rasuvo is not indicated for treatment of neoplastic diseases.

This product includes the following Black Box Warning:

WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY AND DEATH

Rasuvo should be used only by physicians whose knowledge and experience include the use of antimetabolite therapy. Because of the possibility of serious toxic reactions (which can be fatal), Rasuvo should be used only in pat
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SOURCE Medac Pharma, Inc.
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