FDA OKs a New Methotrexate Injection Device

Rasuvo, a prefilled syringe, may make injection easier.


The Food and Drug Administration (FDA) has approved an injectable form of methotrexate that is administered in a prefilled auto-injector; it’s the second such product approved in less than a year. The new product, called Rasuvo, is indicated for adults with severe rheumatoid arthritis (RA) or psoriasis, and for children with polyarticular juvenile idiopathic arthritis (pJIA).

Methotrexate is one of the most commonly used treatments for inflammatory types of arthritis. A disease-modifying antirheumatic drug (DMARD), it can help slow joint destruction over time in addition to relieving pain. Methotrexate is commonly available as a pill or injection.

Until recently, the injectable form had to be measured and drawn into a syringe from a multidose vial. But in October 2013, the FDA approved Otrexup, a prefilled, disposable auto-injector that delivers a single dose of methotrexate without the need for vials or measuring.

Rasuvo also delivers methotrexate in a prefilled auto-injector. It differs from Otrexup by offering more dosing options. Otrexup comes in four strengths: 10 milligrams (mg), 15 mg, 20 mg and 25 mg; Rasuvo is available in 10 strengths, ranging from 7.5 to 30 mg in 2.5 mg increments. (The starting dose for most adults is 7.5 to 10 mg; for children, the dose depends on weight).

“For both Otrexup and Rasuvo, the clear benefit is that patients do not have to pull up the dose themselves and [the shot] is not painful,” says Natalie Azar, MD, a clinical assistant professor in the division of rheumatology at NYU Langone Medical Center in New York City.

But Dr. Azar doesn’t see the extra dosing options as a big advantage. “Most patients will respond equally well to 15 mg and 17.5 mg, and the 5 mg dosing increments of Otrexup have been sufficient in my opinion,” she says.

Mara Becker, MD, director of the division of rheumatology at Children’s Mercy Hospital in Kansas City, Mo., says the approval of Rasuvo is “great news” for kids with arthritis.

“Subcutaneous [beneath the skin] administration of methotrexate is the preferred route in the 2011 American College of Rheumatology recommendations for the treatment of JIA. A [device] that can ease the administration of methotrexate is a great step forward for our patients and could minimize potential errors by having the appropriate dose prefilled in the syringe,” says Dr. Becker.

Whether injections are better than pills for all patients is an ongoing debate. Some studies show injected methotrexate is better absorbed than the oral version, especially at doses greater than 15 mg, while other studies have found no significant difference between the two. There are also questions about whether the injected form reduces common side effects of oral methotrexate, such as nausea and vomiting. But self-injection can be difficult – especially for kids and for adults with arthritic hands – and for many it is less appealing than swallowing a pill.

Medac Pharma, which manufactures Rasuvo, says it has not yet set a price. Its competitor, Otrexup, costs $500 to $600 a month for a 25 mg dose – more than a vial of methotrexate and far more than pills, which cost $20 to $30 for a dozen 2.5 mg tablets.

Dr. Azar says she hasn’t had trouble with insurance companies covering injectable methotrexate, but adds, “This will vary on a case-by-case basis given the patient’s insurance and prescription drug coverage.”

According to a company representative, Rasuvo will be available the first week of October.

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