Rasuvo

Drug - Rasuvo™ (methorexate for subcutaneous injection) [Medac Pharma Inc.]

April 2015

Therapeutic area - Rheumatoid arthritis; polyarticular juvenile idiopathic arthritis; psoriasis

Approval criteria

Approval will only be granted for diagnoses of rheumatoid arthritis; polyarticular juvenile idiopathic arthritis (pJIA); severe, disabling psoriasis.

Rheumatoid Arthritis, pJIA approval criteria:

• Patient must have a diagnosis of rheumatoid arthritis or pJIA AND
• Patient cannot swallow a tablet whole AND
• Patient is not taking any other tablet whole by mouth OR
• Prescriber provides a compelling reason why patient cannot take generically available methotrexate by mouth or injection

Psoriasis approval criteria:

• Patient must have a diagnosis of psoriasis AND
• Patient has tried and failed topical therapy AND
• Patient cannot swallow a tablet whole AND
• Patient is not taking any other tablet whole by mouth OR
• Prescriber provides a compelling reason why patient cannot take generically available methotrexate by mouth or injection

Quantity limits

Strength	Quantity limit per 28 days
7.5 mg/0.15 ml	0.6 ml
10 mg/0.2 ml	0.8 ml
12.5 mg/0.25 ml	1 ml
15 mg/0.3 ml	1.2 ml
17.5 mg/0.35 ml	1.4 ml
20 mg/0.4 ml	1.6 ml
22.5 mg/0.45 ml	1.8 ml
25 mg/0.5 ml	2 ml
27.5 mg/0.55 ml	2.2 ml
30 mg/0.6 ml	2.4 ml

Background information

Rasuvo™ will only be authorized for approved FDA indications.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411