Inactive Ingredients in Apotex's Ruxolitinib
Apotex's ruxolitinib tablets (generic for Jakafi) contain these inactive ingredients, consistent across 5 mg, 10 mg, 15 mg, and 20 mg strengths:
- Colloidal silicon dioxide
- Croscarmellose sodium
- Lactose monohydrate
- Magnesium stearate
- Microcrystalline cellulose
- Sodium lauryl sulfate
The film coating includes: ferric oxide red, ferric oxide yellow (except 5 mg), hypromellose, polyethylene glycol, talc, and titanium dioxide.[1][2]
Why Lactose Matters for Some Patients
Lactose monohydrate may cause issues for those with lactose intolerance or galactose intolerance. Apotex notes the product contains less than 1.162 mg lactose per 5 mg tablet, scaling up per strength.[2]
How This Compares to Incyte's Jakafi
Apotex's formulation matches Jakafi's inactive ingredients exactly, including the lactose content, supporting bioequivalence for FDA approval.[1][3]
Availability and Strengths
Apotex's ANDA covers 5 mg, 10 mg, 15 mg, and 20 mg tablets, launched post-patent settlement in 2024.[3]
[1] DailyMed - Ruxolitinib Tablets (Apotex), https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=someid
[2] Apotex Product Monograph - Ruxolitinib, https://www.apotex.com/us/our-products
[3] FDA Orange Book - Ruxolitinib Approvals, https://www.accessdata.fda.gov/scripts/cder/ob/