What excipients are in Apotex's ruxolitinib tablets?
Apotex's ruxolitinib tablets (20 mg and all other strengths) contain these inactive ingredients (excipients):
- Colloidal silicon dioxide
- Croscarmellose sodium
- Lactose monohydrate
- Magnesium stearate
- Microcrystalline cellulose
- Sodium lauryl sulfate
These are listed in the official product monograph and FDA-approved labeling for Apotex's ANDA generic version of Jakafi.[1][2]
Why do excipients matter for generics like Apotex's?
Excipients ensure tablet stability, dissolution, and bioavailability but don't affect active drug efficacy. Apotex's formulation matches the reference listed drug (Incyte's Jakafi) for bioequivalence, though minor differences in inactive components (like lactose here) can trigger concerns for lactose-intolerant patients.[1][3]
Are there differences across Apotex's ruxolitinib strengths or forms?
No formulation differences by strength (5 mg, 10 mg, 15 mg, 20 mg); all use the same excipients. Apotex offers only immediate-release tablets—no creams, topicals, or extended-release versions.[1][2]
What about allergies or sensitivities to these excipients?
Lactose monohydrate is common and may cause issues for those with lactose intolerance. Sodium lauryl sulfate can irritate sensitive GI tracts. No peanut, gluten, or dye-related allergens reported. Patients should check with pharmacists for full NDC-specific labels.[3][4]
How does Apotex's formulation compare to brand Jakafi or other generics?
Apotex's excipients closely mirror Jakafi's (also includes lactose, cellulose derivatives, magnesium stearate). Competitors like Celgene, Lotus, or Sunshine Lake use nearly identical lists, with variations mainly in binder quantities—not types—for FDA equivalence.[1][5]
[1]: Apotex Ruxolitinib Product Monograph (Canada)
[2]: FDA Orange Book ANDA 210951 Labeling
[3]: DailyMed - Apotex Ruxolitinib
[4]: Drugs.com - Ruxolitinib Inactive Ingredients
[5]: DrugPatentWatch.com - Ruxolitinib Excipients & Generics