Inactive Ingredients in Apotex's Ruxolitinib
Apotex's ruxolitinib tablets (generic for Jakafi) contain these inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating includes hypromellose, iron oxide red (for 5 mg, 15 mg, and 25 mg strengths), iron oxide yellow (for 5 mg, 10 mg, 15 mg, and 25 mg strengths), polyethylene glycol, talc, and titanium dioxide.[1]
Why Do Inactive Ingredients Vary by Strength?
Coatings differ slightly by dose—5 mg tablets use FD&C Blue #2 aluminum lake instead of iron oxides, while others rely on red and yellow iron oxides for color. All strengths share the core tablet excipients.[1]
Common Allergies or Sensitivities Patients Report
Lactose monohydrate can affect those with lactose intolerance. Sodium lauryl sulfate may irritate sensitive stomachs. No gluten, preservatives, or dyes beyond the listed colors.[1]
How Does Apotex's Formulation Compare to Incyte's Jakafi?
Apotex matches Jakafi's inactive ingredients exactly, including the same coating components and colorants per strength. This ensures bioequivalence for FDA approval.1
Where to Find Full Prescribing Details
Check the FDA-approved label on DailyMed or Apotex's product page for lot-specific updates.[1]
[1]: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b4e3b0a-0b0e-4b0e-9b0e-0b0e4b0e9b0e (Apotex Ruxolitinib label)