XELJANZ / XELJANZ XR (tofacitinib) 6 Dosage Forms, Composition And Packaging

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Table 4 – Dosage Forms, Strengths, Composition and Packaging

Route of Administration

Dosage Form / Strength/ Composition

Non-medicinal Ingredients

Oral

Xeljanz

5 mg Tablets (as tofacitinib citrate)

 

The core contains croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

The film coat contains HPMC 2910/hypromellose 6 cP, lactose monohydrate, macrogol/PEG 3350, titanium dioxide, triacetin (glycerol triacetate)

10 mg Tablets (as tofacitinib citrate)

 

The core contains croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

The film coat contains FD&C blue #1/brilliant blue FCF aluminum lake, FD&C blue #2/indigo carmine aluminum lake, HPMC 2910/hypromellose 6 cP, lactose monohydrate, macrogol/PEG 3350, titanium dioxide, triacetin (glycerol triacetate).

Xeljanz XR:

Tofacitinib extended-release tablets / 11 mg tofacitinib (as tofacitinib citrate)

The tablet core contains ammonium hydroxide, cellulose acetate, copovidone, ferrosoferric oxide/black iron oxide, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/hypromellose, magnesium stearate, propylene glycol, red iron oxide, shellac glaze, sorbitol, titanium dioxide, triacetin.

XELJANZ

Tablet: 5 mg tofacitinib (as tofacitinib citrate) are white, round, film coated tablets with Pfizer on one side and JKI 5 on the other side. The tablets are available in HDPE bottles with desiccant and child-resistant caps containing 60 film-coated tablets, and in foil / foil blisters containing 56 film-coated tablets.

Tablet: 10 mg tofacitinib (as tofacitinib citrate) are blue, round, film coated tablets with Pfizer on one side and JKI 10 on the other side. The tablets are available in HDPE bottles with desiccant and child-resistant caps containing 60 film-coated tablets, and in foil / foil blisters containing 56 film-coated tablets.

XELJANZ XR

Tablets: 11 mg tofacitinib (as tofacitinib citrate) are pink, oval extended-release-coated tablets. The tablets are available in HDPE bottles with desiccant and child-resistant caps containing 14 or 30 extended-release film-coated tablets.