LORBRENA (lorlatinib) 6 Dosage Forms, Strengths, Composition And Packaging

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Table – Dosage Forms, Strengths, Composition and Packaging

Route of Administration

Dosage Form / Strength/Composition

Non-medicinal Ingredients

Oral

Film-coated tablet 25 mg, 100 mg

Tablet core contains: dibasic calcium phosphate anhydrous, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate

Film-coating contains: ferrosofferic oxide/Black iron oxide,

hydroxypropyl methylcellulose (HPMC) 2910/hypromellose, iron oxide red, lactose monohydrate,

macrogol/polyethylene glycol (PEG) 3350, titanium dioxide, triacetin

Description

25 mg: 8 mm round tan immediate release film-coated tablet, debossed with “Pfizer” on one side and “25” and “LLN” on the other side.

100 mg: oval (17 x 8.5 mm) lavender immediate release film-coated tablet, debossed with “Pfizer” on one side and “LLN 100” on the other side.

Packaging: LORBRENA is supplied as follows:
25 mg

  • high density polyethylene bottles containing 30, 60, or 100 tablets
  • aluminum foil blisters with aluminum foil backing containing 120 tablets (12 cards of 10 tablets)

100 mg

  • high density polyethylene bottles containing 30, 60, or 100 tablets
  • aluminum foil blisters with aluminum foil backing containing 30 tablets (3 cards of 10 tablets)