LORBRENA Film-coated tablet Ref.[10864] Active ingredients: Lorlatinib

Source: FDA, National Drug Code (US) Revision Year: 2021

Product description

LORBRENA (lorlatinib) is a kinase inhibitor for oral administration. The molecular formula is C₂₁H₁₉FN₆O₂ (anhydrous form) and the molecular weight is 406.41 Daltons. The chemical name is (10R)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-4,8-methenopyrazolo[4,3-h][2,5,11] benzoxadiazacyclotetradecine-3-carbonitrile.

The chemical structure is shown below:

Lorlatinib is a white to off-white powder with a pKa of 4.92. The solubility of lorlatinib in aqueous media decreases over the range pH 2.55 to pH 8.02 from 32.38 mg/mL to 0.17 mg/mL. The log of the distribution coefficient (octanol/water) at pH 9 is 2.45.

LORBRENA is supplied as tablets containing 25 mg or 100 mg of lorlatinib with the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate. The film-coating contains hydroxypropyl methylcellulose (HPMC) 2910/hypromellose, lactose monohydrate, macrogol/polyethylene glycol (PEG) 3350, triacetin, titanium dioxide, ferrosoferric oxide/black iron oxide, and iron oxide red.

Dosage Forms and Strengths
Tablets: 25 mg: 8 mm round, tan, immediate release, film-coated, debossed with “Pfizer” on one side and “25” and “LLN” on the other side. 100 mg: 8.5 mm × 17 mm oval, lavender, immediate release, film-coated, debossed with “Pfizer” on one side and “LLN 100” on the other side.

How Supplied

Table 7 describes the available strengths and package configurations for LORBRENA:

Table 7. LORBRENA Tablets:

Package Configuration	Strength (mg)	NDC	Description
30 count bottle with a child-resistant closure	25	0069-0227-01	8 mm round, tan, immediate release film-coated, debossed with “Pfizer” on one side and “25” and “LLN” on the other side
30 count bottle with a child-resistant closure	100	0069-0231-01	8.5 mm × 17 mm oval, lavender, immediate release, film-coated, debossed with “Pfizer” on one side and “LLN 100” on the other side

Drugs

Drug	Countries
LORBRENA	Brazil, Canada, Ecuador, Japan, United States

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