Brand Name
Lumakras
Generic Name
Sotorasib
View Brand Information FDA approval date: May 28, 2021
Form: Tablet
What is Lumakras (Sotorasib)?
LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C -mutated locally advanced or metastatic non-small cell lung cancer , as determined by an FDA-approved test [see Dosage and Administration.
Approved To Treat
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Brand Information
LUMAKRAS (sotorasib)
1DOSAGE FORMS AND STRENGTHS
Tablets: 320 mg, beige, oval-shaped, immediate release, film-coated, debossed with "AMG" on one side and "320" on the opposite side.
Tablets: 240 mg, yellow, oval-shaped, immediate release, film-coated, debossed with "AMG" on one side and "240" on the opposite side.
Tablets: 120 mg, yellow, oblong-shaped, immediate release, film-coated, debossed with "AMG" on one side and "120" on the opposite side.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Hepatotoxicity
- Interstitial Lung Disease (ILD)/Pneumonitis
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to LUMAKRAS as a single agent at 960 mg orally once daily until disease progression or unacceptable toxicity in 549 patients with NSCLC with
The pooled safety population described in WARNINGS AND PRECAUTIONS also reflects exposure to LUMAKRAS 960 mg once daily in combination with panitumumab in 126 patients who received LUMAKRAS in combination with panitumumab for mCRC in CodeBreaK 300 (NCT05198934) and CodeBreaK 101 (NCT04185883). Among the 126 patients who received LUMAKRAS 960 mg in combination with panitumumab, 40% were exposed for 6 months or longer and 10% were exposed for greater than one year.
4DESCRIPTION
Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C
The chemical structure of sotorasib is shown below:
Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL.
LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only).
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
6PRINCIPAL DISPLAY PANEL - 120 mg Tablet Bottle Carton Label - NDC 55513-488-02
NDC 55513-488-02
LUMAKRAS™
120 mg
Each tablet contains 120 mg sotorasib.
Store at 20°C to 25°C (68°F to 77°F). Excursions
Recommended Dosage: See Prescribing Information.
AMGEN
7PRINCIPAL DISPLAY PANEL - 120 mg Tablet Bottle Carton Label - NDC 55513-488-24
NDC 55513-488-24
LUMAKRAS™
120 mg
Each tablet contains 120 mg sotorasib.
Store at 20°C to 25°C (68°F to 77°F).
Recommended Dosage: See Prescribing
AMGEN
8PRINCIPAL DISPLAY PANEL - 320 mg Tablet Bottle Carton Label
NDC 55513-504-50
LUMAKRAS
320 mg | New strength
Each tablet contains 320 mg sotorasib.
Store at 20°C to 25°C (68°F to 77°F).
Recommended Dosage: See Prescribing
AMGEN
9PRINCIPAL DISPLAY PANEL - 240 mg Tablet Bottle Carton Label
NDC 55513-512-60
LUMAKRAS
240 mg | New strength
Each tablet contains 240 mg sotorasib.
Store at 20°C to 25°C (68°F to 77°F).
Recommended Dosage: See Prescribing
AMGEN
