Lumakras Dosage/Direction for Use

Posology: Patient Selection: KRAS G12C-mutated Locally Advanced or Metastatic NSCLC: Select patients for treatment of locally advanced or metastatic NSCLC with LUMAKRAS based on the presence of KRAS G12C mutation in tumor or plasma specimens. If no mutation is detected in a plasma specimen, test tumor tissue [see Pharmacology: Pharmacodynamics: Clinical Data under Actions].
KRAS G12C-mutated mCRC: Select patients for treatment of mCRC based on the presence of KRAS G12C mutation in tumor specimens [see Pharmacology: Pharmacodynamics: Clinical Data under Actions].
Recommended Dosage: LUMAKRAS as a Single Agent for KRAS G12C-mutated Locally Advanced or Metastatic NSCLC: The recommended dosage of LUMAKRAS is 960 mg (eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity.
LUMAKRAS in Combination with Panitumumab for KRAS G12C-mutated mCRC: The recommended dosage of LUMAKRAS is 960 mg (eight 120 mg tablets) orally once daily in combination with panitumumab until disease progression or unacceptable toxicity.
Administer the first dose of LUMAKRAS prior to first panitumumab infusion.
Refer to the panitumumab full prescribing information for recommended panitumumab dosage information.
If a dose of LUMAKRAS is missed by more than 6 hours, take the next dose as prescribed the next day. Do not take 2 doses at the same time to make up for the missed dose.
If vomiting occurs after taking LUMAKRAS, do not take an additional dose. Take the next dose as prescribed the next day.
Dosage Modifications for Adverse Reactions: LUMAKRAS dose reduction levels are summarized in Table 3.
If adverse reactions occur, a maximum of two dose reductions are permitted. Discontinue LUMAKRAS if patients are unable to tolerate the minimum dose of 240 mg once daily.
When LUMAKRAS is administered in combination with panitumumab, and LUMAKRAS is temporarily withheld or permanently discontinued, temporarily withhold or permanently discontinue panitumumab, respectively [see Pharmacology: Pharmacodynamics: Clinical Data under Actions]. Refer to the full prescribing information of panitumumab for dose modifications for adverse reactions associated with the use of panitumumab.
Treatment with LUMAKRAS as a single agent may be continued if panitumumab is permanently discontinued [see Pharmacology: Pharmacodynamics: Clinical Data under Actions].
Refer to Table 4 for dose modification guidelines and management of adverse reactions associated with the use of LUMAKRAS as a single agent or as combination therapy with panitumumab. (See Tables 3 and 4.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Coadministration of LUMAKRAS with Acid-Reducing Agents: Avoid coadministration of proton pump inhibitors (PPIs) and H₂ receptor antagonists with LUMAKRAS. If treatment with an acid-reducing agent cannot be avoided, take LUMAKRAS 4 hours before or 10 hours after administration of a local antacid [see Interactions and Pharmacology: Pharmacokinetics under Actions].
Special Populations: Pediatric Use: The safety and effectiveness of LUMAKRAS have not been established in pediatric patients.
Geriatric Use: Of the 357 patients with any tumor type who received LUMAKRAS 960 mg orally once daily in CodeBreaK 100, 46% were 65 and over, and 10% were 75 and over. No overall differences in safety or effectiveness were observed between older patients and younger patients treated with LUMAKRAS as a single agent.
In a pooled analysis of 132 patients who received LUMAKRAS 960 mg in combination with panitumumab for KRAS G12C-mutated mCRC, 30% were 65 and over while 9% were 75 and over. No overall differences in safety or efficacy were observed between older patients (≥65 years of age) compared to younger patients, treated with LUMAKRAS 960 mg in combination with panitumumab.
Hepatic Impairment: No dosage modification is recommended in patients with mild to moderate hepatic impairment (Child-Pugh A or B).
The effect of severe hepatic impairment (Child-Pugh C) on the safety of LUMAKRAS is unknown. Monitor for sotorasib adverse reactions in patients with hepatic impairment more frequently since these patients may be at increased risk for adverse reactions including hepatotoxicity [see Pharmacology: Pharmacokinetics under Actions].
Method of Administration: Take the daily dose of LUMAKRAS at the same time each day with or without food [see Pharmacology: Pharmacokinetics under Actions]. Swallow tablets whole. Do not chew, crush or split tablets.
Administration to Patients Who Have Difficulty Swallowing Solids: Disperse tablets in 120 mL (4 ounces) of non-carbonated, room-temperature water without crushing. No other liquids should be used. Stir until tablets are dispersed into small pieces (the tablets will not completely dissolve) and drink immediately or within 2 hours. The appearance of the mixture may range from pale yellow to bright yellow. Swallow the tablet dispersion. Do not chew pieces of the tablet. Rinse the container with an additional 120 mL (4 ounces) of water and drink. If the mixture is not consumed immediately, stir the mixture again to ensure that tablets are dispersed.
If administration through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube is required, follow the process as previously mentioned for the initial dispersion and for the residual rinse of the 120 mg tablets. The dispersed suspension and rinse should be administered as per the NG or PEG tube manufacturer's instructions with appropriate water flushes. Administer the dispersion within 2 hours of preparation, stored at room temperature.