Lumakras

About Lumakras(Sotorasib)

• Sotorasib is sold under the brand name called Lumakras.
• Sotorasib received accelerated FDA approval on May 28, 2021. It’s an inhibitor of the RAS GTPase family, prescribed for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), confirmed by an FDA-approved test, and who have undergone at least one prior systemic therapy. Lumakras targets the KRAS G12C mutation specifically.
• Lumakras functions as an inhibitor of the RAS GTPase family. It specifically targets the KRAS G12C mutation, which is frequently found in non-small cell lung cancer (NSCLC). By inhibiting this mutation, 
• Lumakras disrupts aberrant signaling pathways associated with cancer growth and progression, ultimately inhibiting tumor growth in patients with KRAS G12C-mutated NSCLC.

Strength: 

Lumakras tablets are available in 320 mg and 120 mg 

Recommended Dosage:

• The recommended dosage of Lumakras is 960 mg (either three 320 mg tablets or eight 120 mg tablets) orally once daily. 
• This regimen should be continued until disease progression or unacceptable toxicity occurs. It’s essential to take Lumakras at the same time each day, with or without food. 
• The tablets should be swallowed whole and not chewed, crushed, or split. If a dose is missed by more than 6 hours, the next dose should be taken as prescribed the following day. 
• For patients with swallowing difficulties, Lumakras tablets can be dispersed in 120 mL (4 ounces) of non-carbonated, room-temperature water. Stir for about 3 minutes until the tablets break into small pieces. Drink the mixture immediately or within 2 hours. Rinse the container with an additional 120 mL (4 ounces) of water and drink it.

Taking two doses simultaneously to compensate for a missed dose should be avoided. In case of vomiting after taking Lumakras, an additional dose should not be taken, and the next dose should be taken as prescribed the following day.

Important:

Before beginning treatment, it’s crucial to inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Additionally, disclose all existing medical conditions. Your doctor should also be aware of any medications you are currently taking, including prescriptions, over-the-counter drugs, vitamins, and herbal supplements. This information allows your doctor to evaluate potential interactions and tailor your treatment plan accordingly.

Warnings & Precautions

• Hepatotoxicity and Interstitial Lung Disease (ILD)/Pneumonitis are serious risks associated with Lumakras. Hepatotoxicity, observed in 1.7% of patients, may lead to liver injury and hepatitis, with increased ALT/AST levels noted in 18% of patients. 
• Regular liver function monitoring is advised, and dose adjustment or discontinuation may be warranted based on severity. ILD/pneumonitis occurred in 0.8% of patients, all cases being Grade 3 or 4 at onset, with one fatality reported. 
• Prompt identification of symptoms such as dyspnea, cough, and fever is crucial, with immediate suspension of Lumakras recommended if ILD/pneumonitis is suspected.

Common Lumakras Side Effects:

• Diarrhea
• Musculoskeletal pain
• Nausea
• Fatigue
• Hepatotoxicity
• Cough
• Decreased lymphocytes
• Decreased hemoglobin
• Increased aspartate aminotransferase (AST)
• Increased alanine aminotransferase (ALT)
• Decreased calcium
• Increased alkaline phosphatase
• Increased urine protein
• Decreased sodium

Use in Specific Population

• There is insufficient data available regarding the use of Lumakras in pregnant women. 
• Regarding lactation, there is a lack of information on the presence of Sotorasib or its metabolites in human milk, its effects on the breastfed child, or milk production. 
• Due to the potential for serious adverse reactions in breastfed infants, women are advised not to breastfeed during the treatment and for one week after the final dose. 
• The safety and effectiveness of the drug have not been established in pediatric patients. In geriatric patients, no significant differences in safety or effectiveness were observed compared to younger patients. 
• For patients with mild to moderate hepatic impairment (Child-Pugh A or B), no dosage adjustment is recommended, although monitoring for adverse reactions is advised. 
• However, the impact of severe hepatic impairment (Child-Pugh C) safety remains unknown, necessitating closer monitoring for adverse reactions, including hepatotoxicity.

Storage and Handling

• Keep the medication stored at temperatures between 20°C to 25°C (68°F to 77°F). Excursions outside this range are allowed between 15°C to 30°C (59°F to 86°F).
• Do not freeze the medicine. 
• Keep the medicine away from pets and children.