Lumacras 120 mg Tablets (Sotorasib)

Adult dose

Administer orally at a dose of 960 mg (eight 120 mg tablets) once daily until disease progression or unacceptable toxicity occurs. Take this medicine at a consistent time each day, with or without food. Swallow the tablets whole. Do not chew, crush, or split the tablets. If a dose is missed by more than 6 hours, take the next dose as prescribed the following day. Do not take 2 doses at the same time to make up for a missed dose. If vomiting occurs after taking this medicine, do not take an additional dose. Take the next dose as prescribed the following day. If the tablets cannot be swallowed, disperse them in 120mL of room-temperature water without crushing them. Do not use any other liquid. Stir until the tablets break into small particles (the tablets will not dissolve completely), then drink immediately or within 2 hours. The mixture will be pale yellow to bright yellow. Drink the dispersed tablet solution. Do not chew the tablet particles in the dispersed solution. Rinse the container with an additional 120 mL of water and drink. If the mixture cannot be consumed immediately, stir it again to disperse the tablets. A maximum of 2 dose reductions is permitted if adverse reactions occur. Discontinue this medicine if the patient cannot tolerate the minimum dose of 240 mg once daily. First dose reduction: 480 mg (4 tablets) once daily Second dose reduction: 240 mg (2 tablets) once daily Symptomatic Grade 2 AST or ALT, or Grade 3 or higher AST or ALT: Withhold this medicine until recovery to Grade 1 or lower or to baseline grade. Then resume this medicine at the next lower dose level. AST or ALT > 3 × ULN and total bilirubin > 2 × ULN (in the absence of another cause): Permanently discontinue this medicine. If ILD/pneumonitis is suspected, withhold this medicine. If ILD/pneumonitis is confirmed, permanently discontinue this medicine. Uncontrolled Grade 3 ~ 4 nausea or vomiting despite appropriate supportive care (including antiemetics): Withhold this medicine until recovery to Grade 1 or lower or to baseline grade. Then resume this medicine at the next lower dose level. Uncontrolled Grade 3 ~ 4 diarrhea despite appropriate supportive care (including antidiarrheals): Withhold this medicine until recovery to Grade 1 or lower or to baseline grade. Then resume this medicine at the next lower dose level. Other Grade 3 ~ 4 adverse reactions: Withhold this medicine until recovery to Grade 1 or lower or to baseline grade. Then resume this medicine at the next lower dose level. Avoid concomitant use of proton pump inhibitors and H2-receptor antagonists with this medicine. If antacid treatment cannot be avoided, administer this medicine 4 hours before or 10 hours after a locally acting antacid.

This medication can cause interstitial lung disease or pneumonitis, which can be fatal. Therefore, if new symptoms such as shortness of breath, cough, or fever occur, treatment should be discontinued immediately, and consultation with medical personnel is required. Patients with allergies to the active ingredient or components of this medication or those with genetic issues like lactose intolerance should not use this medication. It can affect liver function, so regular liver function tests should be conducted before and during administration; if liver dysfunction is found, drug dosage adjustment or discontinuation may be necessary. Common side effects may include diarrhea, myalgia, nausea, fatigue, liver function abnormalities, and cough, while serious side effects reported include pneumonia, hepatotoxicity, and respiratory failure. This medication may interact with certain gastrointestinal drugs or drugs that break down in the liver, potentially reducing efficacy or increasing side effects. It's essential to consult a healthcare professional if taking other medications. Pregnant or nursing women are advised to avoid this medication due to insufficient safety data; breastfeeding is recommended to be suspended for one week during and after taking the medication. Safety for children has not been established, and while elderly patients can use it without specific dosage adjustments, their health status should be monitored closely. Patients with mild to moderate renal impairment do not need special dosage adjustments, but use in severe renal impairment is not recommended. Safety is not established for patients with severe liver dysfunction, and those with liver dysfunction should have more frequent liver function tests.

• Interstitial lung disease
• interstitial pneumonia
• hepatotoxicity
• diarrhea
• musculoskeletal pain
• nausea
• fatigue
• cough
• shortness of breath
• arthralgia

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture and is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance

Yellow, elongated film-coated tablets

Package unit

240 tablets/box [8 tablets/PTP x 30], 56 tablets/box [8 tablets/PTP x 7]