TM Owner Amgen
Lumakras 120mg Tablet
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Indications & Clinical Uses
- Lumakras 120 mg film-coated tablets contain sotorasib, a targeted inhibitor of the KRAS G12C protein, and are prescribed by cancer specialists for adults whose tumour has been shown by a validated test to carry a KRAS G12C mutation.
- In the United States Lumakras is approved as a single agent for locally advanced or metastatic non-small cell lung cancer after at least one prior systemic therapy, and in combination with panitumumab for KRAS G12C-mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
- The recommended dose on the current United States label remains 960 mg once daily, taken as eight 120 mg tablets at about the same time each day, with or without food.
- The same medicine is authorised in the European Union under the different brand name LUMYKRAS, where it is conditionally approved for the lung cancer indication only, also at 960 mg once daily.
- Amgen manufactures both.
Side Effects
- Lumakras has NO boxed warning.
- The reactions reported in at least one in five patients with lung cancer are diarrhoea, musculoskeletal pain, nausea, tiredness, abnormal liver blood tests and cough; European data give diarrhoea in about 37 percent, nausea in about 25 percent and fatigue in about 19 percent.
- Liver injury is the most important laboratory effect and can be severe, so raised liver enzymes must be acted on promptly.
- Tell your cancer team straight away about yellowing of the skin or eyes, dark urine, pain over the right ribs, severe or persistent diarrhoea with dehydration, or any new or worsening breathlessness, cough or fever, which may indicate interstitial lung disease or pneumonitis - a rare but potentially fatal reaction that requires the drug to be stopped immediately while it is investigated.
Precautions & Warnings
- Treatment should only start after a validated test has confirmed a KRAS G12C mutation.
- Liver function is tested before treatment and then every three weeks for the first three months, and monthly thereafter or as clinically indicated; the dose may be reduced, interrupted or stopped depending on the result.
- If interstitial lung disease or pneumonitis is suspected, Lumakras is withheld immediately and permanently discontinued if no other cause is found.
- Swallow the tablets whole at about the same time each day; if you cannot swallow them, they may be dispersed in water as the label describes.
- Women who can become pregnant should use effective contraception, and breastfeeding is not advised.
- Tell your team about liver disease or hepatitis.
- The 120 mg tablets are stored at 20°C to 25°C in the original bottle; the European pack has no special storage requirement.
Avoid Interactions
- Sotorasib needs an acid stomach to be absorbed, so medicines that REDUCE its effect matter most.
- Proton pump inhibitors such as omeprazole can cut exposure by up to 65 percent and H2 blockers such as famotidine by 35 to 38 percent - avoid both; if an antacid is unavoidable, take Lumakras four hours before or ten hours after it.
- Strong CYP3A4 inducers including rifampicin, carbamazepine, phenytoin, mitotane and St John's wort reduce sotorasib exposure by about half and must be avoided.
- Sotorasib can INCREASE levels of medicines carried by P-glycoprotein, such as digoxin, and of certain CYP3A4 substrates, so these may need dose changes and monitoring.
- Give your cancer team a full list of every prescription medicine, over-the-counter product, herbal remedy and supplement you take.
References
Frequently Asked Questions
Lumakras (sotorasib) treats adults with KRAS G12C-mutated cancer. In the United States it is used alone for advanced non-small cell lung cancer after at least one prior systemic therapy, and with panitumumab for KRAS G12C-mutated metastatic colorectal cancer after chemotherapy. A validated mutation test is required first.
The recommended dose of Lumakras (sotorasib) on the current United States label is 960 mg once daily, which is eight 120 mg tablets taken together at about the same time each day. You can take them with or without food, and the tablets are swallowed whole.
The commonest side effects of Lumakras (sotorasib) are diarrhoea, muscle and joint pain, nausea, tiredness, cough and abnormal liver blood tests. Report yellow skin or eyes, dark urine, severe diarrhoea, or any new breathlessness, cough or fever, which may mean lung inflammation.
Avoid proton pump inhibitors such as omeprazole and H2 blockers such as famotidine, which can cut Lumakras (sotorasib) absorption by up to 65 percent. Avoid strong CYP3A4 inducers including rifampicin, carbamazepine, phenytoin and St John's wort. Use effective contraception while on treatment.
Liver function is tested before Lumakras (sotorasib) starts, then every three weeks for the first three months and monthly after that. Raised liver enzymes are common and can be severe, so the dose may be reduced, paused or stopped depending on the results.
Yes. Lumakras and Lumykras are the same medicine, sotorasib, from Amgen, sold under different names: Lumakras in the United States and Lumykras in the European Union. The European authorisation is conditional and covers non-small cell lung cancer only, at the same 960 mg daily dose.
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