LuciSot is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

Sotorasib is used to treat metastatic (cancer that has already spread) or locally advanced (cannot be removed by surgery) non-small cell lung cancer (NSCLC) in patients who have received at least one previous treatment and whose tumors have an abnormal KRAS G12C gene. This medicine is also used in combination with panitumumab to treat metastatic (cancer that has already spread) colorectal cancer (cancer of the color or rectum) in patients who have received other cancer treatments (eg, fluoropyrimidine, oxaliplatin, and irinotecan) and whose tumors have an abnormal KRAS G12C gene. Your doctor will perform a genetic test before you use this medicine.

Sotorasib belongs to the group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed.

This medicine is available only with your doctor's prescription.

Treat metastatic (cancer that has already spread) or locally advanced (cannot be removed by surgery).

Non-small cell lung cancer (NSCLC).

Used in combination with panitumumab to treat metastatic (cancer that has already spread) colorectal cancer (cancer of the color or rectum).

LuciSot is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

The recommended dosage of LuciSot is 960 mg (eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity. Take LuciSot at the same time each day with or without food.

Recommended LuciSot Dose Reduction Levels for Adverse Reactions:

1. First dose reduction: 480 mg (4 tablets) once daily

2. Second dose reduction: 240 mg (2 tablets) once daily

Tablets should be swallowed whole & not chewed or crushed.

More common

Black, tarry stools

Bleeding gums

Bloody stools

Chest pain or tightness

Cough

Coughing up blood

Dark urine

Difficulty swallowing

Dizziness

Fever or chills

Headache

Heavy nonmenstrual vaginal bleeding

Light-colored stools

Loss of appetite

Nausea or vomiting

Nosebleeds

Paralysis

Prolonged bleeding from cuts

Red or dark brown urine

Sneezing

Sore throat

Stomach pain

Trouble breathing

Unusual tiredness or weakness

Vomiting of blood or material that looks like coffee grounds

Yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Lonafarnib

Mavacamten

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abemaciclib

Acalabrutinib

Alfentanil

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Apalutamide

Astemizole

Avacopan

Avapritinib

Axitinib

Bedaquiline

Bosutinib

Brigatinib

Calcium Carbonate

Calcium Silicate

Carbamazepine

Ceritinib

Cimetidine

Cisapride

Clindamycin

Cobimetinib

Colchicine

Conivaptan

Crinecerfont

Crizotinib

Cyclosporine

Dabigatran Etexilate

Dasatinib

Dexlansoprazole

Digoxin

Dihydroergotamine

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Diltiazem

Docetaxel

Dofetilide

Doxorubicin

Doxorubicin Hydrochloride Liposome

Dronedarone

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Keep medicine out of the reach of Children.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Your doctor will do blood tests to check your liver before you start taking this medicine, every 3 weeks for the first 3 months, and once a month after you start taking this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If a dose is missed by more than 6 hours, do not take an extra dose. Take the next dose at the regular scheduled time. Do not take extra medicine to make up for the missed dose.

If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.