Description
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.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of sotorasib in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sotorasib in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Lonafarnib
- Mavacamten
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfentanil
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Apalutamide
- Astemizole
- Atrasentan
- Avacopan
- Avapritinib
- Axitinib
- Bedaquiline
- Bosutinib
- Brigatinib
- Cabozantinib
- Calcium Carbonate
- Calcium Silicate
- Carbamazepine
- Cariprazine
- Ceritinib
- Cholera Vaccine
- Cimetidine
- Cisapride
- Clindamycin
- Cobimetinib
- Colchicine
- Conivaptan
- Crinecerfont
- Crizotinib
- Cyclosporine
- Dabigatran Etexilate
- Dasatinib
- Deutivacaftor
- Dexlansoprazole
- Digoxin
- Dihydroergotamine
- Dihydroxyaluminum Aminoacetate
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Liver disease or
- Lung or breathing problems (eg, interstitial lung disease, pneumonitis)—Use with caution. May make these conditions worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
You may take this medicine with or without food. Take the medicine at the same time each day.
Swallow the tablet whole. Do not crush, break, or chew it.
If you cannot swallow the tablets:
- Put the tablets in a glass with 120 milliliters (mL) of non-carbonated, room temperature water without crushing the tablets. Do not use any other liquids.
- Stir until the tablets are in small pieces. The tablets will not completely dissolve. The color of the mixture may be pale to bright yellow.
- Drink the mixture right away or within 2 hours of preparing. Do not chew the small pieces of tablets.
- Add another 120 mL of water to the same glass and drink to make sure get the full dose.
- Stir the mixture again before drinking, if you do not drink the mixture right away.
Tell your doctor if you are also taking a stomach medicine (eg, famotidine, omeprazole, or other H2 blockers or PPIs). Take Lumakras® at least 4 hours before of 10 hours after taking an antacid.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For non-small cell lung cancer or colorectal cancer:
- Adults—960 milligrams (mg) (three 320 mg tablets, four 240 mg tablets, or eight 120 mg tablets) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For non-small cell lung cancer or colorectal cancer:
Missed Dose
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.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
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.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
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
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Blistering, crusting, irritation, itching, or reddening of the skin
- constipation
- cracked, dry, scaly skin
- diarrhea
- difficulty in moving
- discoloration of the fingernails or toenails
- dry skin
- joint or bone pain
- lack or loss of strength
- muscle aches, cramps, pain, or stiffness
- rash with flat lesions or small raised lesions on the skin
- redness, swelling, or pain of the skin
- scaling of the skin on the hands and feet
- swelling of the hands, ankles, feet, or lower legs
- swelling of the testes
- tingling of the hands and feet
- ulceration of the skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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