Description
Adagrasib is used to treat non-small cell lung cancer (NSCLC) that has spread in patients who have received at least one previous treatment and whose tumors have an abnormal KRAS G12C gene. It is also used in combination with cetuximab to treat colorectal cancer (cancer of the colon or rectum) that has spread in patients who have received other cancer medicines (eg, fluoropyrimidine, oxaliplatin, and irinotecan) and whose tumors have an abnormal KRAS G12C gene.
Adagrasib 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 adagrasib 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 adagrasib 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.
- Deuruxolitinib
- Levoketoconazole
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
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Avanafil
- Avapritinib
- Azithromycin
- Bedaquiline
- Bepridil
- Boceprevir
- Bosutinib
- Budesonide
- Buprenorphine
- Buserelin
- Buspirone
- Carbamazepine
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Cisapride
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Cobicistat
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:
- Heart failure or
- Heart rhythm problems or
- 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.
You may take this medicine with or without food. Take the medicine at the same time each day.
Swallow the tablet whole. Do not chew, crush, or split it.
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—600 milligrams (mg) 2 times 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 4 hours or if you vomit after you take a dose, 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.
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. Blood tests may be needed to check for unwanted effects.
This medicine may cause diarrhea, nausea, vomiting, or serious stomach or bowel problems (eg, bleeding, blockage, swelling, narrowing), Check with your doctor right away if you have fever, pain, stomach pain, cramps, or tenderness, watery or bloody diarrhea. Your doctor may give you medicines (eg, diarrhea medicine) to treat it.
This medicine may increase risk of heart rhythm problems, including QT prolongation and torsade de pointes. Check with your doctor right away if you have chest pain or discomfort, irregular or slow heart rate, fainting, or trouble breathing.
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.
Talk with your doctor before using this medicine if you plan to have children. Some men and women using this medicine have become infertile (unable to have children).
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
- Agitation
- bloody urine
- bone pain
- chest pain, discomfort, or tightness
- coma
- confusion
- constipation
- cough
- dark urine
- decreased amount of urine
- depression
- diarrhea
- dizziness
- dry skin
- fainting
- fast heartbeat
- fever or chills
- headache
- hostility
- increased blood pressure
- increased thirst
- irregular or slow heart rate
- irritability
- lethargy
- lightheadedness
- loss of appetite
- lower back or side pain
- muscle twitching
- nausea
- rapid, shallow breathing
- seizures
- sneezing
- sore throat
- stomach pain, severe
- stupor
- swelling
- swelling of the face, fingers, or lower legs
- trouble breathing
- unusual tiredness or weakness
- vomiting
- weight gain
- yellow eyes or skin
Less common
- Anxiety
- blue lips, fingernails, or skin
- blurred vision
- coughing up blood
- decreased appetite
- decreased urination
- decreased weight
- dilated neck veins
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- muscle pain or cramps
- nightmares or unusually vivid dreams
- pale skin
- sunken eyes
- sweating
- unusual bleeding or bruising
- wrinkled skin
Rare
- Inability to speak
- slurred speech
- stiffness
- temporary blindness
- weakness in the arm or legs on one side of the body, sudden and severe
Incidence not known
- General feeling of discomfort or illness
- thickening of bronchial secretions
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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