Description
Avutometinib and defactinib combination is used to treat low-grade serous ovarian cancer that has come back in patients who received other cancer treatments and whose tumors have an abnormal KRAS gene. Your doctor will perform a genetic test before you use this medicine.
Avutometinib and defactinib combination 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.
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 avutometinib and defactinib combination 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 avutometinib and defactinib combination in the elderly.
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 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.
- Adagrasib
- Amprenavir
- Apalutamide
- Aprepitant
- Atazanavir
- Berotralstat
- Boceprevir
- Bosentan
- Carbamazepine
- Cenobamate
- Ceritinib
- Cimetidine
- Ciprofloxacin
- Clarithromycin
- Clofazimine
- Cobicistat
- Conivaptan
- Crizotinib
- Dabrafenib
- Darunavir
- Dexlansoprazole
- Diltiazem
- Dipyrone
- Dronedarone
- Duvelisib
- Ebrotidine
- Efavirenz
- Elagolix
- Encorafenib
- Enzalutamide
- Erythromycin
- Esomeprazole
- Etravirine
- Famotidine
- Fedratinib
- Fluconazole
- Fosamprenavir
- Fosnetupitant
- Fosphenytoin
- Idelalisib
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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
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:
- Eye or vision problems, history of or
- Liver disease or
- Skin problems—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.
Take this medicine with food. Take the capsule at the same time each day.
Swallow the capsule whole. Do not break, chew, or open it.
Swallow the tablet whole. Do not break, chew, or crush it.
Your doctor may give you other medicines (eg, oral antibiotics, topical steroid medicine) before treatment with this medicine to help prevent skin reactions.
Take this medicine at least 2 hours before or 2 hours after taking an antacid (eg, H2 blocker, proton pump inhibitor).
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 forms (capsules and tablets):
- For ovarian cancer:
- Adults—
- Avutometinib capsule: 3.2 milligrams (mg) (four 0.8 mg capsules) taken 2 times a week (Day 1 and Day 4) for the first 3 weeks of each 4 week cycle. Your doctor may adjust your dose as needed and tolerated.
- Defactinib tablet: 200 milligrams (mg) 2 times a day for the first 3 weeks of each 4 week cycle. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For ovarian 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.
Avmapki™: If a dose is missed by more than 24 hours, skip the missed dose. Take the next dose at the regular scheduled time.
Fakzynja™: If a dose is missed by more than 6 hours, skip the missed dose. Take the next dose at the regular scheduled time.
If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.
Storage
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.
Store in the refrigerator. Do not freeze.
Avmapki™: Do not remove the desiccant (drying agent).
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 month after your last dose. Males who are taking this medicine with female partners who can become pregnant must use effective birth control during treatment and for 4 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
Check with your doctor right away if you have blurred vision, changes in vision, seeing flashes or sparks of light, seeing floating spots before the eyes, or a veil or curtain appearing across part of vision, or swelling around the eyes. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) before and during treatment with this medicine.
This medicine may cause serious skin reactions, including acute generalized exanthematous pustulosis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black tarry stools, chest pain, chills, cough, fever, increased sensitivity of the skin to sunlight, painful or difficult urination, redness or other discoloration of the skin, severe sunburn, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. Your doctor will give you medicine to apply or antibiotics to help prevent skin reactions.
This medicine may make your skin more sensitive to sunlight. Avoid spending long periods of time in sunlight. Use sunscreen or sunblock lotions with a sun protection factor (SPF) on a regular basis when you are outdoors. Wear protective clothing and hats and avoid sunlamps and tanning beds.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause rhabdomyolysis (severe muscle problem). Check with your doctor right away if you have dark-colored urine, fever, muscle cramps, spasms, pain, or stiffness, or unusual tiredness or weakness.
If you plan to have children, talk with your doctor before using this medicine. 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
- Bladder pain
- bleeding gums
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody or cloudy urine
- blurred vision
- body aches or pain
- burning, numbness, tingling, or painful sensations
- change in vision
- chills
- confusion
- coughing up blood
- cracked, dry, scaly skin
- difficult, burning, or painful urination
- difficulty breathing or swallowing
- difficulty seeing at night
- dizziness
- dry eye
- ear congestion
- fainting
- fast heartbeat
- frequent urge to urinate
- headache
- increased menstrual glow or vaginal bleeding
- increased sensitivity of the eyes or skin to sunlight
- lightheadedness
- loss of voice
- lower back or side pain
- muscle or bone pain
- nervousness
- nosebleeds
- pain in the chest, groin, or legs, especially the calves
- paralysis
- pounding in the ears
- prolonged bleeding from cuts
- rapid, shallow breathing
- redness or other discoloration of the skin
- seeing flashes or sparks of light
- seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
- severe sunburn
- skin rash
- slow or fast heartbeat
- slurred speech
- sneezing
- stuffy or runny nose
- sudden, severe weakness or numbness in the arm or leg
- sudden loss of coordination
- swelling
- swelling of the hands, ankles, feet, or lower legs
- unsteadiness or awkwardness
- unusual tiredness or weakness
- weakness in the arms, hands, legs, or feet
Less common
- Stomach pain
Incidence not known
- Black, tarry stools
- chest pain
- cough
- dark urine
- fever
- loss of appetite
- muscle cramps, spasms, or stiffness
- nausea or vomiting
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
- 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
- Acid or sour stomach
- belching
- change or loss of taste
- constipation
- decreased appetite
- diarrhea
- dry mouth
- heartburn
- indigestion
- joint swelling
- loosening of the fingernails
- loss or thinning of the hair
- redness or soreness around the fingernails
- stomach discomfort or upset
- swelling or inflammation of the mouth
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.
DRG-80007465
