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cobimetinib (Oral route)

koe-bi-ME-ti-nib

Commonly used brand name(s)

In the U.S.

  • Cotellic

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antineoplastic Agent

Uses For cobimetinib

Cobimetinib is used in combination with vemurafenib to treat melanoma (skin cancer) that has spread or that cannot be removed by surgery. It is only used if the melanoma cells have the BRAF V600E or V600K mutations. Your doctor will use a special test to look for these mutations. Cobimetinib belongs to the group of medicines called antineoplastics (cancer medicines).

cobimetinib is available only with your doctor's prescription.

Before Using cobimetinib

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 cobimetinib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cobimetinib 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 cobimetinib 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 cobimetinib in the elderly.

Breast Feeding

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.

Interactions with Medicines

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 cobimetinib, 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 cobimetinib 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.

  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Varicella Virus Vaccine

Using cobimetinib 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.

  • Adenovirus Vaccine
  • Aprepitant
  • Atazanavir
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Boceprevir
  • Bosentan
  • Carbamazepine
  • Cholera Vaccine, Live
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Diltiazem
  • Dronedarone
  • Efavirenz
  • Enzalutamide
  • Erythromycin
  • Fluconazole
  • Fosaprepitant
  • Fosphenytoin
  • Idelalisib
  • Imatinib
  • Indinavir
  • Influenza Virus Vaccine, Live
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Mitotane
  • Modafinil
  • Nefazodone
  • Nelfinavir
  • Phenobarbital
  • Phenytoin
  • Poliovirus Vaccine, Live
  • Posaconazole
  • Primidone
  • Rifampin
  • Ritonavir
  • Saquinavir
  • Smallpox Vaccine
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Typhoid Vaccine
  • Verapamil
  • Voriconazole
  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

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 cobimetinib 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 cobimetinib, 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 cobimetinib. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Eye or vision problems or
  • Heart disease (eg, cardiomyopathy) or
  • Liver problems or
  • Muscle problems or
  • Other skin problems—Use with caution. May make these conditions worse.

Proper Use of cobimetinib

Medicines used to treat cancer are very strong and can have many side effects. Before using cobimetinib, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take cobimetinib 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.

cobimetinib usually comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take cobimetinib with or without food.

Dosing

The dose of cobimetinib 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 cobimetinib. 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 melanoma:
      • Adults—60 milligrams (mg) (three 20 mg tablets) once a day for 21 days, followed by a 7-day rest period for a 28-day cycle.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

cobimetinib needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

If you vomit after taking your medicine, call your doctor or pharmacist for instructions.

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 While Using cobimetinib

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects. Your doctor may decrease your dose if unwanted effects occur.

Using cobimetinib while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 2 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

cobimetinib may cause fertility (ability to have children) problems in men or women. Talk to your doctor before using cobimetinib if you plan to have children.

Using cobimetinib may cause skin cancers (eg, cutaneous squamous cell carcinoma, basal cell carcinoma). Your doctor should check your skin before taking cobimetinib, every 2 months while taking cobimetinib, and for 6 months after you stop taking cobimetinib. Tell your doctor right away if you have a change in size or color of a mole, new wart, or reddish bump that bleeds or does not heal.

Avoid overexposing your skin to sunlight. Always use sunscreen or sun blocking lotions and wear protective clothing and hats. Tell your doctor if you have sun rash, skin irritation, painful and itchy skin that is hot to the touch, bumps or tiny papules, or thickened, dry, wrinkled skin

cobimetinib may increase your risk of bleeding. Tell your doctor right away if you have bleeding gums, red or black, tarry stools, red or dark brown urine, dizziness, headache, abdominal pain, or unusual vaginal bleeding while you are taking cobimetinib.

cobimetinib may cause cardiomyopathy (heart disease). Tell your doctor right away if you have persistent coughing or wheezing, chest pain, fast, irregular, or pounding heartbeat, swelling of the feet or lower legs, shortness of breath, or unusual tiredness or weakness.

Call your doctor right away if you have a severe skin rash (especially if it covers a large area of your body), acne, or redness, blisters, swelling, peeling, or tenderness of the hands or feet. These may be symptoms of a serious skin problem.

Check with your doctor right away if blurred vision, loss of vision, or any change in vision occurs during treatment. These could be symptoms of a serious eye problem. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

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

Rhabdomyolysis (severe muscle problem) may occur while receiving cobimetinib. Tell your doctor right away if you have dark-colored urine, fever, muscle cramps, spasms, or pain, or unusual tiredness or weakness.

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 (eg, St. John's wort) or vitamin supplements.

cobimetinib 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
  • Abdominal or stomach pain or tenderness
  • bleeding gums
  • blurred vision or any other change in vision
  • chest discomfort or pain
  • chills
  • clay colored stools
  • coughing up blood
  • dark urine
  • decreased appetite
  • difficulty in breathing or swallowing
  • dizziness
  • faintness
  • fast irregular or pounding heartbeat
  • fever
  • headache
  • increased menstrual flow or vaginal bleeding
  • increased sensitivity of the skin to sunlight
  • itching or skin rash
  • loss of appetite
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea and vomiting
  • nervousness
  • nosebleeds
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • 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
  • slow or fast heartbeat
  • swelling of the feet or lower legs
  • unusual tiredness or weakness
  • 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
  • Acne or pimples
  • diarrhea
  • nausea
  • swelling or inflammation of the mouth
  • vomiting

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.

See also: Side effects (in more detail)

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