COBIMETINIB - ORAL

COBIMETINIB - ORAL

PHONETIC PRONUNCIATION: (KOE-bi-ME-ti-nib)

COMMON BRAND NAME(S): Cotellic

GENERIC NAME(S): cobimetinib fumarate

Uses

USES: Cobimetinib is used with another medication (vemurafenib) to treat a type of skin cancer (melanoma). It works by slowing or stopping the growth of cancer cells.


How to use COBIMETINIB - ORAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking cobimetinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily for 21 days, then stopping the medication for 7 days. This is one cycle of treatment. Continue taking the medication this way as directed by your doctor. If you vomit after taking a dose, do not take another dose at that time. Take your next dose at the regular time. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Side Effects

SIDE EFFECTS: Diarrhea, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods. People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: unusual skin changes (such as skin sores/lumps, warts, change in the size/color of a mole), easy bleeding/bruising (such as bleeding of the gums), unusual vaginal bleeding, black/bloody stools, vomit that contains blood or looks like coffee grounds, blood in the urine, muscle pain/tenderness/weakness, signs of kidney problems (such as change in the amount of urine), signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), vision changes (such as blurred vision, vision loss, seeing halos), signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine). Get medical help right away if you have any very serious side effects, including: signs of bleeding in the brain (such as severe headache, weakness on one side of the body, sudden vision changes, slurred speech, seizures, confusion). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking cobimetinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, high blood pressure, heart disease (heart failure), eye problems, liver disease. This drug may cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen/lip balm and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of childbearing age must use reliable forms of birth control while taking cobimetinib and for 2 weeks after the last dose of this medication. If you become pregnant or think you may be pregnant, tell your doctor right away. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 2 weeks after the last dose of this medication is not recommended. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of cobimetinib from your body, which may affect how cobimetinib works. Examples include azole antifungals (such as itraconazole), efavirenz, rifamycins (such as rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for COBIMETINIB - ORAL

Cobimetinib is an oral medication used for the treatment of advanced melanoma that cannot be surgically removed or has spread to other parts of the body.

Cobimetinib inhibits the activity of a specific protein called MEK, which is involved in cell growth and division. By blocking MEK, Cobimetinib helps to slow down or stop the growth of cancer cells.

Cobimetinib is usually taken once daily, with or without food. The dosage will depend on the patient's individual requirements and the prescribing doctor's instructions.

The most common side effects of Cobimetinib include diarrhea, nausea, vomiting, fatigue, rash, photosensitivity, joint pain, headache, and fever. It is important to inform your doctor about any severe or persistent side effects.

Yes, Cobimetinib is often used in combination with another medication called vemurafenib for the treatment of melanoma that has a specific mutation called BRAF V600E or V600K. However, the use of Cobimetinib with other medications should be determined by a healthcare professional.

Cobimetinib may interact with other medications, so it is important to inform your doctor about all the medications, supplements, and herbal products you are taking. Medications that may interact with Cobimetinib include certain antibiotics, antifungals, antidepressants, and heart medications.

Cobimetinib may not be suitable for everyone. It is important to discuss your medical history and current medications with your doctor before starting Cobimetinib. Pregnant or breastfeeding women should also avoid Cobimetinib, as it may harm the unborn baby or pass into breast milk.

The duration of Cobimetinib treatment will depend on various factors, including the stage of melanoma and the response to treatment. Your doctor will determine the appropriate treatment duration for you.

Cobimetinib can cause severe or potentially fatal side effects, such as bleeding, heart problems, or liver problems. It is important to inform your doctor immediately if you experience any unusual symptoms or side effects while taking Cobimetinib.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.