Cobimetinib

Generic name: Cobimetinib
Brand names: Cotellic
Dosage form: oral tablet (20 mg)
Drug class: Multikinase inhibitors

Usage of Cobimetinib

Cobimetinib is used in adults to treat a certain type of metastatic melanoma (skin cancer) that has spread to other parts of the body and cannot be removed with surgery. Cobimetinib is usually given together with another medicine called vemurafenib.

Cobimetinib is used only if your tumor has a specific genetic marker, for which your doctor will test.

Cobimetinib is also used alone to treat adults with blood cancers called histiocytic neoplasms.

Cobimetinib may also be used for purposes not listed in this medication guide.

Cobimetinib side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cobimetinib may cause serious side effects. Call your doctor at once if you have:

vision changes, partial vision loss, seeing halos around lights;

unexplained muscle pain, tenderness, or weakness (especially if you also have fever and dark colored urine);

easy bruising or bleeding (nosebleeds, bleeding gums);

signs of bleeding inside the body--weakness, dizziness, headache, red or pink urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

signs of a heart problem--cough, wheezing, shortness of breath (even with mild exertion), chest pain, fast heartbeats, swelling in your feet or ankles;

low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;

liver problems--nausea, upper stomach pain, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

severe skin reaction--skin pain, itching, redness, bumps or pimples, thickened or wrinkled skin, skin rash that spreads and causes blistering and peeling.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of cobimetinib may include:

nausea, vomiting, diarrhea, upset stomach, heartburn;

bumps similar to acne on face, scalp, chest, or upper back;

dry skin, itching, rash;

tiredness;

swelling of arms, legs, or feet;

pain and burning when you urinate;

lung problems;

fever;

increased sensitivity to sunlight; or

abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Cobimetinib

You should not use cobimetinib if you are allergic to it.

Tell your doctor if you have ever had:

heart disease, heart rhythm disorder;

a history of eye problems (especially a problem with your retina);

liver or kidney disease;

skin problems not related to melanoma;

a muscle disorder;

a bleeding or blood clotting disorder such as hemophilia; or

a condition for which you take a blood thinner such as warfarin (Coumadin, Jantoven).

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using cobimetinib and for at least 2 weeks after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using cobimetinib, and for at least 2 weeks after your last dose.

Cobimetinib may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Relate drugs

How to use Cobimetinib

Usual Adult Dose for Melanoma -- Metastatic:

60 mg orally once a day for first 21 days of each 28-day cycle until disease progression or unacceptable toxicityComments: -The presence of BRAF V600E or V600K mutation in tumor specimens should be confirmed with an FDA-approved test prior to therapy initiation; information on FDA-approved tests available at http://www.fda.gov/CompanionDiagnostics.Use: In combination with vemurafenib, indicated for treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

Usual Adult Dose for Histiocytic Neoplasm:

60 mg orally once a day for first 21 days of each 28-day cycle until disease progression or unacceptable toxicityUse: Treatment of adult patients with histiocytic neoplasms

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What other drugs will affect Cobimetinib

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect cobimetinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Disclaimer

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