Cotellic

The recommended adult dose of Cotellic (Cobimetinib) is 60 mg (three 20 mg tablets) taken once daily. Cotellic (Cobimetinib) is taken daily for 21 days, and then stopped for 7 days. This forms a 28-day cycle. After 7 days without taking Cotellic (Cobimetinib), the 28-day cycle begins again.

Cotellic (Cobimetinib) may be taken with or without food. The tablets should be swallowed whole, with a glass of water.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Cotellic (Cobimetinib) exactly as prescribed by your doctor. If you vomit after taking a dose, do not take another dose. Continue with your regular dosing schedule the next day.

If you miss a dose, and it is less than 12 hours since the missed dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each white, round, film-coated tablet with "COB" debossed on one side contains 20 mg of Cotellic (Cobimetinib) (as 22.2 mg of Cotellic (Cobimetinib) fumarate). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film-coating mixture includes (alphabetical order) Polyethylene Glycol 3350 (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide.

Do not take Cotellic (Cobimetinib) if you are allergic to Cotellic (Cobimetinib) or any ingredients of the medication.

There may be an interaction between Cotellic (Cobimetinib) and any of the following:

• Abiraterone acetate
• Amiodarone
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Bicalutamide
• Bosentan
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Cobicistat
• conivaptan
• Cyclosporine
• Dabrafenib
• Deferasirox
• Dronedarone
• Enzalutamide
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Idelalisib
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Mitotane
• Modafinil
• nefazodone
• Phenobarbital
• Porfimer
• rifabutin
• rifampin
• St. John's wort
• seizure medications (e.g., Carbamazepine, Clobazam, Lamotrigine, Levetiracetam, Lomitapide, Phenytoin)
• siltuximab
• simeprevir
• Stiripentol
• Tocilizumab
• Verteporfin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Anemia: Cotellic (Cobimetinib) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Bleeding: Cotellic (Cobimetinib) can increase the risk of experiencing uncontrolled bleeding. If you have risk factors for bleeding, such as medical conditions that reduce clotting or you are taking blood thinners, discuss with your doctor how Cotellic (Cobimetinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Cotellic (Cobimetinib), and whether any special monitoring is needed.

Heart problems: This medication may worsen symptoms of heart disease. If you have heart disease such as Angina, Congestive Heart Failure, or arrhythmia, discuss with your doctor how Cotellic (Cobimetinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Cotellic (Cobimetinib), and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles. Your doctor may want to monitor your heart function periodically while you are using Cotellic (Cobimetinib), to ensure that any problems are identified early in their development.

High blood pressure: Cotellic (Cobimetinib) may increase your blood pressure. Your doctor will monitor your blood pressure while you are taking Cotellic (Cobimetinib). If you have high blood pressure, discuss with your doctor how Cotellic (Cobimetinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Cotellic (Cobimetinib), and whether any special monitoring is needed.

Liver function: Decreased liver function may cause Cotellic (Cobimetinib) to build up in the body, causing side effects. It has also been reported to cause decreased liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Your doctor may want to test your liver function regularly with blood tests while you are taking Cotellic (Cobimetinib). This often allows reduced liver function to be identified before it becomes too severe.

Muscle effects: Muscle damage has been associated with the use of Cotellic (Cobimetinib). Report any unexplained muscle pain, tenderness, weakness, or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Sensitivity to sunlight: Cotellic (Cobimetinib) may increase the sensitivity of the skin to sunlight, increasing the risk of sunburn. Avoid exposure to sunlight as much as possible, particularly between the hours of 10 am and 2 pm, while you are taking Cotellic (Cobimetinib) and for 7 days after completing treatment. Wear a broad-spectrum sunscreen and lip balm with an SPF of 50 or greater. If you notice any unusual skin rash or peeling, contact your doctor immediately.

Vision: Cotellic (Cobimetinib) may fluid to build up in the back of the eye. It may also contribute to a blockage of the blood vessels that lead out of the eye. If you notice any vision changes or problems, contact your doctor as soon as possible.

Pregnancy: Cotellic (Cobimetinib) should not be used during pregnancy unless the benefits outweigh the risks. Cotellic (Cobimetinib) may cause harm to a developing baby if taken by the mother. If you become pregnant while taking Cotellic (Cobimetinib), contact your doctor immediately. Use 2 forms of effective birth control while taking Cotellic (Cobimetinib) and for at least 3 months after stopping treatment.

Breast-feeding: It is not known if Cotellic (Cobimetinib) passes into breast milk. If you are a breast-feeding mother and are taking Cotellic (Cobimetinib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Cotellic (Cobimetinib) have not been established for children.

Seniors: Seniors may be at an increased risk of experiencing side effects of Cotellic (Cobimetinib). It may be necessary to use a lower dose of Cotellic (Cobimetinib) to reduce the severity of side effects.