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COTELLICTM (co-TELL-ic) (cobimetinib) tablet

Chemotherapy 

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AFINITOR®
a-fin-it-or
Everolimus tablets​

Chemotherapy

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What is COTELLIC?

COTELLIC is a prescription medicine that is used with vemurafenib, to treat a type of skin cancer called melanoma

  • that has spread to other parts of the body or cannot be removed by surgery, and
  • that has a certain type of abnormal “BRAF” gene
  • Your healthcare provider will perform a test for the BRAF gene to make sure that COTELLIC is right for you.
  • COTELLIC is not used to treat melanoma with a normal BRAF gene.
  • It is not known if COTELLIC is safe and effective in children under 18 years of age.

What should I tell my healthcare provider before taking COTELLIC?

Before you take COTELLIC, tell your healthcare provider if you:

  • have any previous or current skin problems other than melanoma
  • have any medical conditions and/or on any medications that increase your risk of bleeding
  • have any heart problems
  • have any eye problems
  • have any liver problems
  • have any muscle problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. COTELLIC can harm your unborn baby.
  • Patients who take COTELLIC should use effective methods of birth control during treatment with COTELLIC and for at least 2 weeks after stopping COTELLIC
  • Talk to your healthcare provider about birth control methods that may be right for you.
  • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with COTELLIC.
  • are breastfeeding or plan to breastfeed. It is not known if COTELLIC passes into your breast milk. Do not breastfeed during treatment with COTELLIC and for 2 weeks after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements because some types of medicines will make COTELLIC more harmful or less effective.

 

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take COTELLIC?

  • Take COTELLIC exactly as your healthcare provider tells you. Do not change your dose or stop taking COTELLIC unless your healthcare provider tells you to.
  • COTELLIC is usually taken once daily for 21 days followed by a 7-day rest period (no drug) for a 28-day cycle.
  • Take your prescribed doses of COTELLIC with or without food.
  • If you miss a dose of COTELLIC or vomiting occurs, take the next dose as scheduled
  • If you take too much COTELLIC, call your healthcare provider or go the nearest hospital emergency room right away.

What should I avoid while taking COTELLIC

Avoid sunlight while you are taking COTELLIC. COTELLIC can make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. To help protect against sunburn:

  • When you go outside, wear clothes that protect your skin, including your head, face, hands, arms, and legs.
  • Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.

What are the possible side effects of COTELLIC?

COTELLIC may cause serious side effects, including:

  • Risk of skin cancers. COTELLIC may cause skin cancers (cutaneous squamous cell carcinoma, keratoacanthoma, or basal cell carcinoma).

Check your skin regularly and tell your healthcare provider right away if you have any skin changes
including:

  • new wart
  • skin sore or reddish bump that bleeds or does not heal
  • change in size or color of a mole

Your healthcare provider should check your skin before you start taking COTELLIC, and every 2 months while taking COTELLIC. Your healthcare provider may continue to check your skin for 6 months after you stop taking COTELLIC.

  • Increased risk of bleeding. COTELLIC may cause bleeding, including blood in the urine, rectal bleeding, unusual or excessive vaginal bleeding, bleeding of the gums, and bleeding within the brain (cerebral hemorrhage).
  • Tell your healthcare provider right away if you experience any of these symptoms:
  • red or black stools that look like tar
  • blood in the urine
  • headache, dizziness or feeling weak
  • abdominal pain
  • unusual vaginal bleeding
  • Heart problems that can lead to inadequate pumping of the blood by the heart. Your healthcare provider should perform tests before you start taking COTELLIC and during your treatment with COTELLIC to check the ability of the heart to pump blood. Signs and symptoms of a decrease in the amount of blood pumped include:
  • persistent coughing or wheezing
  • shortness of breath
  • swelling of your ankles and feet
  • tiredness
  • increased heart rate
  • Rash. Tell your healthcare provider right away if you experience any of these symptoms:
  • a rash that covers a large area of your body, blisters, or peeling skin
  • Eye problems. Tell your healthcare provider right away if you experience any of these symptoms during treatment with COTELLIC:
  • blurred vision
  • distorted vision
  • partly missing vision
  • halos
  • any other vision changes

Some of these eye problems may be a result of something called “serous retinopathy” (a build-up of fluid under the retina of the eye). Your healthcare provider should check your eyes if you notice any of the symptoms above.

The most common side effects of ALIQOPA include:

  • low white blood cell count (leukopenia)
  • low platelets in your blood (thrombocytopenia)
  • diarrhea
  • decreased strength and tiredness
  • lower respiratory tract infection
  • nausea

General information about the safe and effective use of ALIQOPA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about ALIQOPA that is written for health professionals.

What are the ingredients in ALIQOPA?

  • Active ingredient: copanlisib
  • Inactive ingredients: citric acid anhydrous, mannitol, sodium hydroxide

Tell your healthcare provider if you have vomiting, diarrhea, or signs of dehydration that does not go away. ABRAXANE may cause fertility problems in males and females, which may affect your ability to have a child. 

Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of ABRAXANE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

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What should I tell my healthcare provider before taking AFINITOR?

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