cotellic

Cotellic

7,150.0

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Cotellic

Price 7150 euro

Cotellic is used in combination with vemurafenib (Zelboraf).

The U.S. Food and Drug Administration (FDA) approved Cotellic (cobimetinib), a kinase inhibitor for use in combination with vemurafenib for the treatment of advanced melanoma with a BRAF V600E or V600K mutation.

Patient Information

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. You should also read the Medication Guide that comes with vemurafenib (Zelboraf).

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 this medicine is safe and effective in children under 18 years of age.
  • Before taking Cotellic

    Before you start treatment, 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 should use effective methods of birth control during treatment and for at least two weeks after the final dose.
      • 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.
    • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Do not breastfeed during treatment and for two 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 this medicine exactly as your healthcare provider tells you. Do not change your dose or stop taking treatment 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 with or without food.
    • If you miss a dose, or vomiting occurs, take the next dose as scheduled
    • If you take more than your prescribed dose, or overdose, call your healthcare provider or go the nearest hospital emergency room right away.

    What should I avoid while taking Cotellic?

    Avoid sunlight during treatment. 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.
    • Cotellic side effects

      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 treatment, and every two months during treatment. Your healthcare provider may continue to check your skin for six months after you take your final dose.
      • 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, 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:
        • 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.

      • Abnormal liver test or liver injury. Your healthcare provider should perform blood tests before you start, and during treatment. Tell your healthcare provider right away if you experience any of these symptoms:
        • yellowing of your skin or the white of your eyes
        • dark or brown (tea color) urine
        • nausea or vomiting
        • feeling tired or weak
        • loss of appetite
      • Increased levels of an enzyme in the blood. Creatine phosphokinase (CPK) is an enzyme that is primarily found in the muscle, heart, and brain. Treatment with Cotellic may increase the level of this enzyme in your blood and be a sign of muscle damage. Your healthcare provider should perform a blood test before and during treatment. Increased blood levels of CPK can also be an indication of a serious condition caused by injury to the muscles (rhabdomyolysis). Tell your healthcare provider right away if you experience any of these symptoms:
        • muscle aches
        • muscle spasms and weakness
        • dark, reddish urine
      • Photosensitivity. Your skin may become more sensitive to sunlight during treatment. Tell your healthcare provider if you notice any of the following symptoms:
        • red, painful, itchy skin that is hot to touch
        • sun rash
        • skin irritation
        • bumps or tiny papules
        • thick, dry, wrinkled skin

        See What should I avoid while taking Cotellic? for more information on helpful tips on the management of photosensitivity.

      The most common side effects of Cotellic include:

      • diarrhea
      • sunburn or sun sensitivity
      • nausea
      • vomiting
      • fever

      Your healthcare provider will take blood tests during treatment. The most common changes to blood tests include:

      • increased blood levels of liver enzymes (GGT, ALT, or AST)
      • increased blood level of enzyme from muscle (creatinine phosphokinase)
      • decreased blood level of phosphate, sodium or potassium
      • increased blood level of liver or bone enzyme (alkaline phosphatase)
      • decreased blood level of a type of white blood cell (lymphocyte)

      Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects. For more information about side effects, ask your healthcare provider or pharmacist.

      Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

      How should I store Cotellic?

      • Store the tablets at room temperature below 30°C (86°F).
      • Ask your healthcare provider or pharmacist how to safely throw away (dispose of) any unused or expired Cotellic.

      Keep all medicines out of the reach of children and pets.

      General information about Cotellic

      Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.

      If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

      For more information, call Genentech at 1-888-835-2555.

      What are the ingredients in Cotellic?

      Active ingredient: cobimetinib fumarate

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