Cotellic

1 What is Cotellic?

Brand: Cotellic

Generic: Cobimetinib

Brand Name:

Cotellic.

Cobimetinib is an antineoplastic drug used in combination with vemurafenib to treat melanomas that cannot be resected by surgery or that have already metastasized. 

It is only used if the melanoma cells have the BRAF V600E or V600K mutations. These mutations are detected by special tests. This drug requires a prescription.

2 What to Know Before Using

Before taking this drug, the risks and benefits for your body should be discussed with your healthcare provider. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. 

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies in children regarding the correlation of age to the effects of cobimetinib have not been performed while safety and efficacy have not been established. 

Studies in the elderly have not reported any geriatric-specific problems that would limit the usefulness of cobimetinib. Studies regarding infant risk when taking this drug during breastfeeding are still under investigation. Discuss with your healthcare professional the possible risks and benefits before taking this drug while breastfeeding. 

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects. 

Inform your healthcare professional if you are taking any other drugs such as Aprepitant, Atazanavir, Boceprevir, Bosentan, Carbamazepine, Clarithromycin, Cobicistat, Conivaptan, Diltiazem, Dronedarone, Efavirenz, Enzalutamide, Erythromycin, Fluconazole, Fosaprepitant, Fosphenytoin, Idelalisib, Imatinib, Indinavir, Itraconazole, Ketoconazole, Lopinavir, Mitotane, Modafinil, Nefazodone, Nelfinavir, Phenobarbital, Phenytoin, Posaconazole, Primidone, Rifampin, Ritonavir, Saquinavir, St John's Wort, Telaprevir, Telithromycin, Verapamil, or Voriconazole. 

Inform your healthcare professional if you are taking any other prescription or non-prescription drugs. Intake of specific food or using alcohol or tobacco with magnesium is associated with an increased risk of certain side effects. 

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your healthcare provider for any other medical problems such as bleeding problems, eye or vision problems, heart disease, liver problems, muscle problems or other skin problems.

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3 Proper Usage

Discuss with your healthcare professional about the risks and benefits of taking this drug since taking anti-neoplastic drugs are very strong and can have many side effects. To prevent any side effects, take this drug exactly as directed in the label or as prescribed by your healthcare professional. 

You can take this drug with or without food. The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug. 

Adults with melanoma are given 60 milligrams once a day for 21 days, followed by a 7-day rest period for a 28-day cycle. Use and dose in children must be determined by your healthcare professional. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose. 

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. 

Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.  Do not use this drug if the seal on the bottle is broken or missing. Keep the bottle tightly closed.

4 Precautions to Take

Your healthcare provider should closely monitor the effectiveness of this drug as well as check for unwanted effects. Unwanted effects may be screened using blood tests. This drug has teratogenic potential and birth control practice is recommended to prevent occurrence of pregnancy during treatment and for 2 weeks after the last dose. 

Inform your healthcare professional immediately if you become pregnant while taking this drug. Consult with your healthcare profession if you plan to have children, since this drug has been reported to cause fertility problems. Using this medicine may cause skin cancers such as cutaneous squamous cell carcinoma, basal cell carcinoma. 

Your healthcare professional should check your skin before taking this medicine, every 2 months while taking this drug, and for 6 months after you stop taking this drug. Inform your healthcare professional immediately if you have a change in size or color of a mole, new wart, or reddish bump that bleeds or does not heal. 

Limit your exposure to sunlight; wear protective clothing and lways use sunscreen or sun blocking lotions. Inform your healthcare professional if you have sun rash, skin irritation, painful and itchy skin that is hot to the touch, bumps or tiny papules, or thickened, dry, wrinkled skin. 

Consult with your healthcare professional immediately if you have bleeding gums, red or black, tarry stools, red or dark brown urine, dizziness, headache, abdominal pain, or unusual vaginal bleeding, persistent, coughing or wheezing, chest pain, fast, irregular, or pounding heartbeat, swelling of the feet or lower legs, shortness of breath, or unusual tiredness or weakness, severe skin rash, acne, or redness, blisters, swelling, peeling, or tenderness of the hands or feet, blurred vision, loss of vision, pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin, dark-colored urine, fever, muscle cramps, spasms, or pain, or unusual tiredness or weakness, or any change in vision. 

You may be referred to an ophthalmologist to check for any eye problems. Consult with your healthcare professional before taking any other prescription or non-prescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

Side effects may vary for each individual and prompt medical attention should be given if they occur. Inform you healthcare provider immediately if you experience any unusual symptoms such as:

  • abdominal or stomach pain or tenderness
  • bleeding gums
  • blurred vision or any other change in vision
  • chest discomfort or pain
  • chills
  • clay colored stools
  • coughing up blood
  • dark urine
  • decreased appetite
  • difficulty in breathing or swallowing
  • dizziness
  • faintness
  • fast irregular or pounding heartbeat
  • fever
  • headache
  • increased menstrual flow or vaginal bleeding
  • increased sensitivity of the skin to sunlight
  • itching or skin rash
  • loss of appetite
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea and vomiting
  • nervousness
  • nosebleeds,
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts,
  • ed or black, tarry stools red or dark brown urine
  • redness or other discoloration of the skin
  • seeing flashes or sparks of light
  • seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
  • severe sunburn
  • slow or fast heartbeat
  • swelling of the feet or lower legs
  • unusual tiredness or weakness
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. As your body adjusts to the drug, these side effects may eventually disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects. 

If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional.

 If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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