Mekinist

Generic Name: trametinib (tra ME ti nib)
Brand Names: Mekinist

What is Mekinist?

Mekinist (trametinib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Mekinist is used to treat a certain type of metastatic melanoma (skin cancer that has spread to other parts of the body).

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

Important information

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.

Slideshow: Flashback: FDA Drug Approvals 2013

Mekinist should not be used to treat people who have received a BRAF inhibitor for treatment of their melanoma.

It is not known if Mekinist is safe and effective in children.

Before taking this medicine

You should not use Mekinist if you are allergic to trametinib.

To make sure Mekinist is safe for you, tell your doctor if you have:

  • heart disease;

  • high blood pressure;

  • lung disease;

  • liver or kidney disease;

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

  • if you have ever been treated with dabrafenib or vemurafenib to treat your melanoma.

Using Mekinist may increase your risk of developing other types of skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice any new skin symptoms such as redness, sores that will not heal, or a mole that has changed in size or color.

FDA pregnancy category D. Do not use Mekinist if you are pregnant. It could harm the unborn baby. Tell your doctor if you become pregnant during treatment. Use effective birth control while you are using this medication and for at least 4 months after your treatment ends.

See also: Pregnancy and breastfeeding warnings (in more detail)

This medication may affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether trametinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Mekinist?

Take Mekinist exactly as prescribed by your doctor. Your doctor will perform blood tests to make sure you have the correct tumor type to be treated with Mekinist.

Mekinist is usually taken once daily. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Mekinist on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not crush, chew, break, or open a capsule. Swallow it whole.

Your doctor will need to check your skin on a regular basis while you are using this medicine.

Your blood pressure will need to be checked often. Your heart function may need to be checked with an electrocardiograph or ECG (sometimes called an EKG) every 2 or 3 months during your treatment. You may also need regular vision examinations while taking Mekinist.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Mekinist side effects

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

Stop using Mekinist and call your doctor at once if you have:

  • chest pain, dry cough, wheezing, feeling short of breath;

  • severe skin rash or irritation;

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • little or no urinating;

  • vision changes, vision loss, seeing flashes of light or "floaters" in your vision, seeing halos around lights;

  • severe skin rash, skin pain, redness or warmth, redness and peeling skin on your hands or feet;

  • swollen glands; or

  • dangerously high blood pressure (severe headache or dizziness, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Common Mekinist side effects may include:

  • diarrhea;

  • general ill feeling; or

  • acne, mild skin rash.

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.

See also: Side effects (in more detail)

Mekinist Dosing Information

Usual Adult Dose for Melanoma - Metastatic:

2 mg orally once daily. Take at least 1 hour before or 2 hours after a meal.

Duration of therapy: Until disease progression or unacceptable toxicity occurs.

Comments:
-Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation.
-Mekinist is not indicated for treatment of patients who have received prior BRAF-inhibitor therapy.

Approved indication:
Unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

What other drugs will affect Mekinist?

Other drugs may interact with Mekinist, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Mekinist.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2013-07-10, 8:43:57 AM.

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