mekinist

Mekinist (trametinib) is a cancer medicine 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 is sometimes given together with another medicine called dabrafenib (Tafinlar).

Important information

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

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.

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 bleeding or blood clotting disorder such as hemophilia;

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

• if you have ever had a blood clot; 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)

Mekinist can make birth control pills, patches, or injections less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking Mekinist.

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 trametinib.

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

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

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 in the refrigerator and protect from light. Do not freeze. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Do not store the tablets in a pill box.

Mekinist dosing information

Usual Adult Dose for Melanoma - Metastatic:

Single agent: 2 mg orally once a day.
Combination therapy: 2 mg orally once daily with dabrafenib 150 mg orally twice a day.
Duration of therapy: Until disease progression or unacceptable toxicity occurs.

Comments:
-Take at least 1 hour before or 2 hours after a meal.
-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.
-Continue treatment until disease progression or unacceptable toxicity occurs.

Use:
-As a single agent and in combination with dabrafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
-Mekinist as a single agent is not indicated for treatment of patients who have received prior BRAF-inhibitor therapy.

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 while taking Mekinist?

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 this medicine and call your doctor at once if you have:

• fever, severe diarrhea;

• dry cough, wheezing, feeling short of breath;

• eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;

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

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

• dangerously high blood pressure - severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats, seizure;

• signs of bleeding (more likely when taking trametinib and dabrafenib together) - weakness, dizziness, headache, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• signs of a blood clot (more likely when taking trametinib and dabrafenib together) - chest pain, sudden cough or trouble breathing, pain or swelling in an arm or leg, pale skin or cold feeling in an arm or leg; or

• signs of a heart problem (more likely when taking trametinib and dabrafenib together) - shortness of breath (even with mild exertion), pounding heartbeats, swelling in your feet or ankles.

Common Mekinist side effects may include:

• diarrhea, constipation;

• nausea, vomiting, stomach pain, loss of appetite;

• cough;

• night sweats;

• headache, muscle or joint pain;

• swelling in your face, arms, or legs;

• tiredness, 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)

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.