Mekinist

(Trametinib Dimethyl Sulfoxide)

The active ingredient in Mekinist is trametinib, which is a specific type of kinase inhibitor called an MEK inhibitor. It blocks a part of a pathway that tells cancer cells to grow and divide. In cancers with a BRAF V600E mutation, this pathway is overactive, causing uncontrolled cell growth. By inhibiting MEK, Mekinist slows or stops these growth signals, helping to reduce tumor growth. It is often used together with a BRAF inhibitor to improve effectiveness and reduce resistance.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Mekinist. However, the following is a synopsis of the general guidelines for the use of Mekinist:

• Mekinist is taken by mouth once daily.
• It should be taken on an empty stomach, at least 1 hour before or 2 hours after food.
• Swallow tablets whole with water. Do not crush or chew them.
• If using the oral solution, follow preparation instructions exactly as provided by your healthcare provider.
• Take Mekinist at the same time each day.
• If you miss a dose and it is less than 12 hours until your next dose, skip the missed dose. Do not take extra doses.
• Continue taking Mekinist until your healthcare provider tells you to stop.

Your healthcare provider may adjust your dose based on side effects, response to treatment, or other medical conditions.

Some mild or common side effects of trametinib seen in clinical trials include:

• Skin rash.
• Dry skin.
• Swollen lymph nodes.
• Acne-like skin reactions.
• Diarrhea.
• Lightheadedness.
• Dry mouth.
• Increased blood pressure.
• Decreased appetite.

Some individuals may experience serious side effects while using Mekinist. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Heart problems, including cardiomyopathy or heart failure.
• Shortness of breath or trouble breathing.
• Chest pain or signs of blood clots, including pulmonary embolism.
• Severe skin reactions or blistering.
• Bleeding problems, including vomiting blood or material that looks like coffee grounds.
• Eye problems, including blurred vision, eye pain, or vision loss.
• Severe stomach pain, which may indicate gastrointestinal perforation.
• Serious infections or life-threatening reactions.
• Swelling of the face, hands, or legs.

These are not all of the possible side effects of Mekinist. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Mekinist, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Heart problems or a history of cardiomyopathy.
• High blood pressure or hypertension.
• Lung disease or breathing problems.
• Eye conditions or vision changes.
• Liver disease.
• A history of blood clots or bleeding disorders.

Regular monitoring may include blood pressure checks, heart tests, eye exams, and blood work. Serious side effects may occur even after the last dose.

There are no absolute contraindications listed for Mekinist in the prescribing information. However, Mekinist may not be appropriate for certain patients based on medical history, and your healthcare provider will determine if it is safe for you.

Mekinist does not work immediately. Some patients may begin to see treatment effects within weeks, but response time varies depending on cancer type, stage, and whether Mekinist is used alone or in combination therapy. Your healthcare provider will monitor your response through scans and clinical exams.

When Mekinist is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other cancer therapies may increase side effects when used together.
• Medications that affect blood pressure or heart function may increase cardiovascular risks.

Mekinist is available as oral tablets in different strengths. The specific dose depends on the condition being treated, body weight, and whether it is used alone or with other medicines such as dabrafenib.

Mekinist should be stored at room temperature, away from the reach of children or pets. Keep the medication in its original bottle with the desiccant to protect it from moisture.

Mekinist is manufactured by Novartis.

No. There is currently no generic version of Mekinist available.

Do not stop taking Mekinist without speaking to your healthcare provider. Stopping treatment suddenly may affect your cancer therapy. Your provider may stop or adjust treatment if serious side effects occur.

Mekinist can harm an unborn baby. Effective contraception or birth control should be used during treatment and for 4 months after your last dose.

Breastfeeding is not recommended during treatment with Mekinist and for 4 months after your last dose.