Capmatinib

Capmatinib is used to treat non-small cell lung cancer that has spread to other parts of the body (metastatic) or cannot be removed with surgery.

Capmatinib is used only if your cancer has a specific genetic marker (an abnormal "MET" gene). Your doctor will test you for this gene.

Capmatinib may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take capmatinib with or without food.

You will need frequent blood tests to check your liver function.

Do not change your dose or stop taking this medicine without your doctor's advice.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking capmatinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Throw away any tablets that are left 6 weeks after you first opened the bottle.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medications you are taking.

Tell your doctor if you have ever had:

• lung problems other than lung cancer; or
• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using capmatinib should use effective birth control to prevent pregnancy. Capmatinib can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using capmatinib.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

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

Capmatinib may cause serious side effects. Call your doctor right away if you have:

• new or worsening cough, chest pain, trouble breathing;
• fever, cough with mucus;
• severe ongoing nausea and vomiting; or
• signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of capmatinib may include:

• trouble breathing;
• nausea, vomiting, decreased appetite;
• feeling weak or tired;
• abnormal liver function tests; or
• swelling in your hands or feet.

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.

Usual Adult Dose for Non-Small Cell Lung Cancer:

400 mg orally 2 times daily Use: For the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an approved test

Skip the missed dose and take your next dose at the regular time. Do not take two doses at the same time.

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

Capmatinib could make you more sensitive to the sun. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medications work.

Other drugs may affect capmatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all the medicines you are currently taking and any new medicine you start or stop using.