Alecensa is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Alecensa is used to treat a certain type of non-small cell lung cancer that has spread to other parts of the body.

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

Alecensa can cause serious or life-threatening side effects.

Call your doctor right away if you have: heart problems--severe dizziness, very slow heartbeats; lung problems--fever, chest pain, cough, trouble breathing; kidney problems--a change in your urine color, little or no urination, swelling in your lower legs; or liver problems--upper stomach pain, dark urine, loss of appetite, yellowing of the skin or eyes.

Before you start treatment with Alecensa, your doctor will perform a special test to make sure alectinib is the best treatment for your type of lung cancer.

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.

Alecensa works best if you take it with food.

Swallow the capsule whole and do not crush, chew, dissolve, or open it.

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

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Non-Small Cell Lung Cancer:

600 mg orally twice a day

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments: This drug should be taken with food.

Use: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

You should not use Alecensa if you are allergic to alectinib.

Tell your doctor if you have ever had:

• lung or breathing problems other than lung cancer;

• liver disease; or

• slow heartbeats.

Alectinib can harm an unborn baby or cause birth defects if the mother or the father is taking this medicine.

• If you are a woman, do not use Alecensa if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 week after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Alecensa.

It is not known whether alectinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using alectinib and for at least 1 week after your last dose.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

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

Alectinib could make you sunburn more easily. Avoid sunlight or tanning beds during treatment and for at least 7 days after your last dose of Alecensa. Wear protective clothing and use sunscreen (SPF 50 or higher) when you are outdoors.

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

Call your doctor at once if you have:

• a very slow heart rate;

• a light-headed feeling, like you might pass out;

• unexplained muscle pain, tenderness, or weakness;

• lung problems - sudden chest pain or discomfort, wheezing, dry cough or cough with mucus, feeling short of breath;

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed, cold hands and feet;

• kidney problems - a change in your urine color, little or no urination, swelling in your feet or ankles; or

• liver problems - stomach pain (upper right side), loss of appetite, easy bruising or bleeding, feeling tired, dark urine, jaundice (yellowing of the skin or eyes).

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

Common Alecensa side effects may include:

• anemia;

• constipation;

• swelling in your face, eyelids, hands, or lower legs;

• tired feeling; or

• muscle pain.

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.

Other drugs may interact with alectinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.