Alecensa

Alecensa (alectinib) is an oral kinase inhibitor that may be used to treat certain types of non-small cell lung cancer (NSCLC) in adults that have been caused by an abnormal anaplastic lymphoma kinase (ALK) gene, specifically:

• to help prevent your lung cancer from coming back after your tumor has been removed by surgery (adjuvant), or
• as treatment when your lung cancer has spread to other parts of your body (metastatic).

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 works by targeting ALK and RET -- these are 2 tyrosine kinases present in 5% to 7% of people with NSCLC. By preventing the activity of these kinases, Alecensa reduces the viability of cancer cells.

Alecensa was FDA approved on December 11, 2015.

Before you start treatment with Alecensa, your doctor will perform a special test to make sure Alecensa 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.

The usual dosage of Alecensa is 600 mg twice daily.

• 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.

You should not use Alecensa if you are allergic to alectinib or any of the inactive ingredients in Alecensa.

Tell your doctor if you have ever had:

• lung or breathing problems other than lung cancer;
• liver disease; or
• slow heartbeats.

Tell your healthcare provider if you are pregnant, intending to become pregnant, or breastfeeding.

Pregnancy

Alecensa 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 5 weeks 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.

Breastfeeding

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

Common Alecensa side effects may include:

• anemia;
• constipation;
• swelling in your face, eyelids, hands, or lower legs;
• tired feeling; or
• muscle pain, rash, or cough.

Serious side effects and warnings

Alecensa can cause serious or life-threatening side effects.

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

Serious side effects of Alecensa include the following:

Liver problems (hepatotoxicity). These are common with Alecensa and can be severe. Your healthcare provider will do blood tests at least every 2 weeks for the first 3 months, and then 1 time each month andas needed during treatment to check your liver function. Tell your healthcare provider right away if you get any of the following signs and symptoms:

• feeling tired
• feeling less hungry than usual
• yellowing of your skin or the whites of your eyes
• dark urine
• itchy skin
• nausea or vomiting
• pain on the right side of your stomach area
• bleeding or bruising more easily than normal.

Lung problems, which may be severe or life-threatening and similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.

Kidney problems, which may be fatal. Tell your healthcare provider right away if you have a change in the amount or color of your urine, or if you get new or worsening swelling in your legs or feet.

Slow heartbeat (bradycardia). Alecensa may cause very slow heartbeats that can be severe and life-threatening. Your healthcareprovider will check your heart rate and blood pressure during treatment. Tell your healthcareprovider right away if you feel dizzy, lightheaded, or if you faint during treatment. Tell yourhealthcare provider if you take any heart or blood pressure medicines.

Severe muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. Treatment with Alecensa can increase the level of an enzyme called creatine phosphokinase (CPK), which can be a sign of muscle damage. Your healthcare provider will do blood tests at least every 2 weeks for the first month and as needed during treatment. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Hemolytic anemia can happen in some people who take Alecensa. If this happens, you may not have enough healthy red blood cells. Yourhealthcare provider may temporarily stop treatment and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your healthcare provider may either restart you at a lower dose when thehemolytic anemia goes away or may stop your treatment. Tell your healthcare provider right awayif you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.

Severe increase of fat levels in the blood (hypertriglyceridemia). Alecensa can cause severe increases of triglycerides in your blood, which can lead to life-threatening inflammation of the pancreas (pancreatitis). Tell your healthcare provider right away if you develop upper stomach area pain, nausea, vomiting, bloating, or fever.

Call your doctor at once if you have:

• heart problems--severe dizziness, very slow heartbeats;
• 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;
• 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); or
• pancreas problems - upper stomach pain, nausea, vomiting, bloating, or fever.

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

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.

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

Usual Alecensa Adult Dose for Non-Small Cell Lung Cancer:

• 600 mg orally 2 times a day Available as Alecensa 150 mg capsules. Four capsules (4 x 150 mg) make up one dose of Alecensa to be taken twice a day.

Duration of Therapy: Until disease progression or unacceptable toxicityComments: This drug should be taken with food.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time. If you vomit shortly after taking Alecensa, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

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 and lip balm (SPF 50 or higher) when you are outdoors.

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.

Store at room temperature. Do not store at temperatures above 86°F (30°C). Keep in the original container, and keep dry and away from light.

Keep out of the reach of children.

Active ingredient: alectinib.

Inactive ingredients: lactose monohydrate, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, and carboxymethylcellulose calcium.

Capsule shell: hypromellose, carrageenan, potassium chloride, titanium dioxide, corn starch, and carnauba wax.

Printing ink: red iron oxide (E172), yellow iron oxide (E172), FD&C Blue No. 2 aluminum lake (E132), carnauba wax, white shellac, and glyceryl monooleate.

Available as Alecensa 150 mg capsules.

Genentech, Inc. makes Alecensa.