Patient information: uses, side effects, how to take - Alecensa

What is the most important information I should know about ALECENSA?

ALECENSA may cause serious side effects, including:

Liver problems (hepatotoxicity). Liver problems are common with ALECENSA and can be severe. Tell your healthcare provider right away if you get any of the following signs and symptoms of liver problems:

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. ALECENSA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you get any new or worsening symptoms of lung problems, including:

trouble breathing
shortness of breath

cough
fever

Kidney problems. ALECENSA may cause severe kidney problems that can lead to death. Tell your healthcare provider right away if you get 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 healthcare provider will check your heart rate and blood pressure during treatment with ALECENSA. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment with ALECENSA. Tell your healthcare 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. 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
weakness

Breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Hemolytic anemia can happen in some people who take ALECENSA and may cause you to not have enough healthy red blood cells. Tell your healthcare provider right away if you develop:

yellow skin (jaundice)
weakness or dizziness

shortness of breath

Severe increase of fat levels in the blood (hypertriglyceridemia). ALECENSA can cause severe increase of levels of fats in the blood called triglycerides, the most common type of fat in the blood, which can lead to life-threatening inflammation of the pancreas (pancreatitis). Tell your healthcare provider right away if you develop any of the following signs and symptoms of pancreatitis:

upper stomach area (abdomen) pain
nausea
vomiting

bloating
fever

Your healthcare provider will do blood tests before you start and during treatment with ALECENSA to check for side effects.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with ALECENSA if you have side effects.

See "What are the possible side effects of ALECENSA?" for more information about side effects.

What is ALECENSA?

ALECENSA is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene:

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).

Your healthcare provider will perform a test to make sure that ALECENSA is right for you.

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

Before you take ALECENSA, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems
have lung or breathing problems, other than your lung cancer
have a slow heartbeat
are pregnant or plan to become pregnant. ALECENSA can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider will do a test to see if you are pregnant before starting treatment with ALECENSA.
- Use effective birth control (contraception) during treatment with ALECENSA and for 5 weeks after the last dose of ALECENSA.
- Tell your healthcare provider right away if you become pregnant during treatment with ALECENSA or think you may be pregnant.
Males with female partners who are able to become pregnant:
- Use effective birth control (contraception) during treatment with ALECENSA and for 3 months after the last dose of ALECENSA.
are breastfeeding or plan to breastfeed. It is not known if ALECENSA passes into your breast milk. Do not breastfeed during treatment with ALECENSA and for 1 week after the last dose of ALECENSA. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.

How should I take ALECENSA?

Take ALECENSA exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking ALECENSA unless your healthcare provider tells you to.
Take ALECENSA 2 times a day.
Take ALECENSA with food.
Swallow ALECENSA capsules whole. Do not open or dissolve the capsule contents.
If you miss a dose of ALECENSA, do not take the missed dose. Take your next dose at your regular time.
If you vomit after taking a dose of ALECENSA, do not take an extra dose. Take your next dose at your regular time.

What should I avoid while taking ALECENSA?

Avoid spending time in the sunlight during treatment with ALECENSA and for at least 7 days after stopping ALECENSA. Your skin may be sensitive to the sun (photosensitivity) and you may burn more easily and get severe sunburns. Use sun protecting measures, such as sunscreen and lip balm with an SPF 50 or greater to help protect against sunburn.

What are the possible side effects of ALECENSA?

ALECENSA may cause serious side effects, including:

See "What is the most important information I should know about ALECENSA?"

The most common side effects of ALECENSA include:

constipation
tiredness
swelling in your hands, feet, ankles, face and eyelids

rash
cough

These are not all of the possible side effects of ALECENSA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ALECENSA?

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

Keep ALECENSA and all medicines out of the reach of children.

General information about the safe and effective use of ALECENSA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ALECENSA for a condition for which it was not prescribed. Do not give ALECENSA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ALECENSA that is written for health professionals.

What are the ingredients in ALECENSA?

Active ingredient: alectinib

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

Capsule shell contains: carnauba wax, carrageenan, corn starch, hypromellose, potassium chloride and titanium dioxide (E171).

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

Distributed by: Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990

ALECENSA^®is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan

For more information, go to www.ALECENSA.com or call 1-800-253-2367.

Alecensa: Uses, Side Effects and Dosage