Important Safety Information

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

Everyone reacts differently to treatment with ALECENSA. It’s important to know the most serious and most common side effects with ALECENSA.

Your doctor may lower the dose or stop treatment with ALECENSA if any side effects occur. Contact your healthcare provider right away if you have any of the following side effects.

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 doctor will check your heart rate and blood pressure during treatment with ALECENSA. Tell your doctor right away if you feel dizzy, lightheaded, or faint during treatment with ALECENSA. Tell your doctor 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 have any 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 in blood triglycerides, the most common type of fat 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.

What should I tell my doctor before taking ALECENSA?

Before you take ALECENSA, tell your doctor 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 doctor 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 doctor 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 doctor about the best way to feed your baby during this time

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

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 SPF 50 or greater to help protect against sunburn.

What are the possible side effects of 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 the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in full ALECENSA Prescribing Information, including Patient Information.