Safety Information - ALECENSA® (alectinib)

Indications

Who is ALECENSA for?

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 doctor 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.

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 doctor 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. Your doctor will do blood tests at least every 2 weeks for the first 3 months, and then 1 time each month and as needed during treatment with ALECENSA to check your liver function. Tell your doctor 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. 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 doctor right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.

Kidney problems. ALECENSA may cause severe kidney problems that can lead to death. Tell your doctor 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. 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 if you 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. Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with ALECENSA. Tell your doctor 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, 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. Your doctor may temporarily stop ALECENSA and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your doctor may either restart you on ALECENSA at a lower dose when the hemolytic anemia goes away, or may stop your treatment with ALECENSA. Tell your doctor right away if you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.

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
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
- You should 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 who have female partners that are able to become pregnant should 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 7 days after the last dose of 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?

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. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

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

Criteria	ALECENSA dose modification
ALT or AST elevation of >5X ULN with total bilirubin ≤2X ULN	Temporarily withhold until recovery to baseline or to ≤3X ULN, then resume at reduced dose. See dose reduction schedule.
ALT or AST elevation >3X ULN with total bilirubin elevation >2X ULN in the absence of cholestasis or hemolysis	Permanently discontinue ALECENSA.
Total bilirubin elevation >3X ULN	Temporarily withhold until recovery to baseline or to ≤1.5X ULN, then resume at reduced dose. See dose reduction schedule.
Any grade treatment-related ILD/pneumonitis	Permanently discontinue ALECENSA.
Grade 3 renal impairment	Temporarily withhold until serum creatinine recovers to ≤1.5X ULN, then resume at reduced dose. See dose reduction schedule.
Grade 4 renal impairment	Permanently discontinue ALECENSA.
Symptomatic bradycardia	Withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume ALECENSA at previous dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If no contributing concomitant medication is identified, or if contributing concomitant medications are not discontinued or dose modified, resume ALECENSA at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. See dose reduction schedule.
Bradycardia^a (life-threatening consequences, urgent intervention indicated)	Permanently discontinue ALECENSA if no contributing concomitant medication is identified. If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume ALECENSA at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm, with frequent monitoring as clinically indicated. Permanently discontinue ALECENSA in case of recurrence. See dose reduction schedule.
CPK elevation of >5X ULN	Temporarily withhold until recovery to baseline or to ≤2.5X ULN, then resume at same dose.
CPK elevation >10X ULN or second occurrence of CPK elevation of >5X ULN	Temporarily withhold until recovery to baseline or to ≤2.5X ULN, then resume at reduced dose. See dose reduction schedule.
Hemolytic anemia	Withhold ALECENSA if hemolytic anemia is suspected. Upon resolution, resume at reduced dose or permanently discontinue. See dose reduction schedule.

^aHeart rate <60 bpm.
ALT=alanine transaminase; AST=aspartate transaminase; bpm=beats per minute; CPK=creatine phosphokinase; ILD=interstitial lung disease; ULN=upper limit of normal.