ALECENSA Staying Positive Text Program Terms & Conditions

About the Program

The ALECENSA Staying Positive Text Program is an ALECENSA Support Program offering helpful information about ALECENSA, additional resources, and practical tips on an array of topics about living with ALK+ mNSCLC delivered via SMS/text message.

The Staying Positive Text Program includes:

Practical advice from others living with ALK+ mNSCLC about sharing your diagnosis, coping with scan anxiety, practicing self-care, and more
Information on ALECENSA financial assistance programs that may be available
Information on disease and dosing guidance
Text reminders to take your medication
Tips on helpful topics like nutrition and physical activity

More information is available here: https://www.alecensa.com/patient/patient-support/register.html

Terms & Conditions of Use

Please read the Staying Positive Text Program (the “Program”) Terms & Conditions (“Terms”) carefully. By opting in to the Program, you are accepting and agreeing to these Terms. The Program is also subject to Genentech’s Terms & Conditions, Privacy Policy, and any other applicable terms and agreements related to your participation in the Program.

For purposes of these Terms, “Genentech,” “we,” or “us” shall mean Genentech, Inc. and any of its applicable partners, affiliates, subcontractors, and agents.

Binding Arbitration

YOU AGREE TO RESOLVE DISPUTES WITH GENENTECH THROUGH BINDING ARBITRATION, AND YOU WAIVE ANY RIGHT TO PARTICIPATE IN CLASS ACTIONS, ALL AS DETAILED IN OUR TERMS & CONDITIONS, WHICH ARE INCORPORATED INTO THESE TERMS. YOU MAY OPT OUT OF THE BINDING INDIVIDUAL ARBITRATION AND CLASS ACTION WAIVER AS PROVIDED THEREIN.

Opting in to Receive SMS/Text Messages

By opting in to the Program, you expressly consent to receive recurring marketing text messages that may be sent using an automatic telephone dialing system, by or on behalf of Genentech, at the mobile number you provide to us or use when signing up via short code. Please note that we may not be able to deliver messages to all mobile carriers.

Your consent to the Program is voluntary and is not required as a condition of any purchase. The frequency of the messages may vary and, if the Program includes messages that are scheduled for specific intervals, you may receive a separate notification regarding when you will receive the messages.

The Program may include sending/receiving the messages through cellular telephone operators, mobile carriers, and other networks (“mobile provider”). We do not charge for the Program, but text messages are subject to your mobile provider’s terms of service and you are responsible for all charges and fees associated with text messaging imposed by your mobile provider. Message and data rates may apply. If you have any questions about your text plan or data plan, please contact your mobile provider.

Eligibility and Change in Phone Number

You must be a resident of the United States and 18 years of age or older to participate in the Program. By providing the mobile number that you provided when you signed up for the Program, you confirm that you are (a) a resident of the United States; (b) 18 years of age or older; and (c) the subscriber to that mobile number or that you are the customary user of that number and are authorized to opt in to and receive messages on it. You agree to immediately notify Genentech if the mobile number you provided changes.

Support/Help

To request more information, at any time you can text the keyword HELP, either in reply to a message or by texting it to the phone number or short code for the Program. For all questions regarding the Program, you may contact Genentech at (877) GENENTECH (877-436-3683).

How to Opt Out

To cancel the Program, you can text the keyword STOP, either in reply to a message or by texting it to the phone number or short code for the Program (ie, the number from which Program text messages are being sent). After you send the message “STOP” to us, we will send you a one-time opt out reply message to confirm that you have been unsubscribed. If you want to join again, just reply with the keyword START to our confirmation message to resubscribe. You may also opt out by contacting Genentech at (877) GENENTECH (877-436-3683).

If you unsubscribe from the Program, you may continue to receive text messages from Genentech through any other programs you have joined until you separately cancel those programs.

Privacy

We will use reasonable means designed to protect the privacy of any health information sent through the Program. As messages using the Program may not be encrypted, we cannot guarantee that the message you send will remain confidential prior to its delivery. Accordingly, we suggest that you do not send sensitive or confidential information through the Program, nor agree or request to receive such information from us through the Program, if you have concerns regarding confidentiality. For more information regarding our privacy practices, please read our Privacy Policy.

No Guarantee; Limitation of Liability

Genentech does not guarantee the successful delivery of text messages pursuant to the Program. Messages may not be delivered if the mobile phone number is not in range of a transmission site, or if sufficient network capacity is not available at a particular time. Even within a coverage area, factors beyond the control of wireless carriers may interfere with message delivery, including the customer's equipment, terrain, and proximity to buildings, foliage, and weather. Genentech will not be liable for losses or damages arising from (a) non-delivery, delayed delivery, or misdirected delivery of a text message; (b) inaccurate or incomplete content in a text message; or (c) use or reliance on the contents of any text message for any purposes.

UNDER NO CIRCUMSTANCES WILL GENENTECH BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR EXEMPLARY DAMAGES ARISING OUT OF, OR IN CONNECTION WITH, USE OF THE PROGRAM, WHETHER OR NOT GENENTECH HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

You agree to indemnify, defend, and hold Genentech harmless from any third-party claims, liability, damages, or costs arising from your use of the Program or from you providing us with a phone number that is not your own.

If you are dissatisfied with the Program or these Terms, your sole and exclusive remedy is to cancel the Program, as set forth above. Individuals who participate in the Program do so at their own risk.

Changes to SMS Terms

Genentech may revise, modify, or amend these Terms at any time. Any such revision, modification, or amendment shall take effect when it is posted online. You agree to review these Terms periodically to ensure that you are aware of any changes. Your continued consent to receive Program text messages will indicate your acceptance of those changes.

Termination of Text Messaging

Genentech may suspend or terminate your use of the Program if we believe you are in breach of these Terms. Your use of the Program is also subject to termination in the event that your mobile telephone service terminates or lapses. Genentech reserves the right to modify or discontinue, temporarily or permanently, all or any part of the Program, with or without notice.

Not Medical Advice

You understand that Program communications are not intended to be a replacement or substitute for professional medical advice. You acknowledge and understand that you will seek the advice of a physician or other qualified healthcare provider with any questions that arise regarding any medical condition.

Side Effect Reporting

You further understand that the Program involves automated messages and is not a means to communicate product issues or negative 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.

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.

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.