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When living with AFP-High liver cancer (HCC)…

CYRAMZA can help keep you fighting for what matters to you

CYRAMZA, as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alphafetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.

SELECT SAFETY INFORMATION

CYRAMZA may cause serious side effects, including:
Tears in the stomach or bowel wall may happen with CYRAMZA. This can be life threatening. Tell your doctor if you have severe diarrhea, vomiting, or severe abdominal pain. If you have tears in the stomach or bowel wall, you will have to stop receiving CYRAMZA.

This is one of your toughest challenges yet. But you're choosing to press on. Where individual results with CYRAMZA can vary, in a clinical study, CYRAMZA provided…

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More time without disease progression

26% of people had delayed disease progression for 6 months or longer with CYRAMZA vs 6% of people who received placebo.

  • Half of the people who received CYRAMZA + best supportive care lived without their cancer getting worse for 2.8 months vs 1.6 months with placebo + best supportive care.
CYRAMZA may help you live longer

CYRAMZA may help you live longer

37% of people lived 1 year or longer with CYRAMZA vs 30% with placebo.
24% of people lived 1.5 years or longer with CYRAMZA vs 11% with placebo.

  • Half of the people who received CYRAMZA were still alive at 8.5 months vs 7.3 months with placebo.

Tumors shrank (by 30% or more) in 4.6% of people taking CYRAMZA vs 1.1% with placebo. Although people had their tumors shrink with CYRAMZA it was not proven that this shrinkage was caused by CYRAMZA.

CYRAMZA was studied in a clinical trial of 292 people with AFP-High liver cancer (HCC) who received CYRAMZA + best supportive care (197 people) vs those who received placebo + best supportive care (95 people). All people in the study had previously received sorafenib (another type of chemotherapy), and were required to have an alpha-fetoprotein (AFP) level of at least 400 ng/mL.

AFP-High=alpha-fetoprotein high (≥400 ng/mL).

SELECT SAFETY INFORMATION

CYRAMZA may cause serious side effects, including:
Wounds may not heal quickly or completely. Tell your doctor if you have a wound that doesn’t heal properly or have a surgery planned. If you are having surgery, CYRAMZA treatment should be stopped beforehand. Your doctor may put you back on CYRAMZA after your surgical wound has healed.

Explore the Lilly Support Services™ for information on savings and financial assistance.

Learn about how CYRAMZA is thought to work

What to expect during treatment

You've decided to move forward and are ready to start treatment.

CYRAMZA will be given by an IV

CYRAMZA will be given by an intravenous (IV) infusion in either the doctor’s office, a hospital, or an infusion center.

CYRAMZA is given alone for the treatment of AFP-High* liver cancer (HCC).

* AFP-High = alpha-fetoprotein high; levels of alpha fetoprotein that are at least 400 ng/mL.

CYRAMZA will take 60 minutes to administer

The infusions will take about 60 minutes each.1 If your first treatment infusion is tolerated, the time it will take to receive additional CYRAMZA treatment infusions is about 30 minutes.

Before you receive CYRAMZA, your doctor will give you different medicines to help prevent an allergic reaction that may occur during the infusion.

Understand your dosing

Understanding your dosing schedule with CYRAMZA

14 day dosing calendar

CYRAMZA will be given to you once every 2 weeks, or as recommended by your doctor.

Your doctor will determine the number of treatments you receive.

SELECT SAFETY INFORMATION

CYRAMZA may cause serious side effects, including:
Reactions related to infusing CYRAMZA have happened. These can be severe and life threatening. Most of these reactions happened during or after the first or second CYRAMZA infusion. Symptoms of infusion reactions include shaking or stiffness of the body, back pain or spasms, chest pain or tightness, chills, flushing (sudden warmth and/or reddened skin on the face, neck, or upper chest), difficulty breathing, wheezing (a whistling sound in the breath caused by narrowed breathing tubes), becoming blue due to lack of oxygen, and tingling or numbness of the skin. In severe reactions, rapid heartbeat, low blood pressure, and severe trouble breathing may happen. Your healthcare team will give you medicine before each CYRAMZA infusion and will watch you for these side effects. If a reaction happens, CYRAMZA treatment may be infused at a slower rate or may be permanently stopped, depending on how severe the reaction is.

Preparing for treatment

Tips for day of treatment and beyond

You may be nervous about your first treatment. Or maybe you're an old pro at this. But no matter where you're coming from, here are some important tips to help get you through each infusion with CYRAMZA:

Understanding common side effects of CYRAMZA for AFP-High Liver Cancer (HCC)

CYRAMZA may cause side effects. If you experience new symptoms while on treatment, it is important that you speak with your doctor.

Explore the most common side effects of CYRAMZA, below.

CYRAMZA alone

The most common side effects were:

Low blood platelet count; feeling tired; low albumin (protein in the blood); low sodium in the blood; swelling in the arms, legs, hands, or feet; high blood pressure; stomach pain; low white blood cell count; decreased appetite; too much protein in the urine; feeling like you want to throw up (vomit); unusual buildup of fluid in the belly.

The most common serious side effects were:

Unusual buildup of fluid in the belly and pneumonia

Talk to your doctor about any questions or concerns you might have with treatment. Your doctor will be monitoring you throughout treatment and may discuss tips that can help you manage any side effects from CYRAMZA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

Please see Safety Summary for more safety information for CYRAMZA.

SAFETY SUMMARY

Warnings -

Serious side effects include:

  • Severe bleeding, including bleeding in the stomach or bowel, has happened with CYRAMZA. This can be life threatening. If severe bleeding happens, you will have to stop receiving CYRAMZA.
  • Tears in the stomach or bowel wall may happen with CYRAMZA. This can be life threatening. If you have tears in the stomach or bowel wall, you will have to stop receiving CYRAMZA.
  • Wounds may not heal quickly or completely. If you are having surgery, CYRAMZA treatment should be stopped beforehand. Your doctor may put you back on CYRAMZA after your surgical wound has healed.
  • Strokes, mini-strokes, blood clots, and heart attacks have happened to people on CYRAMZA. These can be fatal. If you have one of these events, you will have to stop receiving CYRAMZA.
  • Severe high blood pressure has happened with CYRAMZA. Your doctor will take your blood pressure at least every two weeks while you are receiving CYRAMZA. Depending on your blood pressure, your doctor may pause or permanently stop CYRAMZA.
  • Reactions related to infusing CYRAMZA have happened. These can be severe and life threatening. Most of these reactions happened during or after the first or second CYRAMZA infusion. In severe reactions, rapid heartbeat, low blood pressure, and severe trouble breathing may happen. Your health care team will give you medicine before each CYRAMZA infusion and will watch you for these side effects. If a reaction happens, CYRAMZA treatment may be infused at a slower rate or may be permanently stopped, depending on how severe the reaction is.
  • CYRAMZA may worsen certain types of liver disease.
  • A very rare but serious brain disorder has been found in research trials with CYRAMZA. The disorder is called PRES (posterior reversible encephalopathy syndrome). Signs of PRES may include seizure, headache, nausea, vomiting, blindness, and changes in your thinking. These symptoms may stop or improve within days. However, the changes in thinking can be ongoing, and PRES can be fatal. If you develop PRES, you will have to stop receiving CYRAMZA.
  • Too much protein in the urine (called proteinuria) has been found in research trials with CYRAMZA. This may be a sign of kidney damage. Your doctor will watch your urine protein levels during treatment. If you develop protein in your urine, your doctor may pause your treatment and lower your dose of CYRAMZA. If you have severe proteinuria, you will have to stop receiving CYRAMZA permanently.
  • Thyroid gland problems have been found in research trials with CYRAMZA. Your doctor will do blood tests to track how well your thyroid gland works during treatment.
  • CYRAMZA can harm your unborn baby. You should avoid getting pregnant, and use effective birth control while receiving CYRAMZA and for 3 months after your last dose.
  • CYRAMZA may harm a breastfeeding child. Do not breastfeed your child during treatment with CYRAMZA and for 2 months after your last dose.

Tell your doctor right away if you have:

  • Bleeding or symptoms of bleeding, including lightheadedness.
  • Severe diarrhea, vomiting, or severe abdominal pain.
  • A wound that doesn’t heal properly or have a surgery planned.
  • High blood pressure or symptoms of high blood pressure, including severe headache or lightheadedness or confusion, changes in your vision, or seizure.
  • Symptoms of infusion reactions, including:
    • Shaking or stiffness of the body
    • Back pain or spasms
    • Chest pain or tightness
    • Chills
    • Flushing (sudden warmth and/or reddened skin on the face, neck, or upper chest)
    • Difficulty breathing
    • Wheezing (a whistling sound in the breath caused by narrowed breathing tubes)
    • Becoming blue due to lack of oxygen
    • Tingling or numbness of the skin
  • Had liver disease or other liver problems.
  • Symptoms of PRES, including seizure, headache, nausea or vomiting, or changes in vision or thinking.

Common side effects

The most common side effects of CYRAMZA when given by itself include:

  • Low blood platelet count
  • Feeling tired
  • Low albumin (protein in the blood)
  • Low sodium in the blood
  • Swelling in the arms, legs, hands, or feet
  • High blood pressure
  • Stomach pain
  • Low white blood cell count
  • Not feeling hungry
  • Too much protein in the urine
  • Feeling like you want to throw up (vomit)
  • Unusual buildup of fluid in the belly
  • Low calcium in the blood
  • Headache
  • Diarrhea
  • Nose bleeds
  • Trouble falling or staying asleep
  • Fever
  • Vomiting
  • Back Pain

The most common serious side effects of CYRAMZA when given by itself include:

  • Anemia (a decrease in red blood cells)
  • Blocked digestive tract
  • Unusual buildup of fluid in the belly
  • Pneumonia (infection of one or both lungs)

Some people needed to have extra red blood cells put into their blood.

The most common side effects of CYRAMZA when given with certain chemotherapy medicines include:

  • Low white blood cell count
  • Diarrhea
  • Tiredness
  • Mouth sores with or without swelling in the lining of the mouth
  • Decreased appetite
  • Nose bleeds
  • Low blood platelet count
  • High blood pressure
  • Swelling in the arms, legs, hands, or feet
  • Too much protein in the urine
  • Low white blood cell count with a fever
  • Swelling, redness, or pain in the palms or soles (hand-foot syndrome)
  • Increased production of tears
  • Bleeding in the digestive tract
  • Low albumin (a protein in the blood)

The most common serious side effects of CYRAMZA when given with certain chemotherapy medicines include:

  • Low white blood cell count with a fever
  • Pneumonia
  • Low white blood cell count
  • Diarrhea
  • Blocked digestive tract

Some people needed treatment to increase their white blood cell counts.

The most common side effects of CYRAMZA when given with erlotinib include:

  • Infections
  • Increased levels of liver enzymes
  • Diarrhea
  • High blood pressure
  • Low red blood cell count
  • A sore or inflammation inside the mouth
  • Low blood platelet count
  • Loss of hair
  • Nosebleeds
  • Too much protein in the urine
  • Decrease in a type of white blood cell
  • Low potassium in the blood
  • Swelling in the arms, legs, hands, and feet
  • Headache
  • Gastrointestinal bleeding
  • Gums bleeding
  • Bleeding in the lungs or respiratory tract

The most common serious side effects of CYRAMZA when given with erlotinib include:

  • Pneumonia (infection in one or both lungs)
  • Skin infection (bacterial infection under the skin)
  • Collapsed lung (air or other gas in the pleural cavity in the lungs)

Some people needed to have extra red blood cells put into their blood.

These are not all the possible side effects of CYRAMZA. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Before you receive CYRAMZA, tell your doctor if you:

  • Have had or are at high risk for strokes or heart attack.
  • Have high blood pressure or have blood pressure problems.
  • Are planning to have surgery of any kind.
  • Have ever had liver problems, including cirrhosis or other diseases of the liver.
  • Are pregnant or may be pregnant: CYRAMZA can harm your unborn baby. You should avoid getting pregnant and use effective birth control during treatment with CYRAMZA and for 3 months after the last dose.
  • Are breastfeeding: Your doctor will tell you to stop breastfeeding during treatment with CYRAMZA and for 2 months after the last dose.

Also tell your doctor about all the medicines and supplements you take, whether they have been prescribed for you or you buy them without a prescription.

How to take

  • CYRAMZA is given by intravenous (IV) infusion. The infusion will last 60 minutes. If you handle the first infusion of CYRAMZA well, then your next infusions may only take 30 minutes. The schedule for receiving CYRAMZA depends on what type of cancer you are being treated for. These are typical schedules:
    • Once every 2 weeks for stomach cancer or GE junction cancer that is advanced or has spread to other parts of the body, colorectal cancer that has spread to other parts of the body, hepatocellular carcinoma that has AFP levels of at least 400 ng/mL or higher, or when used with the targeted therapy, erlotinib, for certain types of EGFR mutation positive non-small cell lung cancer that has spread to other parts of the body.
    • Once every 3 weeks, when used with the chemotherapy, docetaxel, for non-small cell lung cancer that has spread to other parts of the body.
    Your doctor will give you other medicines before your CYRAMZA infusion to help lower the chance of an infusion reaction.

Learn more

CYRAMZA is a prescription medicine. For more information, call 1-800-LillyRx.

This summary provides basic information about CYRAMZA but does not include all information known about this medicine. Read the information given to you about CYRAMZA. This information does not take the place of talking with your doctor. Your doctor is the best person to help you decide if CYRAMZA is right for you.

RB CON BS 14SEP2022

CYRAMZA® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

INDICATIONS

CYRAMZA® (sigh-RAM-zuh) is a medicine used to treat certain types of cancer and is prescribed in these ways:

  • By itself or with a chemotherapy medicine called paclitaxel to treat certain kinds of stomach cancer, or cancer of the area where the stomach and esophagus (food pipe) meet that is advanced or has spread to other parts of the body. The area where the stomach and esophagus meet is often called the gastroesophageal (GE) junction. CYRAMZA is for people whose stomach cancer got worse during or after certain other types of chemotherapy.
  • With a chemotherapy medicine called docetaxel to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has gotten worse during or after another type of chemotherapy. People who have tumors with certain abnormal genes should not receive CYRAMZA unless they have already been treated with medicine that targets those changes and their cancer became worse during treatment.
  • With a combination of chemotherapy medicines called FOLFIRI (irinotecan, folinic acid, and fluorouracil). This is given to treat colorectal cancer (CRC) that has spread to other parts of the body and has gotten worse during or after certain other types of chemotherapy.
  • By itself to treat a type of liver cancer called hepatocellular carcinoma (HCC). CYRAMZA is for people who have levels of alpha-fetoprotein of at least 400 nanograms per milliliter (ng/mL) in their blood and have been treated with another type of chemotherapy medicine called sorafenib.
  • In combination with another medicine called erlotinib as a first-line treatment for certain types of EGFR mutation positive non-small cell lung cancer (NSCLC) that has spread to other parts of the body.

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

CYRAMZA is given by intravenous (IV) infusion. An IV infusion is when a needle is placed into your vein and a medicine is given slowly.