CYRAMZA® (ramucirumab) | VEGFR2 Inhibitor

PURPOSE AND SAFETY SUMMARY

Important Facts About CYRAMZA^® (sigh-RAM-zuh). It is also known as ramucirumab.

CYRAMZA is a prescription medicine used to treat certain types of cancer. It is given by intravenous (IV) infusion. An IV infusion is when a needle is placed into your vein and a medicine is given slowly. CYRAMZA 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.

Warnings

CYRAMZA may cause serious side effects, including:

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

For more information, call 1-800-545-5979 or go to CYRAMZA.com.

This summary provides basic information about CYRAMZA. It does not include everything known about this medicine. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other health care provider about CYRAMZA and how it is given. Your doctor is the best person to help you decide if CYRAMZA is right for you.

Please click for Full Prescribing Information for CYRAMZA.

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

RB CON BS 29MAY2020

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CYRAMZA can help your fight

Advanced or Metastatic Stomach or Gastroesophageal (GE) Junction Cancer

Metastatic Non-Small Cell Lung Cancer (NSCLC)

Metastatic Colorectal Cancer (CRC)

AFP-High Liver Cancer (Hepatocellular Carcinoma)

PURPOSE AND SAFETY SUMMARY

Warnings

Common side effects

Before using

How to take

Learn more

CYRAMZA can help your fight

Advanced or Metastatic Stomach or Gastroesophageal (GE) Junction Cancer

Metastatic Non-Small Cell Lung Cancer (NSCLC)

Metastatic Colorectal Cancer (CRC)

AFP-High Liver Cancer (Hepatocellular Carcinoma)

PURPOSE AND SAFETY SUMMARY

Warnings

Common side effects

Before using

How to take

Learn more

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