Important Safety Information
What is the most important information I should know about CYRAMZA?
WARNING: SEVERE BLEEDING, TEARS IN THE STOMACH OR BOWEL WALL, AND DIFFICULTY IN WOUND HEALING
Severe bleeding has occurred with CYRAMZA. These events are sometimes fatal. Tell your doctor right away if you have bleeding or symptoms of bleeding, including lightheadedness. Your treatment will have to be permanently stopped if severe bleeding occurs.
Tears in the stomach or bowel wall may occur with CYRAMZA. These events are sometimes fatal. Tell your doctor if you have severe diarrhea, vomiting, or severe abdominal pain. Your treatment will have to be permanently stopped if this occurs.
Wounds may have difficulty healing with drugs like CYRAMZA. Tell your doctor if you have a wound that doesn’t heal properly. If you develop a wound that won’t heal during treatment, your doctor will stop CYRAMZA until the wound is fully healed. Also tell your doctor if you have planned surgery, as CYRAMZA treatment should be interrupted prior to surgery. Your doctor may restart CYRAMZA after your surgical wound has healed.
- Strokes, ministrokes, blood clots, and heart attacks have occurred in clinical trials with CYRAMZA. These events are sometimes fatal. Your treatment will have to be permanently stopped if these events occur.
- Severe high blood pressure has occurred with CYRAMZA treatment. Your doctor will monitor your blood pressure every two weeks or more throughout treatment and may adjust, interrupt, or permanently stop treatment depending on the results. Tell your doctor if your blood pressure is high or if you have symptoms of high blood pressure, including severe headache or lightheadedness, or neurologic symptoms such as confusion, changes in your vision, or seizure.
- Infusion reactions related to injecting CYRAMZA have occurred. Most of these reactions happened during or after the first or second CYRAMZA infusion. Signs and symptoms of infusion reactions include shaking or stiffness of the body, back pain or spasms, chest pain or tightness, chills, flushing, difficulty breathing, wheezing, becoming blue due to lack of oxygen, and tingling or numbness of the skin. In severe cases, rapid heartbeat, low blood pressure, and severe trouble breathing may occur. Your healthcare team will monitor you for these side effects. In the case of a severe infusion reaction, your CYRAMZA treatment will have to be immediately and permanently stopped.
- CYRAMZA may worsen certain types of liver disease. Tell your doctor if you have or have had liver disease or other liver problems.
- RPLS (reversible posterior leukoencephalopathy syndrome), a very rare but serious brain disorder, has been reported in clinical trials with CYRAMZA. Signs and symptoms of RPLS may include headache, seizures, visual changes, and changes in mental function. These symptoms usually stop or improve within days, but some patients can experience continuing changes in mental function or death.
- Too much protein in the urine (proteinuria) has been reported in clinical trials with CYRAMZA. This may be a sign of kidney damage. Your doctor will monitor your urine protein levels during treatment. If you develop protein in your urine, your doctor may interrupt your treatment and decrease your dose of CYRAMZA. In severe cases your treatment will have to be permanently stopped.
- Thyroid gland problems have been reported in clinical trials with CYRAMZA. Your doctor will do blood tests to monitor your thyroid gland function during treatment.
- CYRAMZA can harm your unborn baby. You should avoid getting pregnant, and use adequate contraception while receiving CYRAMZA and for at least 3 months after stopping CYRAMZA.
What are the most common side effects of CYRAMZA?
- The most common side effects reported in patients treated with CYRAMZA when given in combination with FOLFIRI (irinotecan, folinic acid, and 5fluorouracil) were diarrhea; low white blood cell count; decreased appetite; nosebleeds; mouth sores; low platelet count; high blood pressure; swelling in the arms, legs, hands, or feet; too much protein in the urine; handfoot syndrome; bleeding in the gastrointestinal tract; and low albumin (a protein in the blood). The most common serious adverse events with CYRAMZA plus FOLFIRI were diarrhea, blockage of the intestine, and low white blood cell count with fever. Treatment to increase white blood cell count called granulocyte colonystimulating factors was given to 20% of patients treated with CYRAMZA plus FOLFIRI.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1800FDA1088.
What should I tell my doctor before receiving treatment with CYRAMZA?
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 or have had liver problems, including liver 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 adequate contraception while receiving CYRAMZA and for at least 3 months after stopping CYRAMZA.
- Are breastfeeding: your doctor will tell you to stop breastfeeding during treatment.
Tell your doctor about all the medications you are taking, including prescription and overthecounter medications.
How is CYRAMZA given?
- CYRAMZA is slowly infused (injected) into your vein. The infusion will last about 60 minutes. You will usually receive CYRAMZA once every 2 weeks prior to FOLFIRI.
- Your doctor will also give additional medication(s) prior to your CYRAMZA infusion to address potential side effects.
CYRAMZA is available by prescription only.
Please see full Prescribing InformationPrescribing Information for additional information about CYRAMZA, including Boxed Warnings for severe bleeding, tears in the stomach or bowel wall, and difficulty in wound healing.
RB-C CON ISI 02NOV2015