Important Safety Information
What is the most important safety information I should know about KADCYLA?
KADCYLA is not the same medicine as trastuzumab (Herceptin).
- KADCYLA may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include
vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine, or
- KADCYLA may cause heart problems, including those without symptoms (such as reduced heart function) and those
with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness
of breath, cough, rapid weight gain of greater than 5 lbs in less than 24 hours, dizziness or loss of
consciousness, or irregular heart beat
- Receiving KADCYLA during pregnancy can result in the death of an unborn baby and birth defects. Birth control
should be used while you receive KADCYLA and for 6 months after your last dose of KADCYLA
- If you are exposed to KADCYLA during pregnancy, contact your healthcare provider right away; you are also
encouraged to enroll in the MotHER
Pregnancy Registry by calling 1 (800) 690-67201 (800) 690-6720
- If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding
or stopping KADCYLA
Contact your doctor right away if you experience symptoms associated with these side effects.
What are the additional possible serious side effects of KADCYLA?
- KADCYLA may cause lung problems, including inflammation of the lung tissue,
which can be life-threatening. Signs of lung problems may include trouble breathing, cough, tiredness, and
fluid in the lungs
- Symptoms of an infusion-related reaction may include one or more of the following: the skin getting hot or red
(flushing), chills, fever, trouble breathing, low blood pressure, wheezing, tightening of the muscles in the
chest around the airways, or a fast heartbeat. Your doctor will monitor you for infusion-related reactions
Low platelet count
- Low platelet count may happen during treatment with KADCYLA. Platelets help your blood to clot. Signs of low
platelets may include easy bruising, bleeding, and prolonged bleeding from cuts. In mild cases there may not be
- Symptoms may include numbness and tingling, burning or sharp pain, sensitivity to touch, lack of coordination,
muscle weakness, or loss of muscle function
Skin reactions around the infusion site
- KADCYLA may leak from the vein or needle and cause reactions such as redness, tenderness, skin irritation, or
pain or swelling at the infusion site. If this happens, it is more likely to happen within 24 hours of the
How will my doctor know if KADCYLA is right for me?
You must have a HER2 test to determine if your cancer is HER2-positive before taking KADCYLA, because benefit has
been shown only in patients whose tumors are HER2-positive.
What are the most common side effects of KADCYLA?
The most common side effects seen in people taking KADCYLA are:
- Pain that affects the bones, muscles, ligaments, and tendons
- Low platelet count
- Liver problems
You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1 (888) 835-25551
(888) 835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or
calling 1 (800) FDA-10881 (800) FDA-1088.
Please see KADCYLA full
Prescribing Information, including Most Important Safety Information, for additional Important Safety