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Important Safety Information
What is the most important information I should know about MARGENZA?
MARGENZA can cause serious side effects, including:
- Heart problems that may affect your heart’s ability to pump blood. Your doctor will run tests to monitor your heart function before and during treatment with MARGENZA. Based on test results, your doctor may hold or
discontinue treatment with MARGENZA.
- Tell your healthcare provider right away if you get any of the following signs and symptoms: new or worsening shortness of breath, coughing, feeling tired, swelling of the ankles or legs, swelling of the face, irregular heart beat or palpitations, sudden weight gain of more than 5 pounds in 24 hours, dizziness or feeling light-headed, or loss of consciousness.
- Harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with MARGENZA. Exposure to MARGENZA during pregnancy or within 4 months prior
to conception can result in fetal harm.
- If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with MARGENZA.
- Birth control should be used while receiving MARGENZA and for 4 months after your last dose of MARGENZA.
What are other possible serious side effects of MARGENZA?
Infusion-related reactions. MARGENZA is a medicine that is delivered into a vein through a needle as an infusion. MARGENZA has been associated with infusion-related reactions which can include fever, chills, joint pain, cough, dizziness, tiredness, nausea, vomiting, headache, sweating, fast heart rate, low blood pressure, itching, rash, hives, and shortness of breath. Your healthcare team will monitor you during treatment with MARGENZA and may slow or stop your infusion if you have side effects. You may need to permanently stop MARGENZA if you have a severe infusion reaction.
Before you receive MARGENZA, tell your doctor if you are breastfeeding. It is not known if MARGENZA could pass into breast milk and harm your baby.
What are the most common side effects of MARGENZA in combination with chemotherapy?
The most common side effects with MARGENZA in combination with chemotherapy are fatigue/weakness, nausea, diarrhea, vomiting, constipation, headache, fever, hair loss, abdominal pain, peripheral neuropathy (weakness, numbness, pain, and/or tingling in hands and feet), joint and muscle pain, cough, decreased appetite, shortness of breath, infusion-related reactions, redness/swelling and pain on the palms of the hands and soles of the feet (hand-foot syndrome), and pain in arms and legs.
These are not all the possible side effects of MARGENZA. Your doctor may stop treatment if serious side effects happen. Be sure to contact your healthcare team right away if you have questions or are worried about any side effects.
What does MARGENZA treat?
MARGENZA is a prescription medicine approved for use in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
Please see full Prescribing Information, including Boxed Warning.