MARGENZA offers a chance for more time without cancer growing and spreading

Clinical trial results

In a clinical trial of 536 patients, people treated with MARGENZA plus chemotherapy lived longer without the cancer growing or spreading than people who were treated with trastuzumab plus chemotherapy.

MARGENZA plus chemotherapy lowered the chance of disease progression by 24% compared with trastuzumab plus chemotherapy

Median* time without cancer growing or spreading

5.8 months

MARGENZA plus chemotherapy

(266 people)

4.9 months

Trastuzumab plus chemotherapy

(270 people)

*Median is the middle number in a group of numbers that are listed from lowest to highest.

There was not a statistically significant difference in how long patients lived when comparing MARGENZA + chemotherapy and trastuzumab + chemotherapy.

Patients enrolled in the study had metastasis in the bone, lymph node, lung, liver, breast, skin, or brain. The median age of participants in the study was 56 years (age range 27–86 years), and 78% of patients were less than 65 years old.

A choice of chemotherapy

MARGENZA is FDA-approved to be used in combination with chemotherapy. That gives your doctor the freedom to consider various chemotherapy options based on your individual needs, past treatments, and experience.

In the clinical trial where MARGENZA was studied, MARGENZA was used with a choice of 4 chemotherapies, which included capecitabine, eribulin, gemcitabine, and vinorelbine.

Talk to your doctor about chemotherapy options with MARGENZA

Actor portrayals.

Actor portrayals of an older, female patient in a pink shirt with short brown hair kissing the forehead of a younger woman with long brown hair in a green shirt

Actor portrayals.

Actor portrayals of an older, female patient in a pink shirt with short brown hair kissing the forehead of a younger woman with long brown hair in a green shirt
Talk to your doctor about chemotherapy options with MARGENZA

Here's how you'll get MARGENZA

Dose

Icon of IV Bag

Intravenous
15
mg/kg
Given at an
infusion center

First Infusion

Icon of a clock

Over
120
minutes

Later Infusions

Icon of a clock

Over
30
minutes
(minimum)

 

Icon of a calendar

Every
21
days

Dose

Icon of IV Bag

Intravenous
15
mg/kg
Given at an infusion center

First Infusion

Icon of a clock

Over
120
minutes

Later Infusions

Icon of a clock

Over
30
minutes
(minimum)

 

Icon of a calendar

Every
21
days

On days when both MARGENZA and chemotherapy are to be administered, MARGENZA may be administered immediately
after chemotherapy completion.

What is the most important information I should know about MARGENZA?

See Possible Side Effects
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We're here to help

1-833-377-HER2 (4372)

TerSera SupportSource for MARGENZA is available
Monday–Friday 9 AM to 6 PM ET

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 heartbeat or palpitations, sudden weight gain of more than 5 pounds in 24 hours, dizziness, light-headedness, or loss of consciousness.
  • Harm to your unborn baby. Exposure to MARGENZA during pregnancy or within 4 months prior to conception can result in the death of an unborn baby or birth defects. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with MARGENZA.
    • 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
  • Difficulty breathing
  • Infusion-related reactions
  • Redness/swelling and pain on the palms of the hands and soles of the feet (hand-foot syndrome)
  • 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1-844-334-4035 or medicalinformation@tersera.com.

Please see accompanying Full Prescribing Information, including BOXED WARNING.

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 accompanying Full Prescribing Information, including BOXED WARNING.