HER2-positive (IHC 3+) BTC patient

NOW FDA-APPROVED ZIIHERA: A DUAL HER2-TARGETED TREATMENT FOR HER2-POSITIVE BTC

ZIIHERA is the first and only FDA-approved bispecific antibody* that targets HER2 in adults with previously treated unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC).

*A bispecific antibody is able to target 2 cancer-causing proteins on a tumor cell.

FDA=Food and Drug Administration; HER2=human epidermal factor receptor 2; IHC=immunohistochemistry.

 

HOW ZIIHERA IS THOUGHT TO WORK†

WHAT IS ZIIHERA?

  • ZIIHERA (zye-HAIR-ah) is a therapy designed to target HER2-positive (IHC 3+) cancer cells
  • It is not a chemotherapy; ZIIHERA is a bispecific antibody engineered to target HER2 on tumor cells
  • ZIIHERA is for people who previously received treatment


 

ZIIHERA IS THE FIRST AND ONLY BISPECIFIC ANTIBODY TARGETING TWO SITES ON HER2, WHICH MAY KILL OR SLOW THE GROWTH OF TUMOR CELLS

TARGETING AND BINDING:

ZIIHERA binds to 2 sites on a HER2 protein, which is on the surface of the cancer cell.

INTERNALIZATION:

Binding of ZIIHERA to HER2 results in internalization, a process where ZIIHERA and the bound HER2 protein are absorbed into the cancer cell.

REDUCTION OF HER2:

ZIIHERA being absorbed reduces the amount of HER2 proteins on the surface of the cancer cell.

IMMUNE DEFENSE:

ZIIHERA can recruit the immune system to kill the tumor cell.

†This is how ZIIHERA was shown to work in lab studies.

 

HOW ZIIHERA WAS STUDIED

ZIIHERA WAS STUDIED IN THE LARGEST PHASE 2B‡ TRIAL TO DATE OF PREVIOUSLY TREATED PEOPLE WITH HER2-POSITIVE BTC§

ZIIHERA was studied in a trial of 80 adults with previously treated HER2-positive BTC, 62 of whom were IHC 3+. This trial evaluated how many people responded to treatment (saw their tumors shrink in size) and how long these responses lasted. It also evaluated any side effects people experienced while taking ZIIHERA.

HER2 positivity was determined through 2 types of tests—ISH and IHC.

A HER2 ISH test checks the DNA or RNA of your cancer cells to see if there are extra copies of HER2.

A HER2 IHC test determines your HER2 protein levels using scores that range from 0 to 3+. The higher the score, the more HER2 is overexpressed.

People in the trial took a HER2 test to determine HER2 status. ZIIHERA is approved to treat people with HER2-positive BTC that had a HER2 IHC score of 3+.

Your healthcare provider may use IHC or other tests to determine your HER2 status and see if you may be eligible for ZIIHERA.

People with metastatic HER2-positive (IHC 3+) BTC received ZIIHERA by IV once every 2 weeks

‡A Phase 2b study is designed to evaluate the effectiveness and dosing of a treatment generally over the course of several months to 2 years.

§Only of FDA-approved second-line treatments. Current as of 11/2024.

ISH=in situ hybridization; IV=intravenous.

 

RESULTS WITH ZIIHERA

OF THE 62 PEOPLE WHO WERE IHC 3+

52%

(32/62 people) with a HER2 IHC 3+ score had a response

3%

(2 people) had a complete response, which means that their tumors disappeared

48%

(30 people) had a partial response, which means that their tumors shrank by 30% or more

HOW LONG PEOPLE RESPONDED TO ZIIHERA

OF THE 62 PEOPLE WHO WERE IHC 3+

was the median length of time that responses lasted in the 32 people who responded, which means their tumors shrank or disappeared

OF THE 32 PEOPLE WHO RESPONDED TO ZIIHERA

59%

(19 people) continued responding to ZIIHERA at ≥6 months

44%

(14 people) continued responding to ZIIHERA at ≥12 months

ZIIHERA was FDA approved for this use based on clinical studies that measured how many patients responded and how long they responded. ZIIHERA is still being studied to confirm these results.

Median is the middle number in a set of numbers.

 

POSSIBLE SIDE EFFECTS

ZIIHERA can cause serious side effects, including:

  • Harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZIIHERA.
    • If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with ZIIHERA.
    • Females who are able to become pregnant should use birth control (contraception) during treatment with ZIIHERA and for the 4 months after the last dose.

  • Heart problems that may affect how well your heart pumps blood. Your healthcare provider will check your heart function before and during treatment with ZIIHERA. Call your healthcare provider right away if you get any of the following signs and symptoms of a heart problem:

    • new or worsening shortness of breath
    • feeling more tired than usual
    • swelling of your ankles or feet
    • loss of consciousness
    • irregular heartbeat
    • sudden weight gain
    • dizziness or feeling light-headed

  • Infusion-related reactions, a common side effect that can happen during treatment with ZIIHERA. Your healthcare provider will check for side effects during your infusions. Tell your healthcare provider right away if you get any of the following symptoms during or after your infusions of ZIIHERA:

    • shortness of breath or trouble breathing
    • fever
    • chills
    • rash
    • flushing
    • nausea or vomiting
    • dizziness or feeling lightheaded
    • chest discomfort
  • Diarrhea, a common side effect during treatment with ZIIHERA that may be severe. Your healthcare provider may prescribe an antidiarrheal medicine or other treatment, as needed.
  • Other common side effects of ZIIHERA include stomach pain and feeling tired.

Managing potential side effects

  • The most common side effect of ZIIHERA is diarrhea. Talk to your healthcare provider about any side effects you experience, and they will help you find ways to manage them
  • Your healthcare provider:
    • will give you medicines 30 to 60 minutes before each treatment to help prevent infusion-related reactions or make them less severe
    • may slow down, temporarily stop, or permanently stop your treatment with ZIIHERA if you have certain side effects
    • may do certain tests to check you for some side effects
    • will decide how many treatments you need

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.


 

These are not all of the possible side effects of ZIIHERA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

WHAT TO EXPECT WHEN TAKING ZIIHERA

ONE TREATMENT, ONCE EVERY 2 WEEKS

ZIIHERA is an intravenous (IV) infusion you will receive once every 2 weeks. Your healthcare provider will decide how long you stay on ZIIHERA and may discontinue treatment if you have uncontrolled or unmanaged side effects.

Dosing Schedule

 

 

Image 1

The 1st and 2nd infusions will last 120-150 minutes

If past infusions are
well tolerated,

Image 2

The 3rd and 4th infusions will last 90 minutes

If past infusions are
well tolerated,

Image 3

Each infusion afterwards will be administered over 60 minutes

If you miss a dose, call your healthcare provider as soon as possible to reschedule your appointment.

 

WE'RE HERE TO SUPPORT YOU

JazzCares® logo

JazzCares is committed to helping you get access to your ZIIHERA medication.

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To help you get access to ZIIHERA, JazzCares Specialists are available to assist you with:

  • Understanding your insurance coverage
  • Other cost and coverage questions
  • Referrals to other financial assistance for which you might be eligible
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JazzCares is committed to helping you reduce your out-of-pocket costs for ZIIHERA

  • Savings Card—eligible, commercially insured patients can pay as little as $10 for their ZIIHERA medication, subject to an annual maximum
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Patient Assistance Program, if you are eligible

  • Financial and other eligibility criteria may apply

You can learn more about JazzCares support offerings by calling 1-833-533-JAZZ (5299) Monday–Friday between 8 AM and 8 PM ET or visiting JazzCares.com

Insurance coverage and plans may vary. The JazzCares Program at Jazz Pharmaceuticals provides general information only and is not a guarantee of any coverage or reimbursement outcome. All treatment decisions rest solely with the treating physician or qualified healthcare professional. Jazz Pharmaceuticals reserves the right to terminate or modify this program at any time with or without notice. Other terms and conditions apply.

Learn more about HER2-positive advanced BTC, results with ZIIHERA, and possible side effects from the clinical trial

Download brochure

 

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