ZIIHERA

Generic Name/API: zanidatamab-hrii

Manufacturer: Jazz Pharmaceuticals

Dosage Forms & Strength & Pack Size:
For injection: 300 mg lyophilized powder in a single-dose vial.

Storage:
Store in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the original carton until time of reconstitution. Do not freeze.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

What is ZIIHERA?

  • ZIIHERA is a prescription medicine used to treat adults who have a type of bile duct (cholangiocarcinoma) or gallbladder cancer called biliary tract cancer (BTC), that is human epidermal growth factor receptor 2 (HER2)-positive (IHC 3+). ZIIHERA may be used when your BTC:
    • was previously treated and,
    • cannot be removed by surgery, or
    • has spread to other parts of your body (metastatic).

Your healthcare provider will perform a test to make sure ZIIHERA is right for you.
It is not known if ZIIHERA is safe and effective in children.

ZIIHERA is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of ZIIHERA for this use.

What is the most important information I should know about ZIIHERA?
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 might 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 4 months after the last dose.

Before receiving ZIIHERA, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had any heart problems
  • are breastfeeding or plan to breastfeed. It is not known if ZIIHERA passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you receive treatment with ZIIHERA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of ZIIHERA?
ZIIHERA can cause serious side effects, including:

  • See “What is the most important information I should know about ZIIHERA?”
  • 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 are a serious, but 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 is a serious, but common side effect during treatment with ZIIHERA that may be severe. Your healthcare provider may prescribe an antidiarrheal medicine or other treatment, as needed.

The most common side effects of ZIIHERA include diarrhea, infusion-related reactions, stomach pain and feeling tired.

*The contents of this site are for reference only. We do not offer drug procurement service. All information must not be used for any commercial purpose.

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