Ziihera is a prescription intravenous (IV) bispecific monoclonal antibody designed to treat adults with HER2-positive biliary tract cancer—specifically, cholangiocarcinoma or gallbladder cancer with HER2 IHC 3+ expression—who have received prior treatment and have unresectable or metastatic disease.
Zanidatamab
Generic Name/API:Zanidatamab-hrii
Packaging:1 vial / pack
Storage:Store at 2°C to 8ºC
Dosage:For dosage information, please check the General Information section.
Strength:For injection: 300 mg lyophilized powder in a single-dose vial
Indication: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).
Ziihera (Zanidatamab) is a bispecific HER2-directed antibody indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
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).
STRENGTH:
For injection: 300 mg lyophilized powder in a single-dose vial
DOSAGE:
Premedicate patients with acetaminophen, an antihistamine and a corticosteroid, 30-60 minutes prior to each administration of Ziihera infusion to prevent potential infusion-related reactions (IRRs).
The recommended dosage of Ziihera is 20 mg/kg given as an intravenous infusion once every 2 weeks
SIDE EFFECTS:
- Gastrointestinal disorders
- Diarrheaa
- Abdominal pain
- Nausea
- Vomiting
- Injury, poisoning and procedural complications
- Infusion-related reaction
- General disorders
- Fatigue
- Skin and subcutaneous tissue disorders
- Rash
- Metabolism and nutrition disorders
- Decreased appetite
- Embryo-Fetal Toxicity
- Left Ventricular dysfunction
- Infusion-Related Reactions
- Diarrhea
FAQ
How does Ziihera work?
Ziihera binds two distinct domains on HER2, leading to internalization and reduction of HER2 expression on tumor cells. It enhances antitumor activity via immune-mediated mechanisms like antibody-dependent cellular cytotoxicity and phagocytosis.
How is Ziihera administered?
Administered via IV infusion every two weeks.
- 1st and 2nd infusions: 120–150 minutes
- 3rd and 4th: 90 minutes, if tolerated
- Subsequent: 60 minutes, if prior infusions were well tolerated
Premedication (e.g. acetaminophen, antihistamine, corticosteroid) is required before infusion to reduce risk of infusion-related reactions.
Who is eligible to receive Ziihera?
Adults with HER2-positive BTC (IHC 3+) that is unresectable or metastatic, previously treated, and confirmed by an FDA-approved HER2 test.
What evidence supports its approval?
Approved under FDA accelerated approval in November 2024 based on the HERIZON-BTC‑01 Phase 2b trial showing a 52% objective response rate (ORR) and median duration of response of approximately 14.9 months.
What are the most common side effects?
In a cohort of 80 patients:
- Diarrhea (~50%)
- Infusion-related reactions (~35%)
- Abdominal pain (~29%)
- Fatigue (~24%)
- Nausea (~18%)
- Vomiting (~15%)
- Rash (~19%)
- Decreased appetite (~16%)
What is the cost of Ziihera (Zanidatamab) injection in India?
The cost of Ziihera (Zanidatamab) in India varies as it is newly approved and must generally be imported. Factors like supplier availability, import duties and currency fluctuations affect the final price. For the latest cost details, contact 24/7QualityMeds at +91 9967979080.
How to buy Ziihera (Zanidatamab) injection online in India?
To buy Ziihera (Zanidatamab) injection online in India at a genuine price, contact 24/7QualityMeds. We assist with the import procedure, sourcing from certified suppliers, prescription verification and safe delivery.
What are the key criteria for selecting a supplier?
While selecting a supplier, we essentially ensure that the supplier holds a valid Good Distribution Practice (GDP) certificate and possesses a valid operating license. These credentials confirm that the suppliers adherence to International standards for the proper distribution of medicinal product.
How to buy Zanidatamab-hrii (Ziihera) in Delhi?
To buy Zanidatamab-hrii (Ziihera) in Delhi, reach out to 24/7QualityMeds. Our team helps coordinate your request through legal import and dedicated support.
