Zanidatamab at a glance
Medicine class
Bispecific HER2-targeted monoclonal antibody
Licensed role
Previously treated, unresectable locally advanced or metastatic HER2-positive biliary tract cancer in adults
Administration
Intravenous infusion given by a qualified healthcare professional
Important monitoring
Heart function, infusion reactions and new respiratory symptoms
What is Zanidatamab used for?
Zanidatamab is licensed as monotherapy for:
Adults with unresectable locally advanced or metastatic biliary tract cancer whose tumour is HER2-positive by immunohistochemistry, after previous systemic treatment.
How does Zanidatamab work?
Zanidatamab binds to two different external regions of HER2. This promotes removal of HER2 from cancer-cell surfaces and recruits immune mechanisms that damage or destroy the cells, helping inhibit tumour growth.
Zanidatamab preparations and strengths
Solution for infusion
Route: Intravenous
Strengths: 300 mg
How to take Zanidatamab
It is prepared and given as a drip into a vein by qualified healthcare professionals where emergency treatment is available. It must not be given as a rapid injection or bolus.
A corticosteroid, antihistamine and fever-reducing treatment are usually given beforehand to reduce infusion reactions.
Tell staff immediately if you feel unwell during the infusion.
Fatigue can affect driving or machinery use; use caution until you know how treatment affects you.
Zanidatamab side effects
Common or expected effects
- Diarrhoea
- Infusion-related reactions
- Tiredness or weakness
- Anaemia
- Rash
- Reduced appetite
- Abdominal pain
- Nausea or vomiting
- Raised liver enzymes
Get urgent medical advice
- Severe infusion or allergic reaction, including breathing difficulty, swelling, marked dizziness or collapse
- New or worsening cough or breathlessness, which may indicate pneumonitis
- Symptoms of reduced heart function, such as new breathlessness or swelling
- Severe or persistent diarrhoea, particularly with dehydration or inability to drink
Zanidatamab in pregnancy
Zanidatamab may harm an unborn baby and is not recommended during pregnancy. Pregnancy testing is required before treatment for those who could become pregnant. Effective contraception is needed during treatment and for four months after the final infusion. Pregnancy during or soon after treatment requires prompt specialist review.
Zanidatamab while breastfeeding
It is unknown whether zanidatamab passes into breast milk or affects a breastfed child. The oncology team should make an individual decision about stopping breastfeeding or treatment, taking account of the four-month washout period after the final infusion.
Zanidatamab interactions
No dedicated clinical interaction studies have been conducted. Important cytochrome P450 interactions are not expected because zanidatamab is an antibody, but the oncology team should review all prescribed, non-prescribed and complementary products.
Common questions about Zanidatamab
Answers are fully visible for fast scanning and source review.
How is HER2 status checked?
A tumour sample is tested by immunohistochemistry. The licence requires documented HER2 positivity with an IHC score of 3+.
Is zanidatamab chemotherapy?
No. It is a targeted bispecific antibody, although it is an anti-cancer treatment that can cause significant adverse effects.
Why are other treatments given beforehand?
A corticosteroid, antihistamine and fever-reducing treatment are generally used to lower the risk of infusion-related reactions.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.