Patient leaflet - Ziihera 300 mg powder for concentrate for solution for infusion
1. What Ziihera is and what it is used for
How Ziihera works
Ziihera is a medicine that contains the active subst Zanidatamab is a bispecific antibody that attaches i or antigens on cancer cells. It recognises and attac human epidermal growth factor receptor 2 (HER2). amounts on the surface of some cancer cells where When zanidatamab attaches to the HER2 on cancer cancer cells from growing and may kill them.
What Ziihera is used for
Ziihera is used in adults with biliary tract cancer, a that store and transport bile. It is used when the ca • has high levels of the HER2 protein on its surfac
‘HER2-positive’);
- cannot be removed by surgery (unresectable) an tissues (locally advanced) or other parts of the b • has returned or worsened after previous chemoth
2. What you need to know before you are given Z
You must not be given Ziihera
- If you are allergic to zanidatamab or any of the o medicine (listed in section 6).
If you are not sure if you are allergic, talk to your do are given Ziihera.
Warnings and precautions
Talk to your doctor or nurse before you are given Zii if you have any of the following symptoms before or Ziihera:
- feeling short of breath,
- cough,
- feeling tired,
- swelling of ankles or legs,
- irregular heartbeat,
- sudden weight gain,
- feeling dizzy, or
- loss of consciousness.
These may be symptoms of decreased left ventricul condition where your heart cannot pump blood well check your heart function before starting treatment 4 “Serious side effects” for more details about sign out for.
Infusion reactions
Ziihera is given by a drip into a vein (intravenous in infusion can happen. Your doctor or nurse will moni during and after your infusion as needed. If you get doctor may stop treatment with Ziihera. See section for more details about infusion reactions to look out and thereafter.
Children and adolescents
Ziihera is not recommended in children or adolesce in this age group.
Other medicines and Ziihera
Tell your doctor or nurse if you are taking, have rece any other medicines.
Pregnancy and breast-feeding
Before starting treatment, you must tell your doctor pregnant or breast-feeding, think you may be pregn a baby.
Ziihera may harm the unborn baby. Your doctor will of taking Ziihera for your baby while you are pregna are able to get pregnant, you should use effective c during treatment and for 4 months after stopping Z your doctor about the best contraception for you. Te away if you get pregnant during treatment with Ziih after stopping treatment.
It is not known if Ziihera passes into breast milk. A breast-feed during treatment with Ziihera and for 4 treatment, as it may be harmful to the child. Your d benefits of breast-feeding for your child and the ben medicine.
r the user olution for infusion g. This will allow quick lp by reporting any side w to report side effects.
his medicine because it r.
his includes any possible 4.
era ance zanidatamab.
tself to a specific protein hes to a protein called HER2 is found in large it stimulates their growth. cells, it slows or stops the cancer of the structures ncer:
e (also known as d has spread to nearby ody (metastasised); and erapy treatment.
iihera ther ingredients of this ctor or nurse before you hera, or during treatment, during treatment with ar ejection fraction, a enough. Your doctor will with Ziihera. See section s of heart problems to look fusion). Reactions to the tor you for side effects any serious reaction, your 4 “Serious side effects” for during the infusion nts. It has not been tested ntly taken, or might take or nurse if you are ant or are planning to have advise you about the risks nt or breast-feeding. If you ontraception (birth control) iihera treatment. Talk to ll your doctor straight era or during the 4 months sk your doctor if you can months following octor will consider the efits to you of taking this
Driving and using machin
You may feel tired after any tools or machines.
Ziihera contains sodium
Ziihera contains less tha say it is essentially sodiu
Ziihera contains polysorb
Ziihera contains 0.63 m to 0.105 mg/mL.
Polysorbates may cause known allergies.
3. How you will be giv
Ziihera will be given to y • It is given by a drip in weeks.
The amount of medic calculated by your do • The duration of the in depending on how we • The number of infusi
o how your diseas o how well you tol • Before each infusion, help prevent infusion (medicines to reduce treat pain and inflam and will be given to y
If you miss an appointmen
If you forget or miss you appointment with your d
If you stop receiving Ziihe
Do not stop treatment w It is important that you a recommended by your tr
If you have any further q or nurse.
4. Possible side effect
Like all medicines, this everybody gets them. Tel those not listed in the le
Some side effects may be notice any of the followin
Very common (may affect • Infusion reactions. R may include feeling s loss of appetite, joint
Common (may affect up t • Ejection fraction decr reduce your heart’s a feeling short of breat irregular heartbeat, s consciousness.
Other side effects
The frequency and sever Talk to your doctor or nu
Very common (may affect • diarrhoea
- belly (abdominal) pai • feeling sick (nausea) • vomiting
- feeling tired (fatigue) • decreased appetite • rash
- low levels of red bloo • abnormal liver functi
Uncommon (may affect u • Chest symptoms such If you get any of the abo should talk to your docto treated with Ziihera.
Reporting of side effects
If you get any side effec effects not listed in this the Yellow Card Scheme Yellow Card in the Googl you can help provide mo
5. How to store Ziihera
Ziihera will be stored by where you receive treatm healthcare professionals • Keep this medicine o • Do not use Ziihera aft vial label after EXP. T • Store in a refrigerator • The diluted solution s
Medicines should not be throw away any medicin protect the environment.
es receiving Ziihera. If this happens, do not drive or use n 1 mmol of sodium (23 mg) per dose unit, that is to m-free.
ate 20 g of polysorbate 20 in each vial, which is equivalent allergic reactions. Tell your doctor if you have any en Ziihera ou by a doctor or nurse in a hospital or clinic. to a vein (intravenous infusion) once every two ine you are given depends on your weight and will be ctor.
fusion may differ for the first dose and later doses, ll you tolerate receiving the infusions.
ons you will be given depends on:
e responds to treatment, erate the treatment.
your doctor/nurse may give you some medicines to reactions. These may include antihistamines allergic reactions), corticosteroid (medicines that mation) and antipyretics (medicines to reduce fever) ou 30-60 minutes before you are given the infusion.
t r appointment to receive Ziihera, make another octor or nurse as soon as possible.
ra ith this medicine without talking to your doctor first. re given all the infusions that have been eatment team.
uestions on the use of this medicine, ask your doctor s medicine can cause side effects, although not l your doctor if you get any side effects, including aflet.
serious. Tell a doctor or nurse straight away, if you g side effects:
more than 1 in 10 people)
eactions can either be mild or more severe. Symptoms ick (nausea), fever, chills, feeling tired, headache, and muscle pains, and hot flashes.
o 1 in 10 people)
eased. This medicine may cause heart problems that bility to pump blood. Symptoms of this include h, cough, feeling tired, swelling of ankles or legs, udden weight gain, feeling dizzy, or loss of ity of side effects may vary with the dose you receive. rse if you get any of the following:
more than 1 in 10 people)
n d cells (anaemia), as shown in blood tests on, as shown in blood tests p to 1 in 100 people)
as a dry cough or breathlessness (pneumonitis) ve side effects after treatment with Ziihera, you r straight away and tell them that you are being ts, talk to your doctor. This includes any possible side leaflet. You can also report side effects directly via at www.mhra.gov.uk/yellowcard or search for MHRA e Play or Apple App Store. By reporting side effects re information on the safety of this medicine.
the healthcare professionals at the hospital or clinic ent. The following information is intended for .
ut of the sight and reach of children.
er the expiry date which is stated on the carton and he expiry date refers to the last day of that month. (2 ºC – 8 ºC). Do not freeze.
hould be used immediately after preparation.
disposed of via wastewater. Your pharmacist will es you no longer use. These measures will help
6. Contents of the pack and other information
What Ziihera contains
The active substance is zanidatamab. • One vial of powder for concentrate for solution fo
300 mg of zanidatamab. After reconstitution one contains 50 mg/mL of zanidatamab. • The other ingredients are polysorbate 20 (E432), succinic acid (E363), sucrose, and water for inje What Ziihera looks like and contents of the pack
Ziihera is a white lyophilised powder supplied in a g and flip-off cap.
One carton contains 1 or 2 vials. Not all pack sizes
Marketing Authorisation Holder
Jazz Pharmaceuticals Research UK Limited Building 730, Kent Science Park,
Sittingbourne, Kent ME9 8AG,
United Kingdom
Email: medinfo-uk@jazzpharma.com
Manufacturer
Jazz Pharmaceuticals Ireland Ltd
5th Floor, Waterloo Exchange
Waterloo Road
Dublin 4, D04 E5W7
Ireland
This leaflet was last revised in: September 2025
This medicine has been given ‘conditional approval’ more evidence to come about this medicine. The Medicines and Healthcare products Regulatory information on this medicine at least every year and updated as necessary.
Other sources of information
Detailed information on this medicine is available o Healthcare products Regulatory Agency website: htt There are also links to other websites about rare dis
r infusion contains vial of 6 mL solution disodium succinate, ctions (see section 2).
lass vial with a stopper may be marketed.
. This means that there is
Agency will review new this leaflet will be n the Medicines and p://www.mhra.gov.uk. eases and treatments.
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