Patient leaflet - Zanosar 1 g powder for concentrate for solution for infusion
1. WHAT ZANOSAR IS AND WHAT IT IS USED FOR
This is a cytostatic medicine, which means that it prevents the growth of certain cells.
It is particularly indicated in adults for some tumours of the pancreas (neuroendocrine tumours). This medicine, which is injected intravenously, may be combined with 5-fluorouracil (5-FU).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZANOSAR Zanosar must never be used:
- If you are allergic to the active substance (strepto-zocin) or any of the other ingredients of this med-icine (listed in section 6),
- If you are suffering from severe renal impairment (failure of kidney function),
- In combination with certain vaccines (called live or live-attenuated vaccines),
- In case of breastfeeding.
Warnings and precautions
This medicine also has toxicity to the liver and to the blood. Liver function tests should be done on a regular basis to detect hepatotoxicity.
Zanosar can induce nausea and vomiting. Thus, your doctor can prescribe you some anti-vomiting medicinal products.
When it is combined with another medicine belong-ing to the same class, further appropriate investiga-tions are performed.
You will be given your treatment under the supervi-sion of a physician experienced in the administra-tion of cytostatic medicinal products. He will decide in which setting your tolerance to the treatment will be monitored (laboratory tests, etc).
Men and women should use an effective method of contraception during and after treatment. Please see “Pregnancy, breastfeeding and fertility” below. Monitoring during treatment
This medicine can only be used under strict med-ical supervision: a medical examination and blood tests are required during treatment. If you have any doubt, do not hesitate to ask your doctor or your pharmacist for advice.
Children and adolescents
The safety and efficacy of Zanosar have not been studied in children and adolescents under 18 years old.
Other medicines and Zanosar
Contraindicated associations
This medicine MUST NOT BE USED in the following situations:
- In combination or successive administration with other substances which are potentially toxic to the kidney (unless advised otherwise by your doc-tor).
- Combination with certain vaccines (called live or live-attenuated vaccines).
Associations requiring cautions
Alert your doctor:
- If you are taking a medicine which reduces or abol-ishes the body defences (immunosuppression),
- If you are taking oral anticoagulants (vitamin K antagonist).
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Contraception for men and women
You should use an effective method of contracep-tion during treatment. A period of contraception post-treatment of 90 days for men, and 30 days for women should be applied.
Pregnancy
You should not use this medicine if you are preg-nant or if you are planning to have a baby or if you do not use a method of contraception. Breastfeeding
It has not been determined whether this medicine passes into breast milk. As a cautionary measure you should stop breastfeeding during treatment. Fertility
If you are a man being treated with Zanosar, you are advised not to attempt to father a child for 90 days after treatment and to seek advice on conservation of sperm prior to treatment, because streptozocin may alter male fertility.
If you are a woman, you should continue your con-traception for 30 days after treatment.
Driving and using machines
Zanosar may cause confusion, fatigue or depres-sion, therefore you should not drive or use machines if you experience one of these effects.
Zanosar contains sodium
This medicine contains 30.1 mg sodium (main com-ponent of cooking/table salt) in each vial. This is equivalent to 1.5 % of the recommended maximum daily dietary intake of sodium for an adult.
3. HOW TO USE ZANOSAR
This medicine must only be prepared and adminis-tered by a healthcare professional.
Your doctor will determine the dose you should receive based on your body surface area and gen-eral state.
The treatment will be injected by infusion into one of your veins (intravenous use). The infusion will last from 30 minutes to 4 hours.
Two dosage schedules are generally used:
- Six-weekly regimen: 5 consecutive days every 6 weeks;
- Three-weekly regimen: 5 consecutive days during the first week, and then 1 infusion every 3rd week. A dosage adjustment or discontinuation of treat-ment may be required if toxicity develops. Zanosar can induce nausea and vomiting. Thus, your doctor can prescribe you some anti-vomiting medicinal products.
If you use more Zanosar than you should
Appropriate care measures will be provided to you.
If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them. Very common side effects (may affect more than 1 in 10 people)
Severe nausea and vomiting which have occa-sionally required discontinuation of the treatment. Cases of diarrhoea have also been reported. Common side effects (may affect up to 1 in 10 people) Renal impairment (failure of kidney function) which may be serious. Your doctor may prescribe blood and urine measurements for you before, during and then repeatedly after the end of the treatment. Side effects of unknown frequency (frequency cannot be estimated from the available data)
- Haematological toxicity (blood toxicity) which usu-ally involves a fall in haematocrit values (the per-centage volume of red blood cells compared to the total blood volume), in white cells and in platelets. It may also increase the sensitivity to infections.
- Glucose intolerance, usually mild to moderate and usually reversible.
- Confusion, lethargy, depression.
- Nephrogenic diabetes insipidus (inability of the kidneys to concentrate urine).
- Hepatotoxicity (liver toxicity): increase in some liver enzymes, abnormally low level of albumin in the blood (hypoalbuminaemia).
- Injection site reactions: necrosis (destruction) of tissue when the substance passes outside the vein, burning sensations extending from the injec-tion site to the arm.
- Fever.
Declaration of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ZANOSAR
Keep this medicine out of the sight and reach of children.
Do not use Zanosar after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month.
Before opening: store the vial in a refrigerator (2°C to 8°C); keep the vial in the outer carton in order to protect from light.
After opening, reconstitution and dilution: The reconstituted solution should be immediately diluted. The chemical and physical in-use stability of the resulting solution has been demonstrated for 24 hours below 25°C.
Description:
Country/Lang.:
Date/Time:
Material No.:
MAH No.:
Manufact. No.:
Dimensions/TD:
SKU/DU:
ZANOSAR 1G POWDER UK
115003201
005U4174106
315 x 240 mm
Helevtica Neu Reg/Bold, Dax Pro Reg/Med
405380
In case of co-administration of Zanosar and 5-FU, it is recommended to use a Y-set system. The product does not contain a preservative and is for single use only.
Norge: Zanosar 1g, Pulver til konsentrat til infusjons-væske, oppløsning
face safety sheets, waste- disposal containers and bags. Excreta and vomit should be handled with caution. Pregnant women should be warned and avoid handling cytotoxic agents. Any broken con-tainer should be handled with the same precautions and considered contaminated waste. Disposal of contaminated waste should be done by incinera-tion in rigid containers (labelled accordingly i.e. to indicate they contain such contaminated waste).
The following information is intended for healthcare professionals only:
From a microbiological point of view, unless the method of opening/ reconstitution/ dilution pre-cludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use conditions are the responsibil-ity of the user.
France: Zanosar 1g, poudre pour solution à diluer pour perfusion
Posology:
Italia: Streptozocina Keocyt
The dose is based on the body surface area (m²).
Suomi/Finland: Zanosar 1g, kuiva-aine välikonsen-traatiksi infuusionestettä varten, liuos
Two different dosage schedules can be used: Six-weekly regimen – 500 mg/m²/day, intrave-nously for 5 consecutive days every six weeks until maximum benefit or until treatment-limiting toxic-ity is observed.
Sverige: Zanosar 1g, pulver till koncentrat till infu-sionsvätska, lösning
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
United Kingdom (Northern Ireland): Zanosar 1g, powder for concentrate for solution for infusion
Overdose
Three-weekly regimen – 500 mg/m²/day, intra-venously for 5 consecutive days during cycle 1, followed by 1000 mg/m² every 3rd week during the subsequent cycles.
There is no specific antidote for overdose with Zanosar and treatment of overdose should con-sist of supportive measures. Overdose should be avoided by carefully calculating the dose to be administered.
This leaflet was last revised in Mar 2026.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Detailed information about this medicine is avail-able on the UK Medicines and Healthcare products Regulatory Agency (MHRA) website (https://www. gov.uk/government/organisations/medicines-and- healthcare-products-regulatory-agency).
What Zanosar contains:
Other dosing regimens, with similar dose intensity, have been used in clinical studies with comparable efficacy and safety results.
The active substance is:
Streptozocin................ 1.000g (per a vial of powder) The other ingredients are:
Method of administration
Zanosar should be administered intravenously by infusion. The duration of infusion should be between 30 minutes and 4 hours.
The optimal duration of maintenance therapy with Zanosar has not been established.
Anhydrous citric acid
Sodium hydroxide for pH adjustment
For patients with functional tumours, serial moni-toring of biological markers allows a determination of biochemical response to therapy. For patients with either functional or nonfunctional tumours, response to therapy can be determined by mea-surable reductions of tumour size on imaging. A close monitoring of renal, hepatic and haema-tological functions must be performed before, during and after treatment, as well as blood glu-cose levels. Dose adjustment or discontinuation of the drug may be indicated, depending upon the degree of toxicity noted.
The administration of Zanosar requires hyperhy-dration.
What Zanosar looks like and contents of the pack
This medicinal product is vesicant in nature and as such should be administered with caution through a free-flowing line.
This medicine is in the form of a sterile white to pale yellow powder for infusion preparation.
Box of 1 vial.
In case of extravasation, administration should be stopped immediately. Healthcare professionals should take appropriate protection measures. The initial aim is to minimize the volume of extravasated product into the surrounding tissues and to aspirate as much as possible product from the canula with a syringe. Cold packs should be applied and appro-priate medical monitoring should be performed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ESTEVE PHARMACEUTICALS S.A.S.
Immeuble Cap Sud
Antiemetic premedication is recommended to pre-vent nausea and vomiting.
106, avenue Marx-Dormoy
92120 Montrouge
France
Precautions to be taken before handling or administering the medicinal product
Manufacturer:
Instructions for reconstitution
VALDEPHARM
Zanosar must be reconstituted by a healthcare professional.
Caution in the handling and preparation of the powder and solution should be exercised, and the use of gloves is recommended. If the sterile pow-der of Zanosar or a solution prepared from Zano-sar contacts the skin or mucosae, immediately wash the affected area with soap and water. Procedures for proper handling and disposal of anticancer drugs should be considered. The preparation of injectable solutions of cytotoxic agents should be done by specialist and trained personnel with knowledge of the medicines used and under conditions guaranteeing the protection of the environment and especially the personnel handling the agents. It requires premises intended solely for preparation. Smoking, eating and drink-ing in these premises is forbidden. Personnel han-dling the agents should have at their disposal a set of appropriate handling equipment particularly long sleeved gowns, safety masks, safety cap, safety glasses, sterile single-use PVC gloves, work sur-
Parc Industriel d’Incarville
Parc de la Fringale – CS10606
Dose preparation takes into account the patient body surface area (see section posology above). Each 20 mL vial of Zanosar must be reconstituted with 9.5 mL of a sodium chloride 9 mg/ml (0.9%) solution for injection. Dissolution of the lyophilised powder is completed in less than 2 minutes. The resulting solution is pale-gold.
27106 Val de Reuil
France
This medicine is authorised in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the fol-lowing names:
België/Belgique/Belgien: Streptozocine Esteve 1g, poeder voor concentraat voor oplossing voor infusie Danmark: Zanosar
The pH value of the reconstituted product is 4. After reconstitution, each mL solution contains 100 mg streptozocin per mL.
Deutschland: Zanosar 1g, pulver für ein Konzentrat zur Herstellung einer Infusionslösung
The correct amount of the reconstituted solution (see section 4.2 of the SmPC for the calculation of the dose based on the body surface area) should then be diluted in 500 mL of the same solution that was used for reconstitution.
Nederland: Zanosar 1g, poeder voor concentraat voor oplossing voor infusie
España: Zanosar 1g, polvo para concentrado para solución para perfusion