Neocitec

Leaflet attached to the packaging: patient information

Neocitec

10 mg/ml, concentrate for solution for infusion

Vinorelbine

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Neocitec and what is it used for
• 2. Important information before using Neocitec
• 3. How to use Neocitec
• 4. Possible side effects
• 5. How to store Neocitec
• 6. Contents of the packaging and other information

1. What is Neocitec and what is it used for

Neocitec is an anticancer medicine. It belongs to a group of medicines called vinca alkaloids.
Neocitec is used to treat certain types of advanced lung cancer and breast cancer.

2. Important information before using Neocitec

When not to use Neocitec

• if the patient is allergic (hypersensitive) to vinorelbine or other vinca alkaloids or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has or has recently had a severe infection or has been found to have a significantly reduced number of white blood cells (neutropenia);
• if the patient has a significantly reduced number of platelets;
• if the patient is breastfeeding;
• if the patient has been recently vaccinated or is about to be vaccinated against yellow fever.

If any of the above situations apply to the patient, the medicine should not be used and the doctor should be consulted.

Warnings and precautions

• The doctor should be informed if the patient has a disease called "ischemic heart disease".
• The doctor should be informed if the patient has liver function disorders.
• The doctor should be informed if the patient starts to experience shortness of breath.
• During treatment with this medicine, the patient should not receive radiation therapy that includes the liver area.
• If the patient experiences symptoms of infection (such as fever, chills, or sore throat), they should immediately inform their doctor so that the necessary tests can be performed.
• The doctor should be informed if the patient has been recently vaccinated. Particular caution is advised when using live attenuated vaccines, such as

measles, mumps, rubella, polio, chickenpox, and tuberculosis (BCG) vaccines.

• Avoid contact between the medicine and the eyes, as there is a risk of severe irritation, even corneal ulcers. If the medicine gets into the eye, it should be rinsed immediately with a physiological saline solution and the doctor should be consulted.
• Particular caution is advised if the patient is taking phenytoin, itraconazole, or any other medicine listed in the "Neocitec and other medicines" section.

Before each administration of Neocitec, a blood sample will be taken from the patient to examine its components. If the test results are not satisfactory, treatment may be postponed, and the doctor will recommend further tests until the correct values are obtained.

Children and adolescents

Neocitec is used in patients over 18 years of age. It is not recommended for use in children under 18 years of age.

Neocitec and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken. This is especially important for:

• any medicines that may affect bone marrow function, such as anticancer medicines,
• carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy),
• antibiotics, such as rifampicin, erythromycin, clarithromycin, telithromycin,
• St. John's Wort (Hypericum perforatum),
• ketoconazole and itraconazole (medicines used to treat fungal infections),
• antiviral medicines used to treat AIDS (HIV infection), such as ritonavir (HIV protease inhibitor),
• nefazodone (an antidepressant),
• cyclosporine, tacrolimus (medicines that weaken the immune system),
• verapamil, quinidine (used to treat heart conditions),
• the anticancer medicine lapatinib,
• anticancer medicines, such as mitomycin C and cisplatin; concomitant use of Neocitec with mitomycin C increases the risk of respiratory difficulties (see section 4),
• medicines that prevent blood clots, such as warfarin,
• vaccines (see "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

If a woman is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Neocitec should not be used during pregnancy, unless the benefit to the mother outweighs the risk to the child. The doctor will discuss this with the patient. If pregnancy is suspected or confirmed, the treating doctor should be informed.
Women of childbearing age
Women of childbearing age should use effective contraception (birth control) during treatment and for 7 months after its completion.
Breastfeeding
It is not known whether the medicine passes into human milk, so breastfeeding should be stopped before starting treatment.
Male fertility
Men taking Neocitec should avoid fathering children during treatment and for at least 4 months after its completion.
Before starting treatment, advice should be sought on storing sperm due to the possibility of irreversible infertility caused by vinorelbine treatment.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines.
The patient should not drive or use machines if they experience dizziness or other symptoms that may interfere with their ability to perform these activities.

3. How to use Neocitec

The doctor decides what dose of Neocitec the patient should receive. The dose the patient receives will depend on their overall health and any other anticancer treatment they may be receiving.
Neocitec is used in patients over 18 years of age. It is not recommended for use in patients under 18 years of age.
The medicine is not administered by spinal injection.

The usual dose is 25 to 30 milligrams per week per square meter of body surface area.

Before starting Neocitec treatment and during treatment, the doctor will check the patient's blood count. Based on the results, they will determine when the medicine can be administered.
The nurse will check the patient's height and weight, and based on these measurements, calculate their body surface area. The doctor will then determine the appropriate dose of the medicine.
Before administration, the medicine is diluted with 0.9% sodium chloride solution or 5% glucose solution.
Neocitec is always administered intravenously.It can be administered by intravenous injection lasting 6 to 10 minutes.
After the injection or infusion is completed, the vein will be flushed with a physiological saline solution.
Since the medicine is administered to the patient during their hospital stay, it is unlikely that the patient will receive too little or too much of the medicine. However, if it is suspected that too much medicine has been administered, the doctor or nurse should be consulted. Some symptoms of overdose may occur (e.g., fever, chills, joint pain), and severe constipation is also possible.
If there are any further doubts about using this medicine, the doctor or nurse should be consulted.

4. Possible side effects

Like all medicines, Neocitec can cause side effects, although not everybody gets them.

Severe side effects

All the following side effects are considered severe. If any of them occur, the patient may need urgent medical attention.
Rare(may occur in less than 1 in 1000 people):

• chest pain, heart attack, which can sometimes be fatal,
• severe abdominal and back pain caused by pancreatitis,
• shortness of breath caused by lung disease (interstitial lung disease), which can sometimes be fatal. If the patient is Japanese, the doctor may monitor them particularly closely for this side effect, as it has been shown to occur more frequently in this group of patients.

Very rare(may occur in less than 1 in 10,000 people):

• life-threatening infections with high fever, such as infections in the chest and infections in other parts of the body (sepsis).

Frequency not known(cannot be estimated from the available data):

• generalized allergic reactions. These are severe reactions that can cause significant breathing difficulties, dizziness, rash all over the body, swelling of the eyelids, face, lips, and throat (anaphylactic shock, anaphylaxis, pseudo-anaphylactic reactions)
• breathing difficulties, which can be a symptom of a condition called acute respiratory distress syndrome and can be severe and life-threatening.
• headache, altered mental state, which can lead to confusion and coma, seizures, blurred vision, and high blood pressure, which can be a symptom of a neurological disorder, such as posterior reversible encephalopathy syndrome
• chest pain, shortness of breath, and fainting, which can be a symptom of a blood clot in a blood vessel in the lungs (pulmonary embolism)

If any of these side effects occur, the patient should stop using Neocitec and immediately contact their doctoror go to the emergency department of the nearest hospital.

Other possible side effects

The doctor should be informed if any of the following side effects become troublesome.
Very common(may occur in more than 1 in 10 people):

• low white blood cell count, which increases the risk of infection
• low red blood cell count, which can cause pale skin and weakness or shortness of breath
• mouth and throat inflammation, nausea and vomiting, constipation
• hair loss, pain and (or) redness at the injection site
• weakness of deep tendon reflexes, weakness of the legs
• liver function disorders visible in blood tests

Common(may occur in less than 1 in 10 people):

• low platelet count, which increases the risk of bruising and bleeding
• infections
• diarrhea
• joint pain, muscle pain, jaw pain
• weakness, fatigue, fever, and pain

Uncommon(may occur in less than 1 in 100 people):

• severe symptoms of infection, such as cough, fever, chills, and blood infection
• significant difficulty walking with abnormal sensation of touch
• low blood pressure (hypotension) with symptoms such as dizziness or fainting
• high blood pressure (hypertension) with symptoms such as headache
• sudden feeling of heat and redness of the skin on the face and neck (hot flashes)
• feeling of cold hands and feet
• breathing difficulties or wheezing

Rare(may occur in less than 1 in 1000 people):

• significant low blood pressure, causing dizziness, fainting (severe hypotension, shock)
• intestinal obstruction
• skin rashes on the body (generalized skin reactions)
• skin reactions at the injection site (abscess, necrosis)
• low sodium levels in the blood (hyponatremia)

Very rare(may occur in less than 1 in 10,000 people):

• irregular heartbeat (tachycardia, palpitations, and arrhythmia)

Frequency not known(cannot be estimated from the available data):

• low white blood cell count with fever (febrile neutropenia), generalized infection with low white blood cell count (septic neutropenia, neutropenic infection), low white blood cell count (leukopenia), or low white and red blood cell and platelet count (pancytopenia)
• low sodium levels (due to excessive production of antidiuretic hormone), which can cause weakness, fatigue, or disorientation (syndrome of inappropriate antidiuretic hormone secretion)
• loss of appetite (anorexia)
• headache, dizziness, loss of muscle control, which can be accompanied by gait disturbances, speech changes, and eye movement disorders (ataxia)
• heart failure
• cough
• gastrointestinal bleeding, severe diarrhea, abdominal pain
• liver function disorders
• redness of the skin on the hands and feet (palmar-plantar erythrodysesthesia syndrome)
• chills
• weight loss
• darker skin color along the veins

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Neocitec

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton and vial after "EXP". The expiry date refers to the last day of the month.
Store in a refrigerator (2°C-8°C). Do not freeze. Store the vial in the outer packaging to protect it from light.
Ready-to-use solution
After opening the vial, the contents should be diluted and used immediately. If the solution is not used immediately, the user is responsible for the storage conditions and time before administration. If the dilution was performed under aseptic conditions, the solution remains stable after dilution with sodium chloride or glucose solution for 48 hours when stored in a refrigerator (2°C-8°C).
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be consulted on how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Neocitec contains

The active substance of the medicine is vinorelbine.
Each 1 ml vial contains vinorelbine tartrate equivalent to 10 mg of vinorelbine.
Each 5 ml vial contains vinorelbine tartrate equivalent to 50 mg of vinorelbine.
The excipient is: water for injections.

What Neocitec looks like and contents of the pack

Neocitec is a clear, colorless or pale yellow solution.
Neocitec is packaged in clear glass vials (type I) closed with a rubber stopper covered with a fluoropolymer and an aluminum seal, in a cardboard box.
Pack sizes:
1 vial of 1 ml, 5 vials of 1 ml, and 10 vials of 1 ml
1 vial of 5 ml, 5 vials of 5 ml, and 10 vials of 5 ml

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto von Guericke Allee 1
39179 Barleben, Germany
EBEWE Pharma Ges.m.b.H. Nfg.KG
Mondseestrasse 11
4866 Unterach, Austria
Fareva Unterach GmbH
Mondseestraße 11
4866 Unterach, Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands
VINORELBINE SANDOZ 10 MG/ML, concentraat voor infusie
Poland:
NEOCITEC
Spain
Vinorelbina Sandoz 10 mg/ml concentrado para solución para perfusión EFG
Northern Ireland: Vinorelbine 10mg/ml Concentrate for Solution for Infusion

For more information about this medicine, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Sandoz logo
Date of last revision of the leaflet:08/2024

Information intended for healthcare professionals only.

Special precautions

Neocitec can only be prepared and administered by properly trained personnel.
As with all cytotoxic medicines, all precautions should be taken to avoid contact between the medicine and pregnant personnel.
Appropriate protective clothing (protective glasses, single-use gloves, face mask, and single-use aprons) should be worn. In case of spillage or leakage, the surface should be thoroughly wiped clean.
Contact between the solution and the eyes should be strictly avoided. If the medicine gets into the eyes, they should be rinsed immediately with a physiological saline solution.
After preparing the medicine for use, all surfaces that have come into contact with the medicine should be thoroughly cleaned, and hands and face should be washed.

Medicine intended for intravenous use only. Requires dilution before use, immediately after opening the vial.

Incompatibilities

Neocitec should not be diluted with alkaline solutions (risk of precipitate formation).
Neocitec should not be mixed with other medicinal products, except for 0.9% sodium chloride solution or 5% glucose solution.
No incompatibilities have been observed between Neocitec and glass vials, polyvinyl chloride (PVC) bags, or infusion sets with a polyvinyl chloride (PVC) cannula.

Method of administration

Neocitec can be administered in a slow bolus (over 6 to 10 minutes) after dilution in 20 to 50 ml of 0.9% sodium chloride solution or 5% glucose solution. After administration of the medicine, a flush with at least 250 ml of physiological saline solution should always be performed to rinse the vein.
Neocitec should only be administered intravenously. It is very important to check that the cannula is properly placed in the vein before starting the infusion. If the medicine leaks into the surrounding tissues, significant irritation may occur. In this case, the infusion should be stopped, the vein should be flushed with a physiological saline solution, and the remaining dose should be administered into a different vein. In case of extravasation, intravenous glucocorticoids should be administered to reduce the risk of phlebitis.

Storage and shelf-life

Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original packaging to protect from light.
Do not use after the expiry date stated on the carton and vial after "EXP".
Stability of the solution after dilution:
From a microbiological point of view, the product should be used immediately. If not used immediately, the storage conditions and time before administration are the responsibility of the user. This time should not exceed 24 hours at 2°C to 8°C, unless the dilution was performed under controlled and validated aseptic conditions.
For further information, please refer to the Summary of Product Characteristics.