Neocitec

Package leaflet: Information for the patient

Neocitec
10 mg/ml, concentrate for solution for infusion
Vinorelbinum
Please read carefully the entire leaflet before use, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or nurse.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or nurse immediately. See section 4.

Table of contents:

1. What Neocitec is and what it is 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 pack and other information

1. What Neocitec is and what it is used for

Neocitec is an anticancer medicine. Belongs to a group of medicines called alkaloids of Vinca rosea.
Neocitec is used in the treatment of 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 to 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 if they have significantly reduced white blood cell count (neutropenia);
• if the patient has significantly reduced platelet count;
• if the patient is breastfeeding;
• if the patient has recently been vaccinated or will soon be vaccinated against yellow fever.

If any of the above situations apply to the patient, do not use the medicine and speak to your doctor.

Warnings and precautions

• Inform your doctor if the patient has been diagnosed with ischemic heart disease.
• Inform your doctor if the patient has liver function disorders.
• Inform your doctor if the patient begins to experience shortness of breath.
• The patient should not receive radiotherapy involving the liver area while taking this medicine.
• If the patient develops signs of infection (such as fever, chills, or sore throat), contact the doctor immediately so appropriate tests can be performed.
• Inform your doctor if the patient has recently been vaccinated. Special caution is required when using live attenuated vaccines, such as:

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

• Avoid contact of the medicine with the eyes, as there is a risk of severe irritation or even corneal ulceration. If the medicine gets into the eye, rinse the eye immediately with physiological saline solution and contact a doctor.
• Exercise special caution if the patient is taking phenytoin, itraconazole, or any other medicine listed in the section "Neocitec and other medicines."

Before each dose of Neocitec, a blood sample will be taken to examine blood components. If test results are unsatisfactory, treatment may be delayed, and the doctor will recommend further testing until normal values are obtained.

Children and adolescents
Neocitec is intended for use in patients over 18 years of age. It is not recommended for children under 18 years of age.

Neocitec and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken. This includes in particular:

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

Pregnancy, breastfeeding, and effects on fertility

If a woman is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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 fetus. The doctor will discuss this with the patient. If pregnancy is confirmed or suspected, inform the treating doctor immediately.

Women of childbearing potential
Women of childbearing potential should use an effective method of contraception (pregnancy prevention) during treatment and for 7 months after treatment ends.

Breastfeeding
It is not known whether the medicine passes into human milk; therefore, breastfeeding must be discontinued before starting treatment.

Male fertility
Men receiving Neocitec should avoid fathering children during treatment and for at least 4 months after treatment ends. Before starting treatment, patients should seek advice regarding sperm preservation due to the possibility of irreversible infertility caused by vinorelbine treatment.

Driving and operating machinery
No studies have been conducted on the effect of the medicine on the ability to drive or operate machinery. Do not drive or operate machinery if dizziness or other symptoms occur that may impair the ability to perform these activities.

3. How to use Neocitec

The doctor decides what dose of Neocitec should be given to the patient. The dose the patient will receive
depends on their overall health condition and on any other anticancer treatment they may be receiving.
Neocitec is used in patients over 18 years of age. Its use is not recommended in patients under 18 years of age.
The medicine must not be administered by spinal injection.
The usual dose is 25 to 30 milligrams per week per square metre of the patient's body surface area.
Before starting treatment with Neocitec and during therapy, the doctor will check the patient's blood cell count.
Based on the results, the doctor will determine when the medicine can be administered.
The nurse will measure the patient's height and weight, and based on these measurements will calculate the patient's body surface area.
Taking into account the body surface area, the doctor will 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 may be given as an intravenous injection lasting 6 to 10 minutes.
After completion of the injection or infusion, the vein will be flushed with saline solution.
Since the medicine is administered while the patient is in hospital, it is unlikely that the patient will receive too little or too much medicine.
However, if an overdose is suspected, contact the doctor or nurse. Some symptoms of overdose may occur (e.g. fever, chills, joint pain), and severe constipation is also possible.
If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
All of the adverse reactions listed below are considered serious. If any of them occur,
the patient may require urgent medical attention.
Rare (may occur in fewer than 1 in 1,000 people):

• chest pain, heart attack, which may sometimes lead to death,
• severe abdominal and back pain caused by inflammation of the pancreas (pancreatitis),
• shortness of breath caused by lung disease (interstitial lung disease), which may sometimes lead to death. If the patient is Japanese, the doctor may monitor particularly closely for this adverse reaction, as it has been shown to occur more frequently in this patient group.

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

• life-threatening infections with high fever, e.g. infections within the chest cavity and infections located in other parts of the body (sepsis).

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

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

If any of these adverse reactions occur in the patient, treatment with Neocitec should be discontinued and the patient should immediately contact a doctor or go to the emergency department of the nearest hospital.
Other possible adverse reactions
Inform the doctor if any of the following adverse reactions become bothersome.
Very common (may occur in more than 1 in 10 people):

• decrease in white blood cells, which increases the likelihood of infection
• decrease in red blood cells, which may cause paleness of the skin and weakness or shortness of breath
• inflammation of the mouth or throat, nausea and vomiting, constipation
• hair loss, pain and (or) redness at the injection site
• diminished deep tendon reflexes, leg weakness
• liver function abnormalities detectable in blood tests

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

• decrease in platelets, which increases the risk of bruising and bleeding
• infections
• diarrhoea
• joint pain, muscle pain, jaw pain
• weakness, fatigue, fever, and pain

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

• severe symptoms of serious infection, such as cough, fever, chills, and blood infection
• significant difficulty in movement with abnormal sensation to touch
• decrease in blood pressure (hypotension) with symptoms such as dizziness or feeling faint
• increase in blood pressure (hypertension) with symptoms such as headache
• sudden feeling of warmth and redness of the skin of the face and neck (hot flushes)
• sensation of coldness in hands and feet
• difficulty breathing or wheezing

Rare (may occur in fewer than 1 in 1,000 people):

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

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

• irregular heartbeat (tachycardia, palpitations, and arrhythmias)

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

• decrease in white blood cells with fever (febrile neutropenia), generalized infection associated with decreased white blood cells (neutropenic sepsis, neutropenic infection), decrease in white blood cells (leukopenia), or decrease in white blood cells, red blood cells, and platelets (pancytopenia)
• low sodium levels (due to excessive production of a hormone causing fluid retention), leading to weakness, fatigue, or disorientation (syndrome of inappropriate antidiuretic hormone secretion)
• loss of appetite (anorexia)
• headache, dizziness, loss of muscle control, which may be accompanied by gait disturbances, speech changes, and eye movement disorders (ataxia)
• heart failure
• cough
• gastrointestinal bleeding, severe diarrhoea, abdominal pain
• liver function disorders
• redness of the skin (erythema) of the palms and soles (hand-foot syndrome)
• chills
• weight loss
• darker skin coloration spreading along the veins

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Neocitec

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of the stated month.
Store in a refrigerator (at 2°C–8°C). Do not freeze. Keep the vial in the outer packaging to protect from light.

Ready-to-use solution
After opening, the contents of the vial should be diluted and used immediately. If the solution is not used immediately, the user is responsible for the storage time and conditions prior to administration. If the solution was prepared under aseptic conditions, it remains stable after dilution with sodium chloride or glucose solution for 48 hours when stored refrigerated (at 2°C–8°C).

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Contents of the pack and other information

What Neocitec contains
The active substance 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, colourless or pale yellow solution.
Neocitec is supplied in vials made of colourless glass (type I) closed with a rubber stopper coated with a fluoropolymer and an aluminium seal, packed in a cardboard carton.

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 Authorisation 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 authorised in the Member States of the European Economic Area under the following names:
Netherlands: VINORELBINE SANDOZ 10 MG/ML, concentrate for infusion
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 further information about this medicinal product, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Information intended exclusively for healthcare professionals.

Special precautions
Neocitec must be prepared and administered only by appropriately trained personnel.
As with all cytotoxic medicinal products, all necessary precautions should be taken
to avoid exposure of pregnant healthcare workers to the drug.
Appropriate protective clothing (protective goggles, disposable gloves,
face mask and disposable gowns) must be worn. In case of spillage or leakage, the surface should be
thoroughly wiped.
Contact of the solution with the eyes must be strictly avoided. If the drug comes into contact with the eyes,
the eyes should be immediately irrigated with physiological saline solution.
After preparation of the drug for use, all surfaces exposed to the drug should be thoroughly cleaned,
and hands and face should be washed.
The medicinal product is for intravenous use only. It must be diluted before use,
immediately after opening the vial.
Incompatibilities
Neocitec must not be diluted with alkaline solutions (risk of precipitation).
Neocitec must not be mixed with other medicinal products except 0.9% sodium chloride solution or
5% glucose solution.
Incompatibility between Neocitec and clear glass vials, polyvinyl chloride (PVC) bags or vinyl acetate bags,
and infusion sets with polyvinyl tubing has not been observed.
Method of administration
Neocitec may be administered as 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 drug,
an infusion of at least 250 ml of physiological saline should always be administered to flush the vein.
Neocitec must be administered intravenously only. It is very important to verify that the cannula is correctly positioned in the vein before starting the infusion. If leakage into surrounding tissues occurs,
significant irritation may develop. In such a case, the infusion must be stopped, the vein flushed with physiological saline, and the remaining dose administered into another 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. Keep in the original packaging to protect from light.
Do not use after the expiry date stated on the carton and vial after “EXP”.
Solution stability after dilution:
From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user.
This duration should not exceed 24 hours at a temperature of 2°C to 8°C, unless dilution was carried out under controlled and validated aseptic conditions.
For further information, refer to the Summary of Product Characteristics.