Vinorelbine accord

Package leaflet: Information for the patient

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

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

Table of contents:

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

1. What Vinorelbine Accord is and what it is used for

Vinorelbine Accord is a concentrate for solution for infusion. The active substance,
vinorelbine, belongs to a group of cytostatic agents. These agents interfere with the growth of
cancer cells.
Vinorelbine Accord is indicated in adults for the treatment of cancer, particularly
non-small cell lung cancer and breast cancer in patients over 18 years of age.

2. Important information before using Vinorelbine Accord

When not to use Vinorelbine Accord:

• if the patient is allergic to vinorelbine or to any medicine in the vinca alkaloid family,
• if the patient is allergic to any of the other ingredients of Vinorelbine Accord (listed in section 6),
• if the patient is breastfeeding,
• if the patient has a low white blood cell count (neutrophils) or currently has or recently had (within the last 2 weeks) a severe infection,
• if the patient has a low platelet count,
• if the patient is due to receive or has recently received the yellow fever vaccine.

Vinorelbine Accord is intended for intravenous use only and must not be administered into the spinal canal.
Warnings and precautions
Before starting treatment with Vinorelbine Accord, consult a doctor or pharmacist.
Inform the doctor:

• if the patient has had a heart attack or experienced severe chest pain,
• if the patient has been treated with radiotherapy, particularly if the liver was within the irradiated area,
• if the patient has signs of infection (such as fever, chills, cough),
• if the patient is due to be vaccinated,
• if the patient has impaired liver function,
• if the patient is pregnant.

Vinorelbine Accord must not come into contact with the eyes, as there is a risk of severe eye irritation or even corneal ulceration. In such a case, the eye should be immediately irrigated with physiological saline solution and an ophthalmologist should be consulted.
Before each administration of Vinorelbine Accord, the patient will have blood tests to monitor blood components. If test results are unsatisfactory, treatment may be delayed and further tests performed until values return to normal.

Vinorelbine Accord and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The doctor must exercise particular caution if the patient is taking any of the following medicines:

• blood-thinning medicines (anticoagulants),
• the antiepileptic medicine phenytoin,
• the antifungal medicine itraconazole,
• the anticancer medicine mitomycin C,
• medicines that affect the immune system, such as cyclosporine and tacrolimus,
• concomitant use with lapatinib (a medicine used in cancer treatment),
• St John's wort ( Hypericum perforatum ),
• antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin,
• antiviral medicines used in AIDS (HIV infection), such as ritonavir (HIV protease inhibitors),
• verapamil, quinidine (used in heart diseases).

Vaccinations (e.g. against varicella, mumps, measles, etc.) as well as yellow fever vaccination are not recommended during treatment with Vinorelbine Accord, as they may increase the risk of fatal systemic disease.
Concomitant use of Vinorelbine Accord and other medicines known to have myelotoxic effects (affecting white and red blood cells and platelets) may increase the severity of some adverse reactions.

Vinorelbine Accord with food and drink
No interactions with food and drink are known during treatment with Vinorelbine Accord.

Use in children and adolescents
The safety and efficacy of Vinorelbine Accord in children and adolescents have not been established.

Pregnancy, breastfeeding and fertility

Pregnancy
Before starting treatment, inform the doctor and seek medical advice if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, due to potential risk to the unborn child.
Women of childbearing potential should use effective contraception during treatment and for 7 months after treatment ends.

Breastfeeding
Breastfeeding must not be undertaken while the patient is receiving Vinorelbine Accord (see section 2 "When not to use Vinorelbine Accord").

Fertility
Men should be informed that they should avoid fathering children during treatment with Vinorelbine Accord and for at least 4 months after treatment ends. Men should seek advice regarding sperm storage before starting treatment due to the risk of impaired fertility during treatment with Vinorelbine Accord. Effective contraception should be used during treatment and for 4 months after its completion.

Driving and operating machinery
No studies on the effects of Vinorelbine Accord on the ability to drive and operate machinery have been conducted. Therefore, patients should not drive if so advised by their doctor or if they feel unwell.

3. How to use Vinorelbine Accord

This medicine should always be used as directed by the physician. If in doubt, consult the physician or pharmacist.

Dosage
Vinorelbine Accord must be prepared and administered only by qualified medical personnel specializing in oncology.
Before each administration, a new blood sample will be taken to assess blood cell counts, to confirm that the patient has sufficient blood cells to receive Vinorelbine Accord. If the test results are unsatisfactory, treatment may be postponed, and further tests will be performed until these values return to normal.
The usual dose in adults is 25 to 30 mg/m².

Frequency of administration
Vinorelbine Accord is usually administered once weekly.
The frequency of administration will be determined by the physician.
Always follow the physician's instructions.

Dose adjustment:

• In the case of significant hepatic impairment, the physician may adjust the dose. It is essential to strictly follow the physician's instructions.
• In the case of renal impairment, dose adjustment is not required. It is essential to strictly follow the physician's instructions.

Method and route of administration
Vinorelbine Accord must be diluted before administration.
Vinorelbine Accord must be administered intravenously only. The medicine is given as an intravenous infusion over 6 to 10 minutes.
After administration of the medicine, the vein must be carefully flushed with sterile solution.

Accidental overdose of Vinorelbine Accord
The physician must always ensure that the patient receives a dose appropriate for the individual situation. However, if the patient has any suspicion of overdose or experiences symptoms suggestive of overdose, such as fever, signs of infection, or constipation, seek immediate advice from a physician, emergency department, or pharmacist.

If there are any further questions regarding the use of this medicine, consult the physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if any of the following adverse reactions occur during treatment with Vinorelbine Accord:

• Signs of infection such as cough, fever, chills;
• Severe constipation associated with abdominal pain due to failure to defecate for several days;
• Severe dizziness, feeling faint upon standing, which may indicate a significant drop in blood pressure;
• Severe chest pain not previously experienced, which may indicate impaired heart function due to inadequate blood flow; this is known as ischemic heart disease, such as angina pectoris or myocardial infarction (in some cases leading to death);
• Breathing difficulties, which may be symptoms of a condition called acute respiratory distress syndrome and may be severe and life-threatening;
• Dizziness, low blood pressure, rash affecting the entire body or swelling of the eyelids, lips and throat, which may indicate an allergic reaction;
• Chest pain, shortness of breath and fainting, which may be symptoms of a blood clot in a vessel in the lungs (pulmonary embolism);
• Headaches, altered mental state, which may lead to confusion and coma, seizures, blurred vision and high arterial blood pressure, which may be clinical signs of a neurological disorder such as posterior reversible encephalopathy syndrome (PRES).

Very common adverse reactions (may affect more than 1 in 10 patients):

• Nausea; vomiting, constipation;
• Decreased number of red blood cells (anaemia), which may lead to paleness and cause weakness and shortness of breath;
• Decreased number of white blood cells, which may increase susceptibility to infections;
• Weakness of the lower limbs;
• Reduced speed of reaction; sometimes sensory disturbances;
• Hair loss (alopecia), usually not severe during prolonged treatment;
• Inflammation or pain in the mouth and throat;
• Reactions at the site of administration of Vinorelbine Accord such as: redness, burning sensation, discoloration of veins, phlebitis;
• Liver function disorders (abnormal liver function test results).

Common adverse reactions (may affect up to 1 in 10 patients):

• Decreased number of platelets, which increases the risk of bleeding and haemorrhagic purpura (bruising);
• Joint pain;
• Jaw pain;
• Muscle pain;
• Fatigue (weakness, asthenia);
• Fever;
• Pain in various parts of the body, such as chest pain, pain at the site of the tumour;
• Diarrhoea;
• Infections at various sites.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• Severe difficulty in movement and disturbances in touch sensation;
• Dizziness;
• Sudden hot flushes and redness of the face and neck;
• Sensation of cold hands and feet;
• Breathing difficulties or wheezing (dyspnoea, bronchospasm);
• Blood infection (septicaemia) with symptoms such as fever and worsening general health;
• High blood pressure.

Rare adverse reactions (may affect up to 1 in 1000 patients):

• Heart attack (ischaemic heart disease, angina pectoris, myocardial infarction, in some cases leading to death);
• Lung disease (inflammatory condition and fibrosis, in some cases leading to death);
• Severe abdominal and back pain (pancreatitis);
• Low sodium concentration in blood (which may lead to symptoms such as fatigue, disorientation, muscle twitching, loss of consciousness);
• Ulceration at the site of administration of Vinorelbine Accord (local necrosis);
• Skin rashes such as urticaria and skin eruptions (generalised skin reactions).

Very rare adverse reactions (may affect less than 1 in 10,000 patients):

• Irregular heartbeat (tachycardia); palpitations; cardiac arrhythmias.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Abdominal pain, gastrointestinal bleeding;
• Heart failure, which may cause shortness of breath and ankle swelling;
• Redness on the palms of the hands and soles of the feet;
• Low sodium concentration in blood leading to weakness, muscle tremors, fatigue, confusion, loss of consciousness, associated with excessive production of a hormone causing fluid retention (Syndrome of Inappropriate Antidiuretic Hormone Secretion - SIADH);
• Loss of muscle control, possibly accompanied by gait disturbances, speech disorders, changes and disturbances in eye movement (ataxia);
• Headache;
• Chills with fever;
• Cough;
• Loss of appetite;
• Weight loss;
• Darker skin colouration 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 or pharmacist. 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
Phone: +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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vinorelbine Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and outer packaging following: EXP. The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Store in the original packaging to protect from light.
Diluted solution stability
Chemical and physical stability has been demonstrated for 24 hours at 25°C.
From a microbiological standpoint, unless the method of opening/dilution excludes the risk of microbiological contamination, the product should be used immediately after dilution. If the product is not used immediately, responsibility for storage conditions and duration lies with the user.
Do not freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vinorelbine Accord contains
The active substance is vinorelbine (as tartrate). 1 ml of solution contains 10 mg of vinorelbine (as vinorelbine tartrate).
The other ingredient is water for injections.
Each 1 ml vial contains 10 mg of vinorelbine (as tartrate).
Each 5 ml vial contains 50 mg of vinorelbine (as tartrate).

What Vinorelbine Accord looks like and contents of the pack
Clear, colourless to slightly yellow solution. Vinorelbine Accord is supplied in vials made of clear type I glass, closed with a bromobutyl rubber stopper and sealed with a blue aluminium flip-off cap.
Vinorelbine Accord is available in:
1 ml vial – 1 unit
5 ml vial – 1 unit
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
32009, Lamia, Schimatari, Greece

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Information intended exclusively for medical professionals:

Vinorelbine Accord, 10 mg/ml, concentrate for solution for infusion
Instructions for use
ANTINEOPLASTIC MEDICINAL PRODUCT
Please refer to the Summary of Product Characteristics for detailed information about the medicinal product.

Preparation and administration
Preparation and administration of injection solutions containing cytotoxic agents must be performed by specially trained personnel familiar with the medicinal product, under conditions ensuring environmental protection, and in particular protection of personnel handling the drug. This requires the designation of an area dedicated exclusively to this purpose.
Smoking, eating, or drinking must not be allowed in this area.

Personnel must wear appropriate protective equipment, including long-sleeved gowns, protective masks, caps, protective goggles, sterile disposable gloves, protective covers for work surfaces, and waste disposal bags.

Syringes and infusion sets must be carefully prepared to prevent leakage (use of Luer-lock connectors is recommended).
Any spilled or leaking solution must be wiped up while wearing protective gloves.

Precautions must be taken to avoid exposure of pregnant personnel.

Contact of the solution with the eyes must be strictly avoided. In case of contact with the eyes, immediately rinse thoroughly with physiological saline solution. If irritation persists, consult an ophthalmologist.

In case of skin contact, thoroughly wash the affected area with water.
At the end of handling, clean the exposed area thoroughly and wash hands and face.

Preparation of the infusion solution
No incompatibility has been observed between Vinorelbine Accord and glass vials, PVC bags, polyvinyl acetate bags, or polypropylene syringes.

In polychemotherapy regimens, Vinorelbine Accord must not be mixed with other medicinal products.

Intrathecal administration is contraindicated.
Vinorelbine Accord must be administered only by intravenous infusion.

Vinorelbine Accord may be administered as a slow intravenous bolus (over 6–10 minutes) after dilution in 20–50 ml of 0.9% sodium chloride solution or 5% glucose solution (final concentration: 50 mg/ml), or as a short infusion (20–30 minutes) after dilution in 125 ml of 0.9% sodium chloride solution or 5% glucose solution (final concentration: 50 mg/ml). After administration, the vein must always be flushed with at least 250 ml of isotonic solution by infusion.

Vinorelbine must be administered intravenously only. It is essential to confirm that the cannula has been correctly inserted into the vein before starting the infusion. Extravasation of vinorelbine during intravenous infusion may cause significant irritation. In such a case, the infusion must be stopped immediately, the vein flushed with sodium chloride solution, and the remaining dose administered into another vein. In case of extravasation, intravenous glucocorticoids should be administered to reduce the risk of phlebitis.

Exercise caution when handling excreta and vomit.

Storage
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep in the original packaging to protect from light.

Stability after dilution
Chemical and physical stability has been demonstrated for 24 hours at 25°C.
From a microbiological standpoint, unless the method of opening/dilution precludes the risk of microbial contamination, the product should be used immediately after dilution. If not used immediately, the responsibility for storage duration and conditions lies with the user.
Do not freeze.

Disposal
Unused product or waste material derived from it must be disposed of in accordance with local regulations.