Vinorelbine Accord

Leaflet accompanying the packaging: patient information

Vinorelbine Accord, 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, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Vinorelbine Accord and what is it 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 packaging and other information

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

Vinorelbine Accord is a concentrate for solution for infusion. The active substance, vinorelbine, belongs to a group of cytostatic agents. These agents disrupt the growth of cancer cells.
Vinorelbine Accord is indicated for the treatment of cancer in adults, 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 any other vinca alkaloid,
• 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 reduced white blood cell count (neutrophils) or has recently had a severe infection (within the last 2 weeks),
• if the patient has a reduced platelet count,
• -if the patient is to receive or has recently received a yellow fever vaccine.

The medicine is intended for intravenous use only and should not be administered into the spinal cord.

Warnings and precautions

Before starting treatment with Vinorelbine Accord, consult a doctor or pharmacist.
Inform your doctor:

• if the patient has had a heart attack or has experienced severe chest pain,
• if the patient has been treated with radiation therapy, and the treated area included the liver,
• if the patient has symptoms of infection (such as fever, chills, cough),
• if the patient is to be vaccinated,
• if the patient has liver function disorders,
• if the patient is pregnant.

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

Vinorelbine Accord and other medicines

Inform your 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:

• medicines that thin the blood (anticoagulants),
• an antiepileptic medicine called phenytoin,
• an antifungal medicine called itraconazole,
• a anticancer medicine called mitomycin C,
• medicines that affect the immune system, such as cyclosporine and tacrolimus,
• concomitant use with lapatinib (a medicine used to treat cancer),
• 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).

Vaccines (e.g. against chickenpox, measles, mumps, etc.) and yellow fever vaccination are not recommended during treatment with Vinorelbine Accord, as they may increase the risk of a life-threatening systemic disease.
Concomitant use of Vinorelbine Accord and other medicines with known toxic effects on the bone marrow (affecting white and red blood cells and platelets) may exacerbate some of the side effects.

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, the patient should inform their doctor and seek their advice if they are pregnant, think they may be pregnant, or plan to become pregnant, due to the potential risk to the fetus.
Women of childbearing age should use effective contraception during treatment and for 7 months after its completion.

Breastfeeding

Breastfeeding should be avoided if the patient is taking Vinorelbine Accord (see section 2 "When not to use Vinorelbine Accord").

Fertility

Men should be informed that during treatment with Vinorelbine Accord and for at least 4 months after its completion, they should avoid fathering a child. They should consult their doctor about sperm preservation before starting treatment, due to the risk of fertility changes in men during treatment with Vinorelbine Accord. Effective contraception should be used during treatment and for 4 months after its completion.

Driving and using machines

No studies have been conducted on the effects of Vinorelbine Accord on the ability to drive and use machines. Therefore, patients should not drive vehicles if their doctor advises against it or if they feel unwell.

3. How to use Vinorelbine Accord

This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

Dosage

Vinorelbine Accord can only be prepared and administered by qualified medical personnel specializing in oncology.
Before each administration, a new blood sample will be taken to examine the blood components and confirm that the patient has a sufficient number of blood cells to receive Vinorelbine Accord. If the test results are unsatisfactory, treatment may be delayed, and further tests will be performed until the results return to normal.
The usual dose in adults is 25-30 mg/m².

Frequency of administration

Vinorelbine Accord is usually administered once a week.
The frequency of administration will be determined by the doctor.
Always follow the doctor's instructions.
Dose adjustment:

• In case of severe liver impairment, the doctor may adjust the dose. It is essential to follow the doctor's instructions.
• In case of kidney impairment, dose adjustment is not necessary. It is essential to follow the doctor's instructions.

Method and route of administration

Vinorelbine Accord must be diluted before administration.
Vinorelbine Accord should only be administered intravenously. The medicine is administered as an intravenous infusion over 6-10 minutes.
After administration, the vein should be carefully flushed with a sterile solution.

Overdose of Vinorelbine Accord

The doctor must always ensure that the patient receives a dose that is appropriate for their situation. However, if the patient has any suspicions or experiences symptoms of possible overdose, such as fever, infection symptoms, or constipation, they should consult their doctor, emergency department, or pharmacist.
In case of further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Immediately consult a doctor if the following side effects occur during treatment with Vinorelbine Accord:

The following side effects:

• Infection symptoms, such as cough, fever, chills;
• Severe constipation with abdominal pain caused by not having a bowel movement for several days;
• Severe dizziness, feeling of emptiness in the head when standing up, which may be a sign of significantly decreased blood pressure;
• Severe chest pain that has not occurred before, which may be a sign of heart disease related to insufficient blood flow; this is known as ischemic heart disease, such as angina pectoris and myocardial infarction (in some cases leading to death);
• Difficulty breathing, which may be a sign of a condition called acute respiratory distress syndrome and may be severe and life-threatening;
• Dizziness, low blood pressure, rash covering the whole body, or swelling of the eyelids, lips, and throat, which may be a sign of an allergic reaction.
• Chest pain, shortness of breath, and fainting, which may be a sign of a blood clot in a blood vessel in the lungs (pulmonary embolism);
• Headache, altered mental state, which may lead to confusion and coma, seizures, blurred vision, and high blood pressure, which may be a sign of a neurological disorder, such as posterior reversible encephalopathy syndrome.

Very common side effects (may occur in more than 1 in 10 patients):

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

Common side effects (may occur in up to 1 in 10 patients):

• Decreased platelet count, which increases the risk of bleeding and 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 tumor site;
• Diarrhea;
• Infections in various locations.

Uncommon side effects (may occur in up to 1 in 100 patients):

• Severe difficulty moving and sensory disturbances;
• Dizziness;
• Sudden hot flashes and redness of the face and neck;
• Feeling of cold hands and feet;
• Difficulty breathing or wheezing (dyspnea, bronchospasm);
• Blood infection (sepsis) with symptoms such as fever and deterioration of general health;
• High blood pressure.

Rare side effects (may occur in up to 1 in 1,000 patients):

• Heart attack (ischemic heart disease, angina pectoris, myocardial infarction, in some cases leading to death);
• Lung disease (inflammation and fibrosis, in some cases leading to death);
• Severe abdominal and back pain (pancreatitis);
• Low sodium levels in the blood (which may lead to symptoms such as fatigue, disorientation, muscle tremors, loss of consciousness);
• Ulcers at the injection site of Vinorelbine Accord (local necrosis);
• Skin rashes such as hives and skin eruptions (generalized skin reactions).

Very rare side effects (may occur in less than 1 in 10,000 patients):

• Irregular heartbeat (tachycardia); palpitations; arrhythmias.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Abdominal pain, gastrointestinal bleeding;
• Heart failure, which may cause shortness of breath and swelling of the ankles;
• Redness on the palms and soles;
• Low sodium levels in the blood, leading to weakness, muscle tremors, fatigue, confusion, loss of consciousness, and is associated with excessive production of a hormone that causes fluid retention (Syndrome of Inappropriate Antidiuretic Hormone Secretion - SIADH);
• Loss of muscle control, which may be accompanied by gait disturbances, speech changes, and eye movement disorders (ataxia);
• Headache;
• Chills with fever;
• Cough;
• Loss of appetite;
• Weight loss;
• Darker skin color extending along the veins.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, inform your doctor or pharmacist. 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
Phone: +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 gather more information on the safety of the medicine.

5. How to store Vinorelbine Accord

Keep the 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 after: EXP. The expiry date refers to the last day of the specified month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Store in the original packaging to protect from light.
Shelf life after dilution
Chemical and physical stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, 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, the user is responsible for the storage conditions and time.
Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vinorelbine Accord contains

The active substance of Vinorelbine Accord is vinorelbine (as tartrate). 1 ml of the 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, colorless to slightly yellow solution. Vinorelbine Accord is packaged in type I glass vials, closed with a bromobutyl rubber stopper and sealed with a blue aluminum 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 authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50
95-200 Pabianice

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

Date of last revision of the leaflet: March 2025

Information intended for healthcare professionals only:

Vinorelbine Accord, 10 mg/ml, concentrate for solution for infusion

Instructions for use

ANTICANCER MEDICINE

Refer to the Summary of Product Characteristics for detailed information on the medicine.

Preparation and use

Preparation and administration of cytotoxic agent solutions must be performed by specially trained personnel with knowledge of the medicine, in conditions that ensure environmental protection, and in particular, protection of personnel in contact with the medicine. This requires a dedicated area.
Smoking, eating, and drinking are not allowed in this area.
Personnel must be equipped with appropriate protective equipment, including long-sleeved gowns, protective masks, caps, protective glasses, sterile single-use gloves, protective covers for the workplace, and waste bags.
Syringes and infusion sets should be carefully prepared to avoid leakage (Luer-type connections are recommended).
Spilled or leaked solution should be wiped up wearing protective gloves.
Precautions should be taken to avoid exposure of pregnant staff.
Precautions should be taken to avoid contact of the solution with the eyes. In case of eye contact, the eyes should be immediately rinsed with physiological saline, and an ophthalmologist should be consulted.
In case of skin contact, the affected area should be thoroughly washed with water.
Finally, the exposed area and hands and face should be thoroughly cleaned.
Preparation of the infusion solution
There are no incompatibilities between Vinorelbine Accord and glass vials, PVC bags, polyvinyl chloride bags, and polypropylene syringes.
In the case of polychemotherapy, Vinorelbine Accord should not be mixed with other medicines.
Intraperitoneal administration is contraindicated.
Vinorelbine Accord should only be administered intravenously.
Vinorelbine Accord may be administered in a slow bolus (over 6-10 minutes) after dilution in 20-50 ml of physiological sodium chloride solution or 5% glucose solution (50 mg/ml) or in a short infusion (20-30 minutes) after dilution in 125 ml of physiological sodium chloride solution or 5% glucose solution (50 mg/ml). After administration, the vein should always be flushed with at least 250 ml of isotonic solution.

Storage

Store in a refrigerator (2°C - 8°C). Do not freeze.
Store in the original packaging to protect from light.
Shelf life after dilution
Chemical and physical stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, 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, the user is responsible for the storage conditions and time.
Do not freeze.
Disposal
Unused product or waste derived from it should be disposed of in accordance with local regulations.