Navelbine

Package Leaflet: Information for the User

NAVELBINE, 10 mg/ml, Concentrate for Solution for Infusion

Vinorelbine

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What is Navelbine and What is it Used For
• 2. Before You Use Navelbine
• 3. How to Use Navelbine
• 4. Possible Side Effects
• 5. How to Store Navelbine
• 6. Contents of the Pack and Other Information

1. What is Navelbine and What is it Used For

Navelbine contains the active substance vinorelbine (as tartrate) and belongs to a group of medicines called vinca alkaloids, used in the treatment of cancer.
Navelbine is used to treat certain types of lung cancer and certain types of breast cancer in patients over 18 years of age.

2. Before You Use Navelbine

When Not to Use Navelbine

• if you are breastfeeding;

Warnings and Precautions

Before starting treatment with Navelbine, you should discuss with your doctor or pharmacist if:

• you have had a heart attack or severe chest pain in the past;
• you have had radiation therapy and the liver was in the radiation field;
• you have symptoms of infection such as fever, chills, cough;
• vaccination is planned. Live, attenuated vaccines (e.g., measles, mumps, rubella) should not be administered with Navelbine, as this may increase the risk of life-threatening disease;
• your liver function is not normal;
• you are pregnant.

Before and during treatment with Navelbine, it is necessary to monitor your blood counts to ensure that the treatment is safe for you. If the results of your blood count are not satisfactory, your doctor may recommend a repeat test or postpone treatment until your blood count returns to normal.

Children and Adolescents

Navelbine should not be used in children under 18 years of age.

Navelbine and Other Medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Your doctor should pay special attention if you are taking:

• blood thinners (anticoagulants);
• antiepileptic drugs (e.g., phenytoin);
• antifungal drugs (e.g., itraconazole);
• cancer medicines such as mitomycin C or lapatinib;
• medicines that suppress the immune system, such as cyclosporine and tacrolimus.

Taking Navelbine with other medicines that damage the bone marrow (causing changes in blood counts) may increase the risk of certain side effects.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine and ask for genetic counseling, as vinorelbine may damage the genetic material in cells, which is a potential risk to the child.
Navelbine should not be used during pregnancy unless the expected benefits clearly outweigh the potential risks.
Do not breastfeed while taking Navelbine.
Women of childbearing age must use effective methods of contraception during treatment and for 7 months after treatment ends.
Men taking Navelbine should not plan to conceive a child during treatment and for 4 months after treatment ends. Before starting treatment, they should seek advice on sperm conservation due to possible irreversible infertility caused by Navelbine therapy. It is essential to use effective methods of contraception during treatment and for 4 months after treatment ends.

Driving and Using Machines

No studies have been conducted on the effects of Navelbine on the ability to drive and use machines. In no case should you drive or operate machinery if you feel unwell or if your doctor considers that you should not perform these activities.

3. How to Use Navelbine

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Before and during treatment with Navelbine, your doctor will recommend a blood test (blood count).
The dose of Navelbine will be determined based on the results of the test, your body surface area, and your overall condition. Your doctor will recommend the dose suitable for you and determine the duration of treatment.

Method and Route of Administration

Navelbine must be diluted before administration. Navelbine can only be administered intravenously through an infusion lasting from 6 to 10 minutes. After the infusion is completed, the vein should be thoroughly flushed with a sterile saline solution.

Use of a Higher Than Recommended Dose of Navelbine

Administration of Navelbine should be carried out under the strict control of a doctor. In case of administration of a higher dose of Navelbine than recommended, severe side effects associated with changes in blood counts may occur, which can cause symptoms of infection (such as fever, chills, cough) and severe constipation. You should contact your doctor immediately if you experience any of these symptoms.

Discontinuation of Navelbine Treatment

The decision to stop treatment will be made by your doctor. If you want to stop treatment on your own, you should discuss it with your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

You Should Contact Your Doctor Immediately if You Experience Any of the Following Side Effects:

• Chest pain, shortness of breath, and fainting, which may be symptoms of a blood clot in a blood vessel in the lungs (pulmonary embolism);
• Headache, altered mental state, which can lead to confusion and coma, seizures, blurred vision, and high blood pressure, which may be symptoms of a neurological disorder, such as posterior reversible encephalopathy syndrome;
• Symptoms of severe infection, such as cough, fever, chills;
• Severe constipation accompanied by 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 symptom of heart disease related to insufficient blood flow; this is called ischemic heart disease, such as angina pectoris and myocardial infarction (in some cases leading to death);
• Difficulty breathing, which may be a symptom 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 symptoms of an allergic reaction.

Very Common Side Effects(may affect more than 1 in 10 people):

• Nausea; vomiting; constipation;
• Decreased number of red blood cells (anemia), which can lead to pallor and cause weakness and shortness of breath;
• Decreased number of white blood cells, which can cause susceptibility to infections;
• Weakness of the lower limbs;
• Loss of reaction speed; sometimes sensory disturbances;
• Hair loss, usually not very severe during long-term treatment;
• Inflammation or pain in the mouth and throat;
• Reactions at the site of Navelbine administration, such as redness, burning, discoloration of veins;
• Liver function disorders (abnormal liver function test results).

Common Side Effects(may affect up to 1 in 10 people):

• Decreased number of platelets, which can increase the risk of bleeding and bruising;
• Joint pain;
• Jaw pain;
• Muscle pain;
• Fatigue (weakness, asthenia);
• Fever;
• Pain in various areas, such as chest pain, pain at the tumor site;
• Diarrhea;
• Infections in various locations.

Uncommon Side Effects(may affect up to 1 in 100 people):

• Significant difficulty in moving and sensory disturbances;
• Dizziness;
• Sudden hot flashes and flushing 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 worsening of general health;
• High blood pressure.

Rare Side Effects(may affect up to 1 in 1,000 people):

• 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 can lead to symptoms such as fatigue, disorientation, muscle tremors, loss of consciousness);
• Ulcers at the site of Navelbine administration (local necrosis);
• Skin rashes such as hives and skin eruptions (generalized skin reactions).

Very Rare Side Effects(may affect up to 1 in 10,000 people):

• Irregular heartbeat (tachycardia); palpitations; arrhythmias.

Side Effects with Unknown Frequency(frequency cannot be estimated from the available data):

• Abdominal pain, gastrointestinal bleeding;
• Heart failure, which can 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, associated with excessive production of antidiuretic hormone (SIADH);
• Loss of muscle control, which may be accompanied by gait disturbances, speech disturbances, changes, and disturbances in eye movements (ataxia);
• Headache;
• Chills with fever;
• Cough;
• Loss of appetite;
• Weight loss;
• Darker skin color extending along the veins.

Reporting of Side Effects

If you experience any side effects, including those not listed in this leaflet, you should tell 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, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Navelbine

Keep this medicine out of the sight and reach of children.
Navelbine should be stored in a refrigerator (2°C - 8°C). Protect from light.
Do not freeze.
Do not use Navelbine after the expiry date which is stated on the vial and carton after EXP. The expiry date refers to the last day of that month.
Navelbine can only be prepared for infusion and stored by hospital personnel.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Navelbine Contains

• The active substance is vinorelbine (as tartrate).
• 1 ml of the concentrate for solution for infusion contains 10 mg of vinorelbine.
• The excipient is water for injections.

What Navelbine Looks Like and Contents of the Pack

Navelbine is a concentrate for solution for infusion and is packed in vials (1 ml or 5 ml) made of colorless glass with a stopper made of black chlorobutyl rubber or gray butyl rubber laminated with fluorinated ethylene propylene (FEP), secured with a gray, aluminum cap with a blue polypropylene flip-off cap, in a polystyrene container (intermediate packaging), in a cardboard box.
Navelbine is a colorless or pale yellow solution.
Navelbine is available in:

• packs containing 10 vials of 1 ml,
• packs containing 10 vials of 5 ml. Not all pack sizes may be marketed.

Marketing Authorization Holder

Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France

Manufacturer

FAREVA PAU
Fareva Pau 1,
Avenue du Bearn
64320 IDRON
France

For Further Information, Please Contact the Marketing Authorization Holder:

Pierre Fabre Medicament Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
Tel: 022 559 63 00
Date of Last Revision of the Leaflet:January 2024
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Information Intended for Healthcare Professionals Only:

Only hospital personnel with experience in handling cytotoxic drugs should prepare and administer Navelbine. To prevent contact of the drug or its solution with the skin and eyes, personnel should wear gowns, goggles, gloves, and face masks. In case of spillage, the solution should be immediately wiped up.
Contact of the drug with the eyes should be avoided. In case of accidental contact of the drug with the eyes, they should be rinsed thoroughly with a 9 mg/ml (0,9%) sodium chloride solution.
After completing the procedure of administering the drug, personnel should thoroughly clean the surfaces used for preparing the drug and wash their hands and face.
It has been shown that after dissolving Navelbine in 9 mg/ml (0.9%) sodium chloride for injection or in 5% glucose solution for injection, Navelbine is physically and chemically stable for 1 day at 20°C +/- 5°C exposed to light, 40 days at 20°C +/- 5°C in a light-protected place, or 40 days in a refrigerator (2°C - 8°C) in a light-protected place, in neutral glass bottles, polyvinyl chloride, or polyethylene, or in polyvinyl acetate bags.
From a microbiological point of view, the solution should be used immediately. If not used immediately, the user is responsible for the storage conditions and storage time, which normally should not exceed 24 hours at 2°C - 8°C, unless the drug has been opened and diluted under controlled and validated aseptic conditions.
There are no incompatibilities between Navelbine and neutral glass bottles or polyvinyl chloride (PVC), polyvinyl acetate, polyethylene, or infusion sets with PVC.
It is recommended to administer Navelbine in an infusion over 6 to 10 minutes after dissolving it in 20-50 ml of 9 mg/ml (0.9%) sodium chloride for injection or 5% glucose solution for injection.
After administering the drug, the vein should be thoroughly flushed with a saline solution in a volume of 250 ml.
Navelbine can only be administered intravenously. Before starting the infusion of Navelbine, it should be checked that the needle is properly placed in the vein. If Navelbine accidentally enters the surrounding tissues, it may cause irritation.
In such a case, the infusion should be stopped immediately, the vein should be flushed with a saline solution, and the remaining part of the drug should be administered into a different vein.
In case of accidental extravasation of Navelbine into the surrounding tissues, to avoid phlebitis, glucocorticoids should be administered intravenously immediately.
Navelbine should be stored in a refrigerator (2°C - 8°C). Protect from light.
Do not freeze.
Any unused product or waste material should be disposed of in accordance with local requirements.