Vinorelbine Accord

Package leaflet: Information for the user

Vinorelbine Accord 10 mg/ml concentrate for solution for infusion

Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Vinorelbine Accord is and what it is used for
2. What you need to know 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 Vinorelbina Accord is and what it is used for

Vinorelbina 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 malignant cells. Vinorelbina Accord is indicated for the treatment of tumours in adults, particularly non-small cell lung cancer and breast cancer in patients over 18 years of age.

2. What you need to know before using Vinorelbina Accord

Do not use Vinorelbina Accord
if you are allergic to vinorelbine or to any of the medicines belonging to the family of
vinca alkaloids;
if you are allergic to any of the other ingredients of Vinorelbina Accord (listed in section 6);
if you are breastfeeding;
if you have a low number of white blood cells (neutrophils) or if you currently have or recently had (within the past 2 weeks) a serious infection;
if you have a low number of platelets;
if you are about to receive (or have just received) the yellow fever vaccine.
This medicine is strictly for intravenous use only and must not be injected into the spinal column.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vinorelbina Accord.
Inform your doctor:

• if you have a history of heart attacks or severe chest pain;
• if you have been treated with radiotherapy in an area including the liver;
• if you have symptoms of infection (such as fever, chills, cough);
• if you are about to receive a vaccine;
• if your liver is not functioning normally;
• if you are pregnant.

Vinorelbina Accord must not come into contact with the eyes, as this may cause severe irritation or even corneal ulcers. If this occurs, immediately rinse the eye with normal saline solution and contact an ophthalmologist. Before each administration of Vinorelbina Accord, a blood sample will be taken to analyze its components. If the results of these tests are unsatisfactory, treatment may be postponed and further monitoring carried out until these values return to normal.

Other medicines and Vinorelbina Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor should pay particular attention if you are taking any of the following medicines:

• medicines to thin the blood (anticoagulants);
• an antiepileptic medicine called phenytoin;
• an antifungal medicine called itraconazole;
• an anticancer medicine called mitomycin C;
• medicines that interfere with 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 for AIDS (HIV), such as ritonavir (HIV protease inhibitors);
• verapamil, quinidine (used for heart problems).

Vaccines (e.g. varicella, mumps, measles, etc.) and yellow fever vaccines are not recommended during treatment with Vinorelbina Accord, as they may increase the risk of a fatal systemic disease.
The use of Vinorelbina Accord together with other medicines known to have myelotoxic effects (affecting white and red blood cells and platelets) may worsen certain side effects.

Vinorelbina Accord with food and drinks
There are no interactions with food and drinks during treatment with Vinorelbina Accord.

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

Pregnancy, breastfeeding and fertility

If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine, as there are potential risks to the unborn child.

Pregnancy
Before starting treatment, you must inform your doctor and seek medical advice if you are pregnant, think you may be pregnant, or intend to become pregnant, as there may be potential risks to the unborn child.
If you are a woman of childbearing potential, you must use an effective method of contraception during treatment and for 7 months after the end of treatment.

Breastfeeding
You must not breastfeed while being treated with Vinorelbina Accord (see section 2 Do not use Vinorelbina Accord).

Fertility
Men treated with Vinorelbina Accord are advised not to father a child during treatment and for 4 months after the end of treatment, and should seek advice about the possibility of sperm preservation before starting treatment, as Vinorelbina Accord may impair male fertility.
You must use an effective method of contraception during treatment and for 4 months after the end of treatment.

Driving and using machines
No studies have been conducted on the effects of Vinorelbina Accord on the ability to drive or use machines. Therefore, do not drive if your doctor has advised you not to, or if you feel unwell.

3. How to use Vinorelbina Accord

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
Vinorelbina Accord may be prepared and administered only by qualified healthcare personnel specialized in oncology.
Before each administration, a new blood sample must be taken to monitor blood components, to ensure that the patient has sufficient blood cells to receive Vinorelbina Accord. If test results are unsatisfactory, treatment may be postponed and further tests carried out until these values return to normal.
The usual dose for adults is 25–30 mg/m².
Frequency of administration
Vinorelbina Accord is administered once a week. The exact frequency will be determined by your doctor.
Always follow your doctor’s instructions.
Dose adjustment:

• In case of significant hepatic impairment, the dose may be adjusted by the doctor. Follow your doctor’s instructions.
• In case of renal impairment, no dose adjustment is necessary. Follow your doctor’s instructions.

Method and route of administration
Vinorelbina Accord must be diluted before administration.
Vinorelbina Accord must be administered intravenously only. It will be given as an intravenous infusion over 6 to 10 minutes.
After administration, the vein must be flushed with a sterile solution.
If you take more Vinorelbina Accord than you should
Your doctor must always ensure that you receive the dose appropriate for your condition. However, contact your doctor, emergency services, or pharmacist if you suspect an overdose or experience symptoms such as fever, signs of infection, or constipation.
If you have any doubts, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately, during administration of Vinorelbina Accord, if you experience any of the following symptoms:

• Signs of infection, such as cough, fever, and chills,
• Severe constipation with abdominal pain, when your bowel has not moved for several days,
• Severe dizziness, feeling of lightheadedness when standing up, indicating a severe drop in blood pressure,
• Severe chest pain that is unusual for you; symptoms may be due to impaired heart function caused by reduced blood flow, known as ischemic heart disease, such as angina pectoris and myocardial infarction (sometimes fatal),
• Breathing difficulties, which may be symptoms of a disorder known as acute respiratory distress syndrome and can be serious and life-threatening,
• Dizziness, low blood pressure, skin rashes affecting the entire body, or swelling of the eyelids, face, lips, or throat, which may be signs of an allergic reaction,
• Chest pain, shortness of breath, and fainting, which may be symptoms of a blood clot in a lung vessel (pulmonary embolism),
• Headache, altered mental status that may lead to confusion and coma, seizures, blurred vision, and high blood pressure, which may indicate a neurological disorder such as reversible posterior encephalopathy syndrome.

Very common side effects (may affect more than 1 in 10 people)

• Nausea, vomiting, constipation;
• A decrease in red blood cells, which may make the skin pale and cause weakness or breathlessness;
• A decrease in white blood cells, making you more susceptible to infections;
• Weakness in the lower limbs;
• Loss of some reflex responses, occasionally changes in touch sensation;
• Hair loss (alopecia), usually not severe with prolonged treatment;
• Inflammation or sores in the mouth or throat;
• Reactions at the site where Vinorelbina Accord was administered, such as redness, burning pain (causing a burning sensation), abnormal vein color, vein inflammation;
• Liver disorders (abnormal liver tests).

Common side effects (may affect up to 1 in 10 people)

• A decrease in platelets, which may increase the risk of bleeding or bruising;
• Joint pain;
• Jaw pain;
• Muscle pain;
• Tiredness (asthenia, fatigue);
• Fever;
• Pain in various parts of the body, for example chest pain and pain at the site of the tumor;
• Diarrhea;
• Infections in different areas.

Uncommon side effects (may affect up to 1 in 100 people)

• Severe difficulties with body movements and sense of touch;
• Dizziness;
• Sudden sensation of warmth and skin redness of the face and neck;
• Feeling of coldness in hands and feet;
• Difficulty breathing or shortness of breath (dyspnea and bronchospasm);
• Blood infection (sepsis) with symptoms such as high fever and worsening of general physical 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, sometimes fatal);
• Pulmonary toxicity (inflammation and fibrosis, sometimes fatal);
• Severe abdominal and back pain (pancreatic inflammation);
• Low levels of sodium in the blood (which may cause symptoms of fatigue, confusion, muscle twitching, and loss of consciousness);
• Ulcers at the injection site where Vinorelbina Accord was administered (local necrosis);
• Skin rashes on the body, such as irritation and rashes (generalized skin reactions).

Very rare side effects (may affect up to 1 in 10,000 people)

• Irregular heartbeat (tachycardia), palpitations, heart rhythm disorders.

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

• Abdominal pain, gastrointestinal bleeding;
• Heart failure, which may cause breathlessness and swelling of the ankles;
• Redness of hands and feet (erythema);
• Low sodium levels due to excessive production of a hormone causing fluid retention and leading to weakness, fatigue, or confusion (Syndrome of Inappropriate Antidiuretic Hormone Secretion, SIADH);
• Loss of muscle control, which may be associated with abnormal gait, speech disturbances, and eye movement abnormalities (ataxia);
• Headache;
• Chills with fever;
• Cough;
• Loss of appetite;
• Weight loss;
• Darker skin color along the path of the veins.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this 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 packaging after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the container in the original outer packaging to protect the medicine from light.

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

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Vinorelbina Accord and contents of the pack
Clear solution, colourless to pale yellow. Vinorelbina Accord is supplied in type I transparent
glass vials with a bromobutyl rubber stopper and a blue flip-off aluminium seal.
Vinorelbina Accord is available in:
1 vial of 1 ml
1 vial of 5 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland
Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia,
Schimatari, 32009,
Greece

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

The following information is intended exclusively for doctors and healthcare professionals:
Vinorelbina Accord 10 mg/ml concentrate for solution for infusion
Instructions for use
ANTINEOPLASTIC AGENT
Refer to the Summary of Product Characteristics for detailed information regarding
this product.
Handling and use
The preparation and administration of injectable solutions of cytotoxic agents must be carried out
by qualified, specialized personnel experienced with these drugs, under conditions ensuring environmental protection and, in particular, protection of the personnel handling the drugs. A dedicated preparation area is required.
Smoking, eating, or drinking in this area is prohibited.
Personnel must be provided with appropriate materials for handling, including long-sleeved gowns, protective masks, caps, protective eyewear, sterile disposable gloves, protective covers for the work area, and waste collection bags.
Syringes and infusion sets must be assembled carefully to prevent leaks (use of Luer lock connectors is recommended).
Spills and leaks must be cleaned up while wearing protective gloves.
Precautions must be taken to avoid exposure of pregnant personnel.
Contact with the eyes must be absolutely avoided. If this occurs, immediately flush the eyes with normal saline solution. In case of irritation, consult an ophthalmologist.
In case of skin contact, wash the affected area thoroughly with water.
At the end of the procedure, any exposed surfaces must be carefully cleaned, and hands and face washed.
Preparation of the infusion solution
There are no incompatibilities between Vinorelbina Accord and glass vials, PVC bags, vinyl acetate bags, or polypropylene syringes.
In case of polychemotherapy, Vinorelbina Accord must not be mixed with other agents.
Intrathecal administration is contraindicated.
Vinorelbina Accord must be administered by intravenous infusion only.
Vinorelbina Accord may be administered as a slow bolus (6–10 minutes) after dilution in 20–50
ml of normal saline solution or 50 mg/ml (5%) glucose solution, or as a short infusion (20–30 minutes) after dilution in 125 ml of normal saline solution or 50 mg/ml (5%) glucose solution. Administration must always be followed by an infusion of at least 250 ml of isotonic solution to flush the vein.
Vinorelbine must be administered intravenously only. It is very important to ensure, before starting the injection, that the cannula is correctly positioned within the vein. If vinorelbine infiltrates into surrounding tissues during intravenous administration, severe irritation may occur. In such cases, the injection must be stopped immediately, the vein flushed with saline solution, and the remaining dose administered through another vein. In case of extravasation, intravenous glucocorticoids may be administered to reduce the risk of phlebitis.
Faeces and vomit must be handled with care.
Storage
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep in the original packaging to protect the medicinal product from light.
Stability after dilution
Chemical and physical stability in use has been demonstrated for 24 hours at 25°C.
From a microbiological standpoint, unless the method of opening/dilution excludes the risk of microbial contamination, the product should be used immediately after dilution. If not used immediately, the duration and conditions of storage are the responsibility of the user.
Do not freeze.
Disposal
Unused medicine and waste material arising from this medicine must be disposed of in accordance with local regulations.