JAVLOR 25 мг/мл Концентрат для инфузионного раствора

Содержание инструкции

1. Javlor 25 mg/mL concentrate for solution for infusion
   1. What is Javlor and what is it for
   2. What you need to know before using Javlor
   3. How to use Javlor
   4. Possible side effects
   5. How to store Javlor
   6. Contents of the pack and other information

Javlor 25 mg/mL concentrate for solution for infusion

Vinflunine

Read this leaflet carefully before 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.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What Javlor is and what it is used for
• 2. What you need to know before you use Javlor
• 3. How to use Javlor
• 4. Possible side effects
• 5. How to store Javlor
• 6. Contents of the pack and other information

1. What is Javlor and what is it for

Javlor contains the active substance vinflunine, belonging to a group of anticancer drugs
called vinca alkaloids. These drugs affect the growth of tumor cells
by blocking cell division and causing cell death (cytotoxicity).
Javlor is used for the treatment of bladder and urinary tract cancer at an advanced
stage or metastatic, after failure of a previous therapy containing platinum.

2. What you need to know before using Javlor

Do not use Javlor

• If you are allergic to the active ingredient (vinflunine) or to other vinca alkaloids (vinblastine, vincristine, vindesine, vinorelbine)
• If you have had (within the last 2 weeks) or are currently experiencing a severe infection,
• If your white blood cell and/or platelet counts are too low,
• If you are breastfeeding.

Warnings and precautions
Consult your doctor:

• if you have problems with your liver, kidneys or heart.
• if you experience any neurological symptom that could be a sign of "reversible posterior encephalopathy syndrome": brain swelling with usually temporary effects, such as headache, altered mental status that can lead to confusion and coma, seizures, vision changes, high blood pressure, nausea and vomiting, as it may be necessary to stop taking this medicine.
• If you experience symptoms of hyponatremia (low sodium levels in the blood) or symptoms of "inappropriate antidiuretic hormone secretion syndrome", such as headache, fatigue,

seizures or coma. During treatment with Javlor, regular monitoring of serum sodium levels is recommended.

• if you are taking other medicines mentioned in the following section “Other medicines and Javlor”.
• if you have constipation, or if you are being treated with pain medications (opioids), or if you have abdominal cancer or if you have previously undergone abdominal surgery. Constipation is a very common side effect of Javlor medicine. Laxatives may be given to prevent constipation.
• if you wish to become pregnant (see important recommendations for men and women in the section below “Pregnancy, breastfeeding and fertility”).

Your blood cell count will be checked regularly before and during treatment, as low blood cell count is a very common side effect of Javlor.
Intrathecal (into the spinal cord) administration of Javlor can be fatal. Javlor must not be administered by the intrathecal route.

Children and adolescents
Javlor is not suitable for use in children and adolescents.

Other medicines and Javlor
Tell your doctor if you are taking, have recently taken or might take any other medicine.
In particular, you should tell your doctor if you have taken medicines containing any of the following active ingredients:

• ketoconazole and itraconazole, used to treat fungal infections,
• opioids, used to treat pain,
• ritonavir, used to treat HIV infection,
• doxorubicin and pegylated liposomal doxorubicin, paclitaxel and docetaxel, used to treat some types of cancer,
• rifampicin, used to treat tuberculosis or meningitis,
• herbal preparations containing St. John's wort used to treat mild to moderate depression.

Or if you are taking medicines known to cause changes in the electrocardiogram (ECG), in particular medicines known to cause a "prolongation of the QT interval".

Javlor with food and drink
You should tell your doctor if you drink grapefruit juice as it may increase the effect of Javlor.
You should also drink water and eat fiber-rich foods.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine.
If you are a woman or a man of childbearing potential, you should use adequate and effective contraception during treatment and for 4 months if you are a man or 7 months if you are a woman after your last dose of Javlor.

Pregnancy
You should not take Javlor if you are pregnant unless absolutely necessary.
If you become pregnant during treatment, you should be informed of the risk to the unborn child and should be monitored carefully.

Breastfeeding
You should not breastfeed while taking Javlor.

Fertility
If you wish to become pregnant, consult your doctor. Before starting therapy, you may request advice on sperm preservation due to the possibility of irreversible infertility due to therapy with vinflunine.

Driving and operating machinery
Javlor can cause side effects such as fatigue and dizziness. Do not drive or operate machinery if you experience side effects that affect your ability to concentrate and react.

3. How to use Javlor

Dosage
The recommended dose of Javlor in adult patients is 320 mg/m² of body surface area (this is
calculated by the doctor based on weight and height). The treatment will be repeated every 3 weeks.
No dose adjustment is necessary based on age for patients under 75 years of age. The
doctor will modify the dose if the patient is 75 years of age or older.
The doctor may also modify the initial dose of Javlor based on physical condition and in specific
situations:

• if the patient has had previous pelvic irradiation
• if the patient has moderate or severe kidney problems
• if the patient has liver problems.

During treatment, the doctor may reduce the dose of Javlor, delay or discontinue treatment
if certain undesirable effects occur.

How Javlor is administered
Javlor MUST be administered EXCLUSIVELY by intravenous route.
Javlor must be administered by healthcare professionals (qualified in the use of oncological
treatments in specialized healthcare facilities) by intravenous infusion (instillation into the vein)
lasting 20 minutes.
Javlor is a concentrate that must be diluted before administration.

If you are given more Javlor than you should receive
The medicine is administered by the doctor or nurse. In the event that you are given
an excessive amount (an overdose), the doctor will check for side effects.

If you forget to take Javlor
It is very important not to miss a dose of this medicine. If you miss an appointment, call
your doctor immediately to schedule a new appointment.

If you stop taking Javlor
The doctor will decide when to stop treatment. If you wish to discontinue treatment prematurely,
you should discuss other therapeutic options available to you with your doctor.
If you have further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Tell your doctor immediatelyif you develop any of the following serious side effects during treatment with Javlor:

• fever and/or chills, which may be signs of infection,
• chest pain, which may be a sign of a heart attack,
• constipation that does not respond to treatment with laxatives,
• neurological symptoms that may be a sign of "reversible posterior encephalopathy syndrome": brain swelling with usually temporary effects, such as headache, altered mental status that can lead to confusion and coma, seizures, vision changes, high blood pressure, nausea and vomiting (see section 2 “Warnings and precautions”).

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

• abdominal pain, nausea, vomiting
• constipation, diarrhea
• inflammation of the oral mucosa (stomatitis)
• fatigue (asthenia), muscle pain (myalgia)
• loss of the sense of touch due to nerve damage (peripheral sensory neuropathy)
• weight loss, decreased appetite
• hair loss (alopecia)
• reactions at the injection site (pain, redness, swelling)
• fever
• low levels of white blood cells, red blood cells and/or platelets (identified in blood tests).
• low levels of sodium in the blood (hyponatremia) in blood tests.

Common (may affect up to 1 in 10 people)

• infections (neutropenic infection, febrile neutropenia, infections (viral, bacterial, fungal)) with symptoms such as high fever and worsening of general health
• cold chills, excessive sweating (hyperhidrosis), pain
• allergy (hypersensitivity), dehydration, headache, skin rash (pruritus), urticaria
• loss of intestinal muscle movement (ileus), digestive disorders (dyspepsia), difficulty swallowing (dysphagia), disorders affecting the mouth (pain in the mouth, on the tongue and toothache) altered taste
• muscle weakness, jaw pain, pain in a limb, back pain, joint pain, muscle pain, bone pain, ear pain
• dizziness, insomnia, transient loss of consciousness (fainting)
• difficulty with movements due to nerve damage (neuropathy) and nerve pain (neuralgia)
• fast heartbeat (tachycardia), increased blood pressure, decreased blood pressure
• difficulty breathing (dyspnea), cough, chest pain
• swelling of arms, hands, feet, ankles, legs or other parts of the body (edema)
• inflammation of the veins (phlebitis) and formation of blood clots in blood vessels (venous thrombosis).

Uncommon (may affect up to 1 in 100 people)

• blood infection with low levels of white blood cells (neutropenic sepsis)
• vision disorders
• dry skin, skin redness (erythema)
• nerve damage causing problems with muscle contraction (peripheral motor neuropathy)
• inflammation of the channel leading to the stomach (esophagitis), painful swallowing (odynophagia), sore throat (pharyngolaryngeal pain), gum disorders
• weight gain
• urinary problems that may be a sign of kidney failure (renal insufficiency)
• sounds or ringing in the ears (tinnitus)
• increased liver enzymes (transaminases) identified in blood tests
• "Syndrome of Inappropriate Antidiuretic Hormone Secretion", a condition that causes low levels of sodium in the blood
• pain at the tumor site
• sensation of dizziness (vertigo)
• heart attack (myocardial infarction), reduced blood supply (myocardial ischemia)
• difficulty breathing, which may be a symptom of a condition known as acute respiratory distress syndrome and can be severe and life-threatening
• extravasation (when a drug normally injected into a vein leaks or is accidentally injected into the surrounding tissue of the vein, where it can cause serious damage).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor. You can also report side effects directly through the
national reporting system detailed in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Javlor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
pack after EXP.
It is very unlikely that you will be asked to store this medicine.
The storage conditions are described in detail in the section intended for doctors or
healthcare professionals.

Intact vial
Store in a refrigerator (2°C - 8°C).
Store in the original packaging to protect the medicine from light.

Diluted solution
The diluted solution must be used immediately.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment

6. Contents of the pack and other information

What Javlor contains

• The active substance is vinflunine. Each mL of concentrate contains 25 mg of vinflunine (as bitartrate) A 2 mL vial contains 50 mg of vinflunine (as bitartrate) A 4 mL vial contains 100 mg of vinflunine (as bitartrate) A 10 mL vial contains 250 mg of vinflunine (as bitartrate)
• The other component is water for injections.

Description of Javlor and contents of the pack
Javlor is a clear solution, from colourless to pale yellow. It is available in clear glass vials
closed with a rubber stopper containing 2 mL, 4 mL or 10 mL of concentrate. Each pack
contains 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
PIERRE FABRE MEDICAMENT
Les Cauquillous
81500 Lavaur
France

Manufacturer
FAREVA PAU
FAREVA PAU 1
Avenue du Béarn
F-64320 Idron
France
For any information about this medicinal product, please contact the local representative of the marketing authorisation holder.

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
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The following information is intended exclusively for physicians or healthcare professionals:
INSTRUCTIONS FOR USE
General precautions for preparation and administration
Vinflunine is a cytotoxic anti-cancer medicinal product and particular caution should be exercised when using
Javlor, as with other potentially toxic preparations. Appropriate procedures must be followed for the handling and disposal of
anti-cancer medicinal products. All transfer procedures require strict adherence to aseptic techniques, preferably using a vertical laminar flow safety cabinet. Javlor must be prepared and administered exclusively by
personnel adequately trained in the handling of cytotoxic agents. Any personnel who are pregnant should not handle Javlor. The use of gloves,
goggles and protective clothing is recommended.
If the solution comes into contact with the skin, it must be washed immediately and thoroughly
with water and soap. If it comes into contact with mucous membranes, these must be washed
thoroughly with water.
Dilution of the concentrate
The volume of Javlor (concentrate) corresponding to the calculated dose of vinflunine must be mixed in
a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion. A glucose solution 50 mg/mL (5%) for infusion may also
be used. The diluted solution must be protected from light until administration.
Method of administration
Javlor is FOR INTRAVENOUS USE ONLY.
Javlor is for single use only.
After dilution of the Javlor concentrate, the infusion solution must be administered as
follows:

• An intravenous access must be established for a 500 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose solution 50 mg/mL (5%) for infusion, into a large vein preferably in the upper forearm or using a central venous catheter. Avoid veins on the back of the hand and those near joints.
• The intravenous infusion must be started with half of the 500 mL bag, i.e. 250 mL, of sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose solution 50 mg/mL (5%) for infusion, at a free flow rate for vein flushing.
• The Javlor infusion solution must be connected (piggy-back technique) to the injection port closest possible to the 500 mL bag to further dilute Javlor during administration.
• The Javlor infusion solution must be infused over 20 minutes.
• The patency must be frequently checked and precautions taken to avoid extravasation throughout the duration of the infusion.
• After completing the infusion, the remaining 250 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose solution 50 mg/mL (5%) for infusion must be run at a flow rate of 300 mL per hour. In order to flush the vein, the administration of Javlor must always be followed by at least an equal volume of sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose solution 50 mg/mL (5%) for infusion.

Disposal
Unused medicinal product and waste materials derived from such medicinal product must be disposed of in accordance with
current local regulations for cytotoxic medicinal products.
Storage conditions:

Intact vial
Store in a refrigerator (2°C - 8°C).
Keep in the original packaging to protect from light.

Diluted solution
The following chemical and physical stability has been demonstrated for the diluted solution:

• protected from light in a polyethylene or polyvinyl chloride infusion bag: a maximum of 6 days in a refrigerator (2°C - 8°C) or a maximum of 24 hours at 25°C;
• exposed to light in a polyethylene or polyvinyl chloride infusion set: a maximum of 1 hour at 25°C. From a microbiological point of view, the product must be used immediately after dilution. If not used immediately, the storage times and conditions are the responsibility of the user and should not normally exceed 24 hours at temperatures between 2°C and 8°C, unless the preparation has been carried out in controlled and validated aseptic conditions.