Javlor - patient leaflet, side effects, dosage

Patient leaflet - Javlor

B. PACKAGE LEAFLET

Package Leaflet: Information for the user

Javlor 25 mg/mL concentrate for solution for infusion vinflunine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor.
– If you get any side effects talk to your doctor. This includes any possible side effects not listed

in this leaflet. See Section 4.

What is in 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. Content of the pack and other information

1. What Javlor is and what it is used for

Javlor contains the active substance vinflunine, which belongs to a group of anticancer medicines called vinca alkaloids. These medicines affect cancer cell growth by stopping cell division, leading to cell death (cytotoxicity).

Javlor is used to treat advanced or metastatic cancer of the bladder and urinary tract when a previous therapy with platinum-containing medicines has failed.

2. What you need to know before you use Javlor

Do not use Javlor

– if you are allergic to the active substance (vinflunine) or to other vinca alkaloids (vinblastine, vincristine, vindesine, vinorelbine),
– if you have had (in the last 2 weeks) or currently have a severe infection,
– if you are breast-feeding,
– if your levels of white blood cells and/or platelets are too low

Warnings and precautions

Tell your doctor:

– if you have liver, kidney or heart problems,
– if you experience any neurological symptoms such as headaches, changed mental state which may lead to confusion and coma, convulsions, blurred vision and high blood pressure as you may need to stop taking this medicine,
– if you are taking other medicines mentioned in “Using other medicines” below,
– if you have constipation, or if you are treated with medicines against pain (opioids), or if you have an abdominal cancer, or if you had abdominal surgery,
– if you would like to father a child (see “Pregnancy, breast-feeding and fertility” below).

Your blood cell counts will be checked regularly before and during your treatment, since low counts of blood cells is a very common side effect with Javlor.

Constipation is a very common side effect of Javlor. To prevent constipation you may be given laxatives.

Used in children and adolescents

Javlor is not intended 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 medicines.

In particular, you should tell your doctor if you are taking medicines containing any of the following active substances:

– ketoconazole and itraconazole, used to treat fungal infection,
– opioids, used to treat pain,
– ritonavir, used to treat HIV infection,
– doxorubicin and pegylated liposomal doxorubicin, used to treat some kinds of cancer,
– rifampicin, used to treat tuberculosis or meningitis,
– herbal preparation containing hypericum perforatum (St John’s wort) used to treat minor to

moderate depression.

Javlor with food and drink

You should tell your doctor if you are drinking grapefruit juice since it may increase the effect of Javlor.

You should also drink water and eat high fibre foods.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before starting your therapy.

If you are a woman or a man of reproductive potential, you should use an adequate method of contraception during treatment and for 3 months after your last dose of Javlor.

You should not be given Javlor if you are pregnant, unless it is absolutely necessary.

You must not breastfeed during treatment with Javlor

If you would like to father a child, seek advice from your doctor. You may want to seek counseling on sperm storage before starting your therapy.

Driving and using machines

Javlor may cause side effects such as tiredness and dizziness. Do not drive or use machines if you experience side effects that affect your ability to concentrate and react.

3. How to use Javlor

Dose

The recommended dose in adult patients is 320 mg/m2 body surface (this is calculated by the doctor based on your weight and your height). The treatment will be repeated every 3 weeks.

Your doctor will adjust the starting dose of Javlor based on your age and physical conditions and in specific situations:

– if you had a previous irradiation of the pelvis
– if you have moderate or severe kidney problems

– if you have liver problems.

During treatment, your doctor may reduce the dose of Javlor, delay or interrupt the treatment if you experience certain side effects.

How Javlor is given

Javlor will be given to you by a qualified healthcare professional as an intravenous infusion (drip into your vein) lasting 20 minutes. Javlor must not be given intrathecally (into the spine).

Javlor is a concentrate that has to be diluted before administration.

4. Possible side effects

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

Tell your doctor immediately if you develop any of the following serious side effects while being treated with Javlor:

– fever and / or chills which could be signs of infection,
– chest pain which could be sign of heart attack,
– constipation that resists to laxative treatment,
– headaches, changed mental state which may lead to confusion and coma, convulsions, blurred vision and high blood pressure, which could be sign of a neurological disorder such as “posterior reversible encephalopathy syndrome” (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, diarrhoea
– inflammation of the mucosa of the mouth
– tiredness, muscle pain
– lack of sense of touch
– weight decrease, decrease of appetite
– loss of hair
– reactions at injection site (pain, redness, swelling)
– fever
– low levels of white blood cells, red blood cells and/or platelets (seen in blood test)
– low levels of blood sodium (hyponatraemia).

Common (may affect up to 1 in 10 people)

– chills, excessive sweating
– allergy, dehydration, headache, skin rash, itching
– digestive problems, pain in the mouth, on the tongue and toothache, taste alteration
– muscular weakness, pain in jaw, pain in extremity, back pain, pain in joints, muscular pain, bone

pain, ear pain

– dizziness, insomnia, transiant loss of consciousness
– difficulties with body movements
– fast heartbeat, raised blood pressure, reduced blood pressure
– breathing difficulties, cough, chest pain
– swelling of your arms, hands, feet, ankles, legs or other parts of your body
– inflammation of the veins (phlebitis).

Uncommon (may affect up to 1 in 100 people)

– visual disturbances
– dry skin, redness of the skin
– muscle contraction disorders
– pain in the throat, gum disorders
– weight increase
– urinary problems
– ringing or buzzing in the ears (tinnitus)
– increase in liver enzymes (seen in blood test)
– “Syndrome of inappropriate antidiuretic hormone secretion”, which is a condition that causes low

levels of blood sodium

– tumour pain.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in 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 vial label and the carton after EXP.

It is most unlikely that you will be asked to store this medicine yourself.

Storage conditions are detailed in the section intended for medicinal or heathcare professionals.

Unopened vials

Store in a refrigerator (2°C-8°C).

Store in the original package in order to protect from light.

Diluted solution

The diluted solution should be use immediately

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Content of the pack and other information

What Javlor contains

– The active substance is vinflunine. Each mL of concentrate contains 25 mg of vinflunine (as ditartrate).

One 2 mL vial contains 50 mg of vinflunine (as ditartrate).

One 4 mL vial contains 100 mg of vinflunine (as ditartrate).

One 10 mL vial contains 250 mg of vinflunine (as ditartrate).

– The other ingredient is water for injections.

What Javlor looks like and contents of the pack

Javlor is a clear, colourless to pale yellow solution. It comes in clear glass vials closed by 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 medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in MM/YYYY

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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The following information is intended for medical or healthcare professionals only:

INSTRUCTION FOR USE

General precautions for preparation and administration.

Vinflunine is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Javlor. Procedure for proper handling and disposal of anticancer medicinal products should be considered. All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood. Javlor solution for infusion should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents. Pregnant staff should not handle Javlor. The use of gloves, goggles and protective clothing is recommended.

If the solution comes into contact with the skin, this should be washed immediately and thoroughly with soap and water. If it comes into contact with mucous membranes, the membranes should be flushed thoroughly with water.

Dilution of the concentrate

The volume of Javlor (concentrate) corresponding to the calculated dose of vinflunine should be mixed in a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion. Glucose 50 mg/mL (5%) solution for infusion may also be used. The diluted solution should be protected from light until administration (see section 6.3).

Method of administration

Javlor is for intravenous use ONLY.

Javlor is for single use only.

After dilution of the Javlor concentrate, the solution for infusion will be administered as follows:

A venous access should be established for a 500 mL bag of sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for infusion, on a large vein preferably in the upper part of the forearm or using a central venous line. The veins of the hand dorsum and those close to joints should be avoided.
The intravenous infusion should be started with half of the 500 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion, i.e. 250 mL, at a free flowing rate to flush the vein.
The Javlor solution for infusion should be piggy-backed to the side injection port closest to the 500 mL bag to further dilute Javlor during administration.
The Javlor solution for infusion should be infused over 20 minutes.
The patency should be assessed frequently and extravasation precautions should be maintained throughout the infusion.
After the infusion is completed, the remaining 250 mL from the sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion bag should be run at a flowing rate of 300 mL/h. In order to flush the vein, administration of Javlor solution for infusion should always be followed by at least an equal volume of sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.

Storage conditions