Javlor 25 mg/ml concentrate for solution for infusion
vinflunine
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
- 1. What Javlor is and what it is used for
- 2. Before you use Javlor
- 3. How to use Javlor
- 4. Possible side effects
- 5. How to store Javlor
- 6. Further information
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.
Before You Use Javlor
Do not use Javlor
- if you are allergic (hypersensitive) to the active substance (vinflunine) or to other vinca alkaloids (vinblastine, vincristine, vindesine, vinorelbine),
- if you have had (within 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
Take special care with Javlor
Tell your doctor:
- if you have liver, kidney or heart problems,
- if you are taking other medicines mentioned in “Using other medicines” below,
- if you have constipation, or if you are treated with drugs 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 and breast-feeding” 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.
Javlor is not intended for use in children.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal preparations.
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,
- ritonavir, used to treat HIV infection,
- pegylated liposomal doxorubicin, used to treat some kinds of cancer,
- rifampicin, used to treat tuberculosis or meningitidis,
- herbal preparation containing hypericum perforatum (St John’s wort) used to treat minor to moderate depression.
You should tell your doctor if you are drinking grapefruit juice.
You may be given laxatives to prevent constipation, which is a very common side effect of Javlor.
You should also drink water.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or think you may be pregnant.
You should not be given Javlor if you are pregnant, unless it is absolutely necessary.
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. 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.
You must not breastfeed during treatment with Javlor
Driving and using machines
Javlor has not been studied for its possible effects on the ability to drive and use machines. If you experience common side effects, such as dizziness or syncope, that affect your ability to concentrate and react, do not drive or use machines.
How To Use Javlor
Dose
The usual 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.
In specific situations your doctor will adjust the dose of Javlor:
- if you had a previous irradiation of the pelvis and/or an altered physical condition
- if you experience certain side effects
- if you have moderate or severe kidney or liver problems.
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 is a concentrate that has to be diluted before administration.
Possible Side Effects
Like all medicines, Javlor can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency cannot be estimated from the available data.
Very common side effects
- abdominal pain, nausea, vomiting
- constipation, diarrhoea
- inflammation of the mucosa of the mouth
- fatigue, muscle pain
- weight decrease, loss of appetite
- loss of hair
- pain at the site of injection
- decrease in the number of white blood cells (neutropenia) or red blood cells (anaemia) or platelets
- fever.
Common side effects
- fever with infection, chills, excessive sweating
- allergy, dehydration, headache, cutaneous reaction, itching
- digestive problems, paralytic intestine, pain in the mouth, on the tongue and toothache, modification of the taste
- muscular weakness, pain in jaw, pain in extremity, back pain, pain in joints, muscular pain, bone pain
- dizziness, insomnia, neurologic disorders, loss of consciousness
- difficulties with body movements or sens of touch,
- accelerated heartbeat, raised blood pressure, reduced blood pressure, vein thrombosis
- breathing difficulties, cough, swelling (oedema), chest pain.
Uncommon side effects
- increase of liver enzymes
- generalized infection
- visual disturbances, dry eye
- vertigo, muscle contraction disorders
- heart attack (myocardial infection, myocardial ischaemia)
- acute respiratory distress, pain in the throat, gum disorders
- renal failure
- weight increase.
Cases of electrocardiography alterations have been observed after the administration of Javlor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. Your doctor may reduce the dose of Javlor or interrupt the treatment.
How To Store Javlor
Keep out of the reach and sight of children.
Do not use Javlor 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
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 to protect the environment.
Further 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 Javor 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 concentrate. Each pack contains 1 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last approved in September 2009.
For any information about this medicine, please contact the Marketing Authorisation Holder.
EU_JAVLOR 25 mg/ml – Date of last approval 21-Sep-2009
No comments:
Post a Comment