25 mg / mL concentrate for infusion solution
vinflunine
What Javlor is and what it is used for
Javlor contains the active substance vinflunine which belongs to a group of cancer drugs called vinca alkaloids. These drugs affect the growth of cancer cells by interrupting cell division, leading to cell death (cytotoxicity).
Javlar is used to treat advanced or metastatic cancer of the bladder and urinary tract when previous treatment with platinum-containing drugs has not been effective.
What you need to know before using Javlor
Do not use Javlor
- if you are allergic to vinflunine or any other wine alkaloid (vinblastine, vincristine, vindesine, vinorelbine).
- if you have, or within the last two weeks have had, a serious infection .
- if you are breast-feeding.
- if you have low levels of white blood cells and / or platelets .
Warnings and cautions
Talk to your doctor before using Javlor:
- if you have any problems with your liver, kidneys or heart.
- if you have any neurological symptoms such as headache, altered mood that can lead to confusion and coma , seizures, blurred vision and high blood pressure because you may then need to stop treatment.
- if you are taking other medicines mentioned under the heading “Using other medicines” below.
- if you are constipated, if you are being treated with painkillers ( opioids ), if you have stomach cancer or if you have had surgery on your stomach.
- if you are male and planning to have children (see section “Pregnancy, breast-feeding and fertility” below).
The number of blood cells in your blood will be checked regularly before and during treatment because low blood cell count is a very common side effect of Javlor.
Constipation is a very common side effect of Javlor. To prevent constipation, you may be given laxatives.
Children and young people
Javlar is not intended for children and adolescents.
Other Medicines and Javlor
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are taking medicines that contain any of the following active substances:
- ketoconazole and itraconazole, for the treatment of fungal infections.
- opioids , for the treatment of pain.
- ritonavir for the treatment of HIV – infection .
- doxorubicin and pegylated liposomal doxorubicin, for the treatment of certain cancers.
- rifampicin, for the treatment of tuberculosis or meningitis .
- natural remedy containing St. John’s wort (Hypericum perforatum), for the treatment of mild to moderate depression.
Javler with food and drink
You should tell your doctor if you usually drink grapefruit juice as it may increase the effect of Javlor.
You should also drink water and eat foods high in fiber.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
If you are a woman or a man of childbearing age should use reliable contraception during treatment and for 3 months after your last Javlor- dose.
You should not be treated with Javlor if you are pregnant unless it is necessary.
You must not breastfeed during treatment with Javlor.
If you are a man and want to have children, you should consult your doctor. You may also want to consult about the possibility of preserving sperm before starting treatment.
Driving and using machines
Javlar can cause side effects such as fatigue and dizziness. If you experience side effects that affect your ability to concentrate and react, do not drive or use machines.
How to use Javlor
Dosage
The recommended dose for adult patients is 320 mg / m 2 body surface area (calculated by your doctor based on your weight and height). The treatment will be repeated every three weeks.
Your doctor will adjust the starting dose of Javlor based on your age and physical condition and in special situations:
- if you have previously had radiation treatment of the pelvis.
- if you have moderate or severe kidney problems.
- if you have liver problems.
During treatment, your doctor may lower the dose of Javlor, postpone or discontinue treatment if you experience any side effects.
How Javlor is given
Javlar will be given by qualified healthcare professionals as an intravenous infusion (in the form of a drip into a vein) for 20 minutes. Javler should not be given intrathecally (in the spinal cord). Javlor is a concentrate that must be diluted before use.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you get any of the following symptoms while being treated with Javlor:
- Fever and / or chills, which may be a sign of an infection .
- Chest pain, which may be a sign of a heart attack.
- Constipation, which is not relieved by laxatives .
- Headache, altered mood that can lead to confusion and coma , seizures, blurred vision and high blood pressure . This may be a sign of a neurological disease such as “posterior reversible encephalopathy syndrome” (see section 2 “Warnings and precautions”).
Other side effects that may occur:
Very typ IgA (can occur in more than 1 in 10)
- abdominal pain, nausea, vomiting
- constipation, diarrhea,
- inflammation of the lining of the mouth
- fatigue, muscle pain
- loss of sensation
- weight loss, loss of appetite
- hair loss
- injection site reactions (pain, redness , swelling)
- fever
- low level of white blood cells , red blood cells and / or platelets (seen in blood tests)
- low level of sodium in the blood ( hyponatremia ).
Common (may affect up to 1 in 10 people)
- chills, increased sweating
- allergies , dehydration, headaches, rashes, itching
- digestive problems, pain in the mouth, on the tongue and toothache, taste change
- muscle weakness, jaw pain, pain in the extremities , back pain, joint pain, muscle aches, leg pain, earache
- dizziness, difficulty sleeping, transient loss of consciousness
- difficulties with certain body movements
- fast heart rate , high blood pressure , low blood pressure
- difficulty breathing, cough, chest pain
- swelling in arms, hands, feet, ankles, legs or other body parts
- inflammation of the veins ( phlebitis ).
Uncommon (may affect up to 1 in 100 people)
- visual disturbances
- dry skin, reddening of the skin
- problems with muscle contractions
- sore throat, gum problems
- weight gain
- urinary tract problems
- ringing or buzzing sound in the ears ( tinnitus )
- increased levels of liver enzymes (seen in blood tests)
- inadequate antidiuretic hormone ( ADH ) secretion ( “syndrome of inappropiate antidiuretic hormone secretion” SIADH), which is a condition that causes low sodium levels in the blood
- tumor pain.
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 after EXP and the carton after EXP. data.
It is unlikely that you will be responsible for the storage of this medicine. Storage instructions are given in the section intended for healthcare professionals.
Unopened vial:
Store in a refrigerator (2 ° C – 8 ° C).
Store in the original package. Sensitive to light.
Diluted solution:
A diluted solution should be used 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.
Contents of the pack and other information
Content declaration
- The active substance is vinflunine. Each ml of concentrate contains 25 mg of vinflunine (as ditartrate).A vial of 2 ml contains 50 mg of vinflunine (as ditartrate).
One vial each of 4 ml contains 100 mg of vinflunine (as ditartrate).A vial of 10 ml contains 250 mg of vinflunine (as ditartrate). - The other ingredient is water for injections.
What the medicine looks like and contents of the pack
Javlor is a clear, colorless to the pale yellow solution, which is supplied in clear glass vials containing 2 ml, 4 ml, or 10 ml of concentrate sealed with a rubber stopper. Each pack contains 1 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pierre Fabre Medicine
45 place Abel Gance
F-92100 Boulogne
France
Manufacturer
Pierre Fabre Medicine Production
Establishment Aquitaine Pharm International
Avenue du Bèarn
F-64320 Idron
France