What Bratoma is and what it is used for?
The active ingredient of this medicine is temozolomide. Bratoma is an antitumor agent and used for the treatment of specific forms of brain tumors:
Before you take Bratoma
Do not take Bratoma
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Bratoma:
Children and adolescents
Do not give this medicine to children under the age of 3 years because it has not been studied. There
is limited information in patients over 3 years of age who have taken Bratoma.
Other medicines and Bratoma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
Bratoma must NOT be administered if you are pregnant unless clearly indicated by your doctor.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you might get pregnant, you should use a reliable method of contraception during treatment.
If you are breast-feeding, tell your doctor. You should not breast-feed during treatment with Bratoma.
Bratoma may cause permanent infertility. Male patients should use effective contraception and not father a child for up to 6 months after stopping treatment. It is recommended to seek advice on conservation of sperm prior to treatment.
Driving and using machines
Bratoma may make you feel tired or sleepy. In this case, do not drive or use any tools or machines until you see how this medicine affects you (see section 4).
How to take Bratoma?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dosage and duration of treatment: Your doctor will work out your dose of Bratoma. This is based on your size height and weight and if you have a recurrent tumor and have had chemotherapy treatment in the past. You may be given other medicines (anti-emetics) to take before and/or after taking Bratoma to prevent or control nausea and vomiting.
Patients with newly-diagnosed glioblastoma multiforme: If you are a newly-diagnosed patient, treatment will occur in two phases:
During the concomitant phase, your doctor will start Bratoma at a dose of 75 mg/m2 (usual dose). You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy. The Bratoma dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase. Once the radiotherapy is completed, you will interrupt treatment for 4 weeks. This will give your body a chance to recover. Then, you will start the monotherapy phase.
During the monotherapy phase, the dose and way you take Bratoma will be different. Your doctor will work out your exact dose. There may be up to 6 treatment periods (cycles). Each one lasts 28 days. You will take your new dose of Bratoma alone once daily for the first 5 days (“dosing days”) of each cycle. The first dose will be 150 mg/m2. Then you will have 23 days without Bratoma. This adds up to a 28-day treatment cycle.
After Day 28, the next cycle will begin. You will again take Bratoma once daily for 5 days followed by 23 days without Bratoma. The Bratoma dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Bratoma only: A treatment cycle with Bratoma lasts 28 days. You will take Bratoma alone once daily for the first 5 days. This daily dose depends on whether or not you have received chemotherapy before.
If you have not been previously treated with chemotherapy, your first dose of Bratoma will be 200 mg/m2 once daily for the first 5 days. If you have been previously treated with chemotherapy, your first dose of Bratoma will be 150 mg/m2 once daily for the first 5 days. Then, you will have 23 days without Bratoma. This adds up to a 28 day treatment cycle.
After Day 28, the next cycle will begin. You will again receive Bratoma once daily for 5 days, followed by 23 days without Bratoma.
Before each new treatment cycle, your blood will be tested to see if the Bratoma dose needs to be adjusted. Depending on your blood test results, your doctor may adjust your dose for the next cycle.
How to take Bratoma: Take your prescribed dose of Bratoma once a day, preferably at the same time each day. Take the capsules on an empty stomach; for example, at least one hour before you plan to eat breakfast. Swallow the capsules whole with a glass of water. Do not open, crush or chew the capsules. If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose. If you accidentally get some in your eyes or nose, flush the area with water. Depending on the prescribed dose, you may have to take more than one capsule together, eventually with different strengths (content of active substance, in mg). The color of the capsule cap is different for each strength (see section 6).
You should make sure you fully understand and remember the following:
Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle. Always take Bratoma exactly as your doctor has told you. It is very important to check with your doctor or pharmacist if you are not sure. Any errors in how you take this medicine may have serious health consequences.
If you take more Bratoma than you should
If you have taken more Bratoma than you should have, or if someone else accidentally takes your capsules, contact a doctor or hospital for advice straight away. Show them the pack of capsules and this package leaflet. Medical treatment may be necessary.
If you forget to take Bratoma
Take the missed dose as soon as possible during the same day. If a full day has gone by, check with your doctor. Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to do so.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Bratoma treatment can cause a reduction in certain kinds of blood cells. This may cause you to have increased bruising or bleeding, anemia (a shortage of red blood cells), fever and reduced resistance to infections. The reduction in blood cell counts is usually short-lived. In some cases, it may be prolonged and may lead to a very severe form of anemia (aplastic anemia). Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed. In some cases, your Bratoma dose will be reduced or treatment stopped.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
How to store Bratoma?
Keep out of the sight and reach of children and in a locked cupboard, strictly.
Store below 30°C. Protect from light and moisture.
Do not use this medicine after the expiry date which is stated on the bottle label and outer carton.
The medicine 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 Bratoma contains?
The active substance is temozolomide.
The other ingredients are sodium starch glycolate, lactose anhydrous, hydrophobic silica colloidal, tartaric acid powder and stearic acid.
What Bratoma looks like and contents of the pack?
Bratoma 5 mg capsules are hard gelatin capsules with opaque blue cap and opaque white body, containing off-white to pale pink or tan color granular powder.
Bratoma 20 mg capsules are hard gelatin capsules with opaque yellow cap and opaque white body, containing off-white to pale pink or tan color granular powder.
Bratoma 100 mg capsules are hard gelatin capsules with opaque pink cap and opaque white body, containing off-white to pale pink or tan color granular powder.
Bratoma 140 mg capsules are hard gelatin capsules with opaque blue cap and white body , containing off-white to pale pink or tan color granular powder.
Bratoma 250 mg capsules are hard gelatin capsules with opaque white cap and white body , containing off-white to pale pink or tan color granular powder.
It is supplied in the boxes of amber glass bottles with white colored HDPE caps; each one contains 5 capsules.