Bratoma contains a medicine called temozolomide. This medicine is an antitumor agent. Bratoma is used for the treatment of specific forms of brain tumors.
Description & Indications
Warnnings & Precautions
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:
In adults with newly-diagnosed glioblastoma multiforme (GBM); Bratoma is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
In children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma; Bratoma is used in these tumors if they return or get worse after standard treatment.
Before you take Bratoma
Do not take Bratoma
If you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
If you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC). Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
If certain kinds of blood cells are severely reduced (myelo-suppression), such as white blood cell count and platelet count. These blood cells are important for fighting infection and for proper blood clotting. Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Bratoma:
As you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP); if you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Bratoma for 42 days in combination with radiotherapy. In this case, your doctor will also prescribe medicines to help you prevent this type of pneumonia (PCP).
If you have ever had or might now have a hepatitis B infection; this is because Bratoma could cause hepatitis B to become active again, which can be fatal in some cases. Patients shall be carefully checked by their doctor for signs of this infection before treatment is started.
If you have low counts of red blood cells (anemia), white blood cells and platelets, or blood clotting problems before starting the treatment, or if you develop them during treatment. Your doctor may decide to reduce the dose, interrupt, and stop or change your treatment. You may also need other treatments. In some cases, it may be necessary to stop treatment with Bratoma. Your blood will be tested frequently during treatment to monitor the side effects of Bratoma on your blood cells.
As you may have a small risk of other changes in blood cells, including leukemia.
If you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects of Bratoma (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting. If you vomit frequently before or during treatment, ask your doctor about the best time to take Bratoma until the vomiting is under control. If you vomit after taking your dose, do not take a second dose on the same day.
If you develop fever or symptoms of an infection, contact your doctor immediately.
If you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.
If you have liver or kidney problems, your dose of Bratoma may need to be adjusted.
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:
Concomitant phase treatment; Bratoma together with radiotherapy first, followed by treatment with only Bratoma
Monotherapy phase treatment; Bratoma only
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:
How many capsules you need to take every dosing day. Ask your doctor or pharmacist to write it down (including the color).
Which days are your dosing days.
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.
A severe allergic reaction (hives, wheezing or other breathing difficulty)
Severe headache that does not go away
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):
Loss of appetite, difficulty speaking, headache
Vomiting, nausea, diarrhea, constipation
Rash, hair loss
Common side effects (may affect up to 1 in 10 people):
Infections, oral infections, wound infections
Reduced number of blood cells (neutropenia, lymphopenia, thrombocytopenia)
Increased blood sugar
Memory impairment, depression, anxiety, confusion, inability to fall asleep or stay asleep
Impaired coordination and balance
Difficulty concentrating, change in mental status or alertness, forgetfulness