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ALKERAN 2 mg Film Tablet
It is taken orally.
It is Melphalan. Each tablet contains 2 mg of melphalan.
Microcrystalline cellulose, Crospovidone, Colloidal anhydrous silica, Magnesium stearate, Hypromellose, Titanium Dioxide, Macrogol
1. What is ALKERAN and what is it used for?
ALKERAN Tablet contains a medicine called melphalan. Melphalan belongs to a group of drugs defined as cytotoxic (also called chemotherapy). It is used in the treatment of cancer. It works by reducing the number of abnormal cells your body produces. ALKERAN is used in the following situations:
• Multiple myeloma - is a bone marrow cancer. It begins in plasma cells in the bone marrow, which are part of the immune system.
• Advanced ovarian adenocarcinoma - advanced ovarian cancer
• Advanced breast cancer - has a significant therapeutic effect, alone or in combination with other drugs, in a proportion of patients
• Polycythemia vera, a disease in which the number of red blood cells increases in your blood. With the effect of this disease, your blood becomes thicker and coagulates. This causes headaches, drowsiness and shortness of breath.
ALKERAN is in the form of white to off-white, round, biconvex, film-coated tablets debossed with 'GX EH3' on one side and 'A' on the other side. There are 25 tablets in an amber glass bottle with a safety cap for children.
2. How is ALKERAN used?
Instructions for proper use and dose/frequency of administration
Always take ALKERAN as directed by your doctor. It is important that you take your medicine at the right times. In your medicine box it will be written how many tablets and how often you will take. If it is not written or you are not quite sure how to use it, ask your doctor, nurse or pharmacist.
The dose of ALKERAN depends on your blood disease or cancer. During your treatment, your doctor may change your dose according to your needs.
Your doctor will order blood tests regularly while you are using ALKERAN. This is to count your blood cells and change doses if necessary.
• The recommended dose of ALKERAN is 0.15 mg/kg body weight/day for 4 days, repeated at 6-week intervals. Your doctor will tell you the number of tablets.
Advanced ovarian adenocarcinoma (advanced ovarian cancer)
• The recommended dose of ALKERAN is 0.2 mg/kg body weight/day for 5 days. Your doctor will tell you the number of tablets.
• The recommended dose of ALKERAN is 0.15 mg/kg body weight or 6 mg/m2 body area per day for 5 days. Your doctor will tell you the number of tablets.
Polycythemia rubra vera
• The recommended dose of ALKERAN is 6-10 mg per day for 5-7 days. Your doctor will tell you the number of tablets.
Application route and method
ALKERAN is taken orally.
It is important to take your medicine on time. Take ALKERAN tablets with some water. Do not break, crush or chew the tablets.
3. What are the possible side effects?
As with all medicines, ALKERAN can cause side effects in some people.
If any of the following occur, stop using ALKERAN and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department:
• Allergic reaction, symptoms may be as follows
- Hives, skin bumps and itchy rashes
- Swelling of the face, eyelids or lips
- Sudden wheezing and chest tightness
- Collapse (due to severe collapse, cardiac arrest)
• Fever or signs of infection (sore throat, sores in the mouth or problems with urinating)
• Unexpected bruising and bleeding, or feeling extremely tired, dizzy, short of breath. These conditions mean that very little of a certain type of blood cell is produced.
Talk to your doctor if you have any of the following side effects, which may also occur with this medicine:
Very common (affects more than 1 in 10 people)
• Decrease in the number of blood cells and platelets
• Feeling sick (nausea) or being sick (vomiting), diarrhea (diarrhea)
Mouth ulcers (sores) with high dose ALKERAN
Hair loss with high dose ALKERAN
Common (affects less than 1 in 10 people)
Hair loss with ALKERAN used at recommended treatment doses
If you have myeloma with kidney damage, this should happen early in your treatment with ALKERAN.
It causes an increase in the amount of a chemical substance called “urea” in your blood.
Rare (affects less than 1 in 1,000 people)
• A disease in which you have a low number of red blood cells due to premature destruction of red blood cells - this can make you feel extremely tired, breathless and dizzy, have a headache, or make your skin and eyes turn yellow