Methotrexate belongs to the group of medicines known as antimetabolites. It is used to treat some kinds of cancer. It may also be used for other conditions as determined by your doctor, such as severe psoriasis and rheumatoid arthritis. Methotrexate blocks an enzyme needed by the cell to live. This interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by methotrexate, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used. Before you begin treatment with methotrexate, you and your doctor should talk about the good this medicine will do as well as the risk of using it. Methotrexate is available only with your doctor’s prescription.
1. WHAT ABITREXATE IS USED FOR
3. BEFORE YOU TAKE ABITREXATE
Allergies:
Tell your doctor if you have ever had any unusual or allergic reaction to methotrexate. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy and Breastfeeding:
If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine.
Pregnancy:
Tell your doctor if you are pregnant or if you intend to have children. There is a good chance that this medicine may cause birth defects if either the male or female is taking it at the time of conception or if it is taken during pregnancy. Methotrexate may cause harm or even death of the fetus. In addition, many cancer medicines may cause sterility which could be permanent. Although sterility is probably rare with this medicine, the possibility should be kept in mind. Be sure that you have discussed this with your doctor before taking this medicine. It is best to use some kind of birth control while you are taking methotrexate. However, do not use oral contraceptives (“the pill”) since they may interfere with this medicine. Tell your doctor right away if you think you have become pregnant while taking methotrexate.
Breastfeeding:
Tell your doctor if you are breastfeeding or if you intend to breastfeed during treatment with this medicine. Because ABITREXATE may cause serious side effects, breastfeeding is generally not recommended while you are taking it.
Other medicines:
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ABITREXATE, it is especially important that your doctor and pharmacist know you are taking any other prescription or nonprescription (over the counter) medicine. They should also be told if you have ever been treated with x-rays or cancer medicine or if you drink alcohol.
Other medical problems:
The presence of other medical problems may affect the use of ABITREXATE. Make sure you tell your doctor of any other medical problems especially:
- Alcohol abuse (or history of) – increased risk of unwanted effects on the liver
- Chickenpox (including recent exposure) or
- Herpes zoster (shingles) – risk of severe disease affecting other parts of the body
- Colitis
- Disease of the immune system
- Gout (history of) or kidney stones (or history of) – methotrexate may increase levels of a chemical called uric acid in the body, which can cause gout or kidney stones.
- Infection – methotrexate can reduce immunity to infection
- Intestine blockage or
- Kidney disease or
- Liver disease – effects may be increased because of slower removal of methotrexate from the body
- Mouth sores or inflammation or
- Stomach ulcer – may be worsened.
4. HOW TO TAKE ABITREXATE
Do not share medicines prescribed for you with any other person. Always take ABITREXATE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Dosage:
ABITREXATE may be given by mouth. ABITREXATE should be administered under the supervision of a medical doctor experienced in the use of chemotherapeutic agents. The exact amount of medicine has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition. ABITREXATE is often given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your doctor, nurse, or pharmacist to help you plan a way to remember to take your medicines at the right times.
While you are using ABITREXATE, your doctor may want you to drink extra fluids so that you will pass more urine. This will help the drug pass from the body, and will prevent kidney problems and keep your kidneys working well. ABITREXATE commonly causes nausea and vomiting. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your doctor, nurse or pharmacist for ways to lessen these effects. If you vomit shortly after taking a dose of ABITREXATE, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.
Missed dose:
If you miss a dose of this medicine do not take the missed dose at all and do not double the next one. Instead go back to your regular dosing schedule and check with your doctor.
If you take more ABITREXATE than you should:
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Your doctor will tell you how long your treatment with ABITREXATE will last. If you have the impression that the effect of ABITREXATE is too strong or too weak, tell your doctor or pharmacist.
5. POSSIBLE SIDE EFFECTS
ABITREXATE can have side effects. Not all side effects reported for ABITREXATE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ABITREXATE, please consult your doctor, pharmacist or other healthcare professional for advice. Along with their effects, medicines like ABITREXATE can sometimes cause unwanted effects such as blood problems, kidney problems, stomach or liver problems, loss of hair, and other side effects. These and other side-effects are described below. Also because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.
The undesirable effects with ABITREXATE are summarized by organ system. Although not all of these side effects may occur, if they do occur they may need medical attention.
Gastrointestinal disorders:
Frequent: Inflammation of the gums, sores in the mouth and on the lips, loss of appetite, nausea, vomiting, diarrhoea, dark tarry stools, gastrointestinal ulceration, bleeding and enteritis.
Blood disorders:
Frequent: Abnormally small number of red blood cells, white blood cells or platelets in the blood.
Liver Disorders:
Less frequent: ABITREXATE may cause acute (increase in liver enzymes) or chronic (fibrosis and cirrhosis) liver damage or toxicity. Chronic toxicity is potentially lethal.
Nervous system disorders:
Less frequent: Headache, drowsiness, blurred vision, language disorders, muscular weakness or paralysis and convulsions have been reported after ABITREXATE administration. Toxic side-effects have occurred after the intrathecal administration of ABITREXATE.
Respiratory (Pulmonary) disorders:
Less frequent: Potentially fatal inflammation of the lungs has been reported and obstructive lung disease has occurred. Symptoms of ABITREXATE induced lung disease may typically show fever, cough, shortness of breath, oxygen deficiency and infiltration in lung radiography.
Urogenital disorders:
Frequent: Serious kidney disease or impaired kidney function, bladder inflammation, blood in the urine, defective formation of the egg (ovum) or sperm, menstrual dysfunction and vaginal discharge, infertility, abortion, foetal deviations, suppression of sperm formation, loss of libido, and impotence may occur.
Skin and subcutaneous tissue disorders:
Less frequent: Skin rash or itching, reddening of the skin, depigmentation, bruising, acne, boils and increased sensitivity to sunlight or UV rays. Psoriatric lesions may worsen by exposure to UV-radiation.
Other disorders:
Less frequent: Joint or muscle pain, diabetes, osteoporosis, opportunistic infections, inflammation of blood vessels, allergic reactions and sudden death have been reported.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
6. STORING AND DISPOSING OF ABITREXATE
Tablets: Store at or below 25 °C in well-closed containers and protect from light. Do not remove the blisters from the carton until required for use. Do not store in bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down. Do not keep outdated or medicines no longer needed. Be sure that any discarded medicine is out of the reach of children. Store all medicines out of reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).