Patient Medication Information: uses, side effects, how to take - Mercaptopurine Tablets USP
Serious Warnings and Precautions
Cancers: Mercaptopurine Tablets USP may increase your risk of developing cancer. Bone marrow problems: Treatment with Mercaptopurine Tablets USP may affect your bone marrow. This means you may have a reduced number of white blood cells, platelets and red blood cells in your blood. Speak to your healthcare professional if you develop a fever, sore throat, signs of an infection, bleeding from any site, or symptoms of anemia (low red blood cells). Your healthcare professional will conduct blood tests while you are taking Mercaptopurine Tablets USP. Pregnancy: Taking Mercaptopurine Tablets USP may harm your unborn baby or make you lose the pregnancy. Immunosuppresion: Taking Mercaptopurine Tablets USP can reduce your immunity levels, which can cause:
Liver problems: Mercaptopurine Tablets USP is toxic to your liver. This can lead to death. During your treatment your healthcare professional will take blood tests to check your liver function. Your healthcare professional will conduct more frequent tests if you:
Macrophage activation syndrome Taking Mercaptopurine Tablets USP may increase your risk of developing a life-threatening condition called Macrophage activation syndrome (MAS). This condition usually occurs if you have inflammatory bowel disease. Your treatment with Mercaptopurine Tablets USP will end if |
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| you develop MAS. Epstein-Barr virus and cytomegalovirus are infections that can trigger MAS. Your healthcare professional will monitor your health for symptoms of Epstein-Barr virus and cytomegalovirus. |
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What is Mercaptopurine Tablets USP used for?
Mercaptopurine Tablets USP is used in adults and children for maintenance therapy of acute lymphatic (lymphocytic, lymphoblastic) leukemia. Leukemia is cancer of blood cells.
How does Mercaptopurine Tablets USP work?
Mercaptopurine Tablets USP interferes with the growth of cancer cells.
What are the ingredients in Mercaptopurine Tablets USP?
Medicinal ingredient: Mercaptopurine.
Non-medicinal ingredients: Corn starch, hypromellose, lactose, lactose monohydrate, magnesium stearate, potato starch, sodium starch glycolate, and stearic acid.
Mercaptopurine Tablets USP comes in the following dosage forms:
Tablets: 50 mg
Do not use Mercaptopurine Tablets USP if:
- you are allergic to mercaptopurine or any of the other ingredients in Mercaptopurine Tablets USP.
- you are getting immunized with a live vaccine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Mercaptopurine Tablets USP. Talk about any health conditions or problems you may have, including if you:
- suffer from liver or kidney disease.
- have a rare hereditary condition where your body produces little of the enzyme called thiopurine methyltransferase (TPMT). If you are not sure, ask your healthcare professional.
- have an inherited mutation in the NUDT15-gene. The NUDT15-gene is involved with the breakdown of mercaptopurine in the body. You have a higher risk of infections and hair loss if you have this mutation. Your healthcare professional may need to lower your dose.
Other warnings you should know about:
Cancers:
- You are at a greater risk of developing other cancers while taking Mercaptopurine Tablets USP.
- If you are receiving immunosuppressive therapy, taking Mercaptopurine Tablets USP could put you at a greater risk of developing certain types of cancers called lymphoproliferative disorders. These are cancers that affect the blood and immune system.
You may experience photosensitivity (sensitive to light) as a result of taking Mercaptopurine Tablets USP. If you are at an increased risk of developing skin cancer:
- limit your exposure to sunlight and UV light.
- wear protective clothing.
- use a sunscreen with a high protection factor.
Use with other immunosuppressant: Taking a combination of multiple immunosuppressant’s at the same time may increase your risk of developing a viral infection (Epstein-Barr virus). This may put you at a greater risk of developing lymph system disorders.
Fertility: It is not known if Mercaptopurine Tablets USP affects fertility in humans.
Female Patients:
- If you are pregnant, or still able to get pregnant and/or breast-feed, there are specific risks you must discuss with your healthcare professional.
- Avoid becoming pregnant while taking Mercaptopurine Tablets USP. You should use effective methods of birth control while taking Mercaptopurine Tablets USP. Keep using birth control for 6 months after taking your last dose of Mercaptopurine Tablets USP. If you do become pregnant while taking Mercaptopurine Tablets USP, tell your healthcare professional right away.
- For women who can get pregnant: a pregnancy test should be done before you start to take Mercaptopurine Tablets USP
- Mercaptopurine Tablets USP may pass into breast milk. Do not breast-feed while you are taking Mercaptopurine Tablets USP. If you are planning to breastfeed, tell your healthcare professional.
Male Patients:
Use a contraception when having sexual intercourse with a woman (even if she is pregnant). Contraception must be used:
- While taking Mercaptopurine Tablets USP, and
- for 3 months after you take your last dose of Mercaptopurine Tablets USP
Tell your healthcare professional about all other medication that you are taking, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Mercaptopurine Tablets USP:
- allopurinol, thiopurinal (used to treat gout)
- live vaccines
- trimethoprim and sulfamethoxazole (used to treat bacterial infections). It is also known as SEPTRA®
- azathioprine (used as an immunosuppressant)
- mesalazine, olsalazine, or sulphasalazine (used to treat ulcerative colitis)
- warfarin (used to prevent blood clots)
How to take Mercaptopurine Tablets USP:
Important Information: The tablets require safe handling. Mercaptopurine Tablets USP belongs to a group of medicines called cytotoxics, which are an irritant to the eyes and skin. To prevent irritation, it is important to wash your hands immediately after handling or halving the tablets, to avoid contact with the eyes and be careful not to inhale any particles of the tablet. Consult your healthcare professional for instructions on how to safely handle this product if you have any questions.
- It is important you take the tablets at right times.
- Always take Mercaptopurine Tablets USP exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Swallow your tablets with a little water
- Your healthcare professional will determine your dosage based on your body weight or body surface area.
Your dosage may be adjusted if you:
- have a pre-existing condition (i.e. TPMT-deficient and inherited mutations in the NUDT15 gene)
- are elderly
- have kidney or liver disease
- are taking any other cytotoxic medicines
- Laboratory Tests: From time to time, while you are taking Mercaptopurine Tablets USP, your healthcare professional will want you to have a blood test. This is to check your blood cell count and to change your dose if necessary.
Usual dose:
The usual daily maintenance dose is 1.5 to 2.5 mg / kg bodyweight per day
Overdose:
| In you think you, or a person you are caring for, have taken too much Mercaptopurine Tablets USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you forget to take a dose, go back to your regular dosing schedule and tell your healthcare professional. Do not double your next dose.
What are possible side effects from using Mercaptopurine Tablets USP?
Your doctor may take other blood and urine tests to monitor your uric acid levels, a natural body chemical of which levels may rise while being treated with Mercaptopurine Tablets USP.
These are not all the possible side affects you may have when taking Mercaptopurine Tablets USP. If you experience any side effects not listed here, tell your healthcare professional.
- Low sperm count
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Myelosuppression (bone marrow problem): pale skin, lips and nails, fatigue, feeling dizzy, weakness, headaches, shortness of breath. | √ | ||
| Secondary leukaemia (cancer of white blood cells): tiredness, shortness of breath, dizziness, headaches, pale skin | √ | ||
| Myelodysplasia (abnormal blood cell production): fatigue, shortness of breath, unusual paleness, unusual bruising or bleeding | √ | ||
| Hepatosplenic T-cell lymphoma (rare form of lymphoma): fatigue, significant night sweats, unexpected weight loss and fevers, abdominal discomfort | √ | ||
| COMMON | |||
| Nausea | √ | ||
| Vomiting | √ | ||
| Diarrhea | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Anorexia: excessive weight loss, missing meals, eating very little. | √ | ||
| Sprue-like symptoms: pain in abdomen or joints, diarrhea, fat in stool, indigestion, nausea, vomiting, flatulence. | √ | ||
| Mouth ulcer: burning or tingling, painful sores on or around the lips, in the mouth, sore throat. | √ | ||
| Pancreatitis: upper abdominal pain, abdominal pain that radiates to your back, fever, rapid pulse, nausea, vomiting | √ | ||
| Kidney problems: nausea, vomiting, loss of appetite, fatigue and weakness, sleep problems. | √ | ||
| Fever | √ | ||
| Skin problems: sensitive to light | √ | ||
| Blood problems: nausea, vomiting, loss of appetite, severe or prolonged diarrhea, abdominal pain, mouth ulcers | √ | ||
| Liver problems: nausea, vomiting, loss of appetite, abdominal pain, jaundice (yellowing of the skin and eyes) | √ | ||
| Hypersensitivity (allergic reactions): swelling, rash, fever and joint stiffness | √ | ||
| Unexpected bruising or bleeding: Bleeding in urine, stool, gums | √ | ||
| UNCOMMON | |||
| Facial swelling | √ | ||
| UNKNOWN | |||
| Hypoglycemia in children (low blood sugar): thirst, frequent urination, hunger, nausea and dizziness, fast heartbeat, tingling, trembling, nervousness, sweating, low energy | √ | ||
| Alopecia (Hair loss): Gradual thinning on top of head, circular of patchy bald spots, sudden loosening of hair, full body hair loss | √ | ||
| Portal hypertension (High blood pressure portal vein): blood in vomit, blood in stool, bloated | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| stomach with rapid weight, swelling in your legs and feet | ||
Other cancers:
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| √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Keep your Mercaptopurine Tablets USP in a dry, safe place where children cannot see or reach them.
- Mercaptopurine Tablets USP should be stored in a dry place between 15˚ and 30˚C.
- Do not take any tablets after the expiry date shown on the pack
- If your healthcare professional tells you to stop taking the tablets, please return any which are left over to your pharmacist for safe disposal. Only keep them if your healthcare professional tells you to.
- Keep out of reach and sight of children.
If you want more information about Mercaptopurine Tablets USP:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.sterimaxinc.com, or by calling 1-800-881-3550