Details for: PURINETHOL
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00004723 | PURINETHOL | MERCAPTOPURINE | 50 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
PURINETHOL®
(mercaptopurine) is indicated for
maintenance therapy of acute lymphatic (lymphocytic,
lymphoblastic) leukemia in combination with other drugs. The
response to this drug depends upon the particular type of acute
lymphatic leukemia and the age of the patient (child or adult).
PURINETHOL® belongs to a group of medicines called
Antileukemics, which are used to treat leukemia, a cancer of
blood cells. PURINETHOL® is used to treat leukemia of
specific types of blood cells.
What it does
PURINETHOL® is converted in the body to the active form which is then incorporated into cancer cells and interferes with their growth. Since the growth of normal body cells may also be affected by mercaptopurine, other side effects also occur.
When it should not be used
If you have previously experienced an allergic or bad reaction
to mercaptopurine or any of the other ingredients in
PURINETHOL®
tablets listed below.
You should not be immunized with a live vaccine if you are
taking PURINETHOL.
What the medicinal ingredient is
Mercaptopurine is also known as 6-mercaptopurine or 6-MP.
What the non-medicinal ingredients are
Corn starch, lactose, magnesium stearate, potato starch and stearic acid.
What dosage form it comes in
Tablet 50 mg
Warnings and precautions
BEFORE you use PURINETHOL® talk to your doctor or pharmacist if:
- you have previously experienced an allergic or bad reaction to mercaptopurine or any of the other ingredients in PURINETHOL® tablets listed above.
- you are planning to have a baby (this question applies to both men and women)
- you are taking any other medicines (see Interaction with this Medication).
- you suffer from liver or kidney disease
- you have a rare hereditary condition, where you have too little of the natural body chemical thiopurine methyltransferase (TPMT) enzyme in your body. If you are not sure, ask your doctor.
- you are planning to be immunized with a live vaccine.
Mothers receiving PURINETHOL® should not breast-feed. Talk to your doctor, pharmacist or nurse if you need to know of alternative methods to breast-feeding.
As with all cytotoxic chemotherapy, contraceptive precautions should be taken if either partner is taking PURINETHOL® tablets.
Purinethol may increase your risk of developing cancer, especially certain types of leukemia or lymphoma.
Interactions with this medication
Tell your doctor about all other medication that you are taking,
including the following which may interact with
PURINETHOL®
, such as allopurinol, azothioprine,
mesalazine, olsalazine, sulphasalazine and warfarin.
If you are taking certain other medicines such as allopurinol,
your doctor may decrease your dose of PURINETHOL®
Proper use of this medication
Usual Dose
- It is important to take your medicine at the right times. You must take it in the way your doctor has told you to. The label on your pack will tell you how many tablets to take and how often to take them. If the label doesn't say or if you are not sure, ask your doctor or pharmacist
- The dosage is very variable and it may be changed from time to time by your doctor. If you are not sure or the dosage on the label has changed for no apparent reason, ask your doctor
- The usual starting dose for adults and children is worked out by your doctor based on your body weight - 2.5 mg per kg of body weight per day, or on your body surface area - 50 to 75 mg per metre squared of body surface area per day. Elderly patients will have their kidney and liver function tested and if necessary the dose may need to be reduced
- your doctor may reduce your dose of PURINETHOL® if you have kidney or liver disease or you are taking any other medicines that can cause a decrease in the body's ability to produce white blood cells and platelets, such as other cytotoxic medicines
- Swallow your tablets with a little water
PURINETHOL® belongs to a group of medicines called cytotoxics, which are 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.
Overdose
If you take too much PURINETHOL® or if someone else takes your medicine by mistake, tell your doctor immediately
Missed Dose
If you forget to take a dose, go back to your regular dosing schedule and tell your doctor. Do not double your next dose.
Side effects and what to do about them
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Blood or liver problems: nausea, vomiting, loss of appetite, severe or prolonged diarrhea, abdominal pain, mouth ulcers, jaundice (yellowing of the skin and eyes) | ✔ | ✔ | |
| Hypersensitivity reactions such as swelling, rash, fever | ✔ | ✔ | |
| Unexpected bruising or bleeding (ie. Bleeding in urine, stool, gums) | ✔ | ✔ | |
PURINETHOL® may cause side effects in some people,
mainly reduced cell production in the bone marrow.
During your treatment your doctor will take blood tests to
check your liver function. 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
PURINETHOL®
. As with all cytotoxic medicines, there is an
increased risk of damage to the genes in some cells. Cases of
certain types of leukemia and of hepatosplenic T-cell
lymphoma (HSTCL) have been reported in patients treated
with Purinethol.
This is not a complete list of side effects. For any unexpected
effects while taking PURINETHOL®
, contact your doctor or
pharmacist.
How to store
Keep your PURINETHOL® tablets in a dry, safe place where children cannot see or reach them.
- PURINETHOL® Tablets should be stored in a dry place between 15o and 25oC, protected from light.
- Do not take any tablets after the expiry date shown on the pack
- If your doctor 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 doctor tells you to.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals or by contacting the sponsor, Teva Canada
Limited, at:
1-800-268-4127 ext. 1255005 (English)
1-877-777-9117 (French)
or druginfo@tevacanada.com
This leaflet was prepared by Teva Canada Limited.
Last revised: July 16, 2014
Purinethol is a reg'd trademark of / est une marque déposée de
TEVA Pharmaceutical Works Private Ltd. Co.