Language selection

Search

Details for: PURINETHOL

Company: TEVA CANADA LIMITED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
00004723PURINETHOLMERCAPTOPURINE50 MGTABLETORAL
Search Reported Side Effects Report a Side Effect

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.
You should not use PURINETHOL® during pregnancy. If you are pregnant or are thinking of becoming pregnant, you should discuss with your doctor, whether the benefit of taking PURINETHOL® tablets outweighs the possible risk of problems with your pregnancy, before starting your tablets.

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
From time to time while you are taking PURINETHOL® , your doctor will want you to have a blood test. This is to check your blood cell count and to change your dose if necessary

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

Serious side effects, how often they happen 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.
This medicine is for you. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if their symptoms are the same as yours
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.

Date modified: