Co Mycophenolate: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• CO MYCOPHENOLATE is used after kidney, heart and

  liver transplantation to help prevent organ rejection.

• CO MYCOPHENOLATE belongs to a family of drugs

  known as "immunosuppressants". These drugs work to "suppress" or reduce the body's immune response.

• CO MYCOPHENOLATE must be given with other drugs

  such as cyclosporine (Sandimmune^® or Neoral^®) and corticosteroids (e.g., prednisone, prednisolone, methylprednisolone, prednisolone acetate, methylprednisolone acetate) which also suppress your immune system. Together these drugs help prevent the rejection of your transplanted organ.

What it does:

• Your body's immune system works to protect you from

  infections and other foreign material. When you receive a transplant, your immune system recognizes the new organ as foreign, and will try to reject it. CO MYCOPHENOLATE, works to reduce this reaction, so that your body is more likely to accept the transplanted organ.

When it should not be used:

• CO MYCOPHENOLATE should not be used in patients

  allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or to any component of the drug product (see section titled “What the nonmedicinal ingredients are”).

What the medicinal ingredient is:

Mycophenolate mofetil

What the non-medicinal ingredients are:

CO MYCOPHENOLATE tablet contains the following nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone. In addition, the tablet film coating contains: lecithin, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide black, iron oxide red and iron oxide yellow.

What dosage forms it comes in:

CO MYCOPHENOLATE 500 mg tablets are lavender-coloured, film-coated, capsule-shaped, biconvex tablet with ‘MO500’ on one side and “ ” on the other.

WARNINGS AND PRECAUTIONS

Warning Because CO MYCOPHENOLATE suppresses your immune system, you are more likely to get infections and have a greater chance of developing cancer. The chances of developing either are similar to the chances seen in patients taking other immunosuppressants.

Special Note For Female Patients

• Women must avoid pregnancy while taking CO

  MYCOPHENOLATE as it may cause an increased risk of first trimester pregnancy loss or damage to the unborn baby. For this reason it is recommended that you discuss with your doctor if you are pregnant or become pregnant while taking CO MYCOPHENOLATE. You will want to discuss the possible benefits and risks of continuing with this drug.

• Women (who have the potential of becoming pregnant) should have a negative serum (blood) or urine pregnancy test within 1 week prior to beginning therapy.
• Before, during your treatment and for 6 weeks after stopping your treatment with CO MYCOPHENOLATE, you must use two reliable methods of birth control.
• It is recommended that you do not breastfeed your baby if you are taking CO MYCOPHENOLATE as it may pass into breast milk and may harm your baby.

All Patients

• Tell all health professionals you see (doctor, dentist, nurses, pharmacists) that you are taking CO MYCOPHENOLATE.

• Be sure to keep all appointments at your transplant clinic.

  During these visits, complete blood counts will need to be measured weekly in the first month, twice monthly for the second and third months of treatment, and then monthly for the remainder of the first year. Your doctor may sometimes order additional blood tests.

BEFORE you use CO MYCOPHENOLATE talk to your doctor or pharmacist:

• If you have had a bad, unusual or allergic reaction to mycophenolate mofetil, mycophenolic acid, or mycophenolate sodium;
• If you are pregnant, plan to become pregnant, or are breastfeeding a baby;
• About all other health conditions you have now, or have had in the past, especially problems with your stomach or bowel movements;
• About all other medicines or treatments you have used or are using, including any products you buy at a pharmacy, supermarket or health food store.

INTERACTIONS WITH THIS MEDICATION

• Do not take any other drugs without asking your doctor or

  pharmacist first.

• Taking antacids at the same time as CO MYCOPHENOLATE

  may affect the way CO MYCOPHENOLATE works for you and therefore should not be taken simultaneously.

• Taking proton pump inhibitors, such as lansoprazole and

  pantoprazole, at the same time as CO MYCOPHENOLATE may affect the way CO MYCOPHENOLATE works for you.

• Taking Renagel^® (sevelamer), or other calcium free phosphate

  binders at the same time as CO MYCOPHENOLATE may affect the way CO MYCOPHENOLATE works for you and therefore should not be taken at the same time.

• Taking combinations of antibiotics at the same time as CO

  MYCOPHENOLATE may affect the way CO

  MYCOPHENOLATE works for you. Do not take any other drugs without asking your doctor or pharmacist first.

• During treatment with CO MYCOPHENOLATE, vaccinations

  may be less effective and live vaccines should not be given. Do discuss this with your doctor before you get any vaccinations or immunizations.

• Do not take cholestyramine, which is used to treat high blood

  cholesterol

PROPER USE OF THIS MEDICATION

• Your doctor has decided the dose you should take based on

  your medical condition and response to the drug.

• The initial dose of CO MYCOPHENOLATE should be taken

  as soon as possible following transplantation. If you are not sure of your dose, or when to take it, ask your doctor, pharmacist or nurse.

• Space your two doses of CO MYCOPHENOLATE as evenly

  as you can throughout the day leaving about 12 hours between each dose.

• If you have trouble remembering doses, or if you are uncertain

  about how to take them talk to your doctor, nurse or pharmacist and be sure to discuss any concerns you have about taking the drug as prescribed.

• CO MYCOPHENOLATE must be taken with other

  immunosuppressive medicines (such as cyclosporine and corticosteroids). Discuss with your doctor if you are to stop, or to continue, the other immunosuppressant drugs you had been taking.

• Try to take your doses at the same times each day. Taking

  your medicine at the same time each day will also help you remember each dose.

• Vomiting or diarrhea may prevent CO MYCOPHENOLATE

  from being taken up into your body. Always call your doctor if you have either of these episodes.

• Do not change the dose on your own, no matter how you are feeling. Call your doctor.
• Do not stop taking CO MYCOPHENOLATE on your own even if you have been taking it for several years.

Usual dose:

CO MYCOPHENOLATE should be taken on an empty stomach.

Kidney Transplant Patients

Adults:

• A dose of 1 g taken twice a day (daily dose of 2 g) is recommended after kidney transplantation.

Pediatric Patients:

• Pediatric patients with a body surface area** greater than 1.5 m² may be dosed with CO MYCOPHENOLATE tablets at a dose of 1 g twice a day (2 g daily dose).

**Body surface area is the total surface area of the body, and is represented as square meters (m²). It is calculated from your weight and height. Body surface area is used in many measurements in medicine, such as determining the amount of drug you need to take.

Heart Transplant Patients

Adults:

• A dose of 1.5 g twice a day (daily dose of 3 g) is recommended after heart transplantation in adults.

Liver Transplant Patients

Adults:

• A dose of 1.5 g taken twice a day (daily dose of 3 g) is recommended after liver transplantation in adults.

How Do I Take CO MYCOPHENOLATE?

• It is important to leave the tablets in the blister pack or bottle until you need a dose. When you are ready to take a dose, remove the number of tablets you need to make up the dose your doctor prescribed. Swallow the tablets whole with plenty of water; do not crush them. Avoid contact with any powder, including accidental inhalation, from damaged tablets. Wash any powder from your skin with soap and water; rinse eyes with plain water.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

• Never allow your medication to run out between refills. Plan to order your refills about one week ahead of time. That way you will always have a supply in case the pharmacy is closed or out of the drug. Also be sure to take enough medication with you when you go on a holiday.
• If you ever do miss a dose of CO MYCOPHENOLATE, do not catch up on your own; instead call your doctor or pharmacist right away for advice. It is also a good idea to ask your doctor ahead of time what to do about missed doses. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• Like all medicines, along with the beneficial effects of

  treatment, CO MYCOPHENOLATE may cause side effects in people.

• Because CO MYCOPHENOLATE and the other medicines to

  be taken suppress your immune system, you are more likely to get infections. To help reduce complications from infections, tell your doctor about any cold or flu-like symptoms (such as fever or sore throat), any boils on your skin, or pain when you urinate (pass your water).

• The following symptoms are some possible warning signs of

  cancer. To help detect any cancers as soon as possible, report any of these symptoms to your doctor right away:

  • a change in your bowel or bladder habits;
  • any sore that doesn't heal;
  • unusual bleeding or discharge;

  • the appearance of a lump or thickened areas in your

    breast or anywhere else on your body;

  • unexplained stomach upset or any trouble with

    swallowing;

  • an obvious change in a wart or a mole;
  • a nagging cough or hoarseness;
  • night sweats;
  • persistent and severe headaches.

• Patients taking CO MYCOPHENOLATE in combination

  therapy with cyclosporine and corticosteroids may experience an increase in blood pressure.

• Serious common and uncommon side-effects which have been

  reported with CO MYCOPHENOLATE, when used in combination with cyclosporine and corticosteroids, are provided in the following table. Tell your doctor right away if you notice any of these symptoms. Do not stop taking this drug on your own.

^† Do not stop your medicines unless you have discussed this with your doctor first.

This is not a complete list of side effects. For any unexpected effects you have while taking CO MYCOPHENOLATE, contact your doctor or pharmacist.

HOW TO STORE IT

• Keep CO MYCOPHENOLATE out of reach of children. A child who accidentally takes the drug may be seriously harmed. A locked drawer or cupboard is best if you have small children in the house.
• CO MYCOPHENOLATE tablets should be stored at room temperature (15ºC -30ºC). The tablets should be protected from light. Remember to keep each tablet in its original package until you need to take it.
• CO MYCOPHENOLATE should not be used after the expiry date (EXP) shown on the package.

REPORTING SUSPECTED 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 3 ways:

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• 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 MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

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MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Cobalt Pharmaceuticals Company, at: 1-866-254-6111

Cobalt Pharmaceuticals Company

6500 Kitimat Road

Mississauga, ON

Canada, L5N 2B8

Neoral® (cyclosporine) is a registered Trade-Mark of Novartis AG

Sandimmune® (cyclosporine) is a registered Trade-Mark of Novartis AG

Renagel® (sevelamar) is a registered Trade-Mark of Genzyme Corporation.

Last revised: October 16, 2013