Myfortic (Mycophenolic Acid)

How it is taken:

• Do not break,crush, chew or cut MYFORTIC tablets. Do not take any tablets that are broken or split. The tablets should be swallowed whole with plenty of water.
• Space your two doses of MYFORTIC as evenly as you can throughout the day leaving about 12 hours between each dose.
• Try to take your doses at the same times each day. This will help keep a constant amount of drug in your body so it can continue to protect your transplanted organ. Taking your medicine at the same time each day will also help you remember each dose.
• MYFORTIC should be taken on an empty stomach, one hour before or two hours after food intake.
• Vomiting or diarrhea may prevent MYFORTIC from being taken up into your body. Always call your doctor if you have either of these episodes.
• Your doctor has decided the dose of MYFORTIC you should take based on your medical condition and response to the drug. Follow your doctor's instruction carefully. Do not take any more or any less of the drug than your doctor has told you. Do not change the dose on your own, no matter how you are feeling.

How long is treatment continued:

• Treatment will continue for as long as you need immunosuppression to prevent you from rejecting your transplanted kidney.

Overdose:

In case of drug overdosage, contact a healthcare professional (e.g. doctor), hospital emergency department or regional Poison Control Centre, even if there are no symptoms.

Missed dose:

• Missing even a few doses of MYFORTIC may lead to rejection of your transplanted kidney. That is why it is so important to take each dose of MYFORTIC as prescribed.
• 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.
• If you ever do miss a dose of MYFORTIC, do not double dose or 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.
• 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.

Like all medicines, MYFORTIC can cause side effects, although not everybody gets them.

Some effects could be serious:

• If you have symptoms of infection including fever, chills, sweating, fatigue, drowsiness, or lack of energy. If you are taking MYFORTIC you may be more susceptible to infections than usual. These may affect various body systems, the most common being the urinary tract, the respiratory tract and the skin.
• If you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness, these can be the signs and symptoms of an infection of the brain called progressive multifocal leukoencephalopathy.
• If you have enlarged glands, new or enlarging skin growths, or a change in an existing mole. As can happen in patients taking immunosuppressive medication a very small number of MYFORTIC patients have developed cancer of the skin or lymph nodes.
• If you experience unusual tiredness, headache, shortness of breath with exercise or at rest, dizziness, chest pain, looking pale. These are all symptoms of anaemia (decrease in red blood cells).

If you experience any of these, tell your doctor straight away.

Other side effects may include:

Very common side effects (>1 in 10 patients).

• diarrhea
• low level of white blood cells
• reduced level of calcium in the blood , sometimes leading to cramps, (hypocalcemia)
• muscle weakness, muscle spasms, abnormal heart rhythm (possible symptoms of low level of potassium in the blood) (hypokalemia)
• abnormal blood test results (high level of uric acid in the blood) (hyperuricemia)
• headache, dizziness (possible symptoms of high blood pressure) (hypertension)
• dizziness, light-headedness (possible symptoms of low blood pressure) (hypotension)

Common side effects (≤10 in every 100 patients).

• bleeding or bruising more easily than normal (signs of low level of blood platelets—thrombocytopenia)
• muscle spasms, abnormal heart rhythm (possible symptoms of high level of potassium in the blood) (hyperkalemia)
• abnormal blood test results (low level of magnesium in the blood) (hypomagnesemia)
• excessive emotional distress, troubled (symptoms of anxiety)
• dizziness
• headache
• cough
• headache, dizziness, possibly with nausea (possible symptoms of severe high blood pressure) (aggravated hypertension)
• shortness of breath, laborated breathing (possible symptoms of dyspnea or dyspnea exertional)
• pain (e.g. in the abdomen, stomach, or joints)
• constipation
• indigestion
• flatulence
• loose stools
• nausea
• vomiting
• tiredness
• fever
• abnormal results of liver or kidney test
• pain in joint (arthralgia)
• weakness (asthenia)
• muscle pain (myalgia)
• swollen hands, ankles or feet (possible symptoms of edema peripheral)

Uncommon side effects (<1 in 100 patients).

• cyst containing lymph fluid
• difficulty in sleeping
• shakiness
• lung congestion
• shortness of breath
• belching; bad breath
• bowel obstruction
• inflammation of the oesophagus
• bloody or black stools
• tongue discoloration
• dry mouth
• heartburn; inflammation of the gums
• inflammation of the lining of the abdominal cavity
• flu-like symptoms
• swelling of ankles and feet
• loss of appetite
• hair loss
• bruise of the skin
• acne
• fast heart beat; discharge of the eye with itching, redness and swelling
• vision blurred
• kidney disorders
• abnormal narrowing of the tube through which urine passes to the outside of the body
• cough, difficulty breathing, painful breathing (possible symptoms of interstitial lung disease including fatal pulmonary fibrosis)

Other side effect with frequency not known

(Frequency cannot be estimated from the available data)

• rash
• fever, sore throat, frequent infections (possible symptoms of lack of white cells in the blood) (agranulocytosis)

Additional side effects have been reported with the class of drugs to which MYFORTIC belongs.

• inflammation of the colon or of the oesophagus
• abdominal pain
• vomiting
• loss of appetite
• nausea
• inflammation of the pancreas
• intestinal perforation;
• stomach or intestine bleeding
• stomach pain with or without bloody or black stools
• bowel obstruction
• serious infections
• reduction in the number of specific white blood cells or of all blood cells

If any of these affects you, tell your doctor. However, do not stop your medicines unless you have discussed this with your doctor first.

Do not take MYFORTIC if you are allergic (hypersensitive) to mycophenolic acid, mycophenolate sodium or mycophenolate mofetil or to any of the other ingredients of MYFORTIC (see below).

If you think you may be allergic, ask your doctor for advice.

Serious Warnings and Precautions

• MYFORTIC may increase your risk of infection and development of cancer of the lymphoid tissues (called lymphoma) and other cancers.
• MYFORTIC will only be prescribed for you by a doctor with experience in transplantation medicine.
• Female users of childbearing potential must use contraception. Use of MYFORTIC during pregnancy is associated with increased risks of pregnancy loss and congenital malformations.

Follow your doctor's instructions carefully. They may differ from the general information contained in this leaflet.

• For Female Patients:
  • MYFORTIC causes fetal malformations and pregnancy loss, including spontaneous abortion. Therefore, MYFORTIC should not be used in pregnant women unless clearly necessary. Should you become pregnant while on therapy with MYFORTIC, inform your doctor at once. You will want to discuss the possible benefits and risks of continuing with this drug.
  • Women of childbearing potential should have a negative serum (blood) or urine pregnancy test within 1 week prior to beginning therapy. Effective contraception must be used before beginning MYFORTIC therapy, during therapy, and for 6 weeks following discontinuation of therapy.
  • Effective contraception must be used before beginning MYFORTIC therapy, during therapy, and for 6 weeks following discontinuation of therapy, even where there has been a history of infertility, unless due to hysterectomy. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method. If pregnancy does occur during treatment, the patient should inform the physician immediately, and should discuss the potential risk to the fetus with him/her.
  • MYFORTIC should not be used while breast-feeding, or up to 6 weeks after you have stopped therapy. MYFORTIC may pass into breast milk and may harm your baby.
• MYFORTIC may reduce the effectiveness of vaccinations and the use of live attenuated vaccines should be avoided. Discuss it with your doctor before you get any vaccinations or immunizations.
• If you are a sexually active man, you should use condoms during treatment with MYFORTIC and for 13 weeks after stopping the treatment. Your partner should also use effective contraception during your treatment and for 13 weeks after you have stopped MYFORTIC. Tell your doctor straight away if your partner becomes pregnant while you are taking MYFORTIC.

• Tell all health professionals you see (doctors, dentists, nurses, pharmacists) that you are taking MYFORTIC.
• Do not take any other drugs without asking your doctor or pharmacist first. This includes anything you can buy off the shelf such as over-the-counter medicines (e.g. antacids) and natural health products.

Drugs that may interact with MYFORTIC include:

• Immunosuppressive agents other than cyclosporine or corticosteroids (e.g. azathioprine, mycophenolate mofetil, tacrolimus).
• Cholestyramine (a medicine used to treat high blood cholesterol levels).
• Acyclovir (a medicine used to treat herpes infection).
• Gancyclovir (a medicine used to treat cytomegalovirus (CMV) infection).
• Non-prescription medications, including antacids or any natural health product.