Do not take Novufortic if you are allergic to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil, or any of the ingredients in Novufortic.

Novufortic can cause serious side effects, including:

• Possible loss of pregnancy and higher risk of birth defects. Women who take Novufortic during pregnancy have a higher risk of losing the pregnancy (miscarriage) during the first three months, and a higher risk that their baby will be born with birth defects. If you become pregnant while taking Novufortic, do not stop taking it — call your doctor right away.
• Increased risk of serious infections. Novufortic weakens your body's immune system and affects your ability to fight infections. Serious infections — including viral infections such as shingles and cytomegalovirus (CMV), a rare brain infection called progressive multifocal leukoencephalopathy (PML), and fungal infections — can happen and can lead to death.
• Increased risk of certain cancers, including lymphoma and other cancers, especially skin cancer.

Call your doctor right away if you have any signs of infection (a temperature of 100.5°F / about 38°C or greater, cold or flu symptoms, an earache or headache, pain when passing urine or needing to urinate often, white patches in the mouth or throat, unexpected bruising or bleeding, or cuts, scrapes, or incisions that are red, warm, or oozing pus), or if you notice an unexplained fever, tiredness that does not go away, weight loss, swollen lymph nodes, or any new or changing skin spot or mole.

Also tell your doctor right away if you notice weakness on one side of your body, loss of interest in things you usually care about (apathy), confusion or trouble thinking, or trouble controlling your muscles — these can be signs of PML.

Tell your doctor about all of your medical conditions, including if you:

• Have any digestive problems, such as ulcers;
• Plan to receive any vaccines — you should not receive live vaccines while taking Novufortic, and some other vaccines may not work as well during treatment;
• Have Lesch-Nyhan or Kelley-Seegmiller syndrome, or another rare inherited deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) — you should not take Novufortic if you have one of these conditions;
• Are pregnant or are planning to become pregnant;
• Are breastfeeding — it is not known if Novufortic passes into breast milk; you and your doctor will decide whether you should stop taking Novufortic or breastfeed, since you should not do both without talking to your doctor first.

Also tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. In particular, tell your doctor if you take:

• Birth control pills (oral contraceptives);
• Antacids that contain aluminum or magnesium — Novufortic and these antacids should not be taken at the same time;
• Acyclovir or ganciclovir;
• Azathioprine;
• Cholestyramine.

Keep a list of all the medicines you take to show your doctor whenever you get a new medicine. Do not start any new medicine without talking with your doctor first.

Pregnancy and birth control

If you are a woman who is able to become pregnant:

• Your doctor must talk with you about effective birth control methods;
• You should have a negative pregnancy test within 1 week before starting Novufortic;
• You must use 2 different types of effective birth control at the same time — starting 4 weeks before you begin Novufortic, throughout treatment, and for 6 weeks after stopping — unless you choose complete abstinence. Novufortic can reduce the effectiveness of birth control pills you take by mouth.

If you plan to become pregnant, talk with your doctor first — they will help decide whether another medicine to prevent rejection may be right for you. If you become pregnant while taking Novufortic, do not stop taking it — call your doctor right away, and ask about reporting the pregnancy.

• Take Novufortic exactly as prescribed. Your doctor will tell you how much to take.
• Do not stop taking or change your dose of Novufortic without talking to your doctor.
• Take Novufortic on an empty stomach, either 1 hour before or 2 hours after a meal.
• Swallow Novufortic whole. Do not crush, chew, or cut it. Novufortic tablets have a special coating so the medicine passes through your stomach and dissolves in your intestine — breaking the tablet can affect how the medicine works.
• If you forget to take Novufortic, take it as soon as you remember, then take your next dose at its regular time. If it is almost time for your next dose, skip the missed dose. Do not take 2 doses at the same time. Call your doctor or pharmacist if you are not sure what to do.
• If you take more than the prescribed dose, call your doctor right away.
• Do not switch between Novufortic and mycophenolate mofetil tablets, capsules, or oral suspension unless your doctor tells you to. These medicines are absorbed differently, which can change the amount of medicine in your blood.
• Be sure to keep all appointments at your transplant clinic — your doctor will need to perform regular blood tests during treatment.

• Avoid pregnancy (see pregnancy and birth control information above).
• Limit the amount of time you spend in sunlight, and avoid tanning beds and sunlamps. People who take Novufortic have a higher risk of getting skin cancer. Wear protective clothing and use a sunscreen with a high protection factor (SPF 30 or above), especially if you have fair skin or a family history of skin cancer.
• Elderly patients 65 years of age or older may have more side effects with Novufortic because of a weaker immune system.

Serious side effects

See the important safety information above. Additional serious effects can include:

• Low blood cell counts. Novufortic can lower your red blood cells, white blood cells, and platelets. Rarely, it can stop the body from making red blood cells (pure red cell aplasia), causing severe anemia. Your doctor will do blood tests before you start and during treatment. Tell your doctor right away about any unexpected bruising or bleeding, or if you have unusual tiredness, dizziness, fainting, or pale skin.
• Stomach and bowel problems. Bleeding, ulcers, or a tear (perforation) in the stomach or intestine can happen. Bleeding can be severe and you may have to be hospitalized for treatment. Call your doctor right away about severe stomach pain, black or tarry stools, or vomiting blood or material that looks like coffee grounds.

Common side effects

These may include:

• In people with a new transplant: constipation, nausea, diarrhea, vomiting, urinary tract infections, and stomach upset.
• In people who take Novufortic long-term after transplant: nausea, diarrhea, and sore throat.

These are not all of the possible side effects of Novufortic. Tell your doctor about any side effect that bothers you or that does not go away.

For further information

This page is a general summary and does not replace the advice of your doctor or the full prescribing information. For complete details, including all warnings, precautions, and side effects, please contact our team using the Prescribing Information button above. Always follow your doctor's instructions.