Myfortic (Mycophenolate Tablets)

Myfortic (Mycophenolate Tablets)
Myfortic (Mycophenolate Tablets) lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.Myfortic (Mycophenolate Tablets) is used to prevent your body from rejecting a kidney transplant. Myfortic (Mycophenolate Tablets) is usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication.Myfortic (Mycophenolate Tablets) may also be used for other purposes not listed in this medication guide. Important information about Myfortic (Mycophenolate Tablets)   can cause harm to an unborn baby, especially if used during the first trimester of pregnancy. Do not use Myfortic (Mycophenolate Tablets) without telling your doctor if you are pregnant or if you plan to become pregnant during treatment.If you are a woman of child-bearing potential, you will be required to use two forms of birth control to prevent pregnancy before and during your treatment with Myfortic (Mycophenolate Tablets), and for at least 6 weeks after your treatment ends. You will also need to have a negative pregnancy test within 1 week before you start using this medication.Tell your doctor right away if you become pregnant while using Myfortic (Mycophenolate Tablets).Although Myfortic (Mycophenolate Tablets) can cause harm to an unborn baby, not treating the mother after a transplant could pose a greater risk to the mother's health. Myfortic (Mycophenolate Tablets) is sometimes given to pregnant women who are unable to take other needed transplant medications. Your doctor will decide whether you should receive this medication.Using Myfortic (Mycophenolate Tablets) can make it easier for you to bleed from an injury or get sick from being around others who are ill. You may also have an increased risk of certain forms of cancer. Your blood will need to be tested on a weekly or monthly basis while using this medication. Do not miss any scheduled appointments.Do not crush, chew, or break an enteric-coated pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. Before using Myfortic (Mycophenolate Tablets) You should not use Myfortic (Mycophenolate Tablets) if you are allergic to mycophenolic acid or mycophenolate mofetil (CellCept).Before using Myfortic (Mycophenolate Tablets), tell your doctor if you are allergic to any drugs, or if you have:a stomach ulcer or other disorders of your stomach or intestines;kidney disease;a viral, bacterial, or fungal infection; ora rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.If you have any of these conditions, you may need a dose adjustment or special tests to safely use Myfortic (Mycophenolate Tablets).FDA pregnancy category D. This medication can cause harm to an unborn baby, especially if used during the first trimester of pregnancy. Do not use mycophenolic acid without telling your doctor if you are pregnant or if you plan to become pregnant during treatment.If you are a woman of child-bearing potential, you will be required to receive contraceptive counseling and to start using two forms of birth control 4 weeks before the start of your treatment with Myfortic (Mycophenolate Tablets). You will also need to have a negative pregnancy test within 1 week before your treatment begins.Unless you have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. Adolescent girls who have entered puberty are also considered to be of child-bearing potential, even if not yet sexually active.Use two non-hormone forms of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy before and during your treatment with Myfortic (Mycophenolate Tablets), and for at least 6 weeks after your treatment ends. Tell your doctor right away if you become pregnant. Myfortic (Mycophenolate Tablets) can make birth control pills less effective. Ask your doctor about the most effective non-hormonal forms of birth control and which two are best for you.Although Myfortic (Mycophenolate Tablets) can cause harm to an unborn baby, not treating the mother with this medication after a transplant could pose a greater risk to the mother's health. Myfortic (Mycophenolate Tablets) is sometimes given to pregnant women who are unable to take other needed transplant medications. Your doctor will decide whether you should receive this medication.Your name may need to be listed on a national transplant pregnancy registry if you use Myfortic (Mycophenolate Tablets) during pregnancy. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether Myfortic (Mycophenolate Tablets) had any effect on the baby.It is not known whether mycophenolic acid passes into breast milk or if it could harm a nursing baby. Do not breast-feed a baby while taking Myfortic (Mycophenolate Tablets) and for at least 6 weeks after your treatment ends.

Special warnings and precautions for use

Patients receiving immunosuppressive regimens involving combinations of drugs, including Myfortic, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8). The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. As general advice to minimise the risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.

Patients receiving Myfortic should be instructed to immediately report any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.

Patients treated with immunosuppressants, including Myfortic, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8). Among the opportunistic infections are BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML). These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.

There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving Myfortic in combination with other immunosuppressants. In some of these cases, switching MPA derivatives to an alternative immunosuppressant, resulted in serum IgG levels returning to normal. Patients on Myfortic who develop recurrent infections should have their serum immunoglobulins measured. In cases of sustained, clinically relevant hypogammaglobulinaemia, appropriate clinical action should be considered taking into account the potent cytostatic effects that mycophenolic acid has on T- and B-lymphocytes.

There have been reports of bronchiectasis in patients who received Myfortic in combination with other immunosuppressants. In some of these cases, switching MPA derivatives to another immunosuppressant, resulted in improvement in respiratory symptoms. The risk of bronchiectasis may be linked to hypogammaglobulinaemia or to a direct effect on the lung. There have been also isolated reports of interstitial lung disease (see section 4.8). It is recommended that patients who develop persistent pulmonary symptoms, such as cough and dyspnoea, are investigated for any evidence of underlying interstitial lung disease.

Reactivation of hepatitis B (HBV) or hepatitis C (HCV) have been reported in patients treated with immunosuppressants, including the mycophenolic acid (MPA) derivatives Myfortic and mycophenolate mofetil (MMF). Monitoring infected patients for clinical and laboratory signs of active HBV or HCV infection is recommended.

Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MPA derivatives (which include mycophenolate mofetil and mycophenolate sodium) in combination with other immunosuppressants. The mechanism for MPA derivatives induced PRCA is unknown. PRCA may resolve with dose reduction or cessation of therapy. Changes to Myfortic therapy should only be undertaken under appropriate supervision in transplant recipients in order to minimise the risk of graft rejection (see Section 4.8).

Patients receiving Myfortic should be monitored for blood disorders (e.g. neutropenia or anemia – see section 4.8), which may be related to MPA itself, concomitant medications, viral infections, or some combination of these causes. Patients taking Myfortic should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year. If blood disorders occur (e.g. neutropenia with absolute neutrophil count <1.5 x 103/µl or anemia) it may be appropriate to interrupt or discontinue Myfortic.

Patients should be advised that during treatment with MPA vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).

Influenza vaccination may be of value. Prescribers should refer to national guidelines for influenza vaccination.

Because MPA derivatives have been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration and haemorrhage and perforation, Myfortic should be administered with caution in patients with active serious digestive system disease.

It is recommended that Myfortic not be administered concomitantly with azathioprine because concomitant administration of these drugs has not been evaluated.

Mycophenolic acid (as sodium salt) and mycophenolate mofetil should not be indiscriminately interchanged or substituted because of their different pharmacokinetic profiles.

Myfortic has been administered in combination with corticosteroids and ciclosporin.

There is limited experience with its concomitant use with induction therapies such as anti-T-lymphocyte globulin or basiliximab. The efficacy and safety of the use of Myfortic with other immunosuppressive agents (for example, tacrolimus) have not been studied.

Myfortic contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The concomitant administration of Myfortic and drugs which interfere with enterohepatic circulation, for example cholestyramine or activated charcoal, may result in sub-therapeutic systemic MPA exposure and reduced efficacy.

Myfortic is an IMPDH (inosine monophosphate dehydrogenase) inhibitor. Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.

Myfortic therapy should not be initiated until a negative pregnancy test has been obtained. Effective contraception must be used before beginning Myfortic therapy, during therapy and for six weeks following therapy discontinuation (see section 4.6).

Teratogenic effects

Mycophenolate is a powerful human teratogen. Spontaneous abortion (rate of 45-49%) and congenital malformations (estimated rate of 23-27%) have been reported following mycophenolate mofetil exposure during pregnancy. Therefore Myfortic is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection. Female and male patients of reproductive potential should be made aware of the risks and follow the recommendations provided in section 4.6. (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with Myfortic. Physicians should ensure that women and men taking mycophenolate understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult their physician if there is a possibility of pregnancy.

Dose
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.