Myfenax Special Precautions

Inform the doctor immediately: If experiencing any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding; If with existing or history of any problems with the digestive system, e.g. stomach ulcers.
Myfenax reduces the body's defence mechanism. Because of this, there is an increased risk of skin cancer. Therefore, exposure to sunlight and ultraviolet (UV) light should be limited by wearing appropriate protective clothing and using a sunscreen with a high protection factor.
There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving Myfenax in combination with other immunosuppressants. In some of these cases, switching Myfenax to an alternative immunosuppressant resulted in serum IgG levels returning to normal. Patients on Myfenax 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 published reports of bronchiectasis in adults and children who received Myfenax in combination with other immunosuppressants. In some of these cases, switching Myfenax 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 also been isolated reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal. It is recommended that patients who develop persistent pulmonary symptoms, such as cough and dyspnea, are investigated.
Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortion and congenital malformations in case of exposure during pregnancy.
Women with childbearing potential should use two reliable forms of contraception simultaneously before starting and during therapy, and for six weeks after stopping treatment; unless abstinence is the chosen method of contraception. Sexually active (including vasectomized) men are recommended to use condoms during treatment and for at least 90 days after cessation of treatment. Female partners of male patients treated with Myfenax are also recommended to use highly effective contraception for the same period.
Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate. Men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate.
Before starting Myfenax treatment, women of childbearing potential should undergo pregnancy testing. Two serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL are recommended; the second test should be performed 8-10 days after the first one and immediately before starting mycophenolate. Pregnancy tests should be repeated as clinically required (e.g. after any gap in contraception is reported).
Driving and using machines: Myfenax has not been shown to impair the ability to drive or operate machinery.