"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
- Give patients complete dosage instructions and inform them about the increased risk of lymphoproliferative disease and certain other malignancies.
- Inform patients that they need repeated appropriate laboratory tests while they are taking CellCept.
- Inform women of childbearing potential that use of CellCept in pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of birth defects, and that they must use effective contraception.
- Discuss pregnancy plans with female patients of childbearing
- Any female of childbearing potential must use highly effective (two methods) contraception 4 weeks prior to starting CellCept therapy and continue contraception until 6 weeks after stopping CellCept treatment, unless abstinence is the chosen method (see WARNINGS: Pregnancy).
- A patient who is planning a pregnancy should not use CellCept unless she cannot be successfully treated with other immunosuppressant drugs.
Last reviewed on RxList: 6/29/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional CellCept Information
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