Note: Statements are present in all generic, Gengraf, Neoral, and Sandimmune boxed warnings, unless otherwise indicated.
Risk of Infection
Experienced Physicians/Equipped Facility
- For use by physicians experienced in management of systemic immunosuppressive therapy and organ transplant patients in facilities equipped and staffed with adequate laboratory and supportive medical resources.
- The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
Increased Risk of Infection
- Use may increase the susceptibility to infection and the development of neoplasia (e.g. lymphoma) as a result of increased immunosuppression in transplant patients.
- Neoral, Gengraf: May be administered with other immunosuppressive agents in kidney, liver, and heart transplant patients.
- Sandimmune, Generic: Should be administered with adrenal corticosteroids but not with other immunosuppressive agents.
- Injection formulation: Should be administered with adrenal corticosteroids but not with other immunosuppressive agents.
- Sandimmune and generic cyclosporine are not bioequivalent to Neoral or Gengraf and can not be used interchangeably without physician supervision.
- Neoral soft gelatin capsules MODIFIED, Neoral oral solution MODIFIED, and Gengraf oral formulations have increased bioavailability in comparison to Sandimmune and generic soft gelatin capsules and oral solution.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Monitor renal function during therapy & use caution with other nephrotoxic drugs
- Rheumatoid arthritis patients: Physical exam at baseline. Blood pressure and serum creatinine should be assessed at baseline and every 2 weeks during the initial 3 months and then monthly if patient is stable. Also monitor these parameters after initiation of new NSAIDs or NSAID dose increase. If administered with methotrexate monitor CBC and LFTs monthly.
- Psoriasis patients: Careful dermatological and physical exam upon baseline. Baseline labs include serum creatinine (on two occasions), BUN, CBC, serum magnesium, potassium, uric acids & lipids. Monitor these parameters every 2 weeks during initial 3 months and then monthly if patient is stable or more frequently when dosage adjustments are made.
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