Cyclosporine
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.
Bioequivalency/Bioavailbility
- 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.
Blood Concentrations/Monitoring
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.
FDA and Industry Communications
Patient Counseling Information
Package Inserts
Additional Information
Updated January 2018