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cyclosporine modified
generic
Black Box Warnings .
Appropriate Use
admin. only by physicians experienced in immunosuppress. tx and mgmt of organ transplant pts in adequate medical facility; physician responsible for maintenance tx should have all info needed for pt follow-up
Immunosuppressant
immunosuppression incr. infection and neoplasia risks; may admin. in combo w/ other immunosuppressants in liver, kidney, and heart transplants
Bioequivalence
cyclosporine modified formulations have incr. bioavailability vs. non-modified formulations; not bioequivalent, not interchangeable w/o physician supervision; use extreme caution if converting from high-dose cyclosporine non-modified
Monitor Drug Levels
monitor drug levels regularly in transplant and RA pts; adjust dose as appropriate to avoid toxicity due to high levels or organ rejection due to low levels
Skin Malignancy Risk in Psoriasis
previous PUVA tx and to lesser extent methotrexate or other immunosuppressants, UVB, coal tar, or radiation tx incr. risk of skin malignancy in psoriasis pts
HTN, Nephrotoxicity Risk
HTN and nephrotoxicity possible at recommended doses; risk incr. w/ duration and incr. dose; monitor renal fxn
Adult Dosing .
Dosage forms: CAP: 25 mg, 50 mg, 100 mg; SOL: 100 mg per mL
Special Note
- [formulation clarification]
- Info: modified and non-modified cyclosporine products not bioequivalent; caution advised if switching between products
organ transplant rejection prophylaxis
- [dosing protocols vary]
- Start: 7-9 mg/kg/day PO divided bid, give 1st dose 4-12h pre-transplant or postop; Info: for heart, kidney, or liver transplant; adjust dose based on target levels, rejection status, adverse effects
rheumatoid arthritis, severe
- [2.5-4 mg/kg/day PO divided bid]
- Start: 2.5 mg/kg/day PO divided bid, incr. 0.5-0.75 mg/kg/day after 8wk and after 12wk; Max: 4 mg/kg/day; Info: use alone or w/ methotrexate; decr. 25-50% prn adverse effects; D/C if no benefit by 16wk
psoriasis, severe recalcitrant plaque
- [2.5-4 mg/kg/day PO divided bid]
- Start: 2.5 mg/kg/day PO divided bid, incr. 0.5 mg/kg/day q2wk after 4wk; Max: 4 mg/kg/day; Info: decr. 25-50% prn adverse effects; D/C if inadequate response after 6wk on max tolerated dose
atopic dermatitis, moderate-severe refractory (off-label)
- [2-5 mg/kg/day PO divided bid]
- Info: refer to AAAAI/ACAAI guidelines
renal dosing
- [transplant]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
- [all other indications]
- renal impairment: contraindicated
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised
Peds Dosing .
- Dosage forms: CAP: 25 mg, 50 mg, 100 mg; SOL: 100 mg per mL
Special Note
- [formulation clarification]
- Info: modified and non-modified cyclosporine products not bioequivalent; caution advised if switching between products
organ transplant rejection prophylaxis (off-label)
- [dosing protocols vary]
- Start: 7-9 mg/kg/day PO divided bid, give 1st dose 4-12h pre-transplant or postop; Info: for heart, kidney, or liver transplant; adjust dose based on target levels, rejection status, adverse effects
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised