Adult Dosing
Transplant rejection prophylaxis (modified formulations)
- Start: 7-9 mg/kg/day PO divided bid, give 1st dose 4-12 hrs prior to transplant or postop. The initial dose may be +/- 3 mg/kg/day based on use in US transplant centers.
- Then adjust dose based on target levels, rejection status, individual clinical status & adverse effects
- Note: Dilute solution with orange/apple juice. Modified and non modified formulations are not equivalent
Transplant rejection prophylaxis (Non modified formulations)
- Start 15 mg/kg PO x 1; give 4-12 hrs prior to transpalnt or postop, then 10-15 mg/kg/day PO x 1-2 wks
- Taper 5% per wk to a maintenance dose of 5-10 mg/kg/day PO divided bid
- Adjust dose based on target levels, rejection status, adverse effects
- Note: Dilute solution with milk/orange juice. Modified and non modified formulations are not equivalent
Rheumatoid arthritis, severe (modified formulations)
- Start 2.5 mg/kg/day PO divided bid, increase 0.5-0.75 mg/kg/day after 8 wks and again after 12 wks. [Max: 4 mg/kg/day]
- Use alone or with methotrexate. Decrease 25-50% to control adverse effects; discontinue if no benefit by 16 wks
- Note: Dilute solution with orange/apple juice. Modified and non modified formulations are not equivalent
Psoriasis (modified formulations)
- Start 2.5 mg/kg/day PO divided bid x 4 wks. Increase 0.5 mg/kg/day q2 wks if no significant clinical improvement. [Max: 4 mg/kg/day]
- Note: Dilute solution with orange/apple juice. Modified and non modified formulations are not equivalent
Pediatric Dosing
Pediatric Use
- Although studies have not been conducted in children, patients as young as 6 months have received the drug in the mg/kg/day doses with no unusual adverse effects.
[Outline]
- Cyclosporine non-modified formulations have decreased bioavailability vs. modified formulations. These formulations are not bioequivalent, thus should not be interchanged without physician supervision
- Cyclosporine increases risk for development of lymphomas and other malignancies. The increased risk appears related to the intensity and duration of immunosuppression. It should not be administered with other immunosuppressive agents except adrenal corticosteroids
- There have been reports of convulsions in adult and pediatric patients receiving cyclosporine
- There have been post-marketing reports of encephalopathy, including posterior reversible encephalopathy syndrome (PRES) in patients receiving cyclosporine in combination with high dose methylprednisolone . Manifestations include impaired consciousness, convulsions, visual disturbances (including blindness), loss of motor function, movement disorders and psychiatric disturbances
- Cyclosporine when used in high doses, can cause hepatotoxicity and nephrotoxicity. Monitor kidney function; dose dependent increases in serum creatinine and urea during first few weeks may necessitate dose reduction in transplant patients
- Implement infection control measures if WBC drops. Implement bleeding precautions if platelet count drops
- Cyclosporine should not be given to pregnant or lactating women unless benefits outweigh risks
- Monitor cyclosporine blood concentrations closely
- Monitor patients closely when switching from modified to non modified formulations
- RA patients: Monitor BUN/creatinine and at least 2 BP measurements at baseline, then q2 wks x 3 months, then qmo. Monitor BP and creatinine after a NSAID dose increase or initiation of a new NSAID during treatment. If patient also receives methotrexate, evaluate CBC and liver function before starting therapy and monthly during treatment
- Psoriasis patients: Monitor BUN/creatinine and at least 2 BP measurements at baseline, then q2 wks x 3 months, then qmo or when starting or increasing NSAID dose. Monitor CBC, K, Mg, lipid panel, uric acid at baseline, then q2wk x3 months, then qmo or more frequently if adjusting dose. Monitor LFTs
- Transplant patients: Monitor BUN/Cr at baseline, then frequently. Monitor LFTs, K, Mg, lipid panel and serum drug levels
- Consult list of drugs that can increase and decrease cyclosporine concentrations
- Closely monitor renal function (particularly serum creatinine) in patients concomitantly receiving any drug with cyclosporine which may result in additive or synergistic renal impairment
- Monitor cyclosporine blood concentrations closely
- Monitor blood pressure (discontinue if hypertension develops that cannot be controlled by antihypertensives)
- Avoid excess UV light exposure
- Avoid live attenuated vaccines
- Caution should be exercised while administering cyclosporine to pregnant/nursing women, alcoholics, patients with epilepsy or liver disease, alcoholics, and children due to its alcohol content
Cautions: Use Cautiously in
- Hepatic impairment
- Renal impairment
- Concurrent nephrotoxic agent use
- Malabsorption syndromes
- Co-administration of ACE inhibitors
- Elderly patients
Pregnancy Category:C
Breastfeeding: Safety unknown. Cyclosporine concentration in milk is variable. Limited information indicates that cyclosporine produces low levels in breast milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. With typical maternal cyclosporine blood levels, a completely breastfed infant would usually receive about 2% of the maternal weight-adjusted dosage or pediatric transplantation maintenance dosage. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACTlast accessed 2 November 2009). Manufacturer advises a decision to be made whether to discontinue nursing or to discontinue the drug after considering maternal importance of therapy. Ethanol is present in breast milk, and may be orally absorbed by a nursing infant.
US Trade Name(s)
US Availability
cyclosporine (generic; modified)
- CAPS: 25, 100 mg
- SOLN: 100 mg/mL (50 mL)
cyclosporine (generic; non modified)
- CAPS: 25, 100 mg
- SOLN: 100 mg/mL (50 mL)
Gengraf, Neoral (Modified)
- CAPS: 25, 100 mg
- SOLN: 100 mg/mL (50 mL)
Sandimune (non modified)
- CAPS: 25, 50, 100 mg
- SOLN: 100 mg/mL (50 mL)
Canadian Trade Name(s)
Canadian Availability
cyclosporine (generic)
- CAPS: 25, 50, 100 mg
- SOLN: 100 mg/mL (50 mL)
Neoral
- CAPS, 10, 25, 50, 100 mg
- SOLN: 100 mg/mL (50 mL)
UK Trade Name(s)
UK Availability
Deximune
Neoral
- CAPS: 10, 25, 50, 100 mg
- SUSP: 100 mg/mL (50 mL)
Australian Trade Name(s)
Australian Availability
Cicloral
Neoral
- CAPS: 10, 25, 50, 100 mg
- SUSP: 100 mg/mL (50 mL)
Sandimmun
- CAPS: 25, 50, 100 mg
- SOLN: 100 mg/mL (50 mL)
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- SandIMMUNE 100 MG/ML SOLN [Bottle] (NOVARTIS)
50 ml = $496
150 ml = $1479.91 - SandIMMUNE 100 MG CAPS [Box] (NOVARTIS)
30 mg = $309.98
60 mg = $614.96 - Neoral 25 MG CAPS [Box] (NOVARTIS)
30 mg = $45.98
60 mg = $91.97 - Gengraf 25 MG CAPS [Box] (ABBOTT)
60 mg = $85.98
180 mg = $235.94 - Gengraf 100 MG CAPS [Box] (ABBOTT)
60 mg = $315.98
180 mg = $939.96 - SandIMMUNE 25 MG CAPS [Box] (NOVARTIS)
60 mg = $159.99
180 mg = $453.95 - Neoral 100 MG/ML SOLN [Bottle] (NOVARTIS)
50 ml = $335.99
150 ml = $916.01 - Neoral 100 MG CAPS [Box] (NOVARTIS)
30 mg = $185.98
90 mg = $496
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
