Buy Neoral Online

Neoral (cyclosporine)

BOXED WARNING

Should only be prescribed by physicians experienced in management of systemic immunosuppressive therapy for indicated diseases. Manage patients in facilities equipped and staffed w/ adequate lab and supportive medical resources. Increased susceptibility to infection and development of neoplasia (eg, lymphoma) may result from immunosuppression. May be coadministered w/ other immunosuppressive agents in kidney, liver, and heart transplant patients. Not bioequivalent to Sandimmune and cannot be used interchangeably w/o physician supervision. Caution in switching from Sandimmune. Monitor cyclosporine blood concentrations in transplant and rheumatoid arthritis (RA) patients to avoid toxicity due to high concentrations. Dose adjustments should be made to minimize possible organ rejection due to low concentrations in transplant patients. Increased risk of developing skin malignancies in psoriasis patients previously treated w/ PUVA, methotrexate (MTX) or other immunosuppressive agents, UVB, coal tar, or radiation therapy. May cause systemic HTN and nephrotoxicity. Monitor for renal dysfunction, including structural kidney damage, during therapy.

View FDA-Approved Full Prescribing Information for Neoral

THERAPEUTIC CLASS

Cyclic polypeptide immunosuppressant

DEA CLASS

RX

INDICATIONS

Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Treatment of severe, active RA where disease has not adequately responded to MTX. May be used in combination w/ MTX in RA not responding adequately to MTX alone. Treatment of nonimmunocompromised adults w/ severe (eg, extensive and/or disabling), recalcitrant, plaque psoriasis who failed to respond to at least 1 systemic therapy (eg, PUVA, retinoids, MTX) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated.

ADULT DOSAGE

Organ Transplant

Organ Rejection Prophylaxis in Kidney, Liver, and Heart Allogeneic Transplants:
Newly Transplanted Patients:
Initial dose may be given 4-12 hrs prior to transplant or given postoperatively; dose varies depending on transplanted organ and other immunosuppressive agents included in protocol

Suggested Initial Doses:
Renal Transplant: 9±3mg/kg/day
Liver Transplant: 8±4mg/kg/day
Heart Transplant: 7±3mg/kg/day

Give bid

Subsequently adjust dose to achieve a predefined blood concentration

Adjunct therapy w/ adrenal corticosteroids is recommended initially

Conversion from Sandimmune:
Start w/ same daily dose as was previously used w/ Sandimmune (1:1 dose conversion); subsequently adjust dose to attain the pre-conversion blood trough concentration
After conversion, monitor blood trough concentration every 4-7 days while adjusting to trough levels until concentration attains pre-conversion value

Transplant Patients w/ Poor Sandimmune Absorption:
Patients tend to have higher cyclosporine concentrations after conversion to therapy; caution when converting patients at doses >10mg/kg/day
Titrate dose individually based on trough concentrations, tolerability, and clinical response and measure blood trough concentration at least 2X a week (daily if initial dose >10mg/kg/day) until stabilized w/in desired range

Rheumatoid Arthritis

Severe, active rheumatoid arthritis where the disease has not adequately responded to methotrexate (MTX)

W/ or w/o MTX:
Initial: 2.5mg/kg/day, taken bid
Titrate: May increase by 0.5-0.75mg/kg/day after 8 weeks and again after 12 weeks
Max: 4mg/kg/day

Salicylates, NSAIDs, and oral corticosteroids may be continued

D/C if no benefit is seen by 16 weeks

Combination w/ MTX:
Most patients can be treated w/ doses of ≤3mg/kg/day when combined w/ MTX doses of up to 15mg/week

Plaque Psoriasis

In immunocompetent patients w/ severe, recalcitrant, plaque psoriasis who failed to respond to at least 1 systemic therapy (eg, PUVA, retinoids, methotrexate) or for whom other systemic therapies are contraindicated, or cannot be tolerated

Initial: 2.5mg/kg/day, taken bid, for at least 4 weeks
Titrate: If clinical improvement does not occur, increase dose at 2-week intervals by approx 0.5mg/kg/day
Max: 4mg/kg/day

D/C if satisfactory response cannot be achieved after 6 weeks at 4mg/kg/day or the patient's max tolerated dose

PEDIATRIC DOSAGE

Organ Rejection Prophylaxis

Transplant recipients as young as 1 year of age have received cyclosporine (MODIFIED) with no unusual adverse effects

DOSING CONSIDERATIONS

Renal Impairment
In Kidney, Liver, and Heart Transplant:
Reduce dose if indicated
In Rheumatoid Arthritis/Plaque Psoriasis:
Not recommended for use

Hepatic Impairment
Severe: Dose reduction may be necessary

Elderly
Start at lower end of dosing range

Adverse Events
Rheumatoid Arthritis/Plaque Psoriasis:
Reduce dose by 25-50% to control adverse events; d/c therapy if dose reduction is not effective or if adverse event or abnormality is severe

Other Important Considerations
Avoid consumption of grapefruit or grapefruit juice during therapy

ADMINISTRATION

Oral route

Always administer daily dose in 2 divided doses (bid); administer on a consistent schedule w/ regard to time of day and relation to meals

Sol
1. Dilute w/ room temperature orange or apple juice to make sol more palatable; avoid switching diluents frequently or diluting w/ grapefruit juice
2. Take the prescribed amount of sol from the container using supplied dosing syringe, after removal of protective cover, and transfer sol to a glass of orange or apple juice (do not use a plastic container)
3. Stir well and drink at once; do not allow diluted oral sol to stand before drinking
4. Rinse the glass w/ more diluent to ensure that the total dose is consumed
5. After use, dry the outside of dosing syringe w/ a clean towel and replace protective cover
6. Do not rinse dosing syringe w/ water or other cleaning agents; if syringe requires cleaning, it must be completely dry before resuming use

HOW SUPPLIED

Cap: 25mg, 100mg; Sol: 100mg/mL [50mL]

CONTRAINDICATIONS

RA/Psoriasis: Abnormal renal function, uncontrolled HTN, malignancies. Psoriasis: Concomitant PUVA or UVB therapy, MTX, other immunosuppressants, coal tar, or radiation therapy.

WARNINGS/PRECAUTIONS

May cause hepatotoxicity and liver injury (eg, cholestasis, jaundice, hepatitis, liver failure). Elevations of SrCr and BUN may occur and reflect a reduction in GFR; closely monitor renal function and frequent dose adjustments may be indicated. Elevations in SrCr and BUN levels do not necessarily indicate rejection; evaluate patient before initiating dose adjustment. Thrombocytopenia and microangiopathic hemolytic anemia, resulting in graft failure, significant hyperkalemia (sometimes associated w/ hyperchloremic metabolic acidosis) and hyperuricemia reported. Avoid excessive ultraviolet light exposure. Oversuppression of the immune system may result in an increased risk of infection/malignancy; caution w/ a multiple immunosuppressant regimen. Increased risk of developing bacterial, viral, fungal, protozoal, and opportunistic infections (eg, polyomavirus infections). JC virus-associated progressive multifocal leukoencephalopathy and polyomavirus-/BK virus-associated nephropathy reported; consider reduction in immunosuppression if either develops. Convulsions, encephalopathy including posterior reversible encephalopathy syndrome, and rarely, optic disc edema reported. Evaluate before and during treatment for development of malignancies. In RA patients, monitor BP on at least 2 occasions and obtain 2 baseline SrCr levels before treatment, then monitor BP and SrCr every 2 weeks for the first 3 months of therapy, and then monthly if the patient is stable or more frequently during dose adjustments. In psoriasis patients, assess BP on at least 2 occasions and obtain baseline SrCr, BUN, CBC, Mg2+, K+, uric acid, and lipids before treatment, then monitor every 2 weeks for the first 3 months of therapy, and then monthly if the patient is stable or more frequently during dose adjustments. Monitor CBC and LFTs monthly w/ MTX. Monitor SrCr and BP after initiation or increases in NSAID dose for RA. Consider the alcohol content of the drug when given to patients in whom alcohol intake should be avoided or minimized (eg, pregnant or breastfeeding women, patients presenting w/ liver disease or epilepsy, alcoholic patients, or pediatric patients). HTN may occur and persist, and may require antihypertensive therapy.

ADVERSE REACTIONS

Increased susceptibility to infection, neoplasia, renal dysfunction, HTN, hirsutism/hypertrichosis, tremor, headache, gum hyperplasia, diarrhea, N/V, paresthesia, hypertriglyceridemia, hyperesthesia.

DRUG INTERACTIONS

See Boxed Warning, Dose Modification, and Contraindications. Avoid w/ K+-sparing diuretics, aliskiren, orlistat, bosentan, or dabigatran. Vaccinations may be less effective; avoid live vaccines during therapy. Frequent gingival hyperplasia reported w/ nifedipine; avoid concomitant use w/ nifedipine in patients in whom gingival hyperplasia develops as a side effect of cyclosporine. Caution w/ rifabutin, nephrotoxic drugs, HIV protease inhibitors (eg, indinavir, nelfinavir, ritonavir, saquinavir), K+-sparing drugs (eg, ACE inhibitors, ARBs), K+-containing drugs, and K+-rich diet. Ciprofloxacin, gentamicin, tobramycin, vancomycin, trimethoprim w/ sulfamethoxazole, melphalan, amphotericin B, ketoconazole, azapropazon, colchicine, diclofenac, naproxen, sulindac, cimetidine, ranitidine, tacrolimus, fibric acid derivatives (eg, bezafibrate, fenofibrate), MTX, and NSAIDs may potentiate renal dysfunction; closely monitor renal function and reduce dose of coadministered drug or consider alternative treatment if significant renal impairment occurs. Diltiazem, nicardipine, verapamil, fluconazole, itraconazole, ketoconazole, voriconazole, azithromycin, clarithromycin, erythromycin, quinupristin/dalfopristin, methylprednisolone, allopurinol, amiodarone, bromocriptine, colchicine, danazol, imatinib, metoclopramide, nefazodone, oral contraceptives, grapefruit, grapefruit juice, HIV protease inhibitors, boceprevir, and telaprevir may increase levels. Nafcillin, rifampin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, bosentan, octreotide, orlistat, sulfinpyrazone, terbinafine, ticlopidine, and St. John's wort may decrease levels. May increase levels of bosentan, dabigatran, and CYP3A4, P-gp, or organic anion transporter protein substrates. May increase levels of ambrisentan; do not titrate ambrisentan dose to the recommended max daily dose. CYP3A4 and/or P-gp inducers and inhibitors may alter levels; may require dose adjustments of cyclosporine if cyclosporine concentrations are significantly altered. May reduce clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), aliskiren, bosentan, dabigatran, repaglinide, NSAIDs, sirolimus, and etoposide. Digitalis toxicity reported when used w/ digoxin; monitor digoxin levels. May increase levels and enhance toxic effects (eg, myopathy, neuropathy) of colchicine; may reduce colchicine dose. Myotoxicity cases seen w/ lovastatin, simvastatin, atorvastatin, pravastatin, and, rarely fluvastatin; temporarily withhold or d/c statin therapy if signs of myopathy develop or w/ risk factors predisposing to severe renal injury, including renal failure, secondary to rhabdomyolysis. May increase levels of repaglinide, thereby increasing the risk of hypoglycemia; closely monitor blood glucose levels. High doses of cyclosporine may increase the exposure to anthracycline antibiotics (eg, doxorubicin, mitoxantrone, daunorubicin) in cancer patients. May double diclofenac blood levels; dose of diclofenac should be in the lower end of the therapeutic range. May increase MTX levels and decrease levels of active metabolite of MTX. May elevate SrCr and increase levels of sirolimus; give 4 hrs after cyclosporine administration. Convulsions reported w/ high-dose methylprednisolone. Calcium antagonists may interfere w/ cyclosporine metabolism. Avoid in psoriasis patients receiving other immunosuppressive agents or radiation therapy (including PUVA and UVB).

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

Cyclic polypeptide immunosuppressant; results from specific and reversible inhibition of immunocompetent lymphocytes in the G0- and G1-phase of the cell cycle. T-lymphocytes are preferentially inhibited w/ T-helper cell as main target while also possibly suppressing T-suppressor cells. Also inhibits lymphokine production and release (eg, interleukin-2).

PHARMACOKINETICS

Absorption: Incomplete; Tmax=1.5-2 hrs. Pharmacokinetic parameters varied w/ different indications (renal transplant, liver transplant, RA, and/or psoriasis). Distribution: Vd=3-5L/kg (IV); plasma protein binding (90%); found in breast milk. Metabolism: (Extensive) Liver via CYP3A, to a lesser extent GI tract and kidneys. M1, M9, and M4N (major metabolites); oxidation and demethylation pathways. Elimination: Bile (primary), urine (6%, 0.1% unchanged); T1/2=8.4 hrs.

ASSESSMENT

Assess for hypersensitivity to the drug, renal dysfunction, uncontrolled HTN, presence of malignancies, pregnancy/nursing status, and possible drug interactions. RA: Before initiating treatment, assess BP (on at least 2 occasions) and obtain 2 SrCr levels. Psoriasis: Prior to treatment, perform a dermatological and physical examination, including measuring BP. Assess for presence of occult infections and for the presence of tumors. Assess for atypical skin lesions and biopsy them. Obtain baseline SrCr (at least twice), BUN, LFTs, bilirubin, CBC, Mg2+, K+, uric acid, and lipid levels.

MONITORING

Monitor for signs/symptoms of hepatotoxicity, liver injury, nephrotoxicity, thrombocytopenia, microangiopathic hemolytic anemia, HTN, hyperkalemia, lymphomas and other malignancies, serious/polyoma virus infections, convulsions and other neurotoxicities, and other adverse reactions. Monitor cyclosporine blood concentrations routinely in transplant patients and periodically in RA patients. RA: Monitor BP and SrCr every 2 weeks during the initial 3 months of treatment, then monthly if patient is stable. Monitor SrCr and BP after an increase of the dose of NSAIDs and after initiation of new NSAID therapy. If coadministered w/ MTX, monitor CBC and LFTs monthly. Psoriasis: Monitor for occult infections and tumors. Monitor SrCr, BUN, BP, CBC, uric acid, K+, lipids, and Mg2+ levels every 2 weeks during first 3 months of treatment, then monthly if stable.

PATIENT COUNSELING

Instruct to contact physician before changing formulations of cyclosporine, which may require dose changes. Inform that repeated lab tests are required while on therapy. Advise of the potential risks if used during pregnancy and inform of the increased risk of neoplasia, HTN, and renal dysfunction. Inform that vaccinations may be less effective and to avoid live vaccines during therapy. Advise to take the medication on a consistent schedule w/ regard to time and meals, and to avoid grapefruit and grapefruit juice. Inform to avoid excessive sun exposure.

STORAGE

20-25°C (68-77°F). (Sol) Use w/in 2 months upon opening. Do not refrigerate. At <20°C (68°F) may form gel; light flocculation, or formation of light sediment may occur; allow to warm to 25°C (77°F) to reverse changes.

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