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Generic Neoral Cyclosporine 25/100mg

Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral. Cyclosporine, the active ingredient in Neoral, in recommended dosages, can cause systemic hypertension and nephrotoxicity. Renal dysfunction including structural kidney damage is a potential consequence of Neoral and therefore renal function must be monitored during therapy. Care should be taken in using cyclosporine with nephrotoxic drugs.

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Warnings

There is a potential, as with other immunosuppressive agents, for an increase in the occurrence of malignant lymphomas with cyclosporine. It is not clear whether the risk with cyclosporine is greater than that in rheumatoid arthritis patients or in rheumatoid arthritis patients on cytotoxic treatment for this indication. Five cases of lymphoma were detected: four in a survey of approximately 2,300 patients treated with cyclosporine for rheumatoid arthritis, and another case of lymphoma was reported in a clinical trial.

(See Also Boxed Warnings For Psoriasis)

Before initiating treatment, a careful physical examination, including blood pressure measurements (on at least two occasions) and two creatinine levels to estimate baseline should be performed. Blood pressure and serum creatinine should be evaluated every 2 weeks during the initial 3 months and then monthly if the patient is stable. It is advisable to monitor serum creatinine and blood pressure always after an increase of the dose of nonsteroidal anti-inflammatory drugs and after initiation of new nonsteroidal anti-inflammatory drug therapy during Neoral treatment. If co-administered with methotrexate, CBC and liver function tests are recommended to be monitored monthly.

Neoral Adverse Reactions

Before initiating treatment, a careful dermatological and physical examination, including blood pressure measurements (on at least two occasions) should be performed. Since Neoral is an immunosuppressive agent, patients should be evaluated for the presence of occult infection on their first physical examination and for the presence of tumors initially, and throughout treatment with Neoral. Skin lesions not typical for psoriasis should be biopsied before starting Neoral. Patients with malignant or premalignant changes of the skin should be treated with Neoral only after appropriate treatment of such lesions and if no other treatment option exists.

Neoral Drug Interactions

The increase in creatinine is generally reversible upon timely decrease of the dose of Neoral or its discontinuation. Serum creatinine and BUN should be evaluated every 2 weeks during the initial 3 months of therapy and then monthly if the patient is stable. If the serum creatinine is greater than or equal to 25% above the patient's pretreatment level, serum creatinine should be repeated within two weeks. If the change in serum creatinine remains greater than or equal to 25% above baseline, Neoral should be reduced by 25%-50%. If at any time the serum creatinine increases by greater than or equal to 50% above pretreatment level, Neoral should be reduced by 25%-50%. Neoral should be discontinued if reversibility (within 25% of baseline) of serum creatinine is not achievable after two dosage modifications.

Overdosage

Hypertension, which is usually mild to moderate, may occur in approximately 50% of patients following renal transplantation and in most cardiac transplant patients. Glomerular capillary thrombosis has been found in patients treated with cyclosporine and may progress to graft failure. The pathologic changes resembled those seen in the hemolytic-uremic syndrome and included thrombosis of the renal microvasculature, with platelet-fibrin thrombi occluding glomerular capillaries and afferent arterioles, microangiopathic hemolytic anemia, thrombocytopenia, and decreased renal function. The principal adverse reactions associated with the use of cyclosporine in rheumatoid arthritis are renal dysfunction hypertension headache, gastrointestinal disturbances, and hirsutism/hypertrichosis.