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NEORAL (CYCLOSPORINE) CAPSULES AND ORAL SOLUTION: SIDE EFFECTS / ADVERSE REACTIONS FOR PSORIASIS

The principal adverse reactions associated with the use of cyclosporine in patients with psoriasis are headache, renal dysfunction, hypertension, hirsutism/hypertrichosis, hypertriglyceridemia, paresthesia or hyperesthesia, nausea, vomiting, influenza-like symptoms, diarrhea, lethargy, abdominal discomfort, musculoskeletal or joint pain.

In psoriasis patients treated in US controlled clinical studies within the recommended dose range, Neoral (Cyclosporine) capsules and oral solution therapy was discontinued in 1.0% of the patients because of hypertension and in 5.4% of the patients because of increased creatinine. In the majority of cases, these changes were reversible after dose reduction or discontinuation of cyclosporine.

There has been one reported death associated with the use of cyclosporine in psoriasis. A 27-year-old male developed renal deterioration and was continued on cyclosporine. He had progressive renal failure leading to death.

Frequency and severity of serum creatinine increases with dose and duration of Cyclosporine (Neoral) capsules and oral solution therapy. These elevations are likely to become more pronounced and may result in irreversible renal damage without dose reduction or discontinuation.

Infection or Potential Infection: influenza-like symptoms, upper respiratory tract infections

Cardiovascular System: hypertension, urinary system, increased creatinine

Central and Peripheral Nervous System: headache, paresthesia, musculoskeletal system, arthralgia

Body As a Whole / General: pain

Skin and Appendages: hypertrichosis

Respiratory System: bronchospasm, coughing, dyspnea, rhinitis

Gastrointestinal System: abdominal pain, diarrhea, dyspepsia, gum hyperplasia, nausea

The following events occurred in 1% to less than 3% of psoriasis patients treated with Neoral (Cyclosporine) solution and capsules:

Body as a Whole: flushes, hot flushes, fever

Cardiovascular: chest pain

Central and Peripheral Nervous System: insomnia, appetite increased, dizziness, vertigo, nervousness

Gastrointestinal: constipation, abdominal distention, gingival bleeding

Liver and Biliary System: hyperbilirubinemia

Neoplasms: skin malignancies

Reticuloendothelial: platelet, bleeding and related disorders, red blood cell disorder

Respiratory: infection, viral and other infection

Skin and Appendages: folliculitis, acne, keratosis, rash, pruritus, dry skin

Urinary System: micturition frequency

Vision: abnormal vision

Mild hypomagnesemia and hyperkalemia may occur but are asymptomatic. Increases in uric acid may occur and attacks of gout have been rarely reported. A minor and dose related hyperbilirubinemia has been observed in the absence of hepatocellular damage. Cyclosporine therapy may be associated with a modest increase of serum triglycerides or cholesterol. Elevations of triglycerides ( > 750 mg/dL) occur in about 15% of psoriasis patients; elevations of cholesterol ( > 300 mg/dL) are observed in less than 3% of psoriasis patients. Generally these laboratory abnormalities are reversible upon dose reduction or discontinuation of Cyclosporine (Neoral) solution and capsules.

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