Zenapax

Zenapax should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. The recommended dose for Zenapax in adult and paediatric patients is 1 mg/kg. 9% saline solution and is administered intravenously over a 15 minute period.

It may be given via a peripheral or central vein. Zenapax should initially be given within 24 hours before transplantation. The next and each subsequent dose should be given at intervals of fourteen days, for a total of five doses. Elderly Experience with Zenapax in elderly patients (older than 65 years) is limited because of the small number of older patients who undergo renal transplantation, but there is no evidence that elderly patients require a different dosage from younger patients.

Patients with severe renal impairment No dosage adjustment is necessary for patients with severe renal impairment. Patients with severe hepatic impairment Medicinal product no longer authorised3 No data are available for patients with severe hepatic impairment.

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The safety profile of Zenapax was studied in comparison to placebo in patients who concomitantly received immunosuppressive regimens containing cyclosporine and corticosteroids alone, with the addition of azathioprine or with the addition of mycophenolate mofetil.

The data from the four studies (O14392, O14393, O14874 and O15301) showed that the incidence and types of adverse events were similar in both placebo-treated and Zenapax-treated patients. Adverse events were reported by 95% of placebo and 96% of daclizumab treated patients.

9% of the patients in the Zenapax-treated group. Adverse events occurring with a frequency of ≥2% in patients in either group during the first 3 months post-transplant are listed below. Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 8 Very common Hypertension(incl. 9 Very common Dyspepsia (incl. 4% in the Zenapax group. 7% in the Zenapax-treated group.

Hyperglycaemia:

No differences in abnormal haematologic or chemical laboratory test results were seen between placebo-treated and Zenapax-treated groups with the exception of fasting blood glucose. Fasting blood glucose was measured in a small number of placebo- and Zenapax-treated patients.

A total of 16% (10 of 64 patients) of placebo-treated and 32% (28 of 88 patients) of Zenapax-treated patients had high fasting blood glucose values. Most of these high values occurred either on the first day post-transplant when patients received high doses of corticosteroids or in patients with diabetes.

There is no experience of the use of Zenapax in patients who are highly immunised. Anaphylactic reactions following the administration of proteins can occur. Severe, acute (onset within 24 hours) hypersensitivity reactions on both initial and subsequent exposure to Zenapax have been reported rarely.

The clinical manifestations of these reactions include hypotension, tachycardia, hypoxia, dyspnoea, wheezing, laryngeal oedema, pulmonary oedema, flushing, diaphoresis, temperature increase, rash and pruritus. Medications for the treatment of severe hypersensitivity reactions should therefore be available for immediate use.

Patients on immunosuppressive therapy following transplantation are at increased risk for developing lymphoproliferative disorders (LPDs) and opportunistic infections. While Zenapax is an immunosuppressive drug, to date no increase in LPDs or opportunistic infections have been observed in patients treated with Zenapax.

In transplant recipients there is no experience of exposure to second or subsequent treatment courses using Zenapax. 5 g bid), cyclosporine, and corticosteroids, there were more infection related deaths among patients who received Zenapax.

8%). Of these 14 Zenapax patients, 4 died more than 90 days after receiving their last dose of Zenapax, making it unlikely that Zenapax had a role in the infection related death. 9%, respectively. 4%) died. Concomitant use of Zenapax with another antilymphocyte antibody therapy in the context of intensive immunosuppression with cyclosporine, mycophenolate mofetil and corticosteroids may be a factor leading to fatal infection.

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