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daclizumab (cont.)

What should I discuss with my healthcare provider before using daclizumab (Zenapax)?

Because it may cause serious side effects, daclizumab should only be prescribed by a doctor experienced in immunosuppressive therapy and the management of organ transplant patients. Discuss the risks and benefits of using this medication with your doctor.

Before using daclizumab, tell your doctor if you

  • have used daclizumab in the past;
  • have had a previous allergic reaction to daclizumab;
  • have any active or chronic viral, bacterial, or fungal infection; or
  • have a suppressed immune system or take medications that may suppress the immune system (e.g., medicines to prevent rejection of a transplanted organ, some cancer medicines, others).

You may not be able to use daclizumab, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Daclizumab is in the FDA pregnancy category C. This means that it is not known whether daclizumab will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. For women who could become pregnant, contraception is recommended before starting, during, and for four months following treatment with daclizumab to ensure protection from pregnancy.

It is not known whether daclizumab passes into breast milk. Do not use daclizumab without first talking to your doctor if you are breast-feeding a baby.

How should I use daclizumab (Zenapax)?

Daclizumab is administered as an intravenous (into the vein) injection. In most cases, your healthcare provider will administer daclizumab in a hospital or clinic setting. If you are using daclizumab at home, your healthcare provider will give you detailed instructions regarding preparation, administration, and storage of the medication.

The first dose of daclizumab is usually administered within 24 hours of the kidney transplant. Four additional doses are then given at 14 day intervals following transplantation.

When mixing the solution for injection, the bag should be gently inverted to ensure mixing. Do not shake the mixture.

After mixing the solution for injection, it should be used within 4 hours. If the mixture cannot be used within 4 hours, it should be refrigerated between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius) for up to 24 hours. If it is not used within 24 hours, it must be discarded.

Do not use any solution that is discolored or that has particles in it.

Your doctor may want you to have blood tests or other medical evaluations during treatment with daclizumab to monitor progress and side effects.

Your healthcare provider will store daclizumab as directed by the manufacturer. If you are using daclizumab at home, your healthcare provider will give you detailed storage instructions.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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