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Daclizumab is an immunosuppressant. Immunosuppressants decrease the actions of the body's immune system. Daclizumab is used to prevent the body from rejecting a transplanted kidney. Daclizumab is usually used as part of a treatment regimen including other medications. Daclizumab may also be used for purposes other than those listed in this medication guide.
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. There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.
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.
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.
Contact your doctor if you miss a dose of daclizumab.
Seek emergency medical attention if an overdose is suspected. Symptoms of a daclizumab overdose are not known.
Daclizumab can lower the activity of the immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop any signs of illness or infection. Talk to your doctor before receiving any vaccines during treatment with daclizumab. Some vaccines may not be effective, or may be harmful, if received during treatment with daclizumab. In addition, avoiding close contact with people who have recently been vaccinated with a "live" vaccine (e.g. oral polio vaccine, nasal influenza vaccine) may be recommended. There is a chance that the virus can be passed on to you. Tell your doctor and dentist that you are using this medication before having surgery and before starting any other medicines.
There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination. Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication. If you experience a serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to daclizumab, seek emergency medical attention.Other, less serious side effects may also occur. Continue to use daclizumab and notify your doctor if you experience upset stomach, nausea, or vomiting; diarrhea or constipation; tremor or dizziness; headache; or swelling of the hands, feet or legs.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis: For the prophylaxis of acute organ rejection in patients receiving renal transplants: 1.0 mg/kg administered via a peripheral or central vein over a 15 minute period. The standard course of therapy includes 5 doses. The first dose should be given no more than 24 hours before transplantation. The four remaining doses should be given at intervals of 14 days. Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis: >= 1 year:
For the prophylaxis of acute organ rejection in patients receiving renal transplants: 1.0 mg/kg administered via a peripheral or central vein over a 15 minute period. The standard course of therapy includes 5 doses. The first dose should be given no more than 24 hours before transplantation. The four remaining doses should be given at intervals of 14 days.
Talk to your doctor before receiving any vaccines during treatment with daclizumab. Some vaccines may not be effective, or may be harmful, if received during treatment with daclizumab. In addition, avoiding close contact with people who have recently been vaccinated with a "live" vaccine (e.g. oral polio vaccine, nasal influenza vaccine) may be recommended. There is a chance that the virus can be passed on to you. Drugs other than those listed here may also interact with daclizumab. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
- Your pharmacist has additional information about daclizumab written for health professionals that you may read.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 4/12/2009 4:43:07 PM.;
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