- Injection 25 mg per 5 mL
Binds with high-affinity to the Tac subunit of the high-affinity interleukin-2 (IL-2) complex and inhibits IL-2 binding, thereby impairing the response of the immune system to antigenic challenges.
At recommended doses, the Tac subunit of the IL-2 receptor is saturated for about 90 and 120 days posttransplant in children and adult patients, respectively.
Indications and Usage
Prophylaxis of acute organ rejection in patients receiving renal transplants.
Dosage and AdministrationAdults and Children 11 mo of age and older
IV 1 mg/kg for 5 doses as part of an immunosuppressive regimen that contains cyclosporine and corticosteroids. Give the first dose no more than 24 h before transplantation and the remaining 4 doses at intervals of 14 days.
- Concentrate must be diluted before administering to patient.
- For IV infusion only.
- Add prescribed amount of concentrate to 50 mL sterile sodium chloride 0.9% injection. Mix by gently inverting IV bag to avoid foaming. Do not shake.
- Discard any remaining concentrate in vial. Do not save unused concentrate for later use.
- Administer prescribed dose by IV infusion over 15 minutes. Dose is usually repeated every 14 days for total of 5 doses.
- Do not mix with other IV substances or additives or infuse simultaneously through the same IV line. If the same IV line is used for sequential infusion of different medications, flush line with saline solution.
Administer infusion solution within 4 h of preparation or within 24 h if stored in refrigerator. Store unopened vials in refrigerator (36° to 46°F). Do not freeze or shake. Protect from direct light. Diluted infusion solution is stable for 4 h at room temperature or for 24 h if refrigerated.
None well documented.
Laboratory Test Interactions
None well documented.
The safety of daclizumab was determined in patients receiving concomitant cyclosporine and corticosteroids.
Hypertension, hypotension, aggravated hypertension, tachycardia (at least 5%).
Tremor, headache, dizziness, insomnia (at least 5%); depression, anxiety (2% to less than 5%).
Impaired wound healing without infection, acne (at least 5%); pruritus, hirsutism, rash, night sweats, increased sweating, application site reaction (2% to less than 5%).
Pharyngitis, rhinitis, blurred vision (2% to less than 5%).
Constipation, nausea, diarrhea, vomiting, abdominal pain, pyrosis, dyspepsia, abdominal distention, epigastric pain (at least 5%); flatulence, gastritis, hemorrhoids (2% to less than 5%).
Oliguria, dysuria, renal tubular necrosis (at least 5%); renal damage, hydronephrosis, urinary tract bleeding, urinary tract disorder, renal function impairment, urinary retention (2% to less than 5%).
Thrombosis, bleeding, lymphocele (at least 5%).
Edema of the extremities, edema (at least 5%); fluid overload, diabetes mellitus, dehydration (2% to less than 5%).
Muscular pain, back pain (at least 5%); leg cramps, arthralgia, myalgia (2% to less than 5%).
Dyspnea, pulmonary edema, coughing (at least 5%); atelectasis, congestion, hypoxia, rales, abnormal breath sounds, pleural effusion (2% to less than 5%).
Posttraumatic pain, chest pain, fever, pain, fatigue (at least 5%); shivering, generalized weakness, prickly sensation (2% to less than 5%).
Only physicians experienced with immunosuppressive therapy and management of organ transplant patients should prescribe daclizumab. Daclizumab should be given by health care personnel trained in the administration of the drug and who have available laboratory and supportive medical resources.
Monitor patient for signs and symptoms of bacterial, viral, or fungal infection.
Category C .
Safety and efficacy not established in children younger than 11 mo of age.
Use with caution.
Anaphylactic reactions can occur.
It is not known if there will be a long-term effect on the ability of the immune system to respond to antigens first encountered during daclizumab-induced immunosuppression.
- Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting with close monitoring.
- Review dosing schedule with patient, family, or caregiver.
- Advise patient, family, or caregiver that medication will be used in combination with other agents, including cyclosporine and corticosteroids, to achieve max benefit possible.
- Instruct patient to continue to take other medications prescribed for preventing organ transplant rejection.
- Instruct patient to seek medical attention if any of the following occur: skin rash; hives; rapid heart beat; difficulty breathing; unexplained shortness of breath; fever, chills, or other signs of infection.
- Advise patient to notify health care provider if bothersome adverse reactions occur.
- Caution patient that medication may cause dizziness or blurred vision and to use caution when driving or performing other tasks that require mental alertness, coordination, or physical dexterity until tolerance is determined.
- Caution women of childbearing potential to use effective contraception before starting therapy, during therapy, and for 4 mo following completion of treatment with daclizumab.
Copyright © 2009 Wolters Kluwer Health.