DrugindexOnline^{2nd edition}

Pronouncation: (da-KLIZ-uh-mab)
Class: Immunosuppressive

Trade Names:
Zenapax
- Injection 25 mg per 5 mL

Mechanism of Action

Pharmacology

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.

Pharmacokinetics

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.

Contraindications

Standard considerations.

Dosage and Administration

Adults 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.

General Advice

• 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.

Storage/Stability

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.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

The safety of daclizumab was determined in patients receiving concomitant cyclosporine and corticosteroids.

Cardiovascular

Hypertension, hypotension, aggravated hypertension, tachycardia (at least 5%).

CNS

Tremor, headache, dizziness, insomnia (at least 5%); depression, anxiety (2% to less than 5%).

Dermatologic

Impaired wound healing without infection, acne (at least 5%); pruritus, hirsutism, rash, night sweats, increased sweating, application site reaction (2% to less than 5%).

EENT

Pharyngitis, rhinitis, blurred vision (2% to less than 5%).

GI

Constipation, nausea, diarrhea, vomiting, abdominal pain, pyrosis, dyspepsia, abdominal distention, epigastric pain (at least 5%); flatulence, gastritis, hemorrhoids (2% to less than 5%).

Genitourinary

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%).

Hematologic-Lymphatic

Thrombosis, bleeding, lymphocele (at least 5%).

Metabolic-Nutritional

Edema of the extremities, edema (at least 5%); fluid overload, diabetes mellitus, dehydration (2% to less than 5%).

Musculoskeletal

Muscular pain, back pain (at least 5%); leg cramps, arthralgia, myalgia (2% to less than 5%).

Respiratory

Dyspnea, pulmonary edema, coughing (at least 5%); atelectasis, congestion, hypoxia, rales, abnormal breath sounds, pleural effusion (2% to less than 5%).

Miscellaneous

Posttraumatic pain, chest pain, fever, pain, fatigue (at least 5%); shivering, generalized weakness, prickly sensation (2% to less than 5%).

Precautions

Warnings 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 Monitor patient for signs and symptoms of bacterial, viral, or fungal infection.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 11 mo of age.

Elderly

Use with caution.

Hypersensitivity

Anaphylactic reactions can occur.

Immune system

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.

Patient Information

• 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.