Classifications: biologic response modifier; monoclonal antibody; immunosuppressant; interleukin-2 (il-2) receptor antagonist; Therapeutic:immunosuppressant; monoclonal antibody
Pregnancy Category: C
5 mg/mL injection
Immunosuppressant IgG-1 monoclonal antibody produced by recombinant DNA technology. Binds to interleukin-2 (IL-2) receptor
complex of lymphocytes.
Daclizumab inhibits IL-2mediated activation of lymphocytes which is the major pathway for cellular immune rejection
Prophylaxis of acute organ rejection in renal transplant.
Hypersensitivity to daclizumab; murine protein hypersensitivity, pregnancy (category C), lactation.
Moderate-to-severe renal impairment; allergies, asthma, or history of allergic responses to medications; fungal or herpes
infection, lymphoma, neoplastic disease, vaccination, varicella, viral infection.
Route & Dosage
Adult/Child (>11 mo): IV 1 mg/kg. Start first dose no more than 24 h prior to transplant; repeat q14d for 4 more doses
PREPARE: IV Infusion: Add calculated amount of drug (based on patient's body weight) to 50 mL of NS. Invert infusion bag to dissolve, but do not
shake. Discard if diluted solution is colored or has particulate matter.
ADMINISTER: IV Infusion: Infuse diluted drug over 15 min.
- Use diluted solution immediately or store at room temperature for 4 h or at 2°8° C (36°46°
F) for 24 h. Discard after 24 h.
- Store unopened vials at 2°8° C (36°46° F) and protect from light.
Adverse Effects (≥1%)Body as a Whole:
Edema (general and in extremities), pain, fever, fatigue
, shivering, generalized weakness, arthralgia
, myalgia, hypersensitivity
Tremor, headache, dizziness, insomnia
, anxiety, depression
Chest pain, hypertension, hypotension, tachycardia, thrombosis, bleeding. GI: Constipation
, nausea, diarrhea
, vomiting, abdominal pain, dyspepsia, abdominal distention, epigastric pain, flatulence,
, hemorrhoids. Urogenital:
Oliguria, dysuria, renal
tubular necrosis, hydronephrosis, urinary tract bleeding, renal
insufficiency. Respiratory: Dyspnea
edema, cough, atelectasis, congestion, pharyngitis, rhinitis, hypoxia
, rales, abnormal breath sounds,
pleural effusion. Skin:
Impaired wound healing, acne
, pruritus, hirsutism, rash, night sweats. Other: Diabetes
mellitus, dehydration, blurred vision.
InteractionsDrug: Mycophenolate, cyclosporine
may increase mortality.
120 d. Half-Life:
20 d (1138 d).
Assessment & Drug Effects
- Monitor carefully for and immediately report S&S of opportunistic infection or anaphylactoid reaction (see Appendix F).
Patient & Family Education
- Use effective contraception before beginning daclizumab therapy, during therapy, and for 4 mo after completion of therapy.
- Avoid vaccinations during daclizumab therapy.