Zenapax

Zenapax

[ze′nah-paks]

trademark for a preparation of daclizumab, an immunosuppressant used after kidney transplantation.

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daclizumab

Zenapax

Pharmacologic class: Immunomodulator, humanized immunoglobulin G₁ monoclonal antibody

Therapeutic class: Immunosuppressant

Pregnancy risk category C

FDA Boxed Warning

• Drug should be prescribed only by physician experienced in immunosuppressive therapy and managing organ transplant recipients, and given by trained personnel in facility with adequate diagnostic and treatment resources.
• Prescribing physician should have complete information needed for patient follow-up.

Action

Binds to alpha subunit of high-affinity interleuken-2 (IL-2) receptor complex, inhibiting IL-2 binding and blocking critical pathway in cellular immune response against allografts. Also impedes immunologic response to antigens.

Availability

Injection: 25 mg/5 ml

⊘Indications and dosages

➣ Prevention of acute organ rejection in kidney transplantation

Adults: 1 mg/kg by I.V. infusion, usually for five doses. Give first dose no more than 24 hours before transplantation; give remaining doses at 14-day intervals.

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• elderly patients
• pregnant or breastfeeding patients
• children.

Administration

• Know that drug is given as part of immunosuppressive combination therapy.
• Don't give by direct I.V. injection.
• Mix diluted dose with 50 ml of sterile normal saline solution.
• Deliver through peripheral or central vein over 15 minutes.
• Don't add or infuse other drugs through same I.V. line.
• Administer diluted drug within 4 hours of preparation if stored at room temperature or within 24 hours if refrigerated. Discard prepared solution after 24 hours.
• Protect undiluted solution from direct light.

Route	Onset	Peak	Duration
I.V.	Rapid	After 5th dose	120 days

Adverse reactions

CNS: headache, tremor, dizziness, prickly sensations, insomnia, fatigue, weakness, depression, anxiety

CV: tachycardia, chest pain, hypotension, hypertension, thrombosis

EENT: blurred vision, rhinitis, pharyngitis

GI: nausea, vomiting, constipation, diarrhea, abdominal pain, abdominal distention, flatulence, epigastric pain, heartburn, dyspepsia, gastritis, hemorrhoids

GU: kidney enlargement, urinary tract bleeding, dysuria, urinary retention, renal insufficiency, oliguria, renal tubular necrosis

Hematologic: bleeding

Metabolic: diabetes mellitus, dehydration, fluid overload

Musculoskeletal: myalgia; joint, back, or leg pain

Respiratory: dyspnea, cough, hypoxia, crackles, crepitus, rhonchi, congestion, abnormal or decreased breath sounds, hemoptysis, upper respiratory tract infection, atelectasis, pleural effusion

Skin: acne, wound infection, impaired wound healing

Other: lymphocele (cystic mass), pain, edema at injection site, peripheral edema, cellulitis, cytomegalovirus infection, shivering, fever

Interactions

None significant

Patient monitoring

☞ Monitor patient closely. Drug increases risk of infectious complications and secondary cancers.
• Monitor bone marrow function and CBC and platelet count frequently.
• Assess cardiovascular, respiratory, and renal function during infusion and periodically between infusions.
• Monitor blood glucose level, especially in patients receiving high-dose corticosteroids concurrently with daclizumab.

Patient teaching

• Explain that drug's purpose is to prevent transplant rejection.
☞ Instruct patient to immediately report difficulty breathing or swallowing, tightness in jaw or throat, chest pain, or pain at infusion site.
☞ Tell patient to promptly report changes in urinary pattern, unusual bleeding or bruising, rash, fever, and other adverse effects.
• Inform patient that drug increases risk of infection. Caution him to avoid crowds and exposure to illness.
• As appropriate, review all other significant and life-threatening adverse reactions.

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Zenapax®

Daclizumab, see there