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daclizumab

   Also found in: Wikipedia 0.02 sec.
daclizumab /da·cliz·u·mab/ (dah-kliz´u-mab) an immunosuppressant used to prevent acute organ rejection in renal transplant patients.
daclizumab,
an immunosuppressant.
indications It is used to help prevent acute allograft rejection in renal transplant patients.
contraindications Known hypersensitivity to this drug contraindicates its use.
adverse effects Life-threatening effects are pulmonary edema, tachycardia, thrombosis, renal tubular necrosis, and hydronephrosis. Other adverse effects include headache, prickly sensation, coughing, atelectasis, congestion, constipation, abdominal pain, pyrosis, hypertension, bleeding, oliguria, dysuria, renal damage, and impaired wound healing. Common side effects include chills, tremors, dyspnea, wheezing, vomiting, nausea, and diarrhea.

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.

RouteOnsetPeakDuration
I.V.RapidAfter 5th dose120 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.


daclizumab
Dacliximab, Zenapax® Transplant medicine A monoclonal antibody used with other agents to ↓ transplant-related GVHD and organ rejection in kidney and liver graft recipients, and Pts with treatment refractory psoriasis, uveitis, tropical spastic paraparesis and some leukemias. See Kidney transplant.


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These include sirolimus, tacrolimus, and daclizumab.
The agreement provides for shared development and commercialization of daclizumab in MS and indications other than transplant and respiratory diseases, and for shared development and commercialization of M200 (volociximab) and HuZAF(TM) (fontolizumab) in all indications.
Ten patients who failed to respond to daclizumab before starting ONTAK, achieved an overall response rate of 80% (1 complete, 7 partial).
 
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