Reports not available

Discontinuation-  Drug was withdrawn in about 8% of  patients during clinical trials 

Most common adverse reactions-

Cardiovascular -   tachycardia , theombosis  5%

CNS -  tremor, headache, dizziness, hypertension, hypotension, aggrevated hypertension 2%

Dermatologic-  impaired wound healing without infection, acne 5%
                           pruritus, hirsutism, rash, night sweats, increased sweating 2%

GI - constipation, nausea, diarrhea, vomiting, abdominal pain, pyrosis, dyspepsia,
      abdominal distention, epigastric pain not food related  5%
      flatulance, gastritis, hemorrhoids 2%
                      
GU-  oliguria, dysuria, tubular necrosis 5%
         renal damage, hydronephrosis, urinary tract bleeding, urnary tract disorder,

Hematologic   -   bleeding 5%

Hematologic /lymphatic-   lymphocele  5%

Musculoskeletal -  musculoskeletal pain, back pain  5%
                                arthalgia, myalgia,  2%

Metabolic/nutrional -   edema extremities, edema  5%
                                      fluid overload, diabetes melitus, dehydration 2%

Ophthalmic -  vision blurred 5%

Psychiatric - insomnia 5%

Respiratory -  dyspnea, pulmonary edema, coughing,  5%
                         congestion, pharyngitis, rhinitis, hypoxia, abnormal breath sounds,
                         pleural effusion  2%

Miscellaneous-   posttraumatic pain, chest pain, fever, pain, fatigue 5%
                            application reaction, shivering, generalised weakness 2%
 
 
         renal insufficiency 2%

hypersensitivity to the drug

Special precautions-

Mortality-  use of daclizumab as a part of imunosuppressive regimen including cyclosporine, mycophenolate mofetil, and corticosteroids may be associated with an in crease in mortality

Hypersensitivity reactions- severe acute ( onset within 24 hours ) hypersensitivity reactions, including anaphylaxis have been observed both on initial exposure to daclimab and following reexposure.

The reactions include, hypotension, bronchospasm, wheezing, laryngeal edema,
pulmonary edema,cyanosis

Patients previously administered daclizumab should only be reexposed to subsequent
course of therapy with caution.

Pregnancy-  Dacllizumab should be used in pregnant women unless the potential benefit
justifies the potential risk.

Lactation - Decison should be taken to discontinue nursing or discontinue the drug taking
in account  the importance of drug to the mother.

Children- Safety profile of daclizumab in pediatric transplant was shown to be comparable
to adults

Elderly- caution must be used in giving immunosppressive drugs to elderly patients

Indication-

Renal rejection prophylaxis
Acute organ rejection in patients receiving transplants

Dosage-

Recommended dose- 1mg/kg . The calculated volume of daclizumab should be mixed
with 50ml of sterile 0.9% sodium chloride solution and administered via a peripheral
or central vein over a 15 minute period

1. Patients previously administered daclizumab should only be reexposed to subsequent
course of therapy with caution.

2. Pregnancy-  Daclizumab should be used in pregnant women unless the potential benefit
    justifies the potential risk.

3. Lactation - Decison should be taken to discontinue nursing or discontinue the drug taking
    in account  the importance of drug to the mother.

Pregnancy- 

Dacllizumab should be used in pregnant women unless the potential benefit
justifies the potential risk.

Lactation -

Decison should be taken to discontinue nursing or discontinue the drug taking
in account  the importance of drug to the mother.

Children-

Safety profile of daclizumab in pediatric transplant was shown to be comparable
to adults

Elderly-

Caution must be used in giving immunosppressive drugs to elderly patients