DACLIZUMAB

Description: Daclizumab is an immunosuppressant that inhibits IL-2 receptor binding and blocks the activation of lymphocytes. The lymphocytes attack the grafted organ after organ transplantation.
Pharmacokinetics:
Excretion: Terminal elimination half-life: 11-38 days.

Uses

Indications:

This drug is used to avoid acute organ rejection in patients receiving renal transplants. It is used with cyclosporine and corticosteroids.

Contraindications:

Should not be given to patients with known allergic reaction to declizumab.

How to use Daclizumab:

Dosage: The recommended dose of daclizumab for adults and pediatric patients is 1.0 mg/kg.

Daclizumab is given in multiple doses, the first 1 hour before the transplant operation and 5 further doses given at two week intervals after the transplant.
The calculated dose of declizumab should be mixed with 50 mL of sterile 0.9% sodium chloride solution and administered via a peripheral or central vein over a 15-minute period.
Daclizumab should only administered by a healthcare worker.

Availability: This drug has been discontinued.

Warnings

Mortality: The use of daclizumab as part of an immunosuppressive regimen including cyclosporine, mycophenolate mofetil, and corticosteroids may be associated with an increase in mortality or death related to a higher incidence of severe infections. Concomitant use of anti-lymphocyte antibody therapy may also be a factor in some of the fatal infections.

Blood disorders and opportunistic infections: Patients on immunosuppressive therapy are at increased risk for developing lymphoproliferative disorders and opportunistic infections and should be monitored accordingly.

Anaphylaxis: Severe, acute (onset within 24 hours) hypersensitivity reactions including anaphylaxis have been observed both on initial exposure to daclizumab and following re-exposure. These reactions may include hypotension, bronchospasm, wheezing, laryngeal edema, pulmonary edema, cyanosis, hypoxia, respiratory arrest, cardiac arrhythmia, cardiac arrest, peripheral edema, loss of consciousness, fever, rash, urticaria, diaphoresis, pruritus, and/or injection site reactions. If a severe hypersensitivity reaction occurs, therapy with daclizumab should be permanently discontinued.

Side Effects

Common side effects:

Constipation,
Nausea or dizziness originating from the abdomen,
Diarrhea
Vomiting
abdominal pain
pyrosis or burning sensation in the chest
dyspepsia
abdominal distention
epigastric pain

Less common side effects are:

chest pain,
coughing,
diziness,
feve, and
rapid heart rate.
You may notice also that the skin is red, tender and oozing at incision
Shortness of breath,
swelling of the feet or lower legs,
trembling or shaking of the hands or feet,
vomiting or weakness

Hypersensitivity side effects including anaphylaxis have been reported both on initial exposure and following reexposure to daclizumab.

It is recommended that medications used in the treatment of severe hypersensitivity reactions be available for immediate use. If a severe hypersensitivity reaction occurs, therapy with daclizumab should be permanently discontinued.

Precautions

Precautions:

General: Re-administration of daclizumab after an initial course of therapy has not been studied in humans. The potential risks of such re-administration, specifically those associated with immunosuppression and/or the occurrence of anaphylaxis/anaphylactoid reactions, are not known.

Medical conditions: Before using daclizumab, tell your doctor or pharmacist if you have any medical conditions, especially if you are pregnant, planning to become pregnant, or are breast-feeding, if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement, if you have allergies to medicines, foods, or other substances, if you have diabetes or an infection.

Pregnancy Risk: Category C. Daclizumab should not be used in pregnant women unless the potential benefit justifies the potential risk to the fetus.

Breastfeeding: It is not known whether daclizumab is excreted in human milk.

Interactions:

Some medicines may interact with daclizumab. However, no specific interactions with daclizumab are known at this time.

Overdose & Brands

Overdose:

A dose of 1.5 mg/kg has been administered to bone marrow transplant recipients without any associated adverse events.

Daclizumab is contraindicated in patients with known hypersensitivity to daclizumab or to any components of this product.

Brands:

Also marketed as

Zenapax [ Roche ]