Daclizumab Dosage

Applies to the following strengths: 5 mg/mL; 150 mg/mL

Usual Adult Dose for:

Multiple Sclerosis

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Multiple Sclerosis

17 years and older:
150 mcg subcutaneously once a month

Comments:

Sites for injection are the thigh, abdomen, and back of the upper arm.
If a dose is missed within 2 weeks of the scheduled dose, it should be given immediately and the original monthly dosing schedule should be resumed.
If a dose is missed and it is more than 2 weeks from the scheduled dose, the missed dose should be skipped and the original monthly dosing schedule should be resumed.
Only one dose should be administered at one time.

Use: For the treatment of adult patients with relapsing forms of multiple sclerosis (MS) who have had an inadequate response to 2 or more drugs

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Preexisting hepatic impairment (including ALT or AST at least 2 times the ULN): Contraindicated
A history of autoimmune hepatitis or other autoimmune condition involving the liver: Contraindicated
Clinical trials did not include patients with ALT or AST more than 2 times the ULN.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for daclizumab. It includes a communication plan, elements to assure safe use, and an implementation system. For additional informationhttp://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS:
WARNING: HEPATIC INJURY INCLUDING AUTOIMMUNE HEPATITIS AND OTHER IMMUNE-MEDIATED DISORDERS:

This drug can cause severe liver injury including life-threatening events, liver failure, and autoimmune hepatitis. This can occur at any time during treatment and has been reported up to 4 months after the last dose. Therapy is contraindicated in patients with preexisting hepatic disease or impairment. Prior to starting therapy, obtain serum transaminases (ALT and AST) and bilirubin levels. Test transaminase levels and total bilirubin monthly during therapy and for 6 months after the last dose. In case of elevation in transaminases or total bilirubin, therapy interruption or discontinuation may be necessary.
Other Immune-Mediated Disorders: Skin reactions, lymphadenopathy, and non-infectious colitis have occurred in 5% of patients taking this drug. If a patient develops a serious immune-mediated disorder, consider discontinuing therapy and referring the patient to a specialist.
Some patients may require systemic corticosteroids or other immunosuppressant treatment for autoimmune hepatitis or other immune-mediated disorders.

Safety and efficacy have not been established in patients younger than 17 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Treatment should be initiated by a physician experienced in the management of multiple sclerosis.
This drug is for subcutaneous use only.
Patients should be instructed in the proper technique for self-administering this drug.
Sites for injection include the thigh, abdomen, and back of the upper arm.

Storage requirements:

The prefilled syringe should be stored in a refrigerator between 2C to 8C in the original carton to protect from light.
Do not freeze or expose to temperatures above 30C.
Discard the syringe if it becomes frozen.

Reconstitution/preparation techniques:

Remove the prefilled syringe from the refrigerator 30 minutes prior to injection to allow the drug to warm to room temperature; do not use external heat sources such as hot water to warm.
Do not place the syringe back into the refrigerator after allowing it to warm to room temperature.

General: