What is daclizumab, and how does it work?

• Daclizumab (Zinbryta) is an injectable medication used for treating multiple sclerosis (MS). Its mechanism of action is not completely understood. Available data suggests that it may work by modifying immune processes that may be responsible for causing MS by interfering with the activation of lymphocytes (a type of white blood cell) that cause inflammation and destruction of nerves in patients with MS. Daclizumab does not cure MS. It decreases the number of MS flares and lesions.
• The FDA approved daclizumab in May, 2016.

What brand names are available for daclizumab?

• Zinbryta is the brand name for daclizumab available in the US.

Is daclizumab available as a generic drug?

• No, this drug is not available as a generic.

Do I need a prescription for daclizumab?

• Yes, you need a prescription for this drug.

What are the uses for daclizumab?

• Daclizumab is used for the treatment of adult patients with relapsing forms of multiple sclerosis (MS).
• It is reserved for patients who have had an inadequate response to two or more MS drugs because of its safety profile.

Why is there a black box warning for daclizumab?

• Daclizumab can cause severe liver injury including life-threatening events, liver failure, and autoimmune hepatitis. Transaminase and bilirubin levels should be obtained before starting daclizumab, monthly during treatment, and up to 6 months after the last dose.
• It should not be used in patients with liver problems.
• This drug can cause immune-mediated disorders including skin reactions, lymphadenopathy (enlargement of lymph nodes), non-infectious colitis, and other immune-mediated disorders. These conditions may require treatment with oral or injectable corticosteroids or medication to suppress the immune system.
• Daclizumab is available only through a restricted distribution program called the ZINBRYTA REMS Program.

What are the side effects of daclizumab?

Common side effects include:

• Cold symptoms
• Upper respiratory tract infection
• Rash
• Flu
• Dermatitis
• Throat pain
• Bronchitis
• Eczema
• Depression
• Sore throat
• Increased alanine aminotransferase (ALT)

Other side effects include:

• Tonsillitis
• Acne
• Anemia
• Fever

Other less common side effects include:

• Increased levels of liver enzymes
• Diarrhea
• Dry skin
• Skin redness (erythema)
• Folliculitis
• Psoriasis
• Skin exfoliation
• Toxic skin eruption
• Viral infection

Possible serious side effects include:

• Liver damage
• Immune mediated disorders (for example, skin reactions, colitis)
• Serious allergic reactions (anaphylaxis, angioedema)
• Severe infections
• Depression
• Suicidal thoughts, Suicide
• Decreased numbers of white blood cells
• Severe skin reactions
• Non-infectious colitis

What is the dosage for daclizumab?

• The recommended dose is 150 mg injected under the skin once monthly.

Which drugs or supplements interact with daclizumab?

• Combining daclizumab with prescription drugs, non-prescription drugs, herbal products, or dietary supplements that affect the liver may increase the risk of liver damage. Such combinations should be avoided when possible or used cautiously.

Is daclizumab safe to use during pregnancy or while breastfeeding?

• This drug has not been adequately evaluated in pregnant women.
• There is no information about the secretion of  this drug in human milk.

What else should I know about daclizumab?

What preparations of daclizumab are available?

• Injection: 150 mg/mL solution in a single-dose prefilled syringe

How should I keep daclizumab stored?

• Daclizumab should be stored in a refrigerator between 2 C to 8 C (36 F to 46 F) and in the original carton to protect it from light.
• It should not be frozen or exposed to temperatures above 30 C (86 F). It should be discarded if frozen.
• When refrigeration is unavailable, this drug may be stored for 30 days at 30 C (86 F) protected from light. It should not be refrigerated after it is warmed to room temperature. It should be discarded after 30 days if it is not refrigerated.