Daclizumab

What is Daclizumab?

• Daclizumab (ZINBRYTA) is a humanized monoclonal antibody to CD25, the alpha subunit of the IL2 receptor on T lymphocytes used for the treatment of adults with relapsing forms of multiple sclerosis (MS).

What are the uses of this medicine?

• This medicine is used to treat adults with relapsing forms of multiple sclerosis (MS). Because of its risks, ZINBRYTA is generally used in people who have tried 2 or more MS medicines that have not worked well enough.

How does this medicine work?

• Daclizumab (da kliz’ ue mab) is a humanized monoclonal immunoglobulin G1 antibody to the alpha subunit of the IL2 receptor (CD25).
• The IL2 receptor is found on T cells and its engagement results in activation and proliferation of T cells and generation of proinflammatory cytokines.
• Inhibition of the receptor by antibody results in prevention of activation and inhibition of T cell responses.
• Daclizumab has been shown to be effective in reducing in incidence of acute rejection after renal, liver, heart and lung transplantation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have liver problems
• have or have had autoimmune-related liver problems including autoimmune hepatitis
• are allergic to daclizumab or any of the other ingredients in ZINBRYTA. See the end of this Medication Guide for a complete list of ingredients in ZINBRYTA.

What drug interactions can this medicine cause?

• No formal clinical drug interaction studies have been performed with ZINBRYTA.

Is this medicine FDA approved?

• It was approved for use in the United States in 2016.

How should this medicine be used?

Recommended Dosage:

• The recommended dose is 150 mg subcutaneously once monthly.

Administration

• Use ZINBRYTA exactly as your healthcare provider tells you. A healthcare provider should show you how to inject ZINBRYTA before you use it for the first time.
• Inject ZINBRYTA 1 time every month. Try to keep to a particular day of the month to help remember your injection. For example, inject on the first day of each month.
• ZINBRYTA is for use under the skin (subcutaneous injection) of your thigh, stomach (abdomen), or back of the upper arm.
• If you miss a dose of ZINBRYTA, inject your dose of ZINBRYTA as soon as possible within 2 weeks of the missed dose. If it is more than 2 weeks after your missed dose, skip the missed dose. Inject your next dose on schedule. Do not inject more than 1 dose of ZINBRYTA at a time.
• Your healthcare provider should do blood tests before you start ZINBRYTA, every month during your treatment with ZINBRYTA, and monthly for 6 months after you have stopped using ZINBRYTA to check for side effects. Your healthcare provider should check your test results before your next dose.
• ZINBRYTA comes as a:
• Single-Dose Prefilled Autoinjector (ZINBRYTA Pen)
• Single-Dose Prefilled Syringe

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• Single-Dose Prefilled Autoinjector
• Single-Dose Prefilled Syringe

This medicine is available in fallowing brand namesː

• ZINBRYTA

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory tract infection
• flu
• pain or swelling in your nose, throat, or mouth
• bronchitis
• abnormal liver function tests
• dry, itchy, scaly, or inflamed skin (eczema)
• rash
• depression and depressed mood
• swollen lymph glands

ZINBRYTA can cause serious side effects, including:

• Allergic reactions or serious problems that may affect different parts of the body such as your liver, kidneys, heart or blood
• Infections
• Depression and suicide

What special precautions should I follow?

• ZINBRYTA may cause serious liver problems (including autoimmune-related liver problems) that may lead to death. Your healthcare provider should do blood tests to check your liver before you start using ZINBRYTA, every month while you are using ZINBRYTA, and monthly for 6 months after you stop using ZINBRYTA.
• Before you begin using ZINBRYTA, you must enroll in the ZINBRYTA REMS Program.
• Some people using ZINBRYTA develop immune-mediated disorders (a condition where the body's immune system attacks healthy cells in their body) and other immune system problems.
• Some people who use ZINBRYTA may get an infection, such as an upper respiratory tract infection or a urinary tract infection. Some infections may be serious. Call your healthcare provider if you have symptoms of an infection. Talk to your healthcare provider before you get vaccinations while using ZINBRYTA.
• Some people who use ZINBRYTA may develop depression, depressed mood, or suicidal thoughts. Call your healthcare provider right away if you have ever been treated for depression.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if ZINBRYTA will harm your unborn baby.

Can this medicine be used in children?

• It is not known if ZINBRYTA is safe and effective for use in children under 18 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredient: daclizumab Inactive ingredients: Single-Dose Prefilled Autoinjector: sodium succinate, anhydrous; succinic acid; sodium chloride; polysorbate 80 and water for injection. Single-Dose Prefilled Syringe: sodium succinate, anhydrous; succinic acid; sodium chloride; polysorbate 80 and water for injection.

Who manufactures and distributes this medicine?

• Manufactured by: Biogen Inc., Cambridge, MA 02142; Distributed by: AbbVie Inc., North Chicago

ZINBRYTA is a registered trademark of Biogen.

What should I know about storage and disposal of this medication?

• Store ZINBRYTA in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton.
• Do not freeze ZINBRYTA. Do not use ZINBRYTA that has been frozen.
• Do not store ZINBRYTA at temperatures above 86°F (30°C).
• Keep ZINBRYTA away from light.
• If you cannot refrigerate ZINBRYTA, you can store ZINBRYTA at room temperature for up to 30 days.
• If ZINBRYTA has reached room temperature, do not put it back in the refrigerator. Throw away ZINBRYTA that has been outside of the refrigerator for more than 30 days.
• Keep ZINBRYTA and all medicines out of the reach of children.

• Dailymed label info on Daclizumab
• FDA Daclizumab

Daclizumab Resources
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