Zinbryta™ (Daclizumab)

Overview:

Zinbryta™ (Daclizumab) is a prescription medication approved by the Food and Drug Administration (FDA) in 2016 for treating adults with relapsing forms of multiple sclerosis (MS). It is also known by its drug name, Daclizumab.  Daclizumab has been shown to reduce rates of relapse, reduce new brain lesions, and to slow the progression of disability in relapsing-remitting multiple sclerosis (RRMS). Daclizumab is not a cure for MS.

Daclizumab is a laboratory-created monoclonal antibody that targets a docking site (receptor) for a key immune signaling chemical called interleukin-2 (IL-2). IL-2 is required to activate the immune T cells that are involved in MS attacks. By blocking the receptor, daclizumab inhibits certain inflammatory functions of T cells. Daclizumab also increases important immune cells that help regulate the immune system. These cells are able to enter the brain and spinal cord and modulate MS inflammation.

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

Dosing:

Zinbryta is taken by self-injection under the skin every four weeks. Usually, these types of subcutaneous injection are done by the individual who is prescribed the medication, or a loved one, after being given training in the procedure.

The FDA recommends that health care professionals perform blood tests to monitor the individual’s liver function prior to starting Zinbryta, as well as monthly before each dose, and for up to six months after the last dose. Individuals taking Zinbryta will be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program to ensure that ongoing periodic monitoring will be maintained to detect potential problems.

Always follow your doctor’s instructions exactly when taking Zinbryta.

Efficacy Results:

In a study that lasted up to 3 years, 919 people with relapsing MS taking ZINBRYTA had fewer relapses compared to 922 people receiving AVONEX®(interferon beta-1a).

When compared with AVONEX, ZINBRYTA was shown to:

  • Decrease the number of relapses by 45%
  • Reduce the average number of new or newly enlarging T2 lesions (MRI lesions that show the long-term impact of inflammation on the brain) by 54%

In a 1-year clinical trial that studied 412 people with relapsing MS, 208 people were treated with ZINBRYTA and 204 took placebo.

When compared with placebo, ZINBRYTA was shown to:

  • Decrease the number of relapses by 54%
    • 81% of patients taking ZINBRYTA were relapse-free compared with 64% of people taking placebo
  • Reduce the average number of new or newly enlarging T2 lesions by 70%
  • Reduce the average number of new Gd-enhancing lesions (MRI lesions that show active inflammation) by 69%

Both trials showed that ZINBRYTA may help people with relapsing MS by reducing the frequency of relapses and reducing the development of brain lesions.

Side Effects:

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. These can be very serious and can cause death. Call your healthcare provider right away if you have any of the following symptoms while using ZINBRYTA: fever, rash, swelling of the face, tongue or throat or trouble breathing.
  • Infections. 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.
  • Depression and suicide. 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 or have any of the following symptoms while using ZINBRYTA:
  • The most common side effects of ZINBRYTA 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

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ZINBRYTA.

Safety Information:

ZINBRYTA can cause serious side effects, including:

  • Liver problems. 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. Your healthcare provider should check your test results before your next dose.Call your healthcare provider right away if you have any of the following symptoms of liver problems:
  • Immune system problems. 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.

    Call your healthcare provider right away if you have any of the following symptoms:

    • Skin reactions such as rash or skin irritation
    • Tender, painful, or swollen lymph nodes
    • Intestinal problems (colitis)
      • Symptoms can include fever, stomach pain, blood in your stools, or diarrhea that does not go away
    • Any new and unexplained symptoms affecting any part of your body

Because of the risk of serious liver problems (including autoimmune-related liver problems) and other immune system problems, ZINBRYTA is only available through a restricted program called the ZINBRYTA Risk Evaluation and Mitigation Strategy (REMS) Program.

Do not use ZINBRYTA if you:

  • 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

Before using ZINBRYTA, tell your healthcare provider if you:

  • Have or have had liver problems
  • Have or have had skin problems including eczema or psoriasis
  • Have tuberculosis
  • Have an active infection
  • Are planning to receive a vaccine
  • Have or have had depression
  • Are pregnant or plan to become pregnant. It is not known if ZINBRYTA will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if ZINBRYTA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ZINBRYTA

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using ZINBRYTA with other medicines can cause serious side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.


Biogen LogoBiogen is one of the world’s leading biotechnology companies, with a focus on developing therapies for neurodegenerative, hematologic and autoimmune disorders. Founded in 1978, our work in biologics and small-molecule drug discovery has led to the world’s most extensive portfolio of multiple sclerosis therapies and innovative new treatments for hemophilia patients. Our experience, capabilities, and passion for innovation have enabled us to build a pipeline and develop advanced research programs that include exploration of potential candidates for serious and difficult-to-treat neurodegenerative diseases and fibrotic and nonmalignant blood disorders.

We are committed to research that uncovers the underlying biology of complex diseases. Our focus is on illnesses with few, if any, treatment options. Biogen’s success will always be measured by the answer to a simple question: Have we truly made a difference in the lives of patients?

Website: www.biogen.com

Zinbryta Website: www.zinbryta.com


Zinbryta Patient Medication Guide:

zinbryta-medication-guide