FDA approves Zinbryta
The U.S. Food and Drug Administration (FDA) has approved Zinbryta (daclizumab), a once-monthly, self-administered, subcutaneous interleukin-2 receptor blocking antibody indicated for the treatment for relapsing forms of multiple sclerosis (RMS).
Important 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 treatment, every month during treatment, and monthly for 6 months after you stop treatment. 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:
nausea or vomiting
stomach pain
unusual tiredness
not wanting to eat
yellowing of the skin or whites of your eyes
dark urine
Immune system problems. Some people using this medicine develop immune-mediated disorders (a condition where the bodys 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 (REMS) Program.
Before you start treatment, you must enroll in the Zinbryta REMS Program. Talk to your healthcare provider about how to enroll.
Zinbryta can only be given at a certified pharmacy that participates in the Zinbryta REMS Program. Your healthcare provider can give you information on how to find a certified pharmacy.
Zinbryta is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). Because of the associated risks, it is generally used in people who have tried two 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.
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 listed at the end of this Medication Guide.
Before you start treatment, 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 this medicine will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.
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.
Zinbryta 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 during treatment:
fever
rash
swelling of the face, tongue or throat
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 any vaccinations.
Depression and suicide. Some people who use this medicine 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 during treatment:
feel sad or have crying spells
are sleeping a lot more or a lot less than usual
feel hopeless or helpless
are more irritable, angry or aggressive than usual
have trouble paying attention
feel tired or sleepy all the time
have thoughts about hurting yourself or ending your life
The most common side effects 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. Call your doctor for medical advice about side effects.
What are the ingredients in Zinbryta?
Active ingredient: daclizumab
Inactive ingredients: sodium succinate, anhydrous; succinic acid; sodium chloride; polysorbate 80 and water for injection.
Source: drugs.com
