Zinbryta is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Zinbryta is used to treat relapsing forms of multiple sclerosis.

Zinbryta is usually given when other medicines have not been effective.

Zinbryta is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of taking this medicine.

You should not use Zinbryta if you have liver disease or if you have ever had autoimmune hepatitis.

Zinbryta can cause serious or fatal liver problems. Call your doctor right away if you have symptoms such as nausea, vomiting, upper stomach pain, tiredness, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

You will need frequent blood tests to check your liver function during treatment and after you stop using this medicine. Future doses may be delayed based on the results of these tests.

Zinbryta may also increase your risk of certain infections or immune system problems. Call your doctor if you have a skin rash, fever, swollen glands, diarrhea, stomach pain, blood in your stools, or any other new or unusual symptoms.

Use Zinbryta exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Zinbryta is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Zinbryta is usually injected once a month. Follow your doctor's dosing instructions very carefully.

This medicine comes with a Medication Guide and a Patient Wallet Card that lists the symptoms of liver or immune system problems. Read this information carefully and carry the Wallet Card with you at all times so you will know what symptoms to watch for.

This medicine can cause serious or fatal liver problems. You will need blood tests to check your liver function every month while you are using Zinbryta. Your next dose may be delayed based on the results of these tests.

You will also need frequent liver function tests for 6 months after you stop using this medicine.

Store in the original carton in a refrigerator. Protect from heat and light. Do not freeze Zinbryta, and do not use the medicine if it does freeze.

Before injecting your dose, take one vial out of the refrigerator and allow it to reach room temperature for 30 minutes. Do not heat the medicine in a microwave or with hot water. Do not put the vial back into the refrigerator after leaving it at room temperature.

Do not use Zinbryta if it looks cloudy or has particles in it. Call your pharmacist for new medication.

Zinbryta may be stored in the original carton at room temperature for up to 30 days. Once the medicine has reached room temperature, you should not put it back into the refrigerator.

Each single-use prefilled syringe or injection pen is for one use only. Throw away after one use, even if there is still some medicine left inside.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

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

You should not use Zinbryta if you are allergic to daclizumab, or if you have ever had:

• liver disease; or

• a history of autoimmune hepatitis.

To make sure Zinbryta is safe for you, tell your doctor if you have:

• an active infection, including tuberculosis;

• liver problems, including hepatitis B or C;

• skin problems such as eczema or psoriasis;

• depression; or

• if you are scheduled to receive any vaccines.

It is not known whether Zinbryta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether daclizumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding a baby.

Zinbryta is not approved for use by anyone younger than 18 years old.

Use the missed dose as soon as you remember. If you are more than 2 weeks late, skip the missed dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Zinbryta and for at least 4 months after your last dose. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Get emergency medical help if you have signs of an allergic reaction to Zinbryta: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• pale or yellowed skin, confusion or weakness;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);

• pain or burning when you urinate;

• shortness of breath;

• liver problems - loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• any type of infection - sudden weakness or ill feeling, fever, chills, swollen glands, mouth sores, trouble swallowing, cold or flu symptoms; or

• symptoms of depression - sadness, crying spells, drowsiness, trouble concentrating, anger, aggression, feeling hopeless or irritable, or having thoughts about suicide or hurting yourself.

Your treatment may be delayed if you have certain side effects.

Common Zinbryta side effects may include:

• cold symptoms (stuffy nose, sinus pain, sore throat);

• flu symptoms (fever, body aches, sore throat, swollen glands);

• cough, chest tightness;

• mouth pain;

• depressed mood;

• rash or itching;

• dry flaky skin; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Daclizumab can harm your liver. This effect is increased when you also use certain other medicines, including: antibiotics, tuberculosis medicine, antifungal medicine, birth control pills or hormone replacement therapy, certain antidepressants, heart or blood pressure medication, a "statin" cholesterol medication, seizure medicine, and some pain or arthritis medicines (including acetaminophen, Tylenol, Advil, Motrin, and Aleve).

Many drugs can interact with daclizumab. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.