daclizumab (Zinbryta)

Brand Names: Zinbryta

Generic Name: daclizumab

What is daclizumab (Zinbryta)?

Daclizumab 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.

Daclizumab is used to treat relapsing forms of multiple sclerosis. Daclizumab is usually given when other medicines have not been effective.

Daclizumab 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.

Daclizumab may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of daclizumab (Zinbryta)?

Get emergency medical help if you have signs of an allergic reaction (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 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.

What is the most important information I should know about daclizumab (Zinbryta)?

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

This medicine 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.

Daclizumab 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.

What should I discuss with my healthcare provider before using daclizumab (Zinbryta)?

You should not use daclizumab if you are allergic to it, or if you have:

To make sure daclizumab is safe for you, tell your doctor if you have ever had:

It is not known whether this medicine 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.

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

How should I use daclizumab (Zinbryta)?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Daclizumab 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.

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

Daclizumab 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 daclizumab. 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 daclizumab in the original carton in a refrigerator. Protect from heat and light. Do not freeze daclizumab, 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 daclizumab if it looks cloudy or has particles in it. Call your pharmacist for new medication.

Daclizumab 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.

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.


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What happens if I miss a dose (Zinbryta)?

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.

What happens if I overdose (Zinbryta)?

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

What should I avoid while using daclizumab (Zinbryta)?

Do not receive a "live" vaccine while using daclizumab 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.

What other drugs will affect daclizumab (Zinbryta)?

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.

Where can I get more information (Zinbryta)?

Your doctor or pharmacist can provide more information about daclizumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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