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Daclizumab injection is no longer available. If you are currently using daclizumab, you should call your doctor to discuss switching to another treatment.
Daclizumab may cause serious or life-threatening liver damage. The risk of liver damage may be increased in people taking other medications known to cause liver damage, and in people who already have liver disease. Tell your doctor if you have or ever had liver problems or hepatitis. Your doctor may tell you not to use daclizumab injection. Tell your doctor and pharmacist about all the medications you are taking so they can check whether any of your medications may increase the risk that you will develop liver damage during your treatment with daclizumab. Your doctor will monitor you for signs of liver problems during and for 6 months after your treatment with daclizumab. If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, extreme tiredness, unusual bleeding or bruising, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, dark-colored urine, or flu-like symptoms.
Daclizumab may cause serious immune system disorders (conditions that occur when the immune system attacks healthy cells in the body). Tell your doctor if you have or have ever had skin problems, including eczema or psoriasis. If you experience any of the following symptoms, call your doctor immediately: redness, itching, or scaling of the skin; swollen glands in the neck, armpits, or groin; diarrhea; bloody stools; stomach pain; or any new, unexplained symptom affecting any part of your body.
Because of the risks with this medication, daclizumab injection is available only through a special restricted distribution program. A program has been set up by the manufacturer of daclizumab to be sure that people do not use daclizumab injection without the necessary monitoring called the Zinbryta Risk Evaluation and Mitigation Strategies (REMS) Program. Your doctor and your pharmacist must be registered with the Zinbryta REMS program. Ask your doctor for more information about this program and how you will receive your medication.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before, during, and for 6 months after your final dose to check your body's response to daclizumab injection.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with daclizumab injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.
Talk to your doctor about the risk(s) of receiving daclizumab injection.
WHY is this medicine prescribed?
Daclizumab is used to prevent episodes of symptoms and slow the worsening of disability in people who have relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Daclizumab is usually used by people who were not helped by at least two other medications for MS. Daclizumab is in a class of medications called immunomodulators. It is thought to work by decreasing inflammation and decreasing the action of immune cells that may cause nerve damage.
HOW should this medicine be used?
Daclizumab comes as a solution (liquid) in a prefilled syringe to inject subcutaneously (under the skin). It is usually injected once a month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use daclizumab exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
You will receive your first dose of daclizumab in your doctor's office. After that, you can inject daclizumab yourself or have a friend or relative perform the injections. Before you use daclizumab yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it.
You can inject daclizumab in the back of your upper arms, stomach area, or your thighs. Do not inject your medication into skin that is irritated, bruised, reddened, infected, scarred, or tattooed.
Never reuse or share needles or prefilled syringes of medication. Throw away used syringes in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.
Are there OTHER USES for this medication?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before using daclizumab injection,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
If you miss a dose of daclizumab injection, inject your missed dose as soon as you remember it. However, if it is more than 2 weeks after your missed dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed dose. Call your doctor if you miss a dose and have questions about what to do.
What SIDE EFFECTS can this medicine cause?
Daclizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, and call your doctor immediately or get emergency medical treatment:
Daclizumab may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the carton it came in, tightly closed, and out of reach of children. Store daclizumab in the refrigerator but do not freeze it. If you accidentally freeze the medication, you should discard that syringe. Daclizumab may be kept at room temperature for up to 30 days but should be protected from light. Daclizumab should not be put back into the refrigerator after it has been stored at room temperature.
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org
What OTHER INFORMATION should I know?
Before having any laboratory test, tell your doctor and the laboratory personnel that you are using daclizumab injection.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
¶ This branded product is no longer on the market. Generic alternatives may be available.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: April 15, 2018.