Daclizumab Injection

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.

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Talk to your doctor about the risk(s) of receiving daclizumab injection.

🔔 Why is this medication 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.

🔔 Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.