Daclizumab belongs to the class of medications called selective immunomodulators. It is used to treat adults with relapsing remitting multiple sclerosis (RRMS) who are experiencing an active episode of RRMS and for whom other treatments have not been effective or have caused intolerable side effects.

MS is a disease that affects the nervous system. It is believed that MS is an autoimmune disease (a condition in which an individual's immune system starts reacting against their own tissues) and cannot be spread from person to person. For unknown reasons, the immune system sees the myelin sheath (a protective layer covering the nerves) as foreign and attacks it.

Daclizumab appears to affect the immune system by reducing its attack on the myelin sheath, slowing down damage to the nerves.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended dose of daclizumab is 150 mg injected subcutaneously (under the skin), once a month. It should be injected under the skin in the abdominal area, thigh, or back of the arm.

Allow the medication to warm to room temperature, by removing the syringe or pen from the refrigerator 30 minutes before you plan to inject it. Do not heat the medication to warm it up. After it has warmed to room temperature it should not be returned to the refrigerator, however it may be kept at room temperature for up to 30 days.

Before injecting the medication, inspect it carefully to make sure the liquid is not cloudy and does not have any floating particles in it. Discard any syringe that has solution that is not clear and colourless to slightly yellow.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

If you are injecting this medication yourself, your doctor will show you how to use this medication properly. If you are not sure how to use it or have questions about how to use it, contact your doctor. Before using this medication, thoroughly read the patient information provided and ask your doctor if you have any questions. If a caregiver will be giving you the injections, your doctor should instruct them on how to give the injection.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, and it is less than 2 weeks since the missed dose, take it as soon as possible and continue with your regular schedule. If it is more than 2 weeks past the missed dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in the refrigerator, protect it from light and moisture, and keep it out of the reach of children. Do not freeze or expose this medication to high temperatures.

Do not take this medication if you:

• are allergic to daclizumab or any ingredients of the medication
• have decreased liver function or liver disease
• have an autoimmune condition that affects the liver

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• diarrhea
• flu-like symptoms
• skin rash

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• fever
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• skin infection
• swollen lymph nodes
• symptoms of intestinal inflammation (e.g., abdominal pain, fever, prolonged diarrhea, blood in the stools)
• symptoms of a lung infection (LRTI) (e.g., shortness of breath, cough, chest pain)
• symptoms of unusual infections (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• thoughts of self-harm

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Anemia: Daclizumab may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Autoimmune conditions: Rarely, daclizumab, like other similar medications, can cause other serious and possibly fatal autoimmune conditions, including autoimmune liver disease. Your doctor will order blood tests to monitor for changes that could signal the development of one of these conditions. If you experience any unusual or unexpected effects, contact your doctor to have these effects checked out.

Depression: Daclizumab may increase the risk of developing depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of self-harm, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

Gastrointestinal problems: Daclizumab may be associated with inflammation in the digestive system (colitis). If you experience abdominal pain, fever, or ongoing diarrhea, contact your doctor as soon as possible.

Immune system and infections: Daclizumab may lower your ability to fight infections and may increase the risk of infections and reactivate inactive infections. Your doctor may test for tuberculosis before starting this medication. If you have a history of chronic or frequent infections, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Tell your doctor right away if you notice symptoms of a serious infection, such as fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in the sputum, shortness of breath, night sweats, weight loss, nausea, vomiting, diarrhea, redness or swelling of skin or joint, cold sores, or new or worsening pain in any part of the body.

Liver function: Daclizumab may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Vaccines: Vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella, meningococcal, diphtheria) should not be given while you are taking daclizumab and for 4 months after completing treatment.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if daclizumab passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

There may be an interaction between daclizumab and any of the following:

• BCG
• echinacea
• fingolimod
• leflunomide
• natalizumab
• nivolumab
• pimecrolimus
• roflumilast
• tacrolimus
• tofacitinib
• trastuzumab
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.