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Zinbryta

Zinbryta

Daclizumab

Zinbryta (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.

Available form

Injectable, Injectable

Dosage

150mg/1ml, 150mg

Manufacturers

Biogen

Generic brand of

Daclizumab

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Zinbryta information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

The recommended dose of Zinbryta (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 Zinbryta (Daclizumab) yourself, your doctor will show you how to use Zinbryta (Daclizumab) properly. If you are not sure how to use it or have questions about how to use it, contact your doctor. Before using Zinbryta (Daclizumab), 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 Zinbryta (Daclizumab) 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 Zinbryta (Daclizumab) in the refrigerator, protect it from light and moisture, and keep it out of the reach of children. Do not freeze or expose Zinbryta (Daclizumab) to high temperatures.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

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 Zinbryta (Daclizumab). 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 Zinbryta (Daclizumab). 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 Zinbryta (Daclizumab).

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 Zinbryta (Daclizumab).

HEALTH CANADA ADVISORY

March 16, 2018

Health Canada has issued new restrictions concerning the use of Zinbryta (Daclizumab). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Anemia: Zinbryta (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, Zinbryta (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: Zinbryta (Daclizumab) may increase the risk of developing depression. If you have depression or a history of depression, discuss with your doctor how Zinbryta (Daclizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zinbryta (Daclizumab), 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 Zinbryta (Daclizumab) contact your doctor as soon as possible.

Gastrointestinal problems: Zinbryta (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: Zinbryta (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 Zinbryta (Daclizumab). If you have a history of chronic or frequent infections, discuss with your doctor how Zinbryta (Daclizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zinbryta (Daclizumab), 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: Zinbryta (Daclizumab) may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Zinbryta (Daclizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zinbryta (Daclizumab), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Zinbryta (Daclizumab).

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 Zinbryta (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 Zinbryta (Daclizumab), contact your doctor immediately.

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

Children: The safety and effectiveness of using Zinbryta (Daclizumab) have not been established for children.

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