Daclizumab - Subcutaneous Injection

Pronunciation: da-KLIZ-ue-mab

Common Brand Name(s): Zinbryta

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Warning

This medication can cause serious (even fatal) liver problems (including liver failure, autoimmune hepatitis). Liver problems have occurred up to 5 months after the last dose of this medication. Careful monitoring by your doctor (including regular liver function tests) before, during, and for at least 6 months after treatment with daclizumab may decrease your risk. Before using daclizumab, tell your doctor your medical history, especially of liver problems. Tell your doctor right away if you have signs of liver problems such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

This medication may cause you to develop a condition where your body's natural defense (immune system) attacks healthy tissue. This can affect many parts of your body, such as skin, lymph nodes, brain or intestines. Tell your doctor right away if you develop symptoms such as diarrhea that doesn't stop, bloody stools, fever, severe headache, or swollen/tender lymph nodes. Daclizumab can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash. If you have serious side effects, your doctor may prescribe other medications (such as corticosteroids) for you to take.

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Zinbryta REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations. See also Uses section.

Uses

This medication is used to treat a certain type of multiple sclerosis (relapsing multiple sclerosis-MS). Daclizumab belongs to a class of medications known as monoclonal antibodies. It is not a cure for MS but is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.

This drug is being withdrawn from the worldwide market due to risks outweighing benefits of treatment. Immediately contact your doctor for more details.

How To Use

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using daclizumab and each time you get a refill. Carry the Patient Wallet Card with you at all times. If you have any questions, ask your doctor or pharmacist.

This drug is given by injection under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once a month. Learn all preparation and usage instructions in the product package.

Remove this medication from the refrigerator and leave it at room temperature for 30 minutes before injecting. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into any areas of skin that are irritated, tender, red, bruised, infected, scarred, or tattooed.

Use this medication regularly to get the most benefit from it. To help you remember, mark the day on the calendar when you need to receive the medication.

Learn how to store and discard medical supplies safely. Never reuse syringes or needles. Consult your pharmacist.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

See also Warning and Uses sections. Immediately contact your doctor if you are still using this medication. Side effects may still occur for 6 months after daclizumab is stopped.

Cold symptoms (such as stuffy/runny nose), pain/swelling in your nose/throat/mouth, or red, dry, itchy, scaly skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

  • pale skin
  • shortness of breath

Get medical help right away if you have any very serious side effects, including:

  • seizure
  • mental/mood changes (including depression or thoughts of suicide)
  • problems with speech or coordination
  • unusual tiredness

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infections (such as sore throat that doesn't go away, fever, chills).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using daclizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • past/current/returning infections (including fungal, hepatitis B, tuberculosis)
  • liver problems
  • mental/mood problems
  • skin problems (such as eczema, psoriasis)

Daclizumab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as liver function) should be done before you start using this medication, while you are using it, and for at least 6 months after treatment. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, use it as soon as you remember if it is within 2 weeks of the missed dose. If it is more than 2 weeks after your missed dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store in the original package in the refrigerator away from moisture. Do not freeze. If you cannot refrigerate this medication, you can store it at room temperature for up to 30 days. Once this medication has reached room temperature, it must not be put back in the refrigerator and must be used within 30 days. Discard any unused portion of this medication. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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