Pronunciation:

dak-LIZ-oo-mab

Brand Names:

• Zinbryta

Warnings:

Hepatic Injury Including Autoimmune HepatitisDaclizumab can cause severe liver injury, including autoimmune hepatitis and liver failure. Fatal cases have occurred. Obtain transaminase and bilirubin levels before initiation of daclizumab. Monitor and evaluate transaminase and bilirubin levels monthly and up to 6 months after the last dose.Daclizumab is contraindicated in patients with pre-existing hepatic disease or hepatic impairment.Other Immune-Mediated DisordersImmune-mediated disorders including skin reactions, lymphadenopathy, non-infectious colitis, and other immune-mediated disorders can occur with daclizumab.These conditions may require treatment with systemic corticosteroids or immunosuppressive medication.Daclizumab is available only through a restricted distribution program called the ZINBRYTA(R) REMS Program .

Classifications:

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Daclizumab injection is used to treat the relapsing forms of multiple sclerosis (MS). This medicine will not cure MS, but it may slow some of the disabling effects and decrease the number of relapses of the disease. It should only be used when other medicines to treat MS did not work well.

This medicine was available only under a restricted distribution program called the Zinbryta® REMS (Risk Evaluation and Mitigation Strategy) Program.

Daclizumab was voluntarily withdrawn from the worldwide market on March 2, 2018 due to safety concerns.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of daclizumab injection in children younger than 17 years of age. Use of daclizumab injection in children is not recommended because of the risk for liver damage and immune system disorders. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of daclizumab injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Autoimmune liver problems (including hepatitis), history of or
• Liver disease—Should not be used in patients with these conditions.

• Depression, or history of or
• Eczema, history of or
• Mental health problems, or history of or
• Psoriasis, history of or
• Weak immune system—Use with caution. May make these conditions worse.

• Infection, or history of—Daclizumab injection is not recommended for patients with an active infection, including tuberculosis. Caution should be used if you have a chronic infection or history of a recurring infection.

Proper Use of This Medicine:

A nurse or other trained health professional may give you this medicine in a hospital. You may also be taught how to give this medicine at home. It is given as a shot under your skin, usually on the thighs, stomach, or on the back of your upper arms.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully and make sure you understand:

• How to prepare the injection.
• How to use and dispose of the syringes.
• How to give the injection.
• How long the injection can be stored.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

This medicine is available in 2 forms. You may use a prefilled syringe or a prefilled autoinjector.

You might not use all of the medicine in each prefilled syringe or prefilled autoinjector. Use each prefilled syringe or autoinjector only once. Do not save an open syringe or autoinjector.

Check the liquid in the prefilled syringe or prefilled autoinjector. It should be clear and colorless or slightly yellow. Do not use this medicine if it is cloudy or if there are particles in it. Do not use the prefilled syringe or autoinjector if it looks damaged or broken.

Do not inject into skin areas that are red, bruised, tender, infected, or have scars or tattoos.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For multiple sclerosis:
    • Adults—150 milligrams (mg) injected under your skin once a month.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Skip the missed dose if it is more than 2 weeks after your scheduled dose.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep the medicine in the original carton until you are ready to use it. You may also store it at room temperature for up to 30 days. Throw it away after 30 days without refrigeration.

Allow the medicine to warm to room temperature for 30 minutes before using it. Do not warm this medicine in any other way. Do not put the injection back in the refrigerator after warming it to room temperature. Do not use this medicine if it has been frozen.

Do not reuse syringes and needles. Throw away used syringes and needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed before starting treatment, every month during treatment, and every month for 6 months after treatment with daclizumab injection to check for unwanted effects.

You may need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test or has been exposed to tuberculosis.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Immune-mediated problems (eg, colitis, skin reactions, lymphadenopathy) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: severe diarrhea, stomach pain, rash, blistering, crusting, irritation, itching, or reddening of the skin, or swollen, painful, or tender lymph glands in the neck, armpit, or groin.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

It is important to check with your doctor if you have any symptoms of an infection, such as fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination.

While you are being treated with daclizumab, and up to 4 months after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Daclizumab may lower your body's resistance and the vaccine may not work as well, or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

This medicine may cause some people to be anxious, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bladder pain

blistering, crusting, irritation, itching, or reddening of the skin

bloody or cloudy urine

body aches or pain

cough or hoarseness

cracked, dry, or scaly skin

difficult, burning, or painful urination

difficulty with breathing

discouragement

ear congestion

feeling sad or empty

fever or chills

frequent urge to urinate

headache

irritability

lack of appetite

loss of interest or pleasure

loss of voice

lower back or side pain

nasal congestion

painful or difficult urination

rash

runny nose

sneezing

sore throat

swelling

swollen, painful, or tender lymph glands in the neck, armpit, or groin

trouble concentrating

trouble sleeping

unusual tiredness or weakness

Less common

Dark urine

general feeling of tiredness or weakness

light-colored stools

persistent loss of appetite

right upper quadrant tenderness

stomach pain, continuous

vomiting

yellow eyes or skin

Rare

Thoughts or attempts at killing oneself

watery or bloody diarrhea

Incidence not known

Dizziness

fast heartbeat

hives or welts

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

tightness in the chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Blemishes on the skin

pimples

seizures

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.