Daclizumab (dak-LIZ-oo-mab)

Treats multiple sclerosis (MS). This medicine was withdrawn from the worldwide marketing because it may cause some serious side effects.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Allow this medicine to warm to room temperature for 30 minutes.
• Check the liquid in the prefilled syringe or autoinjector. It should be clear and colorless to slightly yellow. Do not use it if it is cloudy, discolored, or has particles in it.
• 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.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. This medicine is given once a month. Skip the missed dose if it is more than 2 weeks of your scheduled dose.
• Store the medicine in the refrigerator. Do not freeze. You may also store it at room temperature for up to 30 days. Do not use external heat sources (including hot water) to warm the medicine. Do not put it back in the refrigerator after allowing it to warm to room temperature. Throw away after 30 days without refrigeration.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how daclizumab works. Tell your doctor about all other medicines that you are taking, including herbal medicines.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive a live vaccine during treatment with this medicine and for up to 4 months after the last dose.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have any kind of infection (including tuberculosis), a weak immune system, or a history of depression or skin problems (including eczema or psoriasis).
• This medicine may cause the following problems:
  • Liver problems
  • Serious skin reactions
  • Immune system problems, including lymphadenopathy (lymph node disease), hemolytic anemia (blood disorder), colitis (severe diarrhea), or inflammation of the organs
  • Increased risk of infection
  • Increased risk of depression or thoughts of suicide
• You will need to have a skin test for tuberculosis (TB) before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or has been exposed to TB.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Changes in mood or behavior, thoughts about hurting yourself
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Severe diarrhea, stomach pain
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Trouble breathing, tiredness, uneven heartbeat
• Weakness on one side of your body, clumsiness, trouble seeing or vision changes, confusion, memory problems

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

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