When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive this medicine if you had an allergic reaction to daclizumab.

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.
• 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 (such as 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.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease or a history of an autoimmune hepatitis. Tell your doctor if you have a history of depression, a fever, any kind of infection, or a weak immune system.
• This medicine may cause the following problems:
  
  • Liver damage
  • Serious skin reactions
  • High risk of infection
• This medicine may increase depression or thoughts of suicide. Tell your doctor right away if you start to feel more depressed or think about hurting yourself.
• 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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Severe diarrhea and stomach pain
• Swollen, painful, or tender lymph glands in neck, armpit, or groin
• Weakness on one side of your body, clumsiness, trouble seeing or vision changes, confusion, memory problems, unusual behavior

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