Pronunciation:

dak-LIZ-oo-mab

Brand Names:

• Zenapax

Dosage Forms:

• Solution

Warnings:

Only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe daclizumab, and they should have complete information requisite for the follow-up of the patient. Daclizumab should only be administered by healthcare personnel trained in the administration of the drug who have available adequate laboratory and supportive medical resources .

Classifications:

Therapeutic

Immune Suppressant

Pharmacologic

Monoclonal Antibody

Uses of This Medicine:

Daclizumab belongs to a class of medicines known as immunosuppressive agents. It is used with other medicines to lower the body's natural immunity in patients who receive kidney transplants.

When a patient receives a kidney transplant, the body's white blood cells will try to get rid of (reject) the transplanted kidney. Daclizumab works by preventing the white blood cells from getting rid of the transplanted kidney. The effect of daclizumab on the white blood cells may also reduce the body's ability to fight infections.

Daclizumab was to be administered only by or under the immediate supervision of your doctor.

Products containing daclizumab were withdrawn from the U.S. market by Roche on September 2009.

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

Studies on the use of daclizumab in children have not been completed. However, daclizumab may cause high blood pressure and dehydration more often in children than it does in adults.

Older adults

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of daclizumab in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

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:

• Cancer Daclizumab may make this condition worse.

• Diabetes Daclizumab can increase the amount of sugar in the blood.

• Infection May decrease the body's ability to fight infection.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

You will receive a total of five doses of this medicine. Your first dose is given to you right before the transplant. Then you will receive one treatment every 14 days.

Precautions While Using This Medicine:

If you are continuing your course of therapy with daclizumab after you are discharged from the hospital, it is very important that your doctor check your progress at regular visits. Your doctor will want to do laboratory tests to make sure daclizumab is working properly.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a skin rash; itching; swelling of the face, tongue, and throat; or trouble with breathing after you get the injection.

You may be more likely to get infections while using this medicine. Tell your doctor if you have symptoms of an infection, such as fever or chills. Try to stay away from people with colds, flu, or other infections.

Using this medicine may cause you to have a higher risk of getting cancer of the lymph system. Talk to your doctor if you have concerns about this risk.

Dental It is important to maintain good dental hygiene and see a dentist regularly for teeth cleaning.

If you are a woman of childbearing age, you should use effective contraception while receiving this medicine.

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 or nurse immediately if any of the following side effects occur:

Less common

Chest pain

coughing

dizziness

fever

nausea

rapid heart rate

red, tender, and oozing skin at incision

shortness of breath

swelling of the feet or lower legs

trembling or shaking of the hands or feet

vomiting

weakness

Rare

Frequent urination

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

Constipation

diarrhea

headache

heartburn

itching, pain, redness, swelling, tenderness, or warmth on skin

joint pain

muscle pain

slow wound healing

trouble with sleeping

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.