Advanced Consumer Information

daclizumab (Intravenous route)

dak-LIZ-oo-mab

Intravenous routeSolution

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe daclizumab. The physician responsible for daclizumab administration 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 .

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 .

Commonly used brand name(s):

In the U.S.

Zenapax

Available Dosage Forms:

Solution

Therapeutic Class: Immune Suppressant

Pharmacologic Class: Monoclonal Antibody

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Uses For daclizumab

Daclizumab belongs to a group of medicines known as immunosuppressive agents. It is used 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 is to be administered only by or under the immediate supervision of your doctor.

Before Using daclizumab

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 daclizumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to daclizumab 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.

Pediatric

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.

Geriatric

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

Proper Use of daclizumab

Dosing

The dose of daclizumab 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 daclizumab. 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:
- To prevent kidney transplant rejection:
  - Adults or children—1 milligram (mg) per kilogram (kg) (0.45 mg per pound) of body weight.

Precautions While Using daclizumab

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.

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 daclizumab.

daclizumab Side Effects

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:

Less common

Chest pain
coughing
dizziness
fever
nausea
rapid heart rate
red, tender, 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
joint pain
muscle pain
slow wound healing
trouble in sleeping

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

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