Pronunciation:

ba-si-LIX-i-mab

Brand Names:

• Simulect

Dosage Forms:

• Powder for Solution

Warnings:

Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe basiliximab. The physician responsible for basiliximab administration should have complete information requisite for the follow-up of the patient. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources .

Classifications:

Therapeutic—

Immune Suppressant

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Basiliximab 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. Basiliximab works by preventing the white blood cells from getting rid of the transplanted kidney. The effect of basiliximab on the white blood cells may also reduce the body's ability to fight infections.

Basiliximab is to be administered only by or under the immediate supervision of your doctor.

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 basiliximab in children have not been completed. Preliminary information on the use of basiliximab in children suggests children have the same side effects from receiving basiliximab as those experienced by adult patients, and basiliximab works as well to prevent rejection of the transplanted kidney in children as it does in adult patients.

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 as 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 basiliximab in the elderly with use in other age groups.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Echinacea

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—Basiliximab may make this condition worse

• Infection—Basiliximab may decrease the body's ability to fight infection

Proper Use of This Medicine:

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:
  • To prevent kidney transplant rejection:
    • Adults—20 milligrams (mg).
    • Children—12 mg per square meter of body surface area (mg/m 2).

Most patients receive one dose before and one dose after surgery.

Precautions While Using This Medicine:

If you are continuing your course of therapy with basiliximab 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 basiliximab is working properly.

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 and for 2 months after treatment with basiliximab is completed.

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 as soon as possible if any of the following side effects occur:

More common

Abdominal pain

back pain

coughing

dizziness

fever or chills

loss of energy or weakness

painful urination

shortness of breath

sore throat

swelling of the ankles, body, face, feet or lower legs

trembling or shaking of the hands or feet

vomiting

white patches in the mouth or throat or on the tongue

Less common

Abnormal vision

agitation

anxiety

bleeding, tender, or enlarged gums

blood in the stool

bruising

chest pain

depression

difficulty in urinating

fatigue

itching

numbness or pain in the legs

skin rash

sores in the mouth

“stocking and gloves” sensation of the hands or feet

tingling

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:

More common

Acne

constipation

diarrhea

headache

heartburn

nausea

trouble in sleeping

weight gain

Less common

Excessive hair growth

joint pain

muscle pain

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.