Simulect

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BASILIXIMAB (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Simulect

Category

  • Immunosuppressant
  • monoclonal antibody

Description

Basiliximab (ba-sil-IK-si-mab) 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. It is available in the following dosage form:

  • Parenteral
  • Injection (U.S.)

Before Receiving This Medicine

In deciding to use a medicine, the risks of receiving the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For basiliximab, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to proteins. Also tell your health care professional if you are allergic to any other substances.

Pregnancy—Basiliximab crosses the placenta. However, basiliximab has not been studied in pregnant women. Women of childbearing age are advised to use contraception before receiving basiliximab. Use of the contraception should continue until 2 months after treatment with basiliximab is completed.

Breast-feeding—It is not known if basiliximab passes into breast milk. Patients receiving basiliximab should not breast-feed their babies.

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.

Other medicines—Tell your health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of basiliximab. 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 basiliximab may be different for different patients. Your doctor will decide what dose should be used for you. The following information includes only the usual doses of basiliximab.

  • 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 Receiving 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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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 above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 07/09/1998

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