Basiliximab (Intravenous Route)

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 .

This product is available in the following dosage forms:

• Powder for Solution

Before Using

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.

Pediatric

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.

Geriatric

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.

Pregnancy

Breastfeeding

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.

Drug Interactions

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


• Tacrolimus

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:

• Cancera€”Basiliximab may make this condition worse

• Infectiona€”Basiliximab may decrease the body`s ability to fight infection

Proper Use

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:
    
    
    
    • Adultsa€”20 milligrams (mg).
    
    
    • Childrena€”12 mg per square meter of body surface area (mg/m 2).
    
    
    
    
  
  
  
  

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

Precautions

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

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


• a€śstocking and glovesa€ť 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.