Basiliximab

A maximum tolerated dose of Simulect® (basiliximab) has not been determined in patients. During the course of clinical studies, Simulect (basiliximab) has been administered to adult renal transplantation patients in single doses of up to 60 mg, or in divided doses over 3-5 days of up to 120 mg, without any associated serious adverse events. There has been one spontaneous report of a pediatric renal transplantation patient who received a single 20-mg dose (2.3 mg/kg) without adverse events.

Mechanism of Action

Interleukin-2 receptor antagonist for activated T lymphocytes (pathway responsible for activating cell-mediated allograft rejection)

Pharmacokinetics

Peak plasma time: 30 min

Concentration: 7.1 mg/L

Vd: 8.6 L (adults); 7.8 ± 5.1 (adolescents); 4.8 ± 2.1 L (children)

Half-Life: 7.2 days (adults); 9.1 days (adolescents); 9.5 days (children)

Metabolism: Unknown

Clearance: 41 mL/hr

Excretion: Unknown

Duration: 36 days

Serious side effects have been reported with basiliximab, including an increased risk of infection. Tell your healthcare provider right away if you have signs or symptoms of an infection such as a fever.

Also tell your healthcare provider if you experience any of the following symptoms, which may indicate a serious reaction to bBasiliximab:

• hives
• rash
• itching
• sneezing
• cough
• wheezing
• difficulty breathing or swallowing
• fast heartbeat
• muscle aches
• fatigue
• lightheadedness, dizziness, or fainting
• weight gain and swelling all over the body
• sore throat, fever, chills, or other signs of infection
• difficult or painful urination
• decreased urination

Basiliximab can cause dizziness. Do not drive or operate heavy machinery until you know how basiliximab affects you.

Do not take basiliximab if you are allergic to basiliximab or to any of its ingredients.

You should not use basiliximab if you are allergic to it.

To make sure you can safely receive basiliximab, tell your doctor if you have any of these other conditions:

• cancer;

• diabetes;

• high cholesterol; or

• an electrolyte imbalance (such as high or low levels of potassium in your blood);

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether basiliximab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using basiliximab.

Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis:

For prophylaxis of acute organ rejection in patients receiving renal transplantation (as a part of an immunosuppressive regimen that includes cyclosporine and corticosteroids): 20 mg infused over 20-30 minutes by central or peripheral intravenous administration. The first 20 mg dose should be given within 2 hours prior to transplantation surgery. The recommended second 20 mg dose should be given 4 days after transplantation.

Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis:

Greater than or equal to 35 kg: Renal transplantation: 20 mg within 2 hours prior to transplant surgery, followed by a second 20 mg dose 4 days after transplantation

Less than or equal to 35 kg: Renal transplantation: 10 mg within 2 hours prior to transplant surgery, followed by a second 10 mg dose 4 days after transplantation

Renal Allotransplantation

Prevention of renal allograft rejection.1 2 3 5

Manufacturer recommends use in conjunction with cyclosporine and corticosteroids.1

Efficacy in preventing acute rejection of a second renal allograft or other solid organ transplants (e.g., liver transplantation) has not been demonstrated.1

Specific Drugs

• It is used to keep the body from turning down the kidney after a kidney transplant.
• It may be given to you for other reasons. Talk with the doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Sneezing.
• Pain, swelling, or new drainage at wound sites.
• Shakiness.
• Feeling very tired or weak.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

(ba si LIK si mab)

You should not use basiliximab if you are allergic to it.

Before you receive this medicine, tell your doctor if you have cancer, diabetes, high cholesterol, or high or low levels of potassium in your blood.

Basiliximab can lower blood cells that help your body fight infections and help your blood clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Avoid receiving a vaccine shortly after you have been treated with basiliximab, unless your doctor has told you to.

There may be other drugs that can interact with basiliximab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Because you will receive basiliximab in a clinical setting, you are not likely to miss a dose.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid receiving a vaccine shortly after you have been treated with basiliximab, unless your doctor has told you to.

Your doctor or pharmacist can provide more information about basiliximab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.01. Revision date: 2/14/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Basiliximab has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of toxicity, embryotoxicity, or teratogenicity. There are no controlled data in human pregnancy. Basiliximab should only be given during pregnancy when benefits outweigh risks.