Basiliximab Injection

IMPORTANT WARNING:

Basiliximab injection should be given only in a hospital or clinic under the supervision of a doctor who is experienced in treating transplant patients and prescribing medications that decrease the activity of the immune system.

WHY is this medicine prescribed?

Basiliximab injection is used with other medications to prevent immediate transplant rejection (attack of the transplanted organ by the immune system of the person receiving the organ) in people who are receiving kidney transplants. Basiliximab injection is in a class of medications called immunosuppressants. It works by decreasing the activity of the body's immune system so it will not attack the transplanted organ.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Basiliximab injection comes as a powder to be mixed with water and injected intravenously (into a vein) by a doctor or nurse in a hospital or medical facility. It is usually given as 2 doses. The first dose is usually given 2 hours before the transplant surgery, and the second dose is usually given 4 days after the transplant surgery.

What SPECIAL PRECAUTIONS should I follow?

Before receiving basiliximab injection,

• tell your doctor and pharmacist if you are allergic to basiliximab injection, any other medications, or any of the ingredients in basiliximab injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have ever been treated with basiliximab injection in the past and if you have or have ever had any medical condition.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while receiving basiliximab injection. Talk to your doctor about birth control methods that you can use before beginning your treatment, during your treatment, and for 4 months after your treatment.

• tell your doctor if you are breast-feeding.

• do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Basiliximab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• heartburn
• swelling of the hands, feet, ankles, or lower legs
• runny nose
• headache
• shaking of a part of the body that you cannot control
• difficulty falling asleep or staying asleep
• pain in the place where you received the injection

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• 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 injection may increase the risk of developing an infection or cancer. Talk to your doctor about the risks of taking this medication.

Basiliximab injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about basiliximab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.