Uses of Belimumab Vials:

• It is used to treat lupus.

What do I need to tell my doctor BEFORE I take Belimumab Vials?

• If you are allergic to this medicine (belimumab vials); any part of this medicine (belimumab vials); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have kidney problems or nervous system problems caused by lupus.
• If you are taking cyclophosphamide.
• If you are taking or will be taking another drug like this one.

This is not a list of all drugs or health problems that interact with this medicine (belimumab vials).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (belimumab vials) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Belimumab Vials?

• Tell all of your health care providers that you take this medicine (belimumab vials). This includes your doctors, nurses, pharmacists, and dentists.
• In some drug studies, more deaths happened in people taking this medicine (belimumab vials) compared to people not taking it. Talk with the doctor if you have questions.
• This medicine may add to the chance of getting some types of cancer. Talk with the doctor.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• Make sure you are up to date with all your vaccines before treatment with this medicine (belimumab vials).
• Talk with your doctor if you have recently had a vaccine or before getting any vaccines. Vaccine use with this medicine (belimumab vials) may either raise the chance of an infection or make the vaccine not work as well.
• If you are 65 or older, use this medicine (belimumab vials) with care. You could have more side effects.
• This medicine may not work as well in black patients. Talk with the doctor.
• Women must use birth control while taking this medicine (belimumab vials) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• If you used this medicine (belimumab vials) when you were pregnant, tell your baby's doctor.
• Infusion reactions have happened with this medicine (belimumab vials). These have happened on the same day as the infusion. Tell your doctor if you have any bad effects during or after the infusion.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Belimumab Vials) best taken?

Use this medicine (belimumab vials) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• Other drugs may be given before this medicine (belimumab vials) to help avoid side effects.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

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, swallowing, 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.
• New or worse behavior or mood changes like depression or thoughts of suicide.
• Chest pain or pressure.
• Slow heartbeat.
• Muscle pain.
• Very bad headache.
• Dizziness or passing out.
• Shortness of breath.
• Cold sweats.
• Very upset stomach or throwing up.
• A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with this medicine (belimumab vials). It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.

What are some other side effects of Belimumab Vials?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Trouble sleeping.
• Headache.
• Upset stomach.
• Diarrhea.
• Nose or throat irritation.
• Pain in arms or legs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Belimumab Vials?

• If you need to store this medicine (belimumab vials) at home, talk with your doctor, nurse, or pharmacist about how to store it.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (belimumab vials) is refilled. If you have any questions about this medicine (belimumab vials), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• What is the difference between Benlysta and Saphnelo?