Uses of Benlysta:

• It is used to treat lupus.

What do I need to tell my doctor BEFORE I take Benlysta?

• If you are allergic to Benlysta (belimumab auto-injectors and prefilled syringes); any part of Benlysta (belimumab auto-injectors and prefilled syringes); 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 Benlysta (belimumab auto-injectors and prefilled syringes).

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 Benlysta (belimumab auto-injectors and prefilled syringes) 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 Benlysta?

• Tell all of your health care providers that you take Benlysta (belimumab auto-injectors and prefilled syringes). This includes your doctors, nurses, pharmacists, and dentists.
• In some drug studies, more deaths happened in people taking Benlysta (belimumab auto-injectors and prefilled syringes) 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 Benlysta (belimumab auto-injectors and prefilled syringes).
• Talk with your doctor if you have recently had a vaccine or before getting any vaccines. Vaccine use with Benlysta (belimumab auto-injectors and prefilled syringes) may either raise the chance of an infection or make the vaccine not work as well.
• If you are 65 or older, use Benlysta (belimumab auto-injectors and prefilled syringes) 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 Benlysta (belimumab auto-injectors and prefilled syringes) 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 Benlysta (belimumab auto-injectors and prefilled syringes) when you were pregnant, tell your baby's doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Benlysta) best taken?

Use Benlysta (belimumab auto-injectors and prefilled syringes) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh or the belly area.
• Take the same day each week.
• Keep taking Benlysta (belimumab auto-injectors and prefilled syringes) as you have been told by your doctor or other health care provider, even if you feel well.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Before using Benlysta (belimumab auto-injectors and prefilled syringes), take it out of the refrigerator and leave it at room temperature for 30 minutes.
• Do not heat or microwave.
• Do not shake.
• Move the site where you give the shot with each shot.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not use if the solution is cloudy, leaking, or has particles.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Do not use Benlysta (belimumab auto-injectors and prefilled syringes) if it has been dropped or if it is broken.
• Throw syringe away after use. Do not use the same syringe more than one time.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• After taking a missed dose, keep taking on your normal day or start a new weekly schedule based on the day the dose is taken.
• If you are not sure what to do if you miss a dose, call your doctor.
• Do not take 2 doses on the same day.

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 Benlysta (belimumab auto-injectors and prefilled syringes). 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 Benlysta?

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.
• Irritation where the shot is given.

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 Benlysta?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• If needed, Benlysta (belimumab auto-injectors and prefilled syringes) can be left out at room temperature for up to 12 hours before use. Throw away any part not used after 12 hours.
• Protect from heat and sunlight.
• Do not put Benlysta (belimumab auto-injectors and prefilled syringes) back in the refrigerator after it has been stored at room temperature.
• 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 Benlysta (belimumab auto-injectors and prefilled syringes) is refilled. If you have any questions about Benlysta (belimumab auto-injectors and prefilled syringes), 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's the difference between Lupkynis and Benlysta?
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