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Benlysta (Belimumab Auto-Injectors and Prefilled Syringes)

Generic Name: Belimumab Auto-Injectors and Prefilled Syringes (be LIM yoo mab)
Brand Name: Benlysta

Uses of Benlysta:

  • It is used to treat lupus.

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

  • If you have an allergy to belimumab or any other part of Benlysta (belimumab auto-injectors and prefilled syringes).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • 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.

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 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 this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Deaths happened more in people taking Benlysta as an infusion into a vein than in people not taking this medicine in trials. Talk with your doctor.
  • 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 chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • Very bad and sometimes deadly infections have happened in patients who take Benlysta. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.
  • Make sure you are up to date with all your vaccines before treatment with this medicine.
  • Talk with your doctor before getting any vaccines. Use with Benlysta 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 with care. You could have more side effects.
  • This medicine may not work as well in black patients. Talk with the doctor.
  • Use birth control that you can trust to prevent pregnancy while taking Benlysta and for 4 months after your last dose.
  • If you get pregnant while taking this medicine or within 4 months after your last dose, call your doctor right away.
  • If you used Benlysta 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 this medicine 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.
  • To gain the most benefit, do not miss doses.
  • 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.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Before using this medicine, 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 if it has been dropped or if it is broken.

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 at the same time or extra doses.

Dosage Information (comprehensive)

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 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 low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • 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. 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:

  • Not able to sleep.
  • Headache.
  • Upset stomach.
  • Loose stools (diarrhea).
  • Nose or throat irritation.
  • Stuffy nose.
  • Runny nose.
  • 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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

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 original container.
  • Protect from heat.
  • If needed, Benlysta can be left out at room temperature for up to 12 hours before use. Throw away any part not used after 12 hours.
  • Do not put this medicine 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.
  • Check with your pharmacist about how to throw out unused drugs.

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.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Benlysta is refilled. If you have any questions about this medicine, 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.

This information should not be used to decide whether or not to take Benlysta or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Benlysta. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: December 6, 2017

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