Uses

What is Benlysta used for?

Benlysta (belimumab) is commonly used for the following conditions.

Learn more about Benlysta for lupus.

Benlysta may also be used for other conditions as determined by your healthcare provider.

How does Benlysta work (mechanism of action)?

Benlysta is a type of medicine called a monoclonal antibody. It blocks a substance in the body, called B lymphocyte stimulator (BLyS), from binding to B cells, which are part of the immune system. In people with certain autoimmune conditions, such as lupus, B cells attack the body’s healthy cells. By stopping BLyS from working, Benlysta reduces the number of B cells in the body, which can help to reduce symptoms.

How is Benlysta supplied (dosage forms)?

Benlysta is available in the following dosage forms that are injected under the skin.

  • 200 mg/mL single-dose autoinjector
  • 200 mg/ mL single-dose prefilled syringe

Benlysta is also available in injectable forms that are given by a healthcare provider.

How should I store Benlysta?

Vials. Benlysta vials are usually given by a healthcare provider in a hospital or clinic. You will not store them at home.

Prefilled Autoinjector or Syringe. Benlysta should be kept in its original carton to protect it from light. It must be stored in the refrigerator, between 36 F to 46 F (2 C to 8 C). Do not shake or freeze the medicine or expose it to a heat source. Benlysta can be stored outside of the refrigerator, up to 86 F (30 C) for up to 12 hours. If it is kept outside of the refrigerator for longer than 12 hours, it should be thrown away.

Side Effects

What are the most common side effects of Benlysta?

The most common side effects of Benlysta are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Nausea
  • Diarrhea
  • Fever
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Chest cold (bronchitis)
  • Trouble sleeping (insomnia)
  • Pain in the arms or legs
  • Depression
  • Migraine
  • Pain, itching, swelling, or redness near the injection site (when injected under the skin)

There may be other side effects of Benlysta that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Benlysta?

While less common, the most serious side effects of Benlysta are described below, along with what to do if they happen.

Severe Allergic Reactions. Benlysta may cause allergic reactions, which can be serious. People who have allergies to multiple other medicines may have a higher risk of developing a severe allergic reaction to Benlysta. Stop using Benlysta and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Anxiousness
  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Cancer. Some people who have used other medicines that suppress the immune system, like Benlysta, have developed cancer. It is not clear if Benlysta increases the risk for cancer. Let your healthcare provider know if you or your family has a history of cancer.

Infection. Benlysta can increase the risk of infections, including serious infections. It can also make current infections worse. Call your healthcare provider if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee
  • Having to pee more often than usual
  • Cough or coughing up mucus
  • Fever, sweats, or chills
  • Warm, red, or painful skin or sores

Progressive Multifocal Leukoencephalopathy (PML). People using Benlysta may develop a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Stop using Benlysta and call your healthcare provider right away if you have any of the following symptoms of PML.

  • Clumsiness or loss of coordination
  • Difficulty walking or speaking
  • Facial drooping
  • Vision problems
  • Thinking, memory, or personality changes

Suicidal Thoughts or Actions. Benlysta may cause depression, as well as suicidal thoughts or actions, in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in your mood or behavior

Warnings & Precautions

Who should not use Benlysta?

Allergies to Ingredients. People who are allergic to any of the following should not use Benlysta.

  • Belimumab
  • Benlysta
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Benlysta.

What should I know about Benlysta before using it?

Do not use Benlysta unless it has been prescribed to you by a healthcare provider. Use it as prescribed.

Do not share Benlysta with other people, even if they have the same condition as you. It may harm them.

Keep Benlysta out of the reach of children. Since this medicine must be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator. 

This medicine is usually injected under the skin. Your first dose will be given in the presence of a healthcare provider who will monitor you for an allergic reaction. After this, you may be able to give the injection at home. Make sure that you or a caregiver understands how to properly prepare and use Benlysta. If you have any questions, talk to your healthcare provider. 

If you are able to become pregnant, your healthcare provider may recommend that you use an effective form of birth control while you are using Benlysta and for another 4 months after your last dose of Benlysta.

What should I tell my healthcare provider before using Benlysta?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Benlysta is right for you.

In particular, make sure that you discuss any of the following.

Risk for Infection. Before starting Benlysta, it is important to talk to your healthcare provider about any serious infections you have had in the past as well as any infections you have currently. You should also let your healthcare provider know if you have an infection that keeps coming back.

Other Medicines and Supplements. Benlysta should not be used while you are using certain other medicines. Before using Benlysta, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Vaccines. Let your healthcare provider know if you have recently received or are scheduled to receive any vaccinations. There are certain vaccines (live vaccines) that you should not receive either right before receiving Benlysta or once you have started using it. Your healthcare provider will confirm whether any upcoming vaccinations are safe.

Severe Lupus in the Central Nervous System. Benlysta is not recommended for use in people who have a severe form of lupus that affects the central nervous system (CNS). This type of lupus can cause symptoms such as seizures and strokes. Before starting Benlysta, let your healthcare provider know if you have any of these symptoms.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Allergic reactions to other medicines, including a severe allergic reaction (anaphylaxis)
  • Cancer
  • Depression, including history of suicidal thoughts or behavior
  • Other mental health issues

Pregnancy. It is not known if or how Benlysta could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should use Benlysta while you are pregnant or trying to get pregnant. If you become pregnant while using Benlysta, you can register for the pregnancy registry by calling 877-311-8972 or at https://mothertobaby.org/ongoing-study/benlysta-belimumab. This registry collects safety information about the use of Benlysta during pregnancy.

Breastfeeding. It is not known if Benlysta passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Benlysta while breastfeeding.

How can I get more information about Benlysta?

For more information about Benlysta, you can visit the manufacturer’s website at www.benlysta.com or call them at 877-423-6597.

Interactions

Does Benlysta interact with foods or drinks?

There are no known interactions between Benlysta and foods or drinks.

It is unknown if drinking alcohol will affect Benlysta.

Does Benlysta interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. In particular, make sure that you discuss if you are using a type of medicine called a biologic or monoclonal antibody, such as rituximab (Rituxan), to treat your condition.

This may not be a complete list of medicines that can interact with Benlysta. Always check with your healthcare provider.

Does Benlysta (belimumab) interact with other drugs you are taking?
Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Benlysta?

If you or someone else has used too much Benlysta, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Benlysta?

If you miss a dose, use Benlysta as soon as you remember. You can then use your next dose at the normal time or update your dosing schedule based on when the missed dose was given. If you are not sure when to use a missed dose, contact your healthcare provider. Do not use double or extra doses. 

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