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Generic Name: Belimumab be-LIM’ue-mab be-LIM-ue-mab
Drug Class: Selective immunosuppressants

What is Benlysta?

Benlysta is an antibody monoclonal that influences the functions of the immune system. Monoclonal antibodies attack and destroy only specific cells in the body. This can help safeguard healthy cells from harm. Benlysta is used in conjunction with other medications to combat active systemic lupus erythematosus (SLE). Benlysta reduces the activity of disease more than other medications taken alone.

Benlysta is also combined with other lupus medications to combat active lupus nephritis (lupus-related kidney inflammation). Both the subcutaneous and intravenous Benlysta formulas are approved for use by adults suffering from SLE and Lupus nephritis. Benlysta's intravenous formula is recommended for use by children aged 5 or older who suffer from SLE and lupus. It isn't known whether Benlysta is safe or efficient for patients with active central nervous system lupus.


A few people have had severe adverse reactions or even been fatally allergic to Benlysta in the days or hours after receiving the injection. Tell your doctor immediately if you experience symptoms like headaches and anxiety, itching, rash, and swelling on your throat or face, nausea, breathing difficulties, and feeling lightheaded or dizzy.

Belimumab can affect the immune system. It is possible to contract infections more frequently, even fatal or serious infections. Call your doctor when you experience fever, chills, a mucus-filled cough, and skin sores. You may also experience swelling or redness on your skin, a higher frequency of urine output, or a burning sensation when you go to the bathroom. Inform your doctor about any new or deteriorating mental health issues, for example, depression, mood or behavior changes, insomnia, or thoughts of hurting yourself or others.

Before you take this drug

Benlysta should not be used if you have an allergy to belimumab. To ensure that Benlysta is safe for you, inform your doctor if you have previously taken:

  • An active or chronic illness.
  • Mental illness or depression.
  • Suicidal ideas or actions.
  • Cancer.
  • A drug allergy.
  • If you have recently had an injection.
  • If you're taking cyclophosphamide, biologic medications, or any other monoclonal antibody medications.

Belimumab could increase the chance of developing certain cancers by altering the way your immune system functions. Consult your physician about your risk. Certain people are contemplating suicide when using Benlysta. Your physician will examine your progress every few checkups. Your family members and other caregivers should be on the lookout for changes in your symptoms or mood.

Belimumab can impact the baby's immune system when you take this medication when you are pregnant. Use effective birth control to avoid the birth of your child while using Benlysta and for a minimum of four months after the last dose. Consult your physician in the event that you become pregnant. Belimumab could impact your baby's immune system; however, the presence of SLE during pregnancy can result in complications like worsened lupus or eclampsia (dangerously high blood pressure) and miscarriage, premature birth, or growth issues for the baby who is not yet born. A mother's SLE could be the cause of heart problems that occur in the infant. The advantages of taking care of SLE can outweigh any risk for the infant.

If you're pregnant, then your name might be added to an official pregnancy registry in order to track how Benlysta affects you and the baby. Be sure that any healthcare professional caring for your baby knows that you were taking Benlysta when you were pregnant. It is not recommended to breastfeed while taking Benlysta. Talk to your physician about any possible risks.

How to take Benlysta?

Benlysta can be given as an infusion into the vein. It is usually given every 2 to 4 weeks. The healthcare professional will administer the injection. The injection must be administered slowly, and the infusion could be up to 1 hour long before it is finished. For adults, Benlysta can be injected beneath the skin, typically once a week, every day. Your healthcare professional may show you the proper use of the medication on your own. Avoid injecting this medication into skin that is swollen, red, tender, or hard.

If you inject at home, make sure you read and follow the Instructions for Use included with your prescription. Talk to your pharmacist or doctor to clarify any instructions. Only inject once you are ready to administer it. Don't use any medicine that appears cloudy, changes color, or contains particles. Contact your pharmacist to inquire about a new medication. You might also be prescribed additional medications to avoid severe reactions or allergic reactions. Continue to take these medications for the time your physician has prescribed. Place the already-filled syringe as well as the injector pen in the original container within the fridge. Avoid freezing or exposing yourself to heat or light. Do not shake the medication. Use the syringe or pen from the refrigerator and allow it to cool to room temperature for 30 minutes prior to injecting the dose. Don't use the medicine if it has been stored at room temperature for more than twelve hours. Avoid putting it back in the refrigerator. Consult your pharmacist about a new medication. The syringe or pen for injection is intended for only one use. Dispose of it after just one use, even if there's still medicine within. Dispose of used needles or syringes. Also, dispose of any injection pens into an impervious to puncture "sharps" container. Be sure to follow the laws of your state or city on the disposal of the container. Pets and children should be kept away from it.

Details on dosage

Usual Adult Dose for Systemic Lupus Erythematosus:

IV: 10 mg/kg IV in 1 hour, at 2-week intervals for the initial 3 doses, and at 4-week intervals following.
Subcutaneous: If you are transitioning from subcutaneous administration to IV, then give the first subcutaneous dose between 1 and 4 weeks following the last IV dose, 200 mg subcutaneously twice every week on the thigh or abdomen (preferably at the exact time every week).
Comments: Consider premedication, such as an antihistamine with or without antipyretics, prior to the infusion.
Subcutaneous dosing does not depend on weight.
Use: Treatment of patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy

Usual Adult Dose for Lupus Nephritis

IV: 10 mg/kg IV for 1 hour at intervals of 2 weeks for the initial 3 doses Then, at four-week intervals afterward,
Subcutaneous: 400 mg (two 200 mg injections) every week for four doses, followed by 200 mg twice a week following that, on the thigh or in the abdomen (preferably at the exact time every week). A patient can switch from subcutaneous to IV administration at any time after the patient has completed the initial two intravenous doses. If a patient is transitioning, take the first subcutaneous dose, 200 mg, one to two weeks following the previous intravenous dose.

Comments: The dose of 400 mg for active lupus necrosis requires the administration of two autoinjectors or two prefilled syringes.
Consider taking a premedication, such as an antihistamine, either with or without an antipyretic, prior to the infusion.
Subcutaneous dosing is not based on weight. Treatment of adult patients suffering from active lupus nephritis receiving standard treatment

Usual Pediatric Dose for Systemic Lupus Erythematosus:

5 years or older: 10 mg/kg IV in 1 hour, at 2-week intervals for the initial 3 doses. Then, at four-week intervals afterward,
Comments: Subcutaneous dosing has not yet been evaluated and is not recommended for patients who are younger than 18 years of age.
Consider premedication, such as an antihistamine, either with or without an antipyretic, prior to infusion.
Use: Treatment of patients 5 years of age and older with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy

Usual Pediatric Dose for Lupus Nephritis

5 years old and over: 10 mg/kg IV in 1 hour, at 2-week intervals for the initial 3 doses. Then, at four-week intervals afterward.

Comments: Subcutaneous dosing has not yet been evaluated and is not permitted for patients who are younger than 18 years of age.
Consider premedication with an antihistamine, either with or without an antipyretic, prior to infusion. Treatment for patients aged 5 and over with active lupus and nephritis receives standard treatment.

What happens if I miss a dose?

Make sure to take the medicine immediately after you remember. You can restart the weekly schedule on the day of your injection or go back to your normal schedule of injections. Don't use two injections at the same time.

Consult your physician about the any course of action. If you do not make an appointment to receive the intravenous injection of Benlysta,

What happens if I overdose?

Get medical attention in an emergency or contact the Poison Help line toll-free at 1-800-222-1222.

What should be avoided?

Avoid being around those who are sick or suffer from infections. Inform your doctor immediately in the event that you show symptoms of an infection. Don't receive a "live" vaccine while using Benlysta. The vaccine might not function effectively and could not completely protect you from diseases. Measles is a live virus that includes rubella, mumps (MMR), and rotavirus. yellow fever, typhoid varicella (chickenpox), zoster (shingles), and the nasal influenza (influenza) vaccine.

Side effects of Benlysta

Take immediate medical care. If you exhibit symptoms of an allergy reaction or aversion to Benlysta, Hives or itching; feeling stressed or light-headed; trouble breathing; and swelling of your lips, tongue, throat, or face. A few people have experienced deadly reactions to the drug within days or hours after having an injection. Tell your doctor immediately if you experience symptoms like headaches, muscle pain, fatigue, a slow heartbeat or a rash, itching, swelling of your throat or face, anxiety, nausea, breathing problems, or feeling lightheaded or dizzy.

You could contract infections more frequently, even deadly or life-threatening infections. Stop using Benlysta and consult your physician as soon as you begin to show signs of infection, like:

  • Skin sores, warmth, or redness.
  • Cough and chest pain. Shortness of breath.
  • Mucus-filled cough.
  • Burning or pain during urination.
  • More frequently urinating than normal.
  • Bloody diarrhea.

Benlysta could cause a serious brain infection, which could result in disability or even death. Consult your doctor immediately if you are experiencing difficulties with speech, thinking, vision, or movement. These symptoms may begin gradually and then get worse. Make sure to contact your doctor anytime if you experience an increase or worsening of depression, anxiety, mood changes, sleep issues, avoiding risky behavior, or thoughts about harming yourself or others.

Common Benlysta side effects could be:

  • Nausea, diarrhea.
  • Febrile illness, the sore throat and stuffy nose, or runny cough.
  • Itching, pain, redness, or swelling after the injection was made under the skin.
  • Discomfort in your arms or legs.
  • Headache, mood depression.
  • Sleep problems (insomnia).

This is not a comprehensive list of all the side effects. Other side effects could occur. Contact your doctor to seek medical advice on adverse effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.

Interaction with other drugs

Other drugs can interfere with belimumab, such as medications that are prescribed and available over the counter, vitamins, and herbal products. Discuss with your doctor all the medicines you are currently taking as well as any medications you are about to start or stop taking.



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