Benlysta is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Benlysta is used together with other medicines to treat active systemic lupus erythematosus (SLE). Benlysta helps decrease disease activity more than when the other medicines are used alone.

Benlysta is also used together with other lupus medicines to treat active lupus nephritis (lupus-related kidney inflammation).

Both the intravenous and subcutaneous formulations of Benlysta are approved for use in adults with SLE and lupus nephritis. The intravenous formulation of Benlysta is approved for use in children at least 5 years old with SLE and lupus nephritis.

It is not known if Benlysta is safe and effective in people with severe active central nervous system lupus.

Some people have had serious or fatal allergic reactions to Benlysta within hours or days after an injection. Tell your doctor right away if you have symptoms such as headache, anxiety, rash, itching, swelling in your face or throat, nausea, trouble breathing, and feeling dizzy or light-headed.

Belimumab affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, cough with mucus, skin sores, warmth or redness under your skin, increased urination, or burning when you urinate.

Report any new or worsening mental health symptoms to your doctor, such as: depression, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others.

Benlysta is given as an infusion into a vein, usually every 2 to 4 weeks. A healthcare provider will give you this injection. The medicine must be given slowly, and the infusion can take about 1 hour to complete.

In adults, Benlysta may also be injected under the skin, usually once weekly on the same day each week. A healthcare provider may teach you how to properly use the medication by yourself. Do not inject this medicine into skin that is bruised, tender, red, or hard.

If you give injections at home, read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

Store the prefilled syringe or injection pen in its original packaging in the refrigerator. Do not freeze or expose to light or high heat. Do not shake the medicine.

Take the syringe or injection pen out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not use if the medicine has been left at room temperature longer than 12 hours. Do not put it back into the refrigerator. Call your pharmacist for new medicine.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

Throw away used needles, syringes, or injection pens in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Systemic Lupus Erythematosus:

IV:
10 mg/kg IV over 1 hour at 2-week intervals for the first 3 doses and at 4-week intervals thereafter
SUBCUTANEOUS:
If transitioning from IV to subcutaneous administration, administer the first subcutaneous dose 1 to 4 weeks after the last IV dose: 200 mg subcutaneously once a week in the abdomen or thigh (preferably on the same day each week)

Comments:
-Consider premedication including an antihistamine, with or without an antipyretic, before the infusion.
-Subcutaneous dosing is not based 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 over 1 hour at 2-week intervals for the first 3 doses and at 4-week intervals thereafter
SUBCUTANEOUS:
400 mg (two 200-mg injections) once a week for 4 doses, then 200 mg once a week thereafter in the abdomen or thigh (preferably on the same day each week)
A patient may transition from IV to subcutaneous administration any time after the patient completes the first 2 intravenous doses. If transitioning, administer the first subcutaneous dose of 200 mg 1 to 2 weeks after the last intravenous dose.

Comments:
-The 400 mg dose for active lupus nephritis requires administration of 2 autoinjectors or 2 prefilled syringes.
-Consider premedication including an antihistamine, with or without an antipyretic, before the infusion.
-Subcutaneous dosing is not based on weight.

Use: Treatment of adult patients with active lupus nephritis who are receiving standard therapy

Usual Pediatric Dose for Systemic Lupus Erythematosus:

5 years and older:
10 mg/kg IV over 1 hour at 2-week intervals for the first 3 doses and at 4-week intervals thereafter

Comments:
-Subcutaneous dosing not been evaluated and is not approved for patients younger than 18 years.
-Consider premedication including an antihistamine, with or without an antipyretic, before the infusion.

Use: Treatment of patients 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy

Usual Pediatric Dose for Lupus Nephritis

5 years and older:
10 mg/kg IV over 1 hour at 2-week intervals for the first 3 doses and at 4-week intervals thereafter

Comments:
-Subcutaneous dosing not been evaluated and is not approved for patients younger than 18 years.
-Consider premedication including an antihistamine, with or without an antipyretic, before the infusion.

Use: Treatment of patients 5 years and older with active lupus nephritis who are receiving standard therapy

You should not use Benlysta if you are allergic to belimumab.

To make sure Benlysta is safe for you, tell your doctor if you have ever had:

• an active or chronic infection;

• depression or mental illness;

• suicidal thoughts or actions;

• cancer;

• a drug allergy:

• if you recently received a vaccine; or

• if you are using cyclophosphamide, biologic medicines, or other monoclonal antibody medicines.

Belimumab may increase your risk of certain cancers by changing the way your immune system works. Ask your doctor about your individual risk.

Some people have thoughts about suicide while using Benlysta. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Belimumab may affect the immune system of your baby if you use this medicine while you are pregnant. Use effective birth control to prevent pregnancy while you are using Benlysta and for at least 4 months after your last dose. Tell your doctor if you become pregnant.

Belimumab may affect your baby's immune system, but having SLE during pregnancy may cause complications such as worsened lupus, eclampsia (dangerously high blood pressure), premature birth, miscarriage, or growth problems in the unborn baby. SLE in the mother may also cause lupus or heart problems to develop in the newborn. The benefit of treating SLE may outweigh any risks to the baby.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Benlysta on the baby. Make sure any doctor caring for your newborn baby knows if you used Benlysta while you were pregnant.

It may not be safe to breastfeed while using Benlysta. Ask your doctor about any risk.

Use the medicine as soon as you remember. You can either restart a weekly schedule based on the new injection day, or you can go back to your regular injection schedule. Do not use 2 injections on the same day.

Call your doctor for instructions if you miss an appointment for an intravenous infusion of Benlysta.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using Benlysta. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Get emergency medical help if you have signs of an allergic reaction to Benlysta: hives, itching; feeling anxious or light-headed; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people have had serious or fatal allergic reactions to this medicine within hours or days after an injection. Tell your doctor right away if you have symptoms such as muscle pain, headache, tiredness, slow heartbeats, rash, itching, swelling in your face or throat, anxiety, nausea, trouble breathing, and feeling dizzy or light-headed.

You may get infections more easily, even serious or fatal infections. Stop using Benlysta and call your doctor right away if you have signs of infection such as:

• skin sores, warmth, or redness;

• cough with mucus, chest pain, shortness of breath;

• cough with mucus;

• pain or burning when you urinate;

• urinating more than usual; or

• bloody diarrhea.

Benlysta may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Also call your doctor at once if you have new or worsening depression, anxiety, mood or behavior changes, trouble sleeping, risk-taking behavior, or thoughts about hurting yourself or others.

Common Benlysta side effects may include:

• nausea, diarrhea;

• fever, sore throat, runny or stuffy nose, cough;

• pain, itching, redness, or swelling where an injection was given under the skin;

• pain in your arms or legs;

• headache, depressed mood; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with belimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.