Benlysta overview
BRAND NAMES:
Benlysta
Generic Names:
Belimumab (no generic available at this time)
Uses:
Treats:
Lupus nephritis
Therapeutic Classes:
B-Lymphocyte Stimulator (BLyS) Inhibitor
Forms:
Injectable
How it’s taken:
Adults only: by subcutaneous injection (injection under the skin)
Adults and children 5 years and older: by intravenous infusion (into a vein)
What is Benlysta used for?
Benlysta is a biologic monoclonal antibody used to treat adults and children 5 years and older with systemic lupus erythematosus (SLE), an autoimmune disease in which the immune system “misfires” and attacks healthy tissues in the skin and internal organs such as the joints and kidneys.
It is also used to treat adults and children 5 years and older with active lupus nephritis, a type of kidney disease caused by SLE. This medication works on the body's immune system to inhibit the survival of B cells, including cells that attack the body.
Note: Benlysta cannot be used by individuals who have severe active SLE that has attacked the central nervous system (spinal cord and brain).
How Benlysta works
The active ingredient in Benlysta, belimumab, reduces the number of white blood cells that produce antibodies, the proteins that attach to “foreign” cells and tissues and target them for attack by the immune system.
Benlysta efficacy
Clinical trials studied patients who were on a standard therapy regimen, taking corticosteroids, antimalarials, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or immunosuppressant medicines. Studies found that when given together with other lupus medications, Benlysta decreases lupus disease activity more than other lupus treatments alone.
Key takeaways
Benlysta is a prescription medication used in combination with other medicines to treat systemic lupus erythematosus. It can also be used to treat people with active lupus nephritis (kidney problems due to lupus).
Be alert to symptoms of an allergic reaction after an injection. Get emergency medical help right away if you have a rash, itching, trouble breathing, or swelling of the face, lips, tongue, or throat.
Because Benlysta affects the immune system, you may get infections more easily. Let your doctor know right away if you have any symptoms of an infection, such as fever, chills, a mucusy cough, sores on the skin, redness, increased urination, or burning during urination.
Tell your doctor if you have any changes in mood or behavior, depression, trouble sleeping, or thoughts about hurting yourself or others.
What form(s) does Benlysta come in
Auto-injector:
200 mg
Prefilled syringe:
200 mg/mL
Injection (vial) for intravenous infusion (IV infusion)
What are common Benlysta doses?
Adults:
Intravenous (IV): Start with 10 mg/kg/dose IV every 2 weeks for 3 doses, then 10 mg/kg per dose via IV every 4 weeks. Or, may switch to subcutaneous injection after at least 2 IV doses.
Subcutaneous (SC): Start with 400 mg SC every week for 4 doses, then 200 mg SC every week. If transitioning from IV, the dose is 200 mg SC every week starting one or two weeks after at least 2 IV doses
Children (5 years and older):
IV: Start with 10 mg/kg/dose IV every 2 weeks for 3 doses, then 10 mg/kg per dose via IV every 4 weeks.
SC: The subcutaneous form of Benlysta is only for use in adult patients. It is not FDA-approved for use in anyone younger than 18 years old.
Common Benlysta prescriptions
Benlysta
1ml of 200mg/ml penBenlysta
120mg solution reconstitutedBenlysta
400mg solution reconstitutedBenlysta
1ml of 200mg/ml syringe
How to take Benlysta
A nurse or other health provider will give you this medicine. This medicine is given through a vein (IV infusion) or as a shot under your skin. If the medicine is given through IV infusion, it must be given slowly, over a period of one hour.
This medicine is available in 3 forms: a vial (glass container), a prefilled syringe, or an autoinjector. The prefilled syringe and autoinjector are the dosage forms you can use at home with proper training.
You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
Check the liquid in the prefilled syringe or autoinjector. It should be colorless or slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it. Do not shake.
Allow the medicine to warm to room temperature for 30 minutes before you use it. Do not warm it in any other way.
Do not remove the needle cap from the prefilled syringe or the ring cap from the autoinjector until you are ready to use it.
You will be shown the body areas where this shot can be given, generally the abdomen or thigh. Choose a new area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, red, bruised, or hard.
You will use each prefilled injection or syringe only once.
Discard used syringes and needles in a sharps container, which is a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
If you store this medicine at home, keep it in the refrigerator. Keep it refrigerated until 30 minutes before use.
Do not freeze.
Store this medicine in its original container until you are ready to use it.
You may also store this medicine at room temperature for up to 12 hours if protected from sunlight. Do not use and do not place this medicine back in the refrigerator if it has been left out for more than 12 hours.
This medicine should come with a medication guide. Ask your pharmacist for a copy if you do not have one. Consult your healthcare provider if you have any questions or concerns.
What to do if you miss a dose of Benlysta
If you administer Benlysta at home, inject the missed dose as soon as you remember. Then, your next dose will either be at the regular time, or you can continue with your weekly dosing based on the new day injected. Do not double up on doses to try to make up for a missed dose. Ask your healthcare professional if you are not sure when to inject Benlysta.
If you receive Benlysta as an infusion in a healthcare setting and you miss an appointment, call your doctor right away for medical advice.
Benlysta contraindications
Do not use Benlysta if you’ve had an allergic reaction to belimumab.
People with severe active central nervous system lupus should not use Benlysta.
Benlysta warnings
It is not known if it is safe to take this medicine during pregnancy. Use an effective form of birth control during treatment with this medicine and for at least 4 months after your last dose. You can discuss effective forms of birth control with your healthcare provider. Tell your doctor right away if you become pregnant while taking Benlysta.
Also, tell your doctor if you:
are breastfeeding (it is not known whether Benlysta passes into breast milk)
are allergic to any medicine
have a history of cancer, depression, or mental illness
have any kind of infection, a weak immune system, or if you have ever had an infection that would not go away or kept coming back
This medicine may cause the following problems:
Increased risk for infection, including progressive multifocal leukoencephalopathy (PML; a serious, life-threatening brain infection that has been reported in people with lupus who take immunosuppressants)
Infusion reactions
Changes in mood or behavior, including depression and thoughts of suicide
Increased risk for certain types of cancer
This medicine may make it easier for you to get infections, including serious infections. Take precautions to prevent illness. Avoid people who are ill. Wash your hands often.
Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
Keep all medicine out of the reach of children. Never share your medicine with anyone.
Benlysta interactions
Before taking Benlysta, tell your doctor about all the medications you take, including prescription and over-the-counter (OTC) drugs, vitamins, and supplements.
Tell your doctor if you are also using cyclophosphamide, any other biologic therapy, or monoclonal antibody medicines.
This medicine may interfere with live vaccines. You should not receive live vaccines 30 days before or during treatment with this medicine. Examples of live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, chickenpox, shingles, and the nasal flu vaccine (this does not apply to the injectable flu vaccine).
Benlysta side effects
Serious side effects may occur, including hypersensitivity reactions. If you have symptoms of an allergic reaction, such as hives, trouble breathing, lightheadedness, dizziness, fainting, severe headache, or swelling of the face, lips, tongue, or throat, get emergency medical help.
Also, Benlysta has been associated with depression and suicidal thoughts or behavior. Report any mood changes to your healthcare professional right away. If you have thoughts of harming yourself or others, you can call or text 988 for the Suicide and Crisis Lifeline or call 911.
Other serious side effects include:
Confusion, memory loss, problems with vision, speech, or walking, which could indicate a serious, life-threatening brain infection
Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle is placed
Anxiety, depression, thoughts of hurting yourself
Change in how much or how often you urinate, bloody or cloudy urine, pain or burning feeling when you urinate
Fever, chills, body aches
Common side effects:
Trouble sleeping
Diarrhea
Nausea
Fever
Bronchitis
Symptoms of a common cold/sore throat
Pain in the extremities
Depression
Migraine
Injection site reactions (with subcutaneous Benlysta)
Sources:
Benlysta, National Library of Medicine DailyMed (2023)
Belimumab injection, Cleveland Clinic (2023)
Belimumab (Rx), Medscape (2023)
Benlysta, Prescribers’ Digital Reference (2023)
Belimumab injection, National Library of Medicine MedlinePlus (2021)
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