Benlysta
Pronunciation: ben-LIST-ah
Generic name: belimumab
Dosage form: single-dose vial for intravenous infusion (120 mg/vial, 400 mg/vial), prefilled syringe for subcutaneous use (200 mg/mL), prefilled autoinjector for subcutaneous use (200 mg/mL)
Drug class: Selective immunosuppressants
What is Benlysta?
Benlysta is used to treat active systemic lupus erythematosus (SLE) or lupus nephritis in adults and children 5 years and older. It is a targeted biologic given by subcutaneous injection or intravenous infusion every 1 to 2 weeks.
Benlysta (belimumab) gained FDA approval on March 9, 2011, for SLE, making it the first new lupus treatment approved in over 50 years and the first medication specifically designed to target the underlying autoimmune process in lupus. There is currently no generic or biosimilar available.
FDA-Approved Uses
Benlysta for lupus is approved to treat adults and children aged 5 years and older with:
- Active systemic lupus erythematosus (SLE) who are receiving standard therapy
- Active lupus nephritis who are receiving standard therapy.
Important Limitation: Benlysta is not approved for severe active central nervous system lupus because its effectiveness has not been evaluated.
How Does Benlysta Work?
Mechanism of Action
Benlysta works by targeting and blocking a protein called B-lymphocyte stimulator (BLyS) that helps B-cells survive and produce antibodies.
- In lupus, B-cells are overactive and produce harmful autoantibodies that attack healthy tissue.
- The BLyS protein keeps these harmful B-cells alive and active.
- Benlysta blocks BLyS, reducing B-cell survival and decreasing autoantibody production.
- Result: Better control of the overactive immune response, improved symptoms such as fatigue, and reduced lupus flares.
Benlysta belongs to the drug class called B-lymphocyte stimulator (BLyS)-specific inhibitors and may also be called an immunomodulator.
Side effects of Benlysta
Common side effects
The most common side effects of Benlysta for lupus are:
- Nausea
- Diarrhea
- Fever
- Sore throat, runny or stuffy nose (nasopharyngitis)
- Persistent cough (bronchitis)
- Pain, itching, redness, or swelling where an injection was given under the skin
- Pain in your arms or legs
- Headache (migraine)
- Depression
- Sleep problems (insomnia).
Good News: Hair loss and weight gain are not common side effects of Benlysta.
Serious side effects and warnings
Serious Infections
Infections could be serious, leading to hospitalization or death. Tell your healthcare provider right away if you have any symptoms of an infection:
- Fever
- Urinating often
- Chills
- coughing up mucus
- pain or burning with urination
- warm, red, or painful skin or sores on your body.
Allergic Reactions
Serious allergic reactions can happen on the day of, or in the days after, receiving Benlysta and may cause death. Symptoms include:
- Itching
- Low blood pressure
- Swelling of the face, lips, mouth, tongue, or throat
- Dizziness or fainting
- Headache
- Trouble breathing
- Nausea
- Anxiousness
- Skin rash.
Mental Health Problems
Tell your healthcare provider right away if you experience:
- Thoughts of suicide or dying
- New or worse depression
- Attempt to commit suicide
- Acting on dangerous impulses
- Trouble sleeping (insomnia)
- Other unusual changes in your behavior or mood
- New or worse anxiety
- Thoughts of hurting yourself or others.
Progressive Multifocal Leukoencephalopathy (PML)
PML is a serious and life-threatening brain infection. Tell your healthcare provider right away about any new or worsening symptoms, such as:
- Memory loss
- Trouble thinking
- Dizziness or loss of balance
- Difficulty talking or walking
- Loss of vision.
Cancer Risk
Benlysta may reduce the activity of your immune system, which may increase your risk of certain cancers. Discuss your individual risk with your doctor.
Live vaccines should not be given concurrently with this medicine.
It is not known if Benlysta is safe for children younger than 5 years.
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 the FDA at 1-800-FDA-1088.
Related/similar drugs
Before receiving
Do not receive a Benlysta injection or infusion if you are allergic to belimumab, Benlysta, or any inactive ingredients in the subcutaneous injection or intravenous infusion.
Before receiving, tell your healthcare provider about all your medical conditions, including if you:
- think you have an infection or have infections that keep coming back. You should not receive Benlysta if you have an infection unless your healthcare provider tells you to
- have or have had mental health problems, such as depression or thoughts of suicide
- have recently received a vaccination, or if you think you may need a vaccination. If you are receiving Benlysta, you should not receive live vaccines, such as measles, mumps, or varicella
- are receiving other cyclophosphamide, biologic medicines, or other monoclonal antibody medicines
- have or have had any type of cancer
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
This medicine may increase your risk of certain cancers by changing the way your immune system works. Ask your doctor about your 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.
Pregnancy
It is not known if Benlysta injection or infusion will harm your unborn baby or affect its immune system. You should talk to your healthcare provider about whether to prevent pregnancy while on Benlysta. If you choose to prevent pregnancy, you should use an effective method of birth control while receiving Benlysta and for at least 4 months after the final dose.
Tell your healthcare provider right away if you become pregnant during your treatment or if you think you may be pregnant. If you become pregnant while receiving this medicine, talk to your healthcare provider about enrolling in the Benlysta Pregnancy Registry. You can enroll in this registry by calling 1-877-311-8972 or going to MotherToBaby to enroll. The purpose of this registry is to collect information about you and your baby's health.
Breastfeeding
It may not be safe to breastfeed while using Benlysta. Ask your doctor about any risks.
How is Benlysta administered?
Benlysta can be administered intravenously (IV) or subcutaneously (SC).
Intravenous (IV) administration
When you first start Benlysta, you may be given it intravenously by a healthcare provider.
- It takes about 1 hour to receive your Benlysta infusion.
- You may need premedication before your infusion to monitor for infusion-related reactions.
- Your healthcare provider will tell you how often you should receive Benlysta, but the infusion is usually given every 2 to 4 weeks.
Subcutaneous (SC) administration
Benlysta can be self-administered by SC injection or administered SC by a caregiver or healthcare provider.
- It is usually administered 1 time a week or 1 time every 2 weeks.
- Your healthcare provider will show you or your caregiver how to give the injections and review the signs and symptoms of possible allergic reactions.
- It is injected under the skin of your stomach (abdomen) or thigh
- Read the Instructions for Use that comes with Benlysta Package Insert for instructions about the right way to give your injections at home.
Benlysta may be prescribed as a single-dose autoinjector or as a single-dose prefilled syringe.
- The single-dose autoinjector can be used in adults or children aged 5 and older who weigh at least 15 kg (33 lb).
- The prefilled syringe has not been studied in children less than 18 years of age.
Do not inject this medicine into skin that is bruised, tender, red, or hard.
- Take the prefilled syringe or autoinjector 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 a 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.
Dosing information
Benlysta (belimumab) dosing varies based on patient age (adult or pediatric), administration route (intravenous IV or subcutaneous SC), and indication (SLE or lupus nephritis treatment).
Intravenous (IV) Benlysta Dosing for SLE or Lupus Nephritis
Adults and Children
- Benlysta IV Dose: 10 mg/kg intravenously
- Initial Dosing Schedule: Every 2 weeks for the first 3 doses (loading doses)
- Maintenance Dosing: Every 4 weeks thereafter.
- Infusion Time: Infuse over 1 hour
Subcutaneous Benlysta Dose for SLE Treatment
Adults
- Dose: 200 mg subcutaneously once weekly.
Pediatric (Age 5+ years)
- Weight ≥ 40 kg: 200 mg subcutaneously once weekly.
- Weight 15 kg to less than 40 kg: 200 mg subcutaneously every 2 weeks.
Subcutaneous Benlysta Dose for Lupus Nephritis
Adults
- Loading Dose: 400 mg (two 200 mg injections) weekly for 4 doses
- Maintenance Dose: 200 mg weekly thereafter.
Pediatrics (Age 5+ Years)
- Weight ≥ 40 kg: Loading dose: 400 mg ( two 200 mg injections) weekly for 4 doses. Maintenance dose: 200 mg weekly thereafter.
- Weight 15 kg to less than 40 kg: Loading dose: 200 mg weekly for 4 doses. Maintenance dose: 200 mg every 2 weeks.
What happens if I miss a dose?
If you miss your subcutaneous dose of Benlysta for lupus, inject a dose as soon as you remember. Then, inject your next dose at your regularly scheduled time or continue dosing based on the new day injected.
Call your doctor for instructions if you miss an appointment for an intravenous infusion of Benlysta.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Benlysta?
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 the disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and the nasal flu (influenza) vaccine.
What other drugs will affect Benlysta?
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.
Research does not support using Benlysta with other biologic treatments, such as rituximab, in people with SLE because of the increased incidence of serious infections and post-injection systemic reactions.
Benlysta J Code
Benlysta J code is J0490 (Injection, belimumab, 10 mg).
Storage
Store your Benlysta autoinjectors and prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C).
Keep the product in the original carton to protect it from light until the time of use.
Do not freeze. Do not shake. Avoid exposure to heat.
Ingredients
Active ingredient: belimumab.
Inactive ingredients (intravenous): citric acid, polysorbate 80, sodium citrate, sucrose.
Inactive Ingredients (subcutaneous): L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride, polysorbate 80, sodium chloride.
Benlysta is available as:
- Single-dose vial (120 mg, 400 mg) lyophilized powder for reconstitution and dilution before intravenous infusion
- Single-dose prefilled syringe (200 mg/mL) for subcutaneous use
- The single-dose prefilled syringe is for adults aged 18 years and older.
- Single-dose prefilled autoinjector (200 mg/mL) for subcutaneous use
- The single-dose autoinjector is for adults and children aged 5 years and older.
Manufacturer
Benlysta is manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19104.
Frequently Asked Questions About Benlysta
How long does it take for Benlysta to work for lupus?
Most patients begin to see improvements in lupus symptoms within 2-6 months of starting Benlysta treatment, although some patients may notice reduced fatigue and joint pain as early as 8 weeks.
However, it can take up to 12 months to see the full benefit. Some patients may notice reduced fatigue and joint pain earlier, while improvements in blood work and reduction in lupus flares typically take longer. It's important to continue treatment as prescribed, even if you don't see immediate results, as Benlysta works gradually to suppress the overactive immune response.
Is Benlysta a chemotherapy drug?
No, Benlysta is not a chemotherapy drug. While both Benlysta and chemotherapy can affect the immune system, they work very differently. Benlysta is a targeted biologic therapy that specifically blocks the BLyS protein, which is involved in lupus. Chemotherapy drugs are broader-acting medications that kill rapidly dividing cells. Benlysta is designed to selectively reduce the overactive B-cells that cause lupus without the widespread cellular damage associated with chemotherapy.
Can I get vaccines while taking Benlysta?
You should not receive live vaccines while taking Benlysta, as they may not work properly and could potentially cause infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and the nasal flu vaccine. However, inactivated vaccines (like the flu shot injection) are generally safe and recommended. Always discuss vaccination plans with your healthcare provider before receiving any vaccine while on Benlysta.
What is the difference between Benlysta IV and subcutaneous injections?
Both forms contain the same active ingredient (belimumab) and are equally effective. The main differences are convenience and the administration method. IV infusions are given at a healthcare facility every 2-4 weeks and take about an hour, with medical supervision for potential reactions. Subcutaneous injections can be self-administered at home weekly or every 2 weeks, offering more flexibility and independence. Your doctor will help determine which method is best based on your lifestyle, comfort level with self-injection, and medical needs.
How should I store Benlysta at home?
Store Benlysta autoinjectors and prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C). Keep the product in the original carton to protect it from light until use. Do not freeze, shake, or expose to heat. Before injection, remove from the refrigerator and let it reach room temperature for 30 minutes. Do not use if it has been left at room temperature for longer than 12 hours. If this happens, discard it and contact your pharmacist for a replacement.
Can I drink alcohol while taking Benlysta?
There are no specific restrictions on alcohol consumption with Benlysta. However, since lupus patients often take other medications (like methotrexate or NSAIDs) that can interact with alcohol, and alcohol can worsen some lupus symptoms like fatigue and depression, moderation is advisable. Additionally, alcohol can impair your immune system, which may increase infection risk while on Benlysta. Discuss your alcohol consumption with your healthcare provider to ensure it's safe given your complete medication regimen.
Will Benlysta cure my lupus?
No, Benlysta will not cure lupus. Lupus is a chronic autoimmune condition that currently has no cure. However, Benlysta can significantly help manage lupus by reducing disease activity, decreasing the frequency and severity of flares, improving symptoms like fatigue and joint pain, and potentially slowing organ damage. Many patients experience substantial improvement in their quality of life and ability to perform daily activities. Treatment goals focus on achieving remission or low disease activity while minimizing side effects.
Can I travel while taking Benlysta?
Yes, you can travel while taking Benlysta, but planning is essential. For subcutaneous injections, bring enough medication for your entire trip plus extra in case of delays. Pack Benlysta in your carry-on luggage with a cooling pack (not frozen) and bring your prescription and a doctor's letter. For international travel, research medication import requirements for your destination. If you're on IV infusions, coordinate with your healthcare provider to find infusion centers at your destination or adjust your dosing schedule around travel dates.
Is there financial assistance available for Benlysta?
Yes, several financial assistance options are available. GSK offers the Benlysta Co-pay Program for eligible patients with commercial insurance, which may significantly reduce your out-of-pocket costs. For uninsured or underinsured patients, GSK provides patient assistance programs based on income qualifications. Additionally, many lupus organizations offer grant programs and financial assistance. The Lupus Foundation of America and other patient advocacy groups provide resources for medication assistance. Contact GSK's patient support services at 1-844-4BENLYSTA or speak with your healthcare provider's financial counselor.
Can I get pregnant while taking Benlysta?
If you're planning to become pregnant or become pregnant while taking Benlysta, discuss this immediately with your healthcare provider. The effects of Benlysta on pregnancy are not fully known, though it may cross the placenta and affect your baby's immune system. Your doctor will weigh the benefits of continued lupus treatment against potential pregnancy risks. If you become pregnant while on Benlysta, consider enrolling in the Benlysta Pregnancy Registry (1-877-311-8972) to help gather safety data. Use effective birth control while taking Benlysta and for at least 4 months after your final dose.
What are the signs of a serious allergic reaction to Benlysta?
Serious allergic reactions can occur during or after Benlysta treatment and require immediate medical attention. Warning signs include: difficulty breathing or wheezing, swelling of face, lips, tongue, or throat, widespread skin rash or hives, severe dizziness or fainting, rapid or irregular heartbeat, chest pain or abdominal pain.
Benlysta Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Benlysta.
Benlysta (belimumab) - GlaxoSmithKline LLC
Formulation type | Strength |
---|---|
Autoinjector | 200 mg/mL |
Pre-Filled Syringe | 200 mg/mL |
Single-Dose Vial | 120 mg |
Single-Dose Vial | 400 mg |
Popular FAQ
How long does it take for Benlysta to work?
Benlysta starts working from your very first injection/infusion, but it may take up to 8 weeks before you notice an improvement in some symptoms, and from 4 to 8 months before the full effects at resolving fatigue, joint, and muscle pain are seen. Once an improvement is seen these effects usually persist long term.
Benlysta is a long-term medication and as long as you are tolerating it well, it is important to persist with dosing for several months to see if it works for you.
What is the difference between Benlysta and Saphnelo?
Both Benlysta and Saphnelo are targeted treatments that may be used to treat systemic lupus erythematosus (SLE) in addition to standard therapy. But their approved indications, recommended target age groups, and the way they work, differ. They are the only two medicines to have been approved to treat SLE since the 1950s.
Continue readingDoes Benlysta stop inflammation?
Benylsta does stop inflammation by reducing the activity of certain white blood cells called autoreactive B-cells that produce antibodies that attack healthy cells. This reduces the inflammation that causes the symptoms of lupus.
What's the difference between Lupkynis and Benlysta?
Benlysta subcutaneous or intravenous injection is approved to treat adults and children 5 years of age and older with systemic lupus erythematosus (SLE) and active lupus nephritis (lupus-related kidney inflammation), while Lupkynis oral capsules are only approved to treat lupus nephritis in adults. Lupkynis has not yet been approved for use in children.
Continue readingDoes Benlysta cause weight gain?
Although weight gain is not listed as a side effect of Benlysta in the product information, a phase IV clinical study that analyzed side effect information from 14,100 people who had taken Benlysta reported weight gain as a side effect for 2.87% of them (404 people). Continue reading
Where do you inject Benlysta?
Benlysta injections given at home are injected subcutaneously (this means just under the skin) and there are 2 main areas where Benlysta can be injected:
- The stomach area (your belly) except for a 2-inch circle around your navel (belly button)
- The top and outer part of your thighs, but not your inner thighs or anywhere close to your knee.
Can Benlysta cause an allergic reaction?
Yes, Benlysta can cause an allergic reaction, but serious and life-threatening allergic reactions are uncommon. Approximately 13% of people will experience a mild to moderate hypersensitivity (allergic) reaction on the day they get their Benlysta infusion. Continue reading
How does Benlysta help lupus?
Benlysta helps lupus by reducing disease activity and flares and decreasing the need for steroid medications by up to 25%. Benlysta works for lupus by binding to a substance called BLyS, which helps B cells to survive for longer. When Benlysta is attached to BLyS, BLyS can no longer bind to and stimulate autoreactive B cells. Continue reading
How long does a Benlysta infusion take?
An infusion of Benlysta takes approximately 1 hour, but you may need to go into the place you are getting your infusion from for a short time before to receive any premedication you may need, and stay for a short time after to monitor for any infusion reactions. Continue reading
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