Benlysta 400mg Inj, 1vl
It is used to treat lupus.It is used to treat kidney problems caused by lupus.
Drug Class
Immunosuppressant, Selective
Pharmacologic Class
B-lymphocyte stimulator (BLyS)-specific inhibitor; Monoclonal antibody
Pregnancy Category
Not assigned (Risk Summary available)
FDA Approved
Mar 2011
DEA Schedule
Not Controlled
Overview
What is this medicine?
Benlysta is a medicine given by injection that helps to reduce the activity of your immune system. It works by targeting a specific protein in your body that can cause lupus symptoms. By lowering the levels of this protein, Benlysta can help reduce inflammation and improve your lupus.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all the information provided. Administration of this drug involves an infusion into a vein over a specified period of time. In some cases, other medications may be administered before this drug to minimize potential side effects.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
Lifestyle & Tips
- Avoid live vaccines while taking Benlysta and for a period after stopping it. Discuss all vaccinations with your doctor.
- Report any signs of infection (fever, chills, sore throat, cough, unusual fatigue) to your doctor immediately.
- Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
- Stay hydrated and maintain good hygiene to help prevent infections.
- Attend all scheduled appointments for infusions and monitoring.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg/kg IV every 2 weeks for the first 3 doses, then 10 mg/kg IV every 4 weeks thereafter.
Condition-Specific Dosing:
Systemic Lupus Erythematosus (SLE):
10 mg/kg IV every 2 weeks for 3 doses, then every 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For patients 5 years of age and older: 10 mg/kg IV every 2 weeks for the first 3 doses, then 10 mg/kg IV every 4 weeks thereafter.
Adolescent:
For patients 5 years of age and older: 10 mg/kg IV every 2 weeks for the first 3 doses, then 10 mg/kg IV every 4 weeks thereafter.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Dialysis:
No specific recommendations; Belimumab is a large protein and unlikely to be removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Pharmacology
Mechanism of Action
Belimumab is a human IgG1Ξ» monoclonal antibody that specifically binds to and inhibits the biological activity of B-lymphocyte stimulator (BLyS, also known as BAFF and TNFSF13B). BLyS is a naturally occurring cytokine that promotes the survival of B lymphocytes, including autoreactive B cells, and is elevated in patients with SLE. By binding to BLyS, belimumab reduces the number of circulating B cells, including naive and activated B cells, and plasma cells, thereby reducing autoantibody production and disease activity in SLE.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV administration)
Tmax:
Not applicable (IV)
FoodEffect:
Not applicable (IV)
Distribution:
Vd:
Approximately 5.2 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 11 to 20 days
Clearance:
Approximately 2.1 mL/day/kg
ExcretionRoute:
Not applicable (protein degradation)
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 16-24 weeks.
PeakEffect:
Maximum reduction in B-cell levels typically observed by 8 weeks.
DurationOfAction:
Maintained with continued dosing every 4 weeks due to long half-life.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
New or worsening behavioral or mood changes, such as:
+ Depression
+ Suicidal thoughts
Chest pain or pressure
Slow heartbeat
Muscle pain
Dizziness or fainting
Shortness of breath
Cold sweats
Severe stomach upset or vomiting
A rare but serious brain condition called progressive multifocal leukoencephalopathy (PML) has been associated with this medication. If you experience any of the following symptoms, contact your doctor right away:
+ Confusion
+ Memory problems
+ Depression
+ Changes in behavior
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Balance problems
+ Vision changes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you're bothered by any of the following side effects or if they don't go away, contact your doctor:
Trouble sleeping
Headache
Upset stomach
Diarrhea
Nose or throat irritation
Pain in arms or legs
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
New or worsening behavioral or mood changes, such as:
+ Depression
+ Suicidal thoughts
Chest pain or pressure
Slow heartbeat
Muscle pain
Dizziness or fainting
Shortness of breath
Cold sweats
Severe stomach upset or vomiting
A rare but serious brain condition called progressive multifocal leukoencephalopathy (PML) has been associated with this medication. If you experience any of the following symptoms, contact your doctor right away:
+ Confusion
+ Memory problems
+ Depression
+ Changes in behavior
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Balance problems
+ Vision changes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you're bothered by any of the following side effects or if they don't go away, contact your doctor:
Trouble sleeping
Headache
Upset stomach
Diarrhea
Nose or throat irritation
Pain in arms or legs
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of infection (fever, chills, body aches, cough, sore throat, painful urination)
- Allergic reactions (rash, hives, swelling of face/lips/tongue, difficulty breathing, dizziness)
- New or worsening depression, anxiety, or thoughts of suicide
- Unusual weakness or numbness
- Severe headache
- Vision changes
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including any symptoms.
If you currently have an infection.
If you have nervous system problems caused by lupus.
If you are taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
* If you have received a vaccine within the past month.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including any symptoms.
If you currently have an infection.
If you have nervous system problems caused by lupus.
If you are taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
* If you have received a vaccine within the past month.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your condition.
As this medication may increase your risk of developing infections, some of which can be severe or life-threatening, it is vital to take precautions. To minimize this risk, wash your hands frequently and avoid close contact with individuals who have infections, colds, or flu. Additionally, ensure you are up to date with all recommended vaccinations before starting treatment with this drug. If you have recently received a vaccine or plan to get vaccinated, consult your doctor, as this medication may either increase the risk of infection or reduce the effectiveness of the vaccine.
This medication can suppress the immune system, which may increase the risk of certain types of cancer. If you have concerns, discuss them with your doctor. Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.
If you are of childbearing potential, it is crucial to use effective birth control while taking this medication and for a specified period after the last dose. Your doctor will advise you on the duration of birth control use. If you become pregnant, notify your doctor immediately. If you have used this medication during pregnancy, inform your baby's doctor.
Infusion reactions can occur with this medication, often on the same day as the infusion. If you experience any adverse effects during or after the infusion, report them to your doctor promptly. If you are breastfeeding, consult your doctor to discuss potential risks to your baby.
As this medication may increase your risk of developing infections, some of which can be severe or life-threatening, it is vital to take precautions. To minimize this risk, wash your hands frequently and avoid close contact with individuals who have infections, colds, or flu. Additionally, ensure you are up to date with all recommended vaccinations before starting treatment with this drug. If you have recently received a vaccine or plan to get vaccinated, consult your doctor, as this medication may either increase the risk of infection or reduce the effectiveness of the vaccine.
This medication can suppress the immune system, which may increase the risk of certain types of cancer. If you have concerns, discuss them with your doctor. Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.
If you are of childbearing potential, it is crucial to use effective birth control while taking this medication and for a specified period after the last dose. Your doctor will advise you on the duration of birth control use. If you become pregnant, notify your doctor immediately. If you have used this medication during pregnancy, inform your baby's doctor.
Infusion reactions can occur with this medication, often on the same day as the infusion. If you experience any adverse effects during or after the infusion, report them to your doctor promptly. If you are breastfeeding, consult your doctor to discuss potential risks to your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Doses up to 20 mg/kg IV have been administered without dose-limiting toxicity.
What to Do:
In case of suspected overdose, contact a poison control center or emergency medical services immediately. Provide supportive care and monitor for adverse reactions. Call 1-800-222-1222 for poison control.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, yellow fever) - due to risk of infection in immunosuppressed patients.
Major Interactions
- Other biologic therapies targeting B cells (e.g., rituximab) - due to potential for additive immunosuppression and increased risk of serious infections.
- Cyclophosphamide (especially IV) - due to potential for increased risk of serious infections when co-administered with belimumab.
Moderate Interactions
- Other immunosuppressants (e.g., azathioprine, methotrexate, mycophenolate mofetil) - potential for increased risk of infection, monitor closely.
- Non-live vaccines - may result in a diminished immune response to vaccination.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic status and monitor for cytopenias.
Timing: Prior to initiation of therapy.
Liver function tests (LFTs)
Rationale: To assess baseline hepatic function.
Timing: Prior to initiation of therapy.
Renal function tests (e.g., creatinine, BUN)
Rationale: To assess baseline renal function.
Timing: Prior to initiation of therapy.
Screening for active infections (e.g., TB, Hepatitis B/C)
Rationale: To rule out pre-existing infections that could be exacerbated by immunosuppression.
Timing: Prior to initiation of therapy.
Mental health assessment
Rationale: To establish baseline for potential psychiatric events.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of infection
Frequency: At each visit and instruct patient to report promptly.
Target: Absence of fever, chills, malaise, localized signs of infection.
Action Threshold: Prompt evaluation and treatment if infection suspected.
Hypersensitivity/Infusion reactions
Frequency: During and for a period after each infusion.
Target: Absence of rash, pruritus, dyspnea, hypotension, angioedema.
Action Threshold: Stop infusion, administer appropriate medical management.
Neuropsychiatric events (e.g., depression, suicidal ideation)
Frequency: At each visit and instruct patient to report promptly.
Target: Stable mood, absence of new or worsening psychiatric symptoms.
Action Threshold: Referral to mental health specialist, consider discontinuation if severe.
SLE disease activity (e.g., SLEDAI, BILAG)
Frequency: Periodically, as per clinical judgment (e.g., every 3-6 months).
Target: Reduction in disease activity, prevention of flares.
Action Threshold: Re-evaluate treatment plan if inadequate response or worsening disease.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Cough
- Unusual fatigue
- Skin rash
- Itching
- Swelling of face/lips/tongue
- Difficulty breathing
- Dizziness
- Headache
- Nausea
- Diarrhea
- Abdominal pain
- New or worsening depression
- Suicidal thoughts or behavior
- Anxiety
- Insomnia
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. There is a pregnancy exposure registry for Benlysta (1-877-681-6296). Human IgG antibodies are known to cross the placental barrier.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies showed no direct embryofetal toxicity but some effects on B-cell development in offspring.
Second Trimester:
Increased placental transfer of IgG antibodies occurs during the second and third trimesters.
Third Trimester:
Increased placental transfer of IgG antibodies occurs during the second and third trimesters. Potential for effects on B-cell development in the fetus.
Lactation
Belimumab is present in human milk. Consider the developmental and health benefits of breastfeeding along with the motherβs clinical need for Benlysta and any potential adverse effects on the breastfed infant from Benlysta or from the underlying maternal condition. Monitor breastfed infants for signs of infection.
Infant Risk:
Low to moderate risk. Potential for infant exposure and effects on infant B-cell development, though oral bioavailability is likely low.
Pediatric Use
Approved for patients 5 years of age and older with active SLE. Safety and efficacy have not been established in pediatric patients younger than 5 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (β₯65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No specific dose adjustment is required.
Clinical Information
Clinical Pearls
- Benlysta is not recommended for patients with severe active lupus nephritis or severe active central nervous system lupus due to insufficient data in these populations.
- Patients should be pre-medicated with an antihistamine, and/or antipyretic prior to infusion to reduce the risk of infusion reactions.
- Monitor patients for at least 1 hour after infusion for signs of hypersensitivity reactions.
- Patients should be advised about the increased risk of infections and psychiatric events, including depression and suicidal ideation.
- Benlysta should not be administered with other biologic therapies targeting B cells (e.g., rituximab) or with intravenous cyclophosphamide.
Alternative Therapies
- Anifrolumab (Saphnelo) - another biologic for SLE
- Hydroxychloroquine (Plaquenil)
- Corticosteroids (e.g., Prednisone)
- Immunosuppressants (e.g., Mycophenolate mofetil, Azathioprine, Methotrexate, Cyclophosphamide)
- Rituximab (off-label use for SLE)
Cost & Coverage
Average Cost:
Highly variable, typically >$1,000 per vial per 400mg vial
Insurance Coverage:
Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.