Benlysta 120mg 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 available
FDA Approved
Jul 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Benlysta is a medicine used to treat lupus. It works by targeting and reducing the number of certain immune cells called B cells, which are overactive in people with lupus. By lowering these cells, Benlysta helps reduce inflammation and symptoms of lupus.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a period of time. In some cases, other medications may be given before this one to help minimize side effects.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best way to store it.
Missing a Dose
If you miss a dose, contact your doctor to find out what steps to take next.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a period of time. In some cases, other medications may be given before this one to help minimize side effects.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best way to store it.
Missing a Dose
If you miss a dose, contact your doctor to find out what steps to take next.
Lifestyle & Tips
- Report any signs of infection (e.g., fever, chills, persistent cough) to your doctor immediately.
- Avoid live vaccines (e.g., MMR, varicella, yellow fever) while taking Benlysta and for a period after stopping treatment. Discuss all vaccinations with your doctor.
- Inform your healthcare provider about all medications you are taking, including over-the-counter drugs, supplements, and herbal products.
- Practice good hygiene, such as frequent handwashing, to reduce the risk of infection.
- If self-administering, follow your healthcare provider's instructions carefully for proper injection technique and storage.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
200 mg subcutaneously once weekly
Dose Range:
200 - 200 mg
Condition-Specific Dosing:
Systemic Lupus Erythematosus (SLE):
200 mg subcutaneously once weekly
Lupus Nephritis (LN):
200 mg subcutaneously once weekly (after initial IV induction if applicable, or as monotherapy)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
No specific recommendations; belimumab is a large protein and not removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Pharmacology
Mechanism of Action
Belimumab is a human IgG1Îģ monoclonal antibody that specifically binds to and inhibits B-lymphocyte stimulator (BLyS), also known as B-cell activating factor (BAFF). BLyS is a naturally occurring cytokine that promotes the survival of B lymphocytes. By inhibiting BLyS, belimumab reduces the number of circulating B cells, including autoreactive B cells, which are thought to play a role in the pathogenesis of systemic lupus erythematosus (SLE) and lupus nephritis.
Pharmacokinetics
Absorption:
Bioavailability:
77%
Tmax:
2-6 days
FoodEffect:
Not applicable (injectable)
Distribution:
Vd:
Approximately 5.2 L (central compartment)
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 18.3 days
Clearance:
Approximately 11.2 mL/day/kg
ExcretionRoute:
Not applicable (protein degradation)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Gradual, clinical improvement seen over several weeks to months. Reduction in B-cell counts observed within weeks.
PeakEffect:
Clinical response typically observed after 6 months of treatment.
DurationOfAction:
Sustained as long as treatment continues.
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
In rare cases, allergic reactions can be fatal.
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ 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 immediately:
+ Confusion
+ Memory problems
+ Depression
+ Changes in behavior
+ Unequal strength in your arms or legs
+ Difficulty speaking or thinking
+ Balance problems
+ Vision changes
PML can cause disability or be life-threatening.
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 notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Trouble sleeping
Headache
Upset stomach
Diarrhea
Nose or throat irritation
* Arm or leg pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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
In rare cases, allergic reactions can be fatal.
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ 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 immediately:
+ Confusion
+ Memory problems
+ Depression
+ Changes in behavior
+ Unequal strength in your arms or legs
+ Difficulty speaking or thinking
+ Balance problems
+ Vision changes
PML can cause disability or be life-threatening.
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 notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Trouble sleeping
Headache
Upset stomach
Diarrhea
Nose or throat irritation
* Arm or leg pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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:
- Fever or chills
- Persistent cough or sore throat
- Unusual fatigue or weakness
- New or worsening skin rash, hives, or itching
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or shortness of breath
- Dizziness or lightheadedness
- New or worsening feelings of depression, anxiety, or thoughts of harming yourself
- Numbness, tingling, or weakness on one side of the body
- Changes in vision
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. Be sure to describe the symptoms you experienced.
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. Never start, stop, or adjust 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. Be sure to describe the symptoms you experienced.
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. Never start, stop, or adjust 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 health.
As this medication may increase your risk of developing infections, some of which can be severe or life-threatening, it is vital to take preventive measures. Frequent handwashing and avoiding close contact with individuals who have infections, colds, or flu can help minimize this risk.
Before starting treatment with this drug, ensure you are up to date with all recommended vaccinations. 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 vaccine's effectiveness.
This medication can weaken your immune system, which may increase the risk of certain types of cancer. If you have concerns, discuss them with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant or may become pregnant, it is crucial to use birth control while taking this medication and for a specified period after the last dose. Consult your doctor to determine the recommended duration of birth control. If you become pregnant, notify your doctor immediately. Additionally, if you took 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 and determine the best course of action.
As this medication may increase your risk of developing infections, some of which can be severe or life-threatening, it is vital to take preventive measures. Frequent handwashing and avoiding close contact with individuals who have infections, colds, or flu can help minimize this risk.
Before starting treatment with this drug, ensure you are up to date with all recommended vaccinations. 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 vaccine's effectiveness.
This medication can weaken your immune system, which may increase the risk of certain types of cancer. If you have concerns, discuss them with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant or may become pregnant, it is crucial to use birth control while taking this medication and for a specified period after the last dose. Consult your doctor to determine the recommended duration of birth control. If you become pregnant, notify your doctor immediately. Additionally, if you took 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 and determine the best course of action.
Overdose Information
Overdose Symptoms:
What to Do:
Contact a poison control center or seek emergency medical attention immediately. Call 1-800-222-1222 (Poison Control). Management should be supportive and directed toward the patient's symptoms.
Drug Interactions
Contraindicated Interactions
- Live vaccines (concurrent administration)
Major Interactions
- Other biologic therapies for SLE (e.g., rituximab, anifrolumab) - increased risk of serious infections and adverse events.
Moderate Interactions
- Immunosuppressants (e.g., azathioprine, methotrexate, mycophenolate mofetil) - increased risk of infection (often used concurrently, but requires careful monitoring).
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To assess baseline blood counts and rule out active infection or cytopenias.
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function.
Timing: Prior to initiation
Renal Function Tests (e.g., serum creatinine, eGFR)
Rationale: To assess baseline kidney function, especially important for lupus nephritis.
Timing: Prior to initiation
Screening for active infections (e.g., Tuberculosis, Hepatitis B/C)
Rationale: Belimumab is immunosuppressive; active infections should be treated before initiation.
Timing: Prior to initiation
Immunization status review
Rationale: Ensure patient is up-to-date on non-live vaccines.
Timing: Prior to initiation
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant cytopenias (e.g., persistent neutropenia, lymphopenia) may warrant dose interruption or discontinuation.
Signs and symptoms of infection
Frequency: Continuously
Target: Absence of infection
Action Threshold: Fever, chills, persistent cough, unusual fatigue, or other signs of infection should prompt immediate medical evaluation.
Signs and symptoms of hypersensitivity/injection site reactions
Frequency: During and after administration, and with subsequent doses
Target: Absence of reactions
Action Threshold: Rash, itching, swelling, dizziness, shortness of breath, or other signs of allergic reaction require immediate intervention.
Lupus disease activity (e.g., SLEDAI, PGA)
Frequency: Periodically (e.g., every 3-6 months)
Target: Reduction in disease activity
Action Threshold: Lack of response or worsening disease may indicate need for re-evaluation of treatment plan.
Mood changes/psychiatric symptoms
Frequency: Periodically
Target: Stable mood
Action Threshold: New or worsening depression, suicidal ideation, or other psychiatric symptoms should be evaluated promptly.
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Sore throat
- Painful urination
- Unusual fatigue
- Skin rash
- Itching
- Swelling of face, lips, or tongue
- Difficulty breathing
- Dizziness
- New or worsening mood changes (e.g., depression, suicidal thoughts)
- Numbness
- Tingling
- Weakness on one side of the body
- Vision changes
Special Patient Groups
Pregnancy
Use only if the potential benefit justifies the potential risk to the fetus. Belimumab is an IgG antibody and can cross the placenta, particularly in the third trimester. A pregnancy exposure registry is available.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally lower fetal exposure.
Second Trimester:
Increasing fetal exposure as placental transfer of IgG antibodies increases.
Third Trimester:
Highest fetal exposure. Potential for effects on infant immune system (e.g., B-cell depletion). Live vaccines should not be given to infants exposed in utero for at least 6 months after birth, or until B-cell counts recover.
Lactation
Probably compatible. Limited human data suggest low levels of belimumab in breast milk. As a large protein, it is likely poorly absorbed orally by the infant.
Infant Risk:
Low. Monitor breastfed infants for signs of infection or adverse effects.
Pediatric Use
The 120mg subcutaneous formulation of Benlysta is not approved for pediatric use. The intravenous formulation is approved for systemic lupus erythematosus (SLE) and lupus nephritis (LN) in pediatric patients aged 5 years and older.
Geriatric Use
No specific dose adjustment is needed. Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. Use with caution due to the generally higher incidence of infections and other comorbidities in the elderly.
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 from clinical trials.
- Patients should be screened for depression and suicidal ideation before and during treatment, as psychiatric events have been reported.
- Patients should complete all appropriate immunizations prior to initiating Benlysta. Live vaccines should not be given concurrently with belimumab.
- Hypersensitivity reactions, including anaphylaxis, can occur. Patients should be monitored during and after administration, especially for the first few doses.
- Increased risk of serious infections, including opportunistic infections. Patients should be advised to report any signs of infection promptly.
Alternative Therapies
- Hydroxychloroquine
- Methotrexate
- Azathioprine
- Mycophenolate Mofetil
- Cyclophosphamide
- Rituximab (off-label for SLE)
- Anifrolumab (another biologic for SLE)
Cost & Coverage
Average Cost:
Typically several thousand dollars per month per 200 mg subcutaneous dose
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.