Benlysta 200mg/ml Pf Auto Inj 4x1ml
It is used to treat lupus.It is used to treat kidney problems caused by lupus.
Drug Class
Immunosuppressant
Pharmacologic Class
B-lymphocyte stimulator (BLyS)-specific inhibitor
Pregnancy Category
Not available
FDA Approved
Jul 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Benlysta is a medicine that helps reduce the activity of certain immune cells (B cells) that can cause inflammation and damage in diseases like lupus. It works by blocking a protein called BLyS, which B cells need to survive. By lowering the number of these overactive B cells, Benlysta can help reduce lupus symptoms and prevent flares.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. Take the injection on the same day every week.
Continue taking this medication as directed by your doctor or healthcare provider, even if you feel well. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
Before using this medication, remove it from the refrigerator and let it sit at room temperature for 30 minutes. Do not heat or microwave the medication. Avoid shaking the container. Rotate the injection site with each dose to avoid tenderness or bruising. Do not inject into skin that is tender, bruised, red, or hard.
Check the solution for cloudiness, leakage, or particles before use. The medication should be colorless to faintly yellow. Do not use the medication if the solution has changed color or if the container has been dropped or damaged.
If your dose requires more than one injection, you may administer them in the same body area, but avoid injecting within 2 inches of each other. Discard the syringe after use and do not reuse it. Dispose of needles in a designated sharps container and do not reuse them. When the container is full, follow local regulations for disposal.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it. Keep it in the original container to protect it from light. If necessary, the medication can be left at room temperature for up to 12 hours before use. Discard any unused portion after 12 hours. Protect the medication from heat and sunlight.
Missed Dose
If you miss a dose, take it as soon as you remember. After taking the missed dose, resume your regular schedule or start a new weekly schedule based on the day you took the dose. Do not take two doses on the same day. If you are unsure about what to do if you miss a dose, consult your doctor.
Additional Guidance
If you have any questions or concerns about using this medication, consult your doctor or pharmacist.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. Take the injection on the same day every week.
Continue taking this medication as directed by your doctor or healthcare provider, even if you feel well. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
Before using this medication, remove it from the refrigerator and let it sit at room temperature for 30 minutes. Do not heat or microwave the medication. Avoid shaking the container. Rotate the injection site with each dose to avoid tenderness or bruising. Do not inject into skin that is tender, bruised, red, or hard.
Check the solution for cloudiness, leakage, or particles before use. The medication should be colorless to faintly yellow. Do not use the medication if the solution has changed color or if the container has been dropped or damaged.
If your dose requires more than one injection, you may administer them in the same body area, but avoid injecting within 2 inches of each other. Discard the syringe after use and do not reuse it. Dispose of needles in a designated sharps container and do not reuse them. When the container is full, follow local regulations for disposal.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it. Keep it in the original container to protect it from light. If necessary, the medication can be left at room temperature for up to 12 hours before use. Discard any unused portion after 12 hours. Protect the medication from heat and sunlight.
Missed Dose
If you miss a dose, take it as soon as you remember. After taking the missed dose, resume your regular schedule or start a new weekly schedule based on the day you took the dose. Do not take two doses on the same day. If you are unsure about what to do if you miss a dose, consult your doctor.
Additional Guidance
If you have any questions or concerns about using this medication, consult your doctor or pharmacist.
Lifestyle & Tips
- Maintain good hygiene to reduce infection risk.
- Avoid live vaccines while on Benlysta and for a period after stopping.
- Report any signs of infection (fever, chills, sore throat) immediately.
- Report any new or worsening mood changes, depression, or thoughts of self-harm.
- Follow proper injection technique as instructed by your healthcare provider.
- Keep all scheduled appointments for monitoring and follow-up.
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
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For SLE and LN in patients 5 years of age and older: 80 mg (15 to <30 kg), 120 mg (30 to <40 kg), 160 mg (40 to <50 kg), 200 mg (âĨ50 kg) subcutaneously once weekly.
Adolescent:
For SLE and LN in patients 5 years of age and older: 80 mg (15 to <30 kg), 120 mg (30 to <40 kg), 160 mg (40 to <50 kg), 200 mg (âĨ50 kg) subcutaneously once weekly.
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 expected to be 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 the biological activity of 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 binding to BLyS, belimumab inhibits its ability to bind to receptors on B cells, thereby reducing the survival of B cells, including autoreactive B cells, and decreasing the differentiation of B cells into immunoglobulin-producing plasma cells. This leads to a reduction in circulating B cells and autoantibodies, which are implicated in the pathogenesis of systemic lupus erythematosus and lupus nephritis.
Pharmacokinetics
Absorption:
Bioavailability:
77-80%
Tmax:
2 to 6 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 5.2 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 18.3 days
Clearance:
Approximately 11.2 mL/day/kg
ExcretionRoute:
Reticuloendothelial system (catabolism)
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 16-24 weeks
PeakEffect:
Not precisely defined for clinical effect; pharmacodynamic effects (e.g., B-cell reduction) are sustained with weekly dosing.
DurationOfAction:
Sustained with weekly administration; effects wane upon discontinuation due to 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 or seek immediate 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
Note: 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're bothered by any of the following side effects or if they persist, contact your doctor:
Trouble sleeping
Headache
Upset stomach
Diarrhea
Nose or throat irritation
Arm or leg pain
Irritation at the injection site
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 or seek immediate 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
Note: 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're bothered by any of the following side effects or if they persist, contact your doctor:
Trouble sleeping
Headache
Upset stomach
Diarrhea
Nose or throat irritation
Arm or leg pain
Irritation at the injection site
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, flu-like symptoms, painful urination, skin sores.
- Allergic reaction: rash, hives, itching, swelling of face/lips/tongue, difficulty breathing, dizziness, chest tightness.
- Psychiatric symptoms: new or worsening depression, suicidal thoughts, anxiety, agitation, insomnia.
- Progressive Multifocal Leukoencephalopathy (PML) symptoms (rare): new or worsening weakness on one side of the body, clumsiness, vision changes, confusion, memory problems.
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.
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. 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.
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 tests and other laboratory evaluations should be performed as directed by your doctor 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 crucial to take precautions. To minimize this risk, wash your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
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 the use of vaccines with this medication may either increase the risk of infection or reduce the vaccine's effectiveness.
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.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
For women of childbearing potential, it is essential 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 used this medication during pregnancy, inform your baby's doctor. Additionally, 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 crucial to take precautions. To minimize this risk, wash your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
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 the use of vaccines with this medication may either increase the risk of infection or reduce the vaccine's effectiveness.
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.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
For women of childbearing potential, it is essential 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 used this medication during pregnancy, inform your baby's doctor. Additionally, if you are breastfeeding, consult your doctor to discuss potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are not well-established, but may include increased risk of adverse effects such as infection or hypersensitivity reactions.
What to Do:
There is no specific antidote. In case of overdose, closely monitor the patient for any signs or symptoms of adverse reactions and provide appropriate symptomatic and supportive treatment. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Live vaccines (concurrent administration)
Major Interactions
- Other B-cell targeted biologics (e.g., rituximab) - increased risk of profound immunosuppression
- Cyclophosphamide (high dose) - increased risk of serious infections
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic status and identify potential 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., serum creatinine, BUN)
Rationale: To assess baseline renal function.
Timing: Prior to initiation of therapy
Screening for infections (e.g., Tuberculosis, Hepatitis B/C)
Rationale: To rule out active or latent infections that could be reactivated or exacerbated by immunosuppression.
Timing: Prior to initiation of therapy
Psychiatric history assessment
Rationale: To identify pre-existing psychiatric conditions, as psychiatric events (e.g., depression, suicidal ideation) have been reported.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: At each visit and with patient self-monitoring
Target: Absence of fever, chills, malaise, localized pain/swelling
Action Threshold: Prompt evaluation and management if infection suspected
Signs and symptoms of hypersensitivity/infusion reactions
Frequency: During and after injection, with patient self-monitoring
Target: Absence of rash, pruritus, dyspnea, hypotension, angioedema
Action Threshold: Discontinue injection, administer appropriate medical therapy
Mood changes, suicidal ideation, depression
Frequency: At each visit and with patient self-monitoring
Target: Stable mood, absence of suicidal thoughts
Action Threshold: Referral to mental health specialist if new or worsening psychiatric symptoms occur
Immunization status
Frequency: Periodically
Target: Up-to-date on inactivated vaccines
Action Threshold: Avoid live vaccines during and for a period after treatment
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Cough
- Painful urination
- Skin rash
- Itching
- Swelling of face/lips/tongue
- Difficulty breathing
- Dizziness
- Depressed mood
- Thoughts of self-harm
- Anxiety
- Insomnia
Special Patient Groups
Pregnancy
Belimumab is an IgG1 monoclonal antibody and is known to cross the placental barrier. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. A pregnancy exposure registry is available for women exposed to Benlysta during pregnancy.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for placental transfer increases with gestational age.
Second Trimester:
Increased placental transfer, potential for fetal exposure.
Third Trimester:
Significant placental transfer, potential for fetal exposure and effects on infant immune system (e.g., B-cell depletion) which may affect response to live vaccines post-birth.
Lactation
Belimumab is excreted in human milk. The amount of belimumab in human milk is low, and systemic absorption by a breastfed infant is expected to be low due to the protein nature of the drug. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Benlysta and any potential adverse effects on the breastfed infant from Benlysta or from the underlying maternal condition. Live vaccines should be avoided in breastfed infants if the mother is receiving belimumab.
Infant Risk:
Low risk, but monitor for signs of infection or other adverse effects. Avoid live vaccines in the infant.
Pediatric Use
Approved for SLE and LN in pediatric patients 5 years of age and older weighing at least 15 kg. Dosing is weight-based for subcutaneous administration. Safety and efficacy in pediatric patients younger than 5 years of age have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (âĨ65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No specific dose adjustment is required, but monitor for increased susceptibility to infections.
Clinical Information
Clinical Pearls
- Benlysta is not recommended for use in patients with severe active lupus nephritis or severe active central nervous system lupus (prior to its approval for LN).
- It is not recommended for use in combination with other biologic therapies targeting B cells (e.g., rituximab) or with intravenous cyclophosphamide.
- Patients should be screened for latent infections (e.g., TB) before starting therapy.
- Patients should be advised to complete all age-appropriate immunizations prior to initiating Benlysta. Live vaccines should not be given concurrently with Benlysta.
- Patients should be monitored for psychiatric events, including depression and suicidal ideation, especially those with a history of psychiatric disorders.
- Proper subcutaneous injection technique is crucial for patient adherence and efficacy.
Alternative Therapies
- Hydroxychloroquine
- Corticosteroids (e.g., prednisone)
- Immunosuppressants (e.g., mycophenolate mofetil, azathioprine, methotrexate, cyclophosphamide)
- Rituximab (off-label for SLE)
- Anifrolumab (Saphnelo) - another biologic for SLE
Cost & Coverage
Average Cost:
Highly variable, typically >$1,000 per 200mg/ml auto-injector
Insurance Coverage:
Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.