Benlysta 200mg/ml Pf Syr 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; Monoclonal antibody
Pregnancy Category
Not available
FDA Approved
Mar 2011
DEA Schedule
Not Controlled
Overview
What is this medicine?
Benlysta is a medicine used to treat lupus. It works by targeting a specific protein in your body that helps certain immune cells (B cells) survive. In lupus, these B cells can be overactive and cause inflammation and damage. By blocking this protein, Benlysta helps reduce the number of these overactive B cells, which can help reduce lupus symptoms and prevent flares.
How to Use This Medicine
Taking Your 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 the medication as directed by your doctor or healthcare provider, even if you're feeling well.
If you'll be administering the injection yourself, your doctor or nurse will provide guidance on the proper technique. Before using the medication, remove it from the refrigerator and let it sit at room temperature for 30 minutes. Do not heat or microwave the medication, and avoid shaking it. 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 medication before use to ensure it is not cloudy, leaking, or contains particles. The solution should be colorless to faintly yellow; do not use it if the color has changed. Also, do not use the medication if it has been dropped or damaged.
If your dose requires more than one injection, you can administer them in the same body area, but make sure to space them at least 2 inches apart. Dispose of the syringe after use and do not reuse it. Throw away needles in a designated sharps disposal container and do not reuse them. When the container is full, follow local regulations for disposal. If you have any questions, consult your doctor or pharmacist.
Storing and Disposing of Your Medication
Store the medication in the refrigerator, but do not freeze it. Keep it in the original container to protect it from light. If needed, the medication can be left at room temperature for up to 12 hours before use. Discard any unused medication after 12 hours. Protect the medication from heat and sunlight.
Missing a Dose
If you miss a dose, take it as soon as you remember. After taking the missed dose, you can either continue with your regular schedule or start a new weekly schedule based on the day you took the missed dose. Do not take two doses on the same day. If you're unsure about what to do if you miss a dose, contact your doctor.
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 the medication as directed by your doctor or healthcare provider, even if you're feeling well.
If you'll be administering the injection yourself, your doctor or nurse will provide guidance on the proper technique. Before using the medication, remove it from the refrigerator and let it sit at room temperature for 30 minutes. Do not heat or microwave the medication, and avoid shaking it. 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 medication before use to ensure it is not cloudy, leaking, or contains particles. The solution should be colorless to faintly yellow; do not use it if the color has changed. Also, do not use the medication if it has been dropped or damaged.
If your dose requires more than one injection, you can administer them in the same body area, but make sure to space them at least 2 inches apart. Dispose of the syringe after use and do not reuse it. Throw away needles in a designated sharps disposal container and do not reuse them. When the container is full, follow local regulations for disposal. If you have any questions, consult your doctor or pharmacist.
Storing and Disposing of Your Medication
Store the medication in the refrigerator, but do not freeze it. Keep it in the original container to protect it from light. If needed, the medication can be left at room temperature for up to 12 hours before use. Discard any unused medication after 12 hours. Protect the medication from heat and sunlight.
Missing a Dose
If you miss a dose, take it as soon as you remember. After taking the missed dose, you can either continue with your regular schedule or start a new weekly schedule based on the day you took the missed dose. Do not take two doses on the same day. If you're unsure about what to do if you miss a dose, contact your doctor.
Lifestyle & Tips
- Avoid live vaccines while on Benlysta and for a period after stopping treatment. Discuss all vaccinations with your doctor.
- Report any signs of infection (fever, chills, sore throat, cough, unusual tiredness) to your doctor immediately.
- Be aware of and report any new or worsening mood changes, depression, or thoughts of self-harm.
- Store prefilled syringes in the refrigerator (2Β°C to 8Β°C / 36Β°F to 46Β°F) in the original carton to protect from light. Do not freeze. Do not shake.
- Allow the syringe to reach room temperature for 30 minutes before injecting. Do not warm it in any other way.
- Rotate injection sites (thigh, abdomen, upper arm) each week.
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 for subcutaneous formulation under 5 years of age. For children 5 to <18 years of age with SLE: 200 mg subcutaneously once weekly.
Adolescent:
200 mg subcutaneously once weekly (for SLE and LN)
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary
Dialysis:
No dosage adjustment necessary; Belimumab is a large protein and not removed by dialysis.
Hepatic Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary
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 B-cell activating factor (BAFF). BLyS is a naturally occurring cytokine that promotes the survival of B lymphocytes. By binding to 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:
75% (subcutaneous)
Tmax:
2 to 6 days (subcutaneous)
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 (subcutaneous)
Clearance:
Approximately 11.2 mL/day/kg (subcutaneous)
ExcretionRoute:
Reticuloendothelial system (catabolism)
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Reduction in B-cell counts observed within weeks; clinical response typically seen after several months of treatment.
PeakEffect:
Peak reduction in B-cell counts typically observed by 8 weeks.
DurationOfAction:
Effects persist for several weeks after discontinuation 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
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 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
* Irritation at the injection site
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 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
* Irritation at the injection site
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:
- Signs of serious infection (e.g., high fever, persistent cough, severe chills, unusual skin lesions)
- Severe allergic reaction (e.g., difficulty breathing, swelling of face/lips/tongue, hives, dizziness, rapid heartbeat)
- New or worsening depression, suicidal thoughts or behavior, anxiety, agitation, or other unusual mood changes
- Progressive multifocal leukoencephalopathy (PML) symptoms (e.g., progressive weakness on one side of the body, clumsiness, vision changes, changes in thinking or memory)
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. Be sure to describe the allergic reaction and its 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. Be sure to describe the allergic reaction and its 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 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 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 that you are up to date with all recommended vaccinations. If you have recently received a vaccine or plan to get vaccinated, consult your doctor to discuss the potential risks and benefits. The use of vaccines in combination with 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 developing certain types of cancer. If you have concerns or questions, discuss them with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to experiencing side effects.
If you are a female patient of childbearing potential, it is essential to use effective birth control methods while taking this medication and for a specified period after the last dose. Consult your doctor to determine the recommended duration of birth control use. If you become pregnant, notify your doctor immediately.
If you were taking this medication during pregnancy, inform your baby's doctor to ensure the best possible care for your child.
If you are breastfeeding, consult your doctor to discuss the potential risks and benefits of continuing to take this medication, as it may affect 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 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 that you are up to date with all recommended vaccinations. If you have recently received a vaccine or plan to get vaccinated, consult your doctor to discuss the potential risks and benefits. The use of vaccines in combination with 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 developing certain types of cancer. If you have concerns or questions, discuss them with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to experiencing side effects.
If you are a female patient of childbearing potential, it is essential to use effective birth control methods while taking this medication and for a specified period after the last dose. Consult your doctor to determine the recommended duration of birth control use. If you become pregnant, notify your doctor immediately.
If you were taking this medication during pregnancy, inform your baby's doctor to ensure the best possible care for your child.
If you are breastfeeding, consult your doctor to discuss the potential risks and benefits of continuing to take this medication, as it may affect your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are not well-established. High doses may increase the risk of adverse effects, particularly infections and hypersensitivity reactions.
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 (concurrent administration)
Major Interactions
- Other biologic therapies for SLE (e.g., rituximab, abatacept, cyclophosphamide, IV immunoglobulins) - increased risk of serious infections and other adverse events. Co-administration is not recommended.
- Live attenuated vaccines (concurrent administration)
Moderate Interactions
- Immunosuppressants (e.g., azathioprine, methotrexate, mycophenolate mofetil, corticosteroids) - increased risk of infection when used concurrently, but often part of standard care for SLE.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline hematologic parameters and monitor for cytopenias.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: To establish baseline liver function.
Timing: Prior to initiation of therapy
Renal Function (SCr, BUN)
Rationale: To establish baseline kidney function.
Timing: Prior to initiation of therapy
Infection screening (e.g., TB, 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
Vaccination status
Rationale: To ensure patient is up-to-date on non-live vaccines and to avoid live vaccines during treatment.
Timing: Prior to initiation of therapy
Psychiatric history assessment
Rationale: To assess for pre-existing depression, suicidal ideation, or other psychiatric disorders.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: At each visit and ongoing patient self-monitoring
Target: Absence of fever, malaise, localized infection signs
Action Threshold: Prompt evaluation and treatment of any suspected infection
Signs and symptoms of hypersensitivity/infusion reactions
Frequency: During and after administration (especially initial doses), and ongoing patient self-monitoring
Target: Absence of rash, urticaria, dyspnea, hypotension, angioedema
Action Threshold: Immediate medical attention for severe reactions; manage with antihistamines, corticosteroids, epinephrine as needed
Psychiatric symptoms (e.g., depression, suicidal ideation, anxiety)
Frequency: At each visit and ongoing patient self-monitoring
Target: Stable mood, absence of new or worsening psychiatric symptoms
Action Threshold: Prompt psychiatric evaluation if new or worsening symptoms occur; consider discontinuation if severe
CBC with differential
Frequency: Periodically, as clinically indicated (e.g., every 3-6 months or if signs of cytopenia)
Target: Within normal limits
Action Threshold: Investigate significant abnormalities; consider dose modification or discontinuation if severe or persistent
Symptom Monitoring
- Signs of infection (fever, chills, sore throat, cough, painful urination, skin lesions)
- Allergic reactions (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
- Mood changes (new or worsening depression, anxiety, suicidal thoughts, unusual behavior)
- Headache
- Nausea
- Diarrhea
- Insomnia
- Pain in arms or legs
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit outweighs the potential risk to the fetus. There is a pregnancy exposure registry for Benlysta. Belimumab is an IgG antibody and can cross the placental barrier, particularly during the third trimester.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies showed no direct embryofetal toxicity.
Second Trimester:
Limited human data.
Third Trimester:
Increased placental transfer of IgG antibodies; potential for fetal exposure and effects on fetal immune development. Consider discontinuing belimumab at least 10 weeks prior to anticipated delivery.
Lactation
Belimumab is present in human milk. The effects of belimumab on the breastfed infant and on milk production are unknown. Consider the developmental and health benefits of breastfeeding along with the motherβs clinical need for belimumab and any potential adverse effects on the breastfed infant from belimumab or from the underlying maternal condition.
Infant Risk:
L3 (Moderate risk) - Due to its large molecular weight, absorption by the infant is unlikely, but potential for effects on infant immune system cannot be excluded. Monitor breastfed infants for signs of infection or adverse reactions.
Pediatric Use
Approved for children aged 5 years and older with active SLE and for children aged 5 years and older with active lupus nephritis. Dosing is 200 mg subcutaneously once weekly. Safety and efficacy in children younger than 5 years have not been established.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No overall differences in safety or effectiveness were observed between elderly and younger patients. No specific dose adjustment is required based on age.
Clinical Information
Clinical Pearls
- Benlysta is a biologic agent and should be administered by patients or caregivers only after proper training by a healthcare professional.
- The subcutaneous formulation is intended for maintenance therapy and offers convenience for patients who prefer self-administration at home.
- Patients should be advised to rotate injection sites to prevent lipodystrophy or skin irritation.
- Ensure patients understand the importance of avoiding live vaccines while on belimumab and for a period after discontinuation.
- Counsel patients on the signs and symptoms of infection and hypersensitivity reactions, and when to seek immediate medical attention.
- Emphasize the importance of reporting any new or worsening psychiatric symptoms, including depression or suicidal thoughts.
- Benlysta is not recommended for patients with severe active central nervous system lupus or severe active lupus nephritis (for IV formulation, SC is approved for LN).
- It is crucial to continue standard background therapy for SLE (e.g., corticosteroids, antimalarials, immunosuppressants) as prescribed by the physician, as Benlysta is used in combination with these therapies.
Alternative Therapies
- Hydroxychloroquine
- Corticosteroids (e.g., prednisone)
- Immunosuppressants (e.g., methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide)
- Rituximab (off-label for SLE)
- Anifrolumab (Saphnelo - Type I interferon receptor antagonist)
Cost & Coverage
Average Cost:
Varies significantly, typically several thousand USD per 200mg/ml prefilled syringe
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 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 of this medication. If you have any questions or concerns about this medication, consult 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.