Please wait while the formulary information is being retrieved.
DRUG IMAGES
BENLYSTA 400 MG VIAL
BENLYSTA 120 MG VIAL
BENLYSTA 200 MG/ML AUTOINJECT
BENLYSTA 200 MG/ML SYRINGE
The following indications for BENLYSTA (belimumab) have been approved by the FDA:
Indications:
Active lupus nephritis
Systemic lupus erythematosus
Professional Synonyms:
Disseminated lupus erythematosus
Lupus erythematosus syndrome
Indications:
Active lupus nephritis
Systemic lupus erythematosus
Professional Synonyms:
Disseminated lupus erythematosus
Lupus erythematosus syndrome
The following dosing information is available for BENLYSTA (belimumab):
The recommended IV dosage of belimumab for the management of systemic lupus erythematosus (SLE) in adults and pediatric patients >=5 years of age is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.
The recommended subcutaneous dosage of belimumab for the management of SLE in adults is 200 mg once weekly via autoinjector or prefilled syringe.
The recommended subcutaneous dosage of belimumab for the management of SLE in pediatric patients 5 to <18 years of age weighing >=40 kg is 200 mg once weekly. The recommended subcutaneous dosage in pediatric patients 5 to <18 years of age weighing 15 to <40 kg is 200 mg once every 2 weeks. Subcutaneous doses should be administered via autoinjector only as the prefilled syringe has not been evaluated in pediatric patients <18 years of age.
Subcutaneous doses should preferably be administered on the same day each week or the same day of alternate weeks, as appropriate.
If transitioning from IV therapy with belimumab to subcutaneous administration, administer the first subcutaneous dose 1-4 weeks after the last IV dose.
If a dose is missed, the dose should be administered as soon as the patient remembers. Dosing can then be resumed on the usual day of administration or a new schedule may be started from the day the missed dose was administered.
The recommended IV dosage of belimumab for the management of lupus nephritis in adults and pediatric patients >=5 years of age is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.
The recommended subcutaneous dosage of belimumab for the management of lupus nephritis in adults is 400 mg (two 200-mg injections) once weekly for 4 doses, then 200 mg once weekly thereafter via autoinjector or prefilled syringe.
Safety and efficacy of subcutaneous administration of belimumab have not been established in pediatric patients <18 years of age.
A transition from IV therapy with belimumab to subcutaneous administration may occur any time after the patient completes the first 2 IV doses. If transitioning to subcutaneous belimumab, administer the first subcutaneous dose of 200 mg 1-2 weeks after the last IV dose.
If a dose is missed, the dose should be administered as soon as the patient remembers. Dosing can then be resumed on the usual day of administration or a new schedule may be started from the day the missed dose was administered.
The recommended subcutaneous dosage of belimumab for the management of SLE in adults is 200 mg once weekly via autoinjector or prefilled syringe.
The recommended subcutaneous dosage of belimumab for the management of SLE in pediatric patients 5 to <18 years of age weighing >=40 kg is 200 mg once weekly. The recommended subcutaneous dosage in pediatric patients 5 to <18 years of age weighing 15 to <40 kg is 200 mg once every 2 weeks. Subcutaneous doses should be administered via autoinjector only as the prefilled syringe has not been evaluated in pediatric patients <18 years of age.
Subcutaneous doses should preferably be administered on the same day each week or the same day of alternate weeks, as appropriate.
If transitioning from IV therapy with belimumab to subcutaneous administration, administer the first subcutaneous dose 1-4 weeks after the last IV dose.
If a dose is missed, the dose should be administered as soon as the patient remembers. Dosing can then be resumed on the usual day of administration or a new schedule may be started from the day the missed dose was administered.
The recommended IV dosage of belimumab for the management of lupus nephritis in adults and pediatric patients >=5 years of age is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.
The recommended subcutaneous dosage of belimumab for the management of lupus nephritis in adults is 400 mg (two 200-mg injections) once weekly for 4 doses, then 200 mg once weekly thereafter via autoinjector or prefilled syringe.
Safety and efficacy of subcutaneous administration of belimumab have not been established in pediatric patients <18 years of age.
A transition from IV therapy with belimumab to subcutaneous administration may occur any time after the patient completes the first 2 IV doses. If transitioning to subcutaneous belimumab, administer the first subcutaneous dose of 200 mg 1-2 weeks after the last IV dose.
If a dose is missed, the dose should be administered as soon as the patient remembers. Dosing can then be resumed on the usual day of administration or a new schedule may be started from the day the missed dose was administered.
Belimumab is administered by IV infusion or subcutaneous injection. Belimumab is commercially available as single-dose vials of lyophilized powder, which is intended for IV use only following reconstitution and dilution; vials should not be used for subcutaneous administration. The drug also is commercially available as autoinjectors and prefilled syringes, which are intended for subcutaneous use only (not for IV use).
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| BENLYSTA 200 MG/ML AUTOINJECT | Maintenance | Adults inject 1 milliliter (200 mg) by subcutaneous route once weekly on the same day of each week in the abdomen or thigh; rotate injection sites |
| BENLYSTA 200 MG/ML SYRINGE | Maintenance | Adults inject 1 milliliter (200 mg) by subcutaneous route once weekly on the same day of each week in the abdomen or thigh; rotate injection sites |
| BENLYSTA 120 MG VIAL | Maintenance | Adults infuse 10 mg/kg over 60 minute(s) by intravenous route every 4 weeks |
| BENLYSTA 400 MG VIAL | Maintenance | Adults infuse 10 mg/kg over 60 minute(s) by intravenous route every 4 weeks |
No generic dosing information available.
The following drug interaction information is available for BENLYSTA (belimumab):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Live Vaccines; Live BCG/Selected Immunosuppressive Agents SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1) CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2) PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency. PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1) |
ACAM2000 (NATIONAL STOCKPILE), ADENOVIRUS TYPE 4, ADENOVIRUS TYPE 4 AND TYPE 7, ADENOVIRUS TYPE 7, BCG (TICE STRAIN), BCG VACCINE (TICE STRAIN), DENGVAXIA, ERVEBO (NATIONAL STOCKPILE), FLUMIST TRIVALENT 2024-2025, IXCHIQ, M-M-R II VACCINE, PRIORIX, PROQUAD, ROTARIX, ROTATEQ, STAMARIL, VARIVAX VACCINE, VAXCHORA ACTIVE COMPONENT, VAXCHORA VACCINE, VIVOTIF, YF-VAX |
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Efgartigimod-alfa SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3) |
VYVGART, VYVGART HYTRULO |
| Anifrolumab/Biologic Therapies SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of anifrolumab with other biologic therapies may result in additive or synergistic effects on the immune system.(1) CLINICAL EFFECTS: Concurrent use of anifrolumab with other biologic therapies may increase the risk of serious infections.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The concurrent use of anifrolumab with other biologic therapies is not recommended.(1) DISCUSSION: The combination of anifrolumab with other biologic therapies has not been studied and is not recommended.(1) |
SAPHNELO |
| IgG Antibodies and Derivatives/Nipocalimab-aahu SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3) |
IMAAVY |
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Belimumab/Biologic Therapies SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Concurrent use of belimumab with other biologic therapies may result in additive or synergistic effects on the immune system.(1) CLINICAL EFFECTS: Concurrent use of belimumab with other biologic therapies may increase the risk of serious infections.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The concurrent use of belimumab with other biologic therapies should be approached with caution.(1) DISCUSSION: In a randomized, double-blind, placebo-controlled trial, more patients who received belimumab and rituximab experienced serious adverse events, serious infections, and post-injection systemic reactions (22.2%, 9%, and 13.2%, respectively) than patients who received belimumab with placebo (13.9%, 2.8%, 9.7%) or standard therapy (19.7%, 5.3%, 5.3%).(1) The combination of belimumab with other biologic therapies has not been studied and should be used cautiously.(1) |
ABECMA, ABRILADA(CF), ABRILADA(CF) PEN, ABRILADA(CF) PEN (2 PACK), ACTEMRA, ACTEMRA ACTPEN, ACTIMMUNE, ADALIMUMAB-AACF(CF), ADALIMUMAB-AACF(CF) (2 PK), ADALIMUMAB-AACF(CF) PEN (2 PK), ADALIMUMAB-AACF(CF) PEN CROHNS, ADALIMUMAB-AACF(CF) PEN PS-UV, ADALIMUMAB-AATY(CF) (2 PACK), ADALIMUMAB-AATY(CF) (2 PK), ADALIMUMAB-AATY(CF) AI CROHNS, ADALIMUMAB-AATY(CF) AUTOINJ(2), ADALIMUMAB-AATY(CF) AUTOINJECT, ADALIMUMAB-ADAZ(CF), ADALIMUMAB-ADAZ(CF) PEN, ADALIMUMAB-ADBM(CF), ADALIMUMAB-ADBM(CF) PEN, ADALIMUMAB-ADBM(CF) PEN CROHNS, ADALIMUMAB-ADBM(CF) PEN PS-UV, ADALIMUMAB-ADBM(CF)PEN, ADALIMUMAB-FKJP(CF), ADALIMUMAB-FKJP(CF) PEN, ADALIMUMAB-RYVK(CF), ADALIMUMAB-RYVK(CF) AUTOINJECT, ADCETRIS, ALFERON N, ALYMSYS, AMJEVITA(CF), AMJEVITA(CF) AUTOINJECTOR, AMTAGVI, ARCALYST, ARZERRA, AUCATZYL, AVASTIN, AVONEX, AVONEX (4 PACK), AVONEX PEN, AVONEX PEN (4 PACK), AVSOLA, BAVENCIO, BESPONSA, BETASERON, BIMZELX, BIMZELX AUTOINJECTOR, BIZENGRI, BLINCYTO, BREYANZI, BREYANZI CD4 COMPONENT, BREYANZI CD8 COMPONENT, BRIUMVI, CAMPATH, CARVYKTI, CIMZIA, CIMZIA (2 PACK), COLUMVI, COSENTYX, COSENTYX (2 SYRINGES), COSENTYX SENSOREADY (2 PENS), COSENTYX SENSOREADY PEN, COSENTYX SYRINGE, COSENTYX UNOREADY PEN, CYLTEZO(CF), CYLTEZO(CF) PEN, CYLTEZO(CF) PEN CROHN'S-UC-HS, CYLTEZO(CF) PEN PSORIASIS-UV, DANYELZA, DARZALEX, DARZALEX FASPRO, ELAHERE, ELREXFIO, ENBREL, ENBREL MINI, ENBREL SURECLICK, ENHERTU, ENSPRYNG, ENTYVIO, ENTYVIO PEN, EPKINLY, ERBITUX, GAMIFANT, GAZYVA, HADLIMA, HADLIMA PUSHTOUCH, HADLIMA(CF), HADLIMA(CF) PUSHTOUCH, HERCEPTIN, HERCEPTIN HYLECTA, HERCESSI, HERZUMA, HULIO(CF), HULIO(CF) PEN, HUMIRA, HUMIRA PEN, HUMIRA(CF), HUMIRA(CF) PEN, HUMIRA(CF) PEN CROHN'S-UC-HS, HUMIRA(CF) PEN PSOR-UV-ADOL HS, HYRIMOZ, HYRIMOZ PEN, HYRIMOZ(CF), HYRIMOZ(CF) PEDIATRIC CROHN'S, HYRIMOZ(CF) PEN, HYRIMOZ(CF) PEN CROHN-UC START, HYRIMOZ(CF) PEN PSORIASIS, ILARIS, IMDELLTRA, IMFINZI, INFLECTRA, INFLIXIMAB, JEMPERLI, KADCYLA, KANJINTI, KESIMPTA PEN, KEVZARA, KEYTRUDA, KINERET, KYMRIAH, LEMTRADA, LOQTORZI, LUNSUMIO, MONJUVI, MVASI, MYLOTARG, NULOJIX, OCREVUS, OCREVUS ZUNOVO, OGIVRI, ONTRUZANT, OPDIVO, OPDIVO QVANTIG, OPDUALAG, ORENCIA, ORENCIA CLICKJECT, OTULFI, PADCEV, PEGASYS, PERJETA, PHESGO, PLEGRIDY, PLEGRIDY PEN, POLIVY, POTELIGEO, PYZCHIVA, REBIF, REBIF REBIDOSE, REMICADE, RENFLEXIS, RIABNI, RITUXAN, RITUXAN HYCELA, RUXIENCE, SARCLISA, SELARSDI, SIMLANDI(CF), SIMLANDI(CF) AUTOINJECTOR, SIMPONI, SIMPONI ARIA, SIMULECT, STELARA, STEQEYMA, SYLVANT, TALTZ AUTOINJECTOR, TALTZ AUTOINJECTOR (2 PACK), TALTZ AUTOINJECTOR (3 PACK), TALTZ SYRINGE, TALVEY, TECARTUS, TECELRA, TECENTRIQ, TECENTRIQ HYBREZA, TECVAYLI, TEVIMBRA, TOFACITINIB CITRATE, TOFIDENCE, TRAZIMERA, TRODELVY, TRUXIMA, TYENNE, TYENNE AUTOINJECTOR, TZIELD, UNITUXIN, UPLIZNA, USTEKINUMAB, USTEKINUMAB-AEKN, USTEKINUMAB-TTWE, VECTIBIX, VEGZELMA, WEZLANA, XELJANZ, XELJANZ XR, YESCARTA, YESINTEK, YUFLYMA(CF) (2 PACK), YUFLYMA(CF) AI CROHN'S-UC-HS, YUFLYMA(CF) AUTOINJECT (2 PCK), YUFLYMA(CF) AUTOINJECTOR, YUSIMRY(CF) PEN, ZEVALIN, ZIRABEV, ZYMFENTRA, ZYMFENTRA (2 PACK), ZYMFENTRA PEN (2 PACK), ZYNLONTA, ZYNYZ |
| IgG Antibodies and Derivatives/Rozanolixizumab-noli SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3) DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3) |
RYSTIGGO |
The following contraindication information is available for BENLYSTA (belimumab):
Drug contraindication overview.
*History of anaphylactic reaction to belimumab.
*History of anaphylactic reaction to belimumab.
There are 0 contraindications.
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Progressive multifocal leukoencephalopathy |
| Severe infection |
| Suicidal ideation |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Depression |
| Malignancy |
The following adverse reaction information is available for BENLYSTA (belimumab):
Adverse reaction overview.
Adverse effects reported in >=5% of patients receiving belimumab include nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reactions (with subcutaneous administration).
Adverse effects reported in >=5% of patients receiving belimumab include nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reactions (with subcutaneous administration).
There are 14 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Infection |
Cellulitis Leukopenia Pneumonia |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Bradycardia Dyspnea Hematoma Hypersensitivity drug reaction Malignancy Progressive multifocal leukoencephalopathy Suicidal Suicidal ideation |
There are 28 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bronchitis Diarrhea Fever Influenza Injection site sequelae Insomnia Migraine Nausea Pain in extremities Pharyngitis Sinusitis Upper respiratory infection Urinary tract infection |
Cystitis Depression Fatigue Injection site erythema Injection site pain Mood changes Pruritus of skin Skin rash Symptoms of anxiety Urticaria Viral gastroenteritis |
| Rare/Very Rare |
|---|
|
Facial edema Headache disorder Hypotension Myalgia |
The following precautions are available for BENLYSTA (belimumab):
Safety and efficacy of IV belimumab have been established for the treatment of SLE and lupus nephritis in pediatric patients 5 to <18 years of age. Use of IV belimumab in combination with standard therapy in pediatric patients >=5 years of age with SLE is supported by evidence from pharmacokinetic and efficacy results from a pediatric study (PLUTO), as well as pharmacokinetic exposure and extrapolation of the established efficacy of belimumab plus standard therapy from the studies of IV belimumab in adults with SLE. Use of IV belimumab plus standard therapy in pediatric patients >=5 years of age with active lupus nephritis is based on the extrapolation of efficacy from the study of IV belimumab plus standard therapy in adults with active lupus nephritis, and also is supported by pharmacokinetic data from studies of IV belimumab in adults with active lupus nephritis and in pediatric patients with SLE.
Use of subcutaneous belimumab in combination with standard therapy in pediatric patients >=5 years of age and weighing >=15 kg with SLE is supported by evidence from an open-label pharmacokinetic pediatric study and a pharmacokinetic, efficacy, and safety study of IV dosing in pediatric patients. The pharmacokinetics of belimumab in pediatric patients following subcutaneous administration are expected to be similar to adults who are administered belimumab subcutaneously and pediatric patients who are administered IV belimumab. Safety and efficacy of subcutaneous belimumab administration in pediatric patients <18 years of age with active lupus nephritis have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Use of subcutaneous belimumab in combination with standard therapy in pediatric patients >=5 years of age and weighing >=15 kg with SLE is supported by evidence from an open-label pharmacokinetic pediatric study and a pharmacokinetic, efficacy, and safety study of IV dosing in pediatric patients. The pharmacokinetics of belimumab in pediatric patients following subcutaneous administration are expected to be similar to adults who are administered belimumab subcutaneously and pediatric patients who are administered IV belimumab. Safety and efficacy of subcutaneous belimumab administration in pediatric patients <18 years of age with active lupus nephritis have not been established.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Data in pregnant women are insufficient to determine whether there is a risk of major birth defects or miscarriage associated with belimumab. Based on animal data and the drug's mechanism of action, the immune system in infants of women receiving belimumab during pregnancy may be adversely affected. The reversibility of these potential effects is unknown.
No evidence of fetal harm was observed following IV administration of belimumab in monkeys with exposures approximately 9 times (based on IV administration) and 20 times (based on subcutaneous administration) the exposure at the maximum recommended human dose. However, reductions of B-cell counts, reductions in the density of lymphoid tissue B-lymphocytes in the spleen and lymph nodes, and altered IgG and IgM titers were observed in monkey fetuses and/or offspring. These effects were reversible within 3-12 months after the discontinuance of the drug.
Monoclonal antibodies, such as belimumab, are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Consider potential risks and benefits prior to administering live or live-attenuated vaccines to infants exposed to belimumab in utero. Monitor infants born to women receiving belimumab during pregnancy for B-cell reduction and other immune dysfunction.
To monitor outcomes of women exposed to belimumab during pregnancy, a pregnancy exposure registry has been established. Patients can enroll in the registry by visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/ or calling 877-311-8972.
No evidence of fetal harm was observed following IV administration of belimumab in monkeys with exposures approximately 9 times (based on IV administration) and 20 times (based on subcutaneous administration) the exposure at the maximum recommended human dose. However, reductions of B-cell counts, reductions in the density of lymphoid tissue B-lymphocytes in the spleen and lymph nodes, and altered IgG and IgM titers were observed in monkey fetuses and/or offspring. These effects were reversible within 3-12 months after the discontinuance of the drug.
Monoclonal antibodies, such as belimumab, are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Consider potential risks and benefits prior to administering live or live-attenuated vaccines to infants exposed to belimumab in utero. Monitor infants born to women receiving belimumab during pregnancy for B-cell reduction and other immune dysfunction.
To monitor outcomes of women exposed to belimumab during pregnancy, a pregnancy exposure registry has been established. Patients can enroll in the registry by visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/ or calling 877-311-8972.
Belimumab is distributed into milk in cynomolgus monkeys. It is not known whether the drug is distributed into human milk, affects milk production, or affects the breast-fed infant. Maternal IgG is distributed into human milk; if belimumab is transferred into human milk, the effects of local exposure in the GI tract and potential limited systemic exposure in the infant to belimumab are unknown.
Data are insufficient to clearly determine the risk of belimumab to an infant during lactation. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for the drug, and any potential adverse effects on the breast-fed child from belimumab or the underlying maternal condition.
Data are insufficient to clearly determine the risk of belimumab to an infant during lactation. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for the drug, and any potential adverse effects on the breast-fed child from belimumab or the underlying maternal condition.
Experience in patients >=65 years of age is insufficient to determine whether they respond differently than younger adults; belimumab should be used with caution in geriatric patients.
The following prioritized warning is available for BENLYSTA (belimumab):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for BENLYSTA (belimumab)'s list of indications:
| Active lupus nephritis | |
| M32.14 | Glomerular disease in systemic lupus erythematosus |
| Systemic lupus erythematosus | |
| M32 | Systemic lupus erythematosus (SLe) |
| M32.0 | Drug-induced systemic lupus erythematosus |
| M32.1 | Systemic lupus erythematosus with organ or system involvement |
| M32.10 | Systemic lupus erythematosus, organ or system involvement unspecified |
| M32.11 | Endocarditis in systemic lupus erythematosus |
| M32.12 | Pericarditis in systemic lupus erythematosus |
| M32.13 | Lung involvement in systemic lupus erythematosus |
| M32.14 | Glomerular disease in systemic lupus erythematosus |
| M32.15 | Tubulo-interstitial nephropathy in systemic lupus erythematosus |
| M32.19 | Other organ or system involvement in systemic lupus erythematosus |
| M32.8 | Other forms of systemic lupus erythematosus |
| M32.9 | Systemic lupus erythematosus, unspecified |
Formulary Reference Tool