Benlysta (belimumab)

No dosing information is available for this tab.

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).

No dosing information is available for this tab.

No formal drug interaction studies have been performed with belimumab to date.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Selected Immunosuppressive Agents/Live Vaccines; Live Bcg

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) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)

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)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Biologic Therapies/Anifrolumab

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)

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)

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)

Moderate Interaction: Assess the risk to the patient and take action as needed.

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)

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)

*History of anaphylactic reaction to belimumab.

There are no contraindication contraindications for this drug.

• Progressive multifocal leukoencephalopathy
• Severe infection
• Suicidal ideation

• Depression
• Malignancy

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).

More Frequent

• Infection
• Stevens-johnson syndrome
• Toxic epidermal necrolysis

Less Frequent

• Cellulitis
• Leukopenia
• Pneumonia

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Bradycardia
• Dyspnea
• Hematoma
• Hypersensitivity drug reaction
• Malignancy
• Progressive multifocal leukoencephalopathy
• Suicidal
• Suicidal ideation

More Frequent

• Bronchitis
• Diarrhea
• Fever
• Influenza
• Injection site sequelae
• Insomnia
• Migraine
• Nausea
• Pain in extremities
• Pharyngitis
• Sinusitis
• Upper respiratory infection
• Urinary tract infection

Less Frequent

• Cystitis
• Depression
• Fatigue
• Injection site erythema
• Injection site pain
• Mood changes
• Pruritus of skin
• Skin rash
• Symptoms of anxiety
• Urticaria
• Viral gastroenteritis

Rare or Very Rare

• Facial edema
• Headache disorder
• Hypotension
• Myalgia

No enhanced messaging available.

Safety and efficacy of belimumab have been established for the treatment of SLE and lupus nephritis in pediatric patients >=5 to years of age who are receiving standard therapy.

Use of IV belimumab in combination with standard therapy in pediatric patients >=5 years of age with SLE is supported by evidence from pharmacokinetic, safety, 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.

Use of subcutaneous belimumab in combination with standard therapy in pediatric patients >=5 years of age and weighing >=15 kg 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 the same adult trial, a pharmacokinetic, efficacy, and safety IV trial in pediatric patients with SLE, and an open-label subcutaneous trial in pediatric patients with SLE. Belimumab exposures for pediatric patients with active lupus nephritis following subcutaneous administration are estimated to be similar to adults with active lupus nephritis who receive IV belimumab.

Safety and efficacy of belimumab in pediatric patients <5 years of age have not been established.

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.

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.

The manufacturer makes no specific dosage recommendations for geriatric patients. Use belimumab with caution in geriatric patients.

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.