Version May 2024
Lupus nephritis :
IV: Initial: 10 mg/kg every 2 weeks for 3 doses; Maintenance: 10 mg/kg every 4 weeks.
SUBQ: 400 mg once weekly for 4 doses, then 200 mg once weekly thereafter.
Switching from IV therapy: Administer the first SUBQ dose of 200 mg 1 to 2 weeks after the last IV dose; may switch to SUBQ therapy after completion of 2 IV doses.
Systemic lupus erythematosus:
IV: Initial: 10 mg/kg every 2 weeks for 3 doses; Maintenance: 10 mg/kg every 4 weeks.
SUBQ: 200 mg once weekly.
Switching from IV therapy: Administer the first SUBQ dose 1 to 4 weeks after the last IV dose.
Missed dose: If a dose is missed, administer the dose as soon as possible and then resume the original schedule on the usual day of administration or start a new weekly schedule based on the date that the missed dose was administered.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
No dosage adjustment necessary.
Refer to adult dosing.
(For additional information see "Belimumab: Pediatric drug information")
Note: Consider premedication for prevention of hypersensitivity and infusion reactions.
Lupus nephritis, active:
IV: Children ≥5 years and Adolescents: Initial: IV: 10 mg/kg/dose every 2 weeks for 3 doses; followed by maintenance therapy of 10 mg/kg/dose every 4 weeks.
SUBQ: Adolescents ≥18 years: SUBQ: 400 mg once weekly for 4 doses, then 200 mg once weekly thereafter; preferably on the same day each week.
Conversion from IV therapy: Adolescents ≥18 years: Administer the first SUBQ dose 1 to 2 weeks after the last IV dose; may switch to SUBQ therapy after completion of 2 IV doses.
Systemic lupus erythematosus (SLE), active:
IV: Children ≥5 years and Adolescents: Initial: IV: 10 mg/kg/dose every 2 weeks for 3 doses; followed by maintenance therapy of 10 mg/kg/dose every 4 weeks.
SUBQ: Adolescents ≥18 years: SUBQ: 200 mg once weekly; preferably on the same day each week.
Conversion from IV therapy: Adolescents ≥18 years: Administer the first SUBQ dose 1 to 4 weeks after the last IV dose.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Children ≥5 years and Adolescents: No dosage adjustment necessary.
Children ≥5 years and Adolescents: No dosage adjustment recommended; however, no formal trials have been conducted.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Gastrointestinal: Diarrhea (12%), nausea (15%)
Hypersensitivity: Hypersensitivity reaction (13%; including anaphylaxis and angioedema), infusion-related reaction (17%)
Infection: Infection (71% to 82%; serious infection: 6%)
Nervous system: Psychiatric disturbance (16%; serious: ≤1%; including anxiety [4%], depression [5% to 6%], insomnia [6% to 7%], suicidal ideation [≤1%], and suicidal tendencies [≤1%])
1% to 10%:
Gastrointestinal: Viral gastroenteritis (3%)
Genitourinary: Cystitis (4%), urinary tract infection (>5%)
Hematologic & oncologic: Leukopenia (4%)
Infection: Influenza (>5%)
Local: Injection-site reaction (6%)
Nervous system: Migraine (5%)
Neuromuscular & skeletal: Limb pain (6%)
Respiratory: Bronchitis (9%), nasopharyngitis (9%), pharyngitis (5%), sinusitis (>5%), upper respiratory tract infection (>5%)
Miscellaneous: Fever (10%)
<1%: Immunologic: Antibody development
Frequency not defined:
Dermatologic: Cellulitis
Respiratory: Pneumonia
Postmarketing: Nervous system: Progressive multifocal leukoencephalopathy
Hypersensitivity (anaphylaxis) to belimumab or any component of the formulation
Concerns related to adverse effects:
• Hypersensitivity/infusion reactions: Acute hypersensitivity reactions including anaphylaxis (with fatalities) have been reported, including in patients who had previously tolerated infusions of belimumab; onset may occur within hours of the infusion or may be delayed. Non-acute hypersensitivity reactions, including facial edema, fatigue, headache, myalgia, nausea, and rash have been reported and may occur up to a week following infusion. Risk for hypersensitivity reactions may be increased in patients with history of multiple drug allergies or significant hypersensitivity. Infusion-related reactions (which may be difficult to distinguish from hypersensitivity) may also occur; symptoms may include angioedema, bradycardia, dyspnea, headache, hypotension, myalgia, pruritus, rash, and urticaria. Monitor for hypersensitivity and infusion-related reactions for an appropriate time following administration and immediately discontinue for severe reactions (and administer appropriate medical treatment) or slow or temporarily interrupt infusion for other infusion reactions. Consider premedication prior to infusion; however, it is unknown if premedication prevents or reduces the severity of hypersensitivity reactions.
• Infections: Serious and potentially fatal infections may occur during treatment. Use with caution and consider the risk and benefit before initiating treatment in patients with severe or chronic infections. Consider interrupting belimumab in patients who develop new infections and initiate appropriate anti-infective treatment; monitor closely.
• Malignancy: Immunosuppressant therapy may increase the risk of malignancy. Consider the risk and benefit before initiating treatment in patients with risk factors for developing new or recurrent malignancy or continuing therapy in patients who develop malignancy while receiving belimumab.
• Progressive multifocal leukoencephalopathy: Cases of progressive multifocal leukoencephalopathy (PML) associated with JC virus (some fatal) have been reported in patients with systemic lupus erythematosus (SLE) receiving immunosuppressants, including belimumab. Risk factors for PML include immunosuppressant therapies and impaired immune function. Consider diagnosis of PML in any patient presenting with new-onset or deteriorating neurologic signs/symptoms; consult a neurologist (or other appropriate specialist). If PML is confirmed, discontinue immunosuppressant treatment, including belimumab.
• Psychiatric events: Psychiatric disorders (including depression and suicidal ideation and behavior) have been reported. Prior to and during treatment, the risk of depression and suicide should be assessed based on medical history and current psychiatric status. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new-onset or worsening depression, anxiety, or other mood changes; risk and benefit of continued treatment should be assessed for patients who develop such symptoms.
Concurrent drug therapy issues:
• Immunizations: Although the manufacturer suggests that live vaccines should not be given within 30 days before or concurrently with belimumab, expert consensus recommends that in general belimumab be held for one dosing interval prior to administration of a live vaccine and then belimumab held for 4 weeks after administration of a live vaccine; individualized consideration should be given to patient risk for vaccine preventable illness and for disease flares if immunosuppressant therapy held (ACR 2022). There is no data available concerning secondary transmission of infection from live vaccines.
Special populations:
• Black patients: Black patients experienced reduced response rates with belimumab plus standard therapy when compared to placebo plus standard therapy in some SLE studies. In a study which compared belimumab plus the standard of care (SoC) to placebo plus SoC in Black patients with SLE, the primary end point (based on specific response rate criteria) was not attained, although improvements favoring belimumab were reported (D’Cruz 2019).
• Patients with systemic lupus erythematosus (SLE) undergoing hip or knee replacement surgery: Patients with severe SLE (referring to patients with severe organ manifestations such as nephritis) should not interrupt therapy when undergoing hip or knee replacement surgery. For patients with SLE without severe disease, hold belimumab for at least 1 week prior to surgery to reduce infection risk; therapy can be restarted once surgical wound shows evidence of healing (eg, no swelling, erythema, or drainage), sutures/staples are removed, and no ongoing nonsurgical site infections (typically ~14 days to reduce infection risk) (ACR/AAHKS [Goodman 2022]).
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous [preservative free]:
Benlysta: 200 mg/mL (1 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Benlysta: 200 mg/mL (1 mL) [contains polysorbate 80]
Solution Reconstituted, Intravenous [preservative free]:
Benlysta: 120 mg (1 ea); 400 mg (1 ea) [contains polysorbate 80]
No
Solution (reconstituted) (Benlysta Intravenous)
120 mg (per each): $735.72
400 mg (per each): $2,452.28
Solution Auto-injector (Benlysta Subcutaneous)
200 mg/mL (per mL): $1,452.75
Solution Prefilled Syringe (Benlysta Subcutaneous)
200 mg/mL (per mL): $1,452.75
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Benlysta: 200 mg/mL (1 mL) [contains polysorbate 80]
Solution Reconstituted, Intravenous:
Benlysta: 120 mg (1 ea); 400 mg (1 ea) [contains polysorbate 80]
Product is only available via authorized pharmacies and distributors. Further information is available at https://www.benlystahcp.com/rheumatology/access-support.
IV: Administer IV over 1 hour through a dedicated IV line. Do NOT administer as an IV push or bolus. Discontinue infusion for severe hypersensitivity reaction (eg, anaphylaxis, angioedema). The infusion may be slowed or temporarily interrupted for minor reactions. Consider premedicating with an antihistamine and antipyretic for prophylaxis against hypersensitivity or infusion reactions.
SUBQ: Allow prefilled syringe and autoinjector to warm to room temperature for 30 minutes prior to administration; do not warm product in any other way. Administer subcutaneously into abdomen or thigh using a different injection site on the same day each week; do not administer into tender, bruised, red, or hard skin. When administering 400 mg doses, 2 individual 200 mg injections are required and should be spaced ≥5 cm (2 inches) apart. Initial use is recommended under supervision of physician; self-injection may occur after proper training.
Parenteral:
IV: Note: For administration by health care professionals trained in management of anaphylaxis. Consider premedicating with an antihistamine and antipyretic for prophylaxis against hypersensitivity or infusion reactions.
Children ≥5 years and Adolescents: Administer diluted solution IV over 1 hour through a dedicated IV line. Do NOT administer as an IV push or bolus. Discontinue infusion for severe hypersensitivity reaction (eg, anaphylaxis, angioedema). The infusion may be slowed or temporarily interrupted for minor reactions.
SUBQ: Adolescents ≥18 years: Allow prefilled syringe and autoinjector to warm to room temperature for 30 minutes prior to administration; do not warm product in any other way. Do not use if product exhibits discoloration or particulate matter or if dropped on a hard surface. Administer SUBQ into the abdomen or thigh; use a different injection site on the same day each week; do not administer into tender, bruised, red, or hard skin. When administering 400 mg doses, 2 individual 200 mg injections are required and should be spaced ≥5 cm (2 inches) apart. Initial use is recommended under supervision of physician; self-injection or injection by caregiver may occur after proper training.
Missed dose: If a dose is missed, administer the dose as soon as possible and then resume the original schedule on the usual day of administration or start a new weekly schedule based on the date that the missed dose was administered.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125370s079,761043s022lbl.pdf#page=41, must be dispensed with this medication.
Lupus nephritis: Treatment of adults and pediatric patients ≥5 years of age with active lupus nephritis who are receiving standard therapy.
Systemic lupus erythematosus: Treatment of adults and pediatric patients ≥5 years of age with active systemic lupus erythematosus (SLE) who are receiving standard therapy.
Limitations of use: Use is not recommended in patients with severe active CNS lupus.
Belimumab may be confused with bamlanivimab, belantamab mafodotin, belinostat, bezlotoxumab, burosumab.
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Anifrolumab: May enhance the immunosuppressive effect of Belimumab. Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Biologic Anti-Psoriasis Agents: Belimumab may enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider therapy modification
Biologic Disease-Modifying Antirheumatic Drugs (DMARDs): Belimumab may enhance the immunosuppressive effect of Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider therapy modification
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccines: Belimumab may diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding subcutaneous belimumab doses for 1 to 2 weeks after each COVID-19 vaccine dose as disease activity permits. The recommendation specifies subcutaneous belimumab and does not mention intravenous belimumab. Risk D: Consider therapy modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
RiTUXimab: Belimumab may enhance the immunosuppressive effect of RiTUXimab. Risk X: Avoid combination
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Patients who could become pregnant should use effective contraception during therapy and for at least 4 months after the last belimumab dose if prevention of pregnancy is warranted.
Based on limited data, use of belimumab may be continued until conception in patients with rheumatic and musculoskeletal diseases who are planning to become pregnant and not able to use alternative therapies; use should be discontinued once pregnancy is confirmed. Conception should be planned during a period of quiescent/low disease activity (ACR [Sammaritano 2020]).
Recommendations for use of belimumab to treat rheumatic and musculoskeletal diseases in patients who are planning to father a child are not available due to limited data (ACR [Sammaritano 2020]).
Belimumab crosses the placenta (Bitter 2023). Belimumab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Placental transfer of belimumab was evaluated in a patient treated with belimumab 10 mg/month prior to and during pregnancy, with the last dose given at 26 weeks gestation. Maternal and cord blood belimumab concentrations at delivery were 4.5 mg/L and 6.7 mg/L, respectively. By 4 months postpartum, belimumab was not measurable (<0.2 mg/L) in the child's serum (Bitter 2023).
Outcome data related to the use of belimumab during pregnancy are becoming available from international pharmacovigilance databases and pregnancy registries (Dernoncourt 2023; Ghalandari 2022; Ghalandari 2023; Juliao 2023; Kao 2021; Petri 2023).
Until additional data are available, belimumab is not currently recommended for the treatment of rheumatic and musculoskeletal diseases during pregnancy. Belimumab should be discontinued once pregnancy is confirmed (ACR [Sammaritano 2020]). If exposure occurs during pregnancy, the manufacturer recommends monitoring the newborn for B-cell reduction and other immune dysfunction.
Data collection to monitor pregnancy and infant outcomes following exposure to belimumab is ongoing. Health care providers are encouraged to enroll patients exposed to belimumab during pregnancy in the pregnancy registry (877-681-6296); patients may also enroll themselves.
Belimumab is present in breast milk (Saito 2020).
Belimumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
A case report describes use of belimumab 10 mg/kg IV initiated postpartum for the maternal treatment of mixed connective tissue disease. Breast milk concentrations of belimumab were <1% of the maternal serum levels when simultaneously measured on three occasions (14 days after the first dose [postpartum day 409]; 1 day after the second dose [postpartum day 411], and 28 days after the second dose [postpartum day 451]). Except for poor weight gain, adverse events were not observed in the infant who was exclusively breastfed for 6 months and partially breastfed until 15 months of age (weight at 2.5 years of age was 10 kg). Routine immunizations were administered without adverse events (Saito 2020).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Concentrations of belimumab are expected to be limited in breast milk due to large molecular weight. Also, because belimumab is unlikely to be absorbed by the infant gastrointestinal tract following exposure via breast milk, treatment with belimumab may be continued or initiated in breastfeeding patients with rheumatic and musculoskeletal diseases (ACR [Sammaritano 2020]).
Monitor during and for an appropriate time after administration for hypersensitivity and/or infusion reactions; infections; worsening of depression, mood changes, or suicidal thoughts
Belimumab is an IgG1-lambda monoclonal antibody that prevents the survival of B lymphocytes by blocking the binding of soluble human B lymphocyte stimulator protein (BLyS) to receptors on B lymphocytes. This reduces the activity of B-cell mediated immunity and the autoimmune response.
Note: Pharmacokinetic data in pediatric patients ≥5 years has been observed to be similar to adult patients.
Onset of action: B cells: 8 weeks; Clinical improvement (SLE Responder Index and flare reduction): 16 weeks (Navarra 2011).
Bioavailability: SUBQ: 74%.
Distribution: Vd: 5 L.
Half-life elimination: Terminal: IV: 19.4 days; SUBQ: 18.3 days.
Time to peak: SUBQ: 2.6 days.
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