Version July 2025
Note: Consider premedication in patients with a history of hypersensitivity or infusion reactions.
Systemic lupus erythematosus, moderate to severe: IV: 300 mg every 4 weeks.
Missed doses : Administer a missed dose as soon as possible but maintain at least 14 days between infusions.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Hypersensitivity reactions, including severe hypersensitivity reactions (ie, anaphylaxis and angioedema), have been reported. Most cases were considered mild or moderate intensity.
Onset: Varied; most reactions occurred during the first 12 weeks of treatment (ie, with the first 3 to 4 infusions) (Ref).
Infections occurred in clinical trials during anifrolumab treatment; severe infection occurred at a much lower rate of incidence, although fatal infections were reported. The most frequently reported types of infections across all clinical trials were respiratory tract infection (ie, nasopharyngitis, pharyngitis, pneumonia, upper respiratory tract infection) and herpes zoster infection, including cases of cutaneous (Ref) and disseminated herpes zoster.
Mechanism: Dose-dependent; anifrolumab binds to type I interferon receptors (IFNAR) and blocks the activity of type I interferons, thereby reducing production of proinflammatory and immunomodulatory proteins involved immune response (ie, B-cell, T-cell, and other immune cell migrations (Ref); cytokines (TNF-α, IL-6); CD80 and CD83 expression of dendritic cells (Ref)
Immunosuppressant therapy may increase the risk of malignancy. Impact on the development and course of malignancies is not fully defined; however, malignancies were observed in clinical trials. Malignant neoplasm (including malignant neoplasm of breast, squamous cell carcinoma) were rarely reported.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Infection: Infection (70%, including influenza, tuberculosis [Tanaka 2021], urinary tract infection; severe infection: 5%) (table 1)
|
Drug (Anifrolumab) |
Placebo |
Number of Patients (Anifrolumab) |
Number of Patients (Placebo) |
Comments |
|---|---|---|---|---|
|
70% |
55% |
459 |
466 |
N/A |
|
5% |
6% |
459 |
466 |
Severe infection |
Respiratory: Bronchitis (11%), upper respiratory tract infection (34%; including nasopharyngitis, pharyngitis, sinusitis [Tanaka 2021]) (table 2)
|
Drug (Anifrolumab) |
Placebo |
Number of Patients (Anifrolumab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
34% |
23% |
459 |
466 |
1% to 10%:
Hematologic & oncologic: Malignant neoplasm (1%; including malignant neoplasm of breast, squamous cell carcinoma) (table 3)
|
Drug (Anifrolumab) |
Placebo |
Number of Patients (Anifrolumab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
1% |
0.6% |
459 |
466 |
Hypersensitivity: Hypersensitivity reaction (3%; including anaphylaxis [<1%], angioedema [<1%], severe hypersensitivity reaction [<1%]) (table 4), infusion-related reaction (9%)
|
Drug (Anifrolumab) |
Placebo |
Number of Patients (Anifrolumab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
3% |
0.6% |
459 |
466 |
Immunologic: Antibody development (2%)
Infection: Herpes zoster infection (6%) (table 5)
|
Drug (Anifrolumab) |
Placebo |
Number of Patients (Anifrolumab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
6% |
1% |
459 |
466 |
Respiratory: Cough (5%), respiratory tract infection (3%) (table 6)
|
Drug (Anifrolumab) |
Placebo |
Number of Patients (Anifrolumab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
3% |
2% |
459 |
466 |
Frequency not defined: Respiratory: Pneumonia
Postmarketing: Neuromuscular & skeletal: Arthralgia
Severe hypersensitivity (eg, anaphylaxis) to anifrolumab or any component of the formulation.
Concerns related to adverse effects:
• Infusion reactions: Infusion reactions have been reported. Discontinue treatment and initiate supportive treatment in patients who develop infusion-related reactions.
Other warnings/precautions:
• Appropriate use: Concurrent use with other biologic therapies, including B-cell–targeted therapies, is not recommended; has not been studied.
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy; live or live attenuated vaccines should not be given concurrently.
• Infections: Carefully consider risk versus benefit in patients with chronic or recurrent infections or known risk factors for infection. Avoid initiating treatment in patients with a significant active infection until the infection resolves or is adequately treated.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Saphnelo: Anifrolumab-fnia 300 mg/2 mL (2 mL) [contains polysorbate 80]
No
Solution (Saphnelo Intravenous)
300 mg/2 mL (per mL): $3,200.38
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Saphnelo: Anifrolumab-fnia 300 mg/2 mL (2 mL) [contains polysorbate 80]
IV: Allow refrigerated solution to reach room temperature prior to administration. Administer by IV infusion using a low-protein binding 0.2 to 15 micron in-line or add-on filter over 30 minutes. Flush infusion set with 25 mL of NS upon completion. Do not administer other medication through same line.
Systemic lupus erythematosus, moderate to severe: Treatment of moderate to severe systemic lupus erythematosus in adults who are receiving standard therapy.
Limitations of use: Efficacy has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Belimumab: Anifrolumab may increase immunosuppressive effects of Belimumab. Risk X: Avoid
Biologic Anti-Psoriasis Agents: May increase immunosuppressive effects of Anifrolumab. Risk X: Avoid
Biologic Disease-Modifying Antirheumatic Drugs: May increase immunosuppressive effects of Anifrolumab. Risk X: Avoid
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. 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 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects 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 increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects 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 increase immunosuppressive effects 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 decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of 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 decrease therapeutic effects 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 increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects 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 Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects 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
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects 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
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before 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 decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Anifrolumab is a humanized monoclonal antibody (IgG1). Human IgG is known to cross the placenta; exposure is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Data collection to monitor pregnancy and infant outcomes following exposure to anifrolumab is ongoing. Health care providers are encouraged to enroll patients exposed to anifrolumab during pregnancy in the Pregnancy Registry (1-877-693-9268).
It is not known if anifrolumab is present in breast milk; however, anifrolumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk.
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.
Signs and symptoms of hypersensitivity and infection.
Anifrolumab is an IgG1-kappa monoclonal antibody that blocks the biologic activity of type 1 interferon receptors (IFNAR); elevated IFNAR plays a role in the pathogenesis of systemic lupus erythematosus. This reduces inflammatory and immunological processes.
Distribution: Vdss: 6.23 L.
Excretion: Clearance: 0.193 L/day.
