Anifrolumab

Anifrolumab-fnia is a human IgG1κ monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR) with high specificity and affinity. This binding inhibits type I IFN signaling, thereby blocking the biologic activity of type I IFNs.

• SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.

• SAPHNELO is contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia [see Warnings and Precautions (5.2) ] . SAPHNELO is contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia.contraindicated

• The recommended intravenous dosage is 300 mg every 4 weeks. ( 2.2 ) • The recommended subcutaneous dosage is 120 mg once every week. ( 2.2 ) • See Full Prescribing Information for complete preparation and administration information. ( 2.3 , 2.4 ) 2.1 Important Administration Information SAPHNELO is intended for use under the guidance of a healthcare provider and may be administered as an intravenous infusion or as a subcutaneous injection. SAPHNELO vials are for intravenous use only and must be diluted prior to intravenous administration [see Dosage and Administration (2.3) ] . SAPHNELO prefilled syringe and autoinjector (SAPHNELO PEN) are for subcutaneous use only [see Dosage and Administration (2.4) ] . 2.2 Recommended Dosage The recommended dosage of SAPHNELO is: • 300 mg, administered as an intravenous infusion over a 30‑minute period every 4 weeks; or • 120 mg, administered as a subcutaneous injection once every week. Missed Dose If a planned intravenous infusion is missed, administer SAPHNELO as soon as possible. Maintain a minimum interval of 14 days between infusions. If a planned subcutaneous dose is missed, instruct the patient to administer SAPHNELO as soon as they remember. Thereafter, instruct the patient to start a new weekly schedule from the day the missed dose was administered or resume dosing on their usual day of administration, providing a minimum interval of 3 days between subcutaneous injections. 2.3 Intravenous Preparation and Administration Instructions SAPHNELO is supplied as a single-dose vial.

• Serious Infections: Serious and sometimes fatal infections have occurred in patients receiving SAPHNELO. SAPHNELO increases the risk of respiratory infections and herpes zoster. Avoid initiating treatment during an active infection. Consider the individual benefit-risk if using in patients with severe or chronic infections. Consider interrupting therapy with SAPHNELO if patients develop a new infection during treatment. ( 5.1 ) • Hypersensitivity Reactions Including Anaphylaxis: Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported. ( 5.2 ) • Malignancy: Consider the individual benefit-risk in patients with known risk factors for malignancy prior to prescribing SAPHNELO. ( 5.3 ) • Immunizations: Avoid use of live or live-attenuated vaccines in patients receiving SAPHNELO. ( 5.4 ) • Not Recommended for Use with Other Biologic Therapies. ( 5.5 ) 5.1 Serious Infections Serious and sometimes fatal infections (including COVID‑19) have occurred in patients receiving immunosuppressive agents, including SAPHNELO. In controlled trials, fatal infections occurred more frequently in patients receiving SAPHNELO [see Adverse Reactions (6.1) ] . In controlled trials, SAPHNELO increased the risk of respiratory infections and herpes zoster (disseminated herpes zoster events have been reported) [see Adverse Reactions (6.1) ] . Avoid initiating treatment with SAPHNELO in patients with any clinically significant active infection until the infection is resolved or adequately treated.

The following clinically significant adverse reactions are also discussed elsewhere in the labeling: • Serious Infections [see Warnings and Precautions (5.1) ] • Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.2) ] • Malignancy [see Warnings and Precautions (5.3) ] Most common adverse drug reactions (incidence ≥5%) are nasopharyngitis, upper respiratory tract infections, bronchitis, infusion related reactions, herpes zoster and cough. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions with Intravenous Administration The safety of SAPHNELO was assessed in adult patients with moderate to severe SLE who received SAPHNELO 300 mg by intravenous infusion every 4 weeks (N=459) for 52 weeks, compared to placebo (N=466) in controlled clinical trials (Trials 1, 2 and 3) [see Clinical Studies (14.1) ]. The population studied had a mean age of 41 years (range: 18 to 69), of which 93% were female, 60% White, 13% Black/African American, and 10% Asian. In the controlled-clinical trials, adverse reactions, irrespective of causality, were reported in 87% of patients receiving SAPHNELO and 79% of patients receiving placebo.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SAPHNELO during pregnancy. For more information about the registry or to report a pregnancy while on SAPHNELO, healthcare providers should contact AstraZeneca at 1‑877‑693‑9268 or https://anifrolumabpregnancyandbreastfeedingstudy.us/ . Risk Summary The limited human data with SAPHNELO use in pregnant women are insufficient to inform on drug‑associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcome. Monoclonal IgG antibodies are known to be actively transported across the placenta as pregnancy progresses; therefore, anifrolumab‑fnia exposure to the fetus may be greater during the third trimester of pregnancy. In an enhanced pre- and post-natal development study with pregnant cynomolgus monkeys that received intravenous administration of anifrolumab-fnia, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28‑times the exposure at the maximum recommended human dose (MRHD) on an Area Under Curve (AUC) basis (see Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.

Metabolism

The pharmacokinetics (PK) of anifrolumab-fnia was studied in adult patients with SLE following intravenous doses ranging from one-third (100 mg) to 3.3 times (1000 mg) the approved intravenous dosage, 300 mg once every 4 weeks, and subcutaneous 120 mg weekly doses, as well as in healthy volunteers following a single intravenous dose at 300 mg and a single subcutaneous dose of 120 mg. Anifrolumab-fnia exhibits non-linear PK in the dose range of 100 mg to 1000 mg with more than dose-proportional increases in the exposure as measured by AUC, following intravenous administration.

• Jul 30, 2021BLABLA761123Astrazeneca Ab
• Apr 24, 2026BLABLA761451Astrazeneca Ab

1. 1Systemic Lupus Erythematosus1408.6%
2. 2Fatigue1318.0%
3. 3Arthralgia905.5%
4. 4Headache905.5%
5. 5Nausea825.0%
6. 6Pain714.3%
7. 7Rash674.1%
8. 8Herpes Zoster603.7%
9. 9Drug Ineffective573.5%
10. 10Condition Aggravated543.3%
11. 11Covid-19493.0%
12. 12Dyspnoea493.0%
13. 13Product Dose Omission Issue493.0%
14. 14Dizziness482.9%
15. 15Pyrexia462.8%

The 10 most recently updated of 48 ClinicalTrials.gov registrations naming Anifrolumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
  Recruiting · Phase 4 · Interventional · 150 enrolled · Aurinia Pharmaceuticals Inc.
  NCT07611214updated 2026-06-12
• A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
  Not yet recruiting · Phase 2 · Interventional · 24 enrolled · AstraZeneca
  NCT07630714updated 2026-06-05
• AZAHAR Study To Describe Anifrolumab in a Real-World Setting
  Completed · Observational · 152 enrolled · AstraZeneca
  NCT06626945updated 2026-06-04
• Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial)
  Recruiting · Phase 2 · Interventional · 20 enrolled · National and Kapodistrian University of Athens
  NCT07584083updated 2026-06-02
• A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
  Recruiting · Phase 3 · Interventional · 245 enrolled · AstraZeneca
  NCT07430306updated 2026-06-02
• A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
  Recruiting · Phase 3 · Interventional · 240 enrolled · AstraZeneca
  NCT06455449updated 2026-05-28
• An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
  Recruiting · Phase 3 · Interventional · 100 enrolled · AstraZeneca
  NCT05835310updated 2026-05-27
• INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
  Recruiting · Observational · 200 enrolled · AstraZeneca
  NCT06314282updated 2026-05-26
• Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
  Recruiting · Observational · 442 enrolled · AstraZeneca
  NCT06659029updated 2026-05-26
• Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
  Active not recruiting · Phase 3 · Interventional · 314 enrolled · AstraZeneca
  NCT05925803updated 2026-05-26

Frequently asked questions

How does Anifrolumab work?

Anifrolumab-fnia is a human IgG1κ monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR) with high specificity and affinity. This binding inhibits type I IFN signaling, thereby blocking the biologic activity of type I IFNs.

What is Anifrolumab used for?

According to FDA labeling, Anifrolumab carries indications including: SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Anifrolumab?

Anifrolumab is classified as Monoclonal antibodies, Type I interferon Receptor Antagonist, Type I interferon Receptor Antagonists.

What are the brand names for Anifrolumab?

Anifrolumab is marketed under brand names including Saphnelo.

What are the contraindications for Anifrolumab?

Anifrolumab labeling lists contraindications including: SAPHNELO is contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia [see Warnings and Precautions (5.2) ] . SAPHNELO is contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia.. Always consult the full prescribing information and a clinician.