SAPHNELO®

What Makes SAPHNELO® Unique

SAPHNELO® (anifrolumab) represents a new echelon in targeted systemic lupus erythematosus (SLE) care. Developed as a fully human monoclonal antibody, it offers precision-driven immunomodulation by selectively blocking type I interferon signaling—a key driver in lupus pathogenesis. For patients inadequately controlled by standard regimens, SAPHNELO® introduces a sophisticated alternative that integrates seamlessly into advanced care protocols.

• Mechanism of action: Inhibits type I interferon receptor (IFNAR1)

• Form: Intravenous monoclonal antibody therapy

• Indication: For adults with moderate to severe, autoantibody-positive SLE

• Not indicated for: Severe lupus nephritis or CNS lupus

• Regulatory designation: Prescription-only, professional use

Why Practitioners Choose SAPHNELO®

SAPHNELO® is more than an immune modulator—it’s a refinement of care. In controlled clinical trials, it consistently outperformed placebo across key disease activity measures, offering a harmonious balance between efficacy and tolerability. Its monthly infusion schedule is designed with both convenience and compliance in mind, ideal for elevated clinical experiences.

• Superior BICLA response at Week 52: 47.1%–47.8% vs. placebo 30.2%–31.5%

• Enhanced steroid tapering success: 51.5% of patients achieved ≤7.5 mg/day (vs. 30.2% placebo)

• Sustained flare reduction: Annualized flare rate of 0.43 vs. 0.64 with placebo

• Tolerability profile: Discontinuation due to AEs lower than comparator arm

Who Is SAPHNELO® Best For?

This elegant solution is thoughtfully tailored for adults living with moderate to severe SLE, particularly those whose disease remains active despite conventional therapy. SAPHNELO® serves as an ideal adjunct for patients seeking optimized control with reduced corticosteroid reliance.

• Indicated for: Adults with autoantibody-positive active SLE

• Ideal candidates: Those experiencing frequent flares or corticosteroid dependency

• Not studied in: Individuals <18 years, or patients with severe renal/CNS involvement

• Best used alongside: Antimalarials, corticosteroids, and/or immunosuppressants

What’s Inside: Active Components of SAPHNELO®

Each vial of SAPHNELO® is meticulously formulated with a premium profile of ingredients designed to ensure stability, bioactivity, and infusion safety. Its composition reflects the precision of biologic engineering.

• Active ingredient: Anifrolumab at 150 mg/mL

• Presentation: 300 mg in 2.0 mL, single-use vial

• Formulation excipients:

  • L-Histidine / L-Histidine hydrochloride monohydrate – buffering agents

  • L-Lysine hydrochloride – tonicity modulator

  • Trehalose dihydrate – protein stabilizer

  • Polysorbate 80 – emulsifier

  • Water for injection – solvent

• Preservative-free formulation

How to Use SAPHNELO® Effectively

Administering SAPHNELO® is a streamlined clinical process that underscores its role as a high-end, precision therapy. Designed for monthly intravenous infusion, the protocol emphasizes simplicity and consistency in therapeutic delivery.

• Recommended dose: 300 mg every 4 weeks

• Infusion duration: Precisely 30 minutes

• Dilution protocol:

  • Withdraw 2.0 mL from 50–100 mL normal saline

  • Replace with 2.0 mL SAPHNELO®; gently invert to mix

• Equipment: Use a 0.2 to 15 μm low-protein-binding in-line filter

• Post-infusion: Flush with 25 mL normal saline

• Administration setting: Healthcare environment only

SAPHNELO® Storage Guidelines

Maintaining the integrity of SAPHNELO® requires adherence to refined storage protocols, reflecting its status as a sensitive biologic of superior precision.

• Unopened vials:

  • Store at 2°C to 8°C (refrigerated)

  • Do not freeze

  • Protect from light

• Once diluted:

  • Room temperature (15–25°C): Stable for 4 hours

  • Refrigerated (2–8°C): Stable for 24 hours

  • Return to room temperature before infusion

Potential Reactions and Safety Notes - SAPHNELO® Side Effects

While SAPHNELO® is well tolerated, a premium therapeutic experience includes vigilance. The most frequently observed effects are mild to moderate infections and infusion reactions. Serious complications are uncommon, but responsible monitoring is essential.

• Most common (≥5%):

  • Nasopharyngitis: 16.3%

  • Upper respiratory infection: 15.5%

  • Herpes zoster: 6.1%

  • Infusion-related reactions: 9.4%

• Serious events:

  • Infections: 4.8% with SAPHNELO®

  • Malignancies (non-NMSC): 0.7%

  • Hypersensitivity, including anaphylaxis: 0.6%

• Long-term safety: Confirmed across 4-year extension studies

SAPHNELO® FAQs

Is SAPHNELO® suitable for pediatric use?
No. Its safety and efficacy have not been established in individuals under 18 years.

Can patients receive vaccines while on SAPHNELO®?
Live or attenuated vaccines are contraindicated during treatment.

Is SAPHNELO® appropriate during pregnancy or breastfeeding?
Due to placental transfer and presence in animal breast milk, use during pregnancy and lactation is not advised unless clearly necessary.

Can it be combined with other biologic agents?
No. SAPHNELO® has not been studied in combination with other biologics.

What if an infusion is missed?
Administer promptly and maintain at least a 14-day interval between doses.

Order SAPHNELO® with Confidence

SAPHNELO® is exclusively available as a single-use 300 mg/2.0 mL vial, distributed under strict cold-chain conditions to preserve its biological integrity. Reserved for professional settings, it must be administered by qualified personnel with IV expertise.

• Format: 300 mg/2 mL per vial

• Use case: Clinic or infusion center only

• Ordering: Via licensed, temperature-controlled medical distributors

• Not for: Self-administration or retail pharmacy sales