SAPHNELO®

Key Benefits of SAPHNELO®

The therapeutic efficacy of SAPHNELO® is derived from its ability to inhibit type I interferon signaling, a key contributor to SLE disease activity. Across pivotal Phase II and III trials, SAPHNELO® demonstrated consistent improvements in clinical response rates when compared to placebo, using validated composite endpoints such as BICLA and SRI-4.

Patients treated with SAPHNELO® were more likely to achieve reductions in corticosteroid use and experienced fewer disease flares over time.

• BICLA response at 52 weeks: 47.1%–47.8% with SAPHNELO vs. 30.2%–31.5% with placebo

• SRI-4 response at 52 weeks: 49.0%–55.5% with SAPHNELO vs. 37.3%–43.0% with placebo

• Corticosteroid tapering (Study 04): 51.5% of SAPHNELO-treated patients reduced prednisone to ≤7.5 mg/day, vs. 30.2% with placebo

• Annualized flare rate (Study 04): 0.43 with SAPHNELO vs. 0.64 with placebo.

Clinical Indications for SAPHNELO®

SAPHNELO® is indicated in combination with standard therapy for adults with moderate to severe, autoantibody-positive systemic lupus erythematosus (SLE). The product is approved only for patients ≥18 years of age and has not been studied in pediatric or elderly populations with sufficient representation.

• Approved indication: Active SLE with autoantibody positivity in adults

• Not indicated: Severe lupus nephritis or CNS lupus

• Pediatric use: Not authorized (<18 years)

• Geriatric use: Limited data; no dose adjustments recommended

• Concomitant therapy: Used in addition to corticosteroids, antimalarials, and/or immunosuppressants.

SAPHNELO® Ingredients

SAPHNELO® contains anifrolumab, formulated in a preservative-free, sterile solution suitable for intravenous infusion. The excipients serve to maintain protein stability and isotonicity.

• Active ingredient: Anifrolumab 150 mg/mL

• Formulation: 300 mg in 2.0 mL (single-dose vial)

• Non-medicinal ingredients:

  • L-Histidine

  • L-Histidine hydrochloride monohydrate

  • L-Lysine hydrochloride

  • Polysorbate 80

  • Trehalose dihydrate

  • Water for injection.

SAPHNELO® Administration Technique

SAPHNELO® is administered as a 300 mg intravenous infusion over 30 minutes, every 4 weeks. Infusion must be performed by healthcare professionals trained in IV therapy, with readiness to manage hypersensitivity reactions.

• Dosage: 300 mg IV every 4 weeks

• Infusion duration: 30 minutes

• Preparation:

  • Withdraw 2.0 mL from infusion bag (50–100 mL normal saline)

  • Add 2.0 mL SAPHNELO® from vial

  • Mix by gentle inversion; do not shake

• Filter requirement: 0.2 to 15 μm low-protein-binding in-line filter

• Flush: Post-infusion, flush IV set with 25 mL normal saline

• Do not co-administer other medications via same line

• Hypersensitivity management: Have resuscitation equipment and trained personnel available.

SAPHNELO® Storage Conditions

Proper storage of SAPHNELO® is critical to preserve protein integrity and clinical efficacy. Stability guidelines differ for undiluted vials and prepared infusion solutions.

• Unopened vials:

  • Store at 2°C to 8°C

  • Protect from light

  • Do not freeze

• Diluted infusion solution:

  • Room temperature (15°C–25°C): Use within 4 hours

  • Refrigerated (2°C–8°C): Use within 24 hours

  • Allow refrigerated solution to reach room temperature prior to administration

• Disposal: Follow local biohazard regulations.

SAPHNELO® Side Effects

In controlled clinical trials, SAPHNELO® was associated with higher incidences of nasopharyngitis, respiratory infections, herpes zoster, and infusion-related reactions. Most adverse events were mild to moderate, though serious and fatal infections were also reported.

Read our comprehensive article about SAPHNELO side effects.

• Most common adverse events (≥5%):

  • Nasopharyngitis: 16.3%

  • Upper respiratory tract infection: 15.5%

  • Herpes zoster: 6.1% vs. 1.3% (placebo)

  • Infusion reactions: 9.4%

• Serious adverse events:

  • Infections: 4.8% (anifrolumab) vs. 5.6% (placebo)

  • Hypersensitivity (including anaphylaxis): 0.6%

  • Malignancies (excluding NMSC): 0.7%

• Discontinuation due to AEs: 4.1% with SAPHNELO vs. 5.2% placebo

• Long-term extension study: Safety profile consistent over 4 years.

FAQs About SAPHNELO®

Q: Is SAPHNELO® suitable for pediatric patients?
A: No. The product is not authorized for use in individuals <18 years of age.

Q: Can SAPHNELO® be used during pregnancy or breastfeeding?
A: Use is not recommended. Anifrolumab crosses the placenta and has been detected in breast milk in animal studies.

Q: Can live vaccines be administered while on SAPHNELO®?
A: No. Concurrent use with live or attenuated vaccines is contraindicated due to infection risk.

Q: Does SAPHNELO® interact with other immunomodulatory agents?
A: Co-administration with other biologics has not been studied and is not recommended.

Q: What happens if a dose is missed?
A: Administer as soon as possible. Maintain a minimum 14-day interval between infusions.

Buy SAPHNELO® Online

SAPHNELO® (anifrolumab) is a prescription-only biologic agent that must be administered under the supervision of a qualified healthcare provider.

• Availability: Single-dose 2 mL vials (300 mg)

• Distribution controls: Cold-chain, light-protected

• Use limitations: Not for patient self-administration

If you’re looking to order SAPHNELO® online for your practice, the Medica Depot sales representatives will show you how.