SAPHNELO®

What Is SAPHNELO®?

SAPHNELO® (anifrolumab) is a lab-made antibody that targets a protein called interferon alpha receptor 1. This receptor plays a big role in the type I interferon pathway, which is known to be overactive in many people with lupus. By blocking that pathway, SAPHNELO® helps calm the immune system and improve symptoms.

It’s not a cure, but it can make a real difference when added to standard lupus treatment, especially for patients who still have active symptoms despite being on medications.

• Targets: Type I interferon pathway by blocking IFNAR1

• Reduces: Immune overactivation, flares, and disease activity

• Works best with: Standard lupus therapies (like steroids and antimalarials)

• Not studied in: Children or people with severe kidney (lupus nephritis) or CNS lupus

Why SAPHNELO® Might Be Right for Your Patients

If you’re caring for patients with lupus who continue to have flares or can’t lower their steroid dose without symptoms coming back, SAPHNELO® might be a helpful option. In clinical trials, more patients on SAPHNELO® saw improvements in disease activity and were able to reduce their corticosteroids.

It’s given just once a month by infusion and has a safety profile that’s manageable for most patients.

• Improved response: More patients met composite lupus activity goals vs. placebo

• Steroid-sparing: Higher rates of reducing prednisone to ≤7.5 mg/day

• Fewer flares: Lower annual flare rate than placebo

• Once-a-month dosing: Helps with treatment adherence

• No dose adjustments needed for older patients

Products in the SAPHNELO® Line

Currently, SAPHNELO® is available as a single product:

• SAPHNELO® 300 mg/2 mL in a single-use vial

• Designed for intravenous use only

• No subcutaneous version available at this time

Where and How SAPHNELO® Is Used

SAPHNELO® is used in a clinical setting, like an infusion center or hospital. It’s not meant for at-home use or self-administration. Patients get it through a 30-minute IV infusion every 4 weeks.

The medication is added to a bag of normal saline (50 to 100 mL) and must be given with a low-protein-binding filter to ensure proper delivery.

• Setting: Healthcare professional administration only

• Infusion time: 30 minutes

• Frequency: Every 4 weeks

• Dose: 300 mg

• Post-infusion flush: Required with 25 mL normal saline

• Do not mix with other IV drugs in the same line

What’s in SAPHNELO®?

The main active ingredient is anifrolumab, a fully human IgG1κ monoclonal antibody. It’s formulated in a preservative-free solution. The excipients help keep the product stable and safe for infusion.

• Active ingredient: Anifrolumab 150 mg/mL

• Other ingredients:

  • L-Histidine

  • L-Histidine hydrochloride monohydrate

  • L-Lysine hydrochloride

  • Trehalose dihydrate

  • Polysorbate 80

  • Water for injection

• Free from: Preservatives and antimicrobial agents

How to Inject SAPHNELO®

SAPHNELO® is not injected like a typical medication—it needs to be infused slowly through a vein. You’ll need to prepare the IV bag carefully and use the right equipment to prevent protein loss or reaction.

• Step 1: Withdraw 2 mL from an IV bag (50–100 mL saline)

• Step 2: Add 2 mL of SAPHNELO® from the vial

• Step 3: Gently mix by inverting (don’t shake)

• Step 4: Infuse over 30 minutes with a 0.2–15 µm filter

• Step 5: Flush the line with 25 mL saline

Always have emergency equipment ready in case of a rare infusion reaction.

How to Store SAPHNELO®

Proper storage keeps SAPHNELO® safe and effective. The vials need refrigeration, and once the medication is mixed for infusion, it must be used in a specific timeframe depending on the storage temperature.

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

• Do not freeze

• Keep away from light

• After dilution:

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

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

• Let refrigerated solutions warm to room temp before infusion

What SAPHNELO® Side Effects Should You Know About?

Like all medications, SAPHNELO® can cause side effects. Most are mild to moderate, but some may be serious. The most common issues are infections, especially upper respiratory tract infections and herpes zoster (shingles).

Infusion reactions can also happen, so it’s important to monitor patients closely during and after treatment.

• Most common side effects:

  • Nasopharyngitis: 16.3%

  • Upper respiratory infection: 15.5%

  • Shingles (herpes zoster): 6.1%

• Infusion reactions: 9.4% (usually mild)

• Serious infections: 4.8% with SAPHNELO®

• Discontinuation due to side effects: 4.1%

• Very rare but possible: Anaphylaxis and malignancies

Questions We Often Hear About SAPHNELO®

Can SAPHNELO® be used in kids?
No, it’s only approved for adults aged 18 and over.

Can patients get vaccines while on SAPHNELO®?
Live or attenuated vaccines should be avoided due to risk of infection.

What if a patient misses a dose?
Give the missed dose as soon as possible. Always keep at least 14 days between infusions.

Can patients take other biologics with SAPHNELO®?
No, it hasn’t been studied in combination with other biologics, so it’s not recommended.

What about use during pregnancy or breastfeeding?
SAPHNELO® crosses the placenta and has been found in breast milk in animal studies. Use only if clearly needed.

Ready to Order SAPHNELO®?

SAPHNELO® is available as a 300 mg/2 mL single-use vial and must be ordered through licensed distributors that can handle refrigerated biologics. It’s not available for direct patient use—only for clinics and healthcare providers.

If you’re looking to buy SAPHNELO® for your practice, contact the team on Medical Spa RX and get assistance.