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SAPHNELO Anifrolumab-fnia 120 mg/.8mL Injection, Solution, 1 syringe — NDC 00310-3080-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SAPHNELO Anifrolumab-fnia 120 mg/.8mL Injection, Solution, 1 syringe — NDC 0310-3080-01 (Billing 00310-3080-01)

by AstraZeneca Pharmaceuticals LP · 1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS

This is a package of 1 syringe of SAPHNELO Anifrolumab-fnia 120 mg/.8mL Injection, Solution from AstraZeneca Pharmaceuticals LP, marketed since Apr 2026 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 00310-3080-01
🏷️ FDA NDC (as labeled) 0310-3080-01 billing pads the labeler segment with a zero
This package
Contains1 syringe Pack sizes3 compare ↓
Main listing for product 0310-3080 · Also comes in: 1 syringe 0310-3080-02 1 syringe 0310-3080-95
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0310-3080-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0310 labeler · 3080 product · 01 package
Package marketed since
Apr 24, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0310308001 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0310-3080-01
Product NDC 0310-3080
11-digit billing NDC 00310308001
NCPDP billing unit ML — per mL (volume)
RxCUI 2565280, 2565286, 2741470, 2741474, 2741478, 2741482
UNII 38RL9AE51Q
Application # BLA761451
SPL Set ID d6203302-2128-41a7-b0b4-0e6c0704d4dc
Established class (EPC) Type I Interferon Receptor Antagonist
Mechanism of action Type I Interferon Receptor Antagonists
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-24
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance ANIFROLUMAB
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 088886
GCN 59069
HICL code 047512
Ingredient (HICL) Anifrolumab-Fnia
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z25
Therapeutic class — specific (HIC3) Immunosuppressant-Interferon Inhibitor, Mab
AHFS code 90:24.28.00
AHFS class Igg1 Monoclonal Antibodies
FDB label name SAPHNELO 120 MG/0.8 ML PEN
FDB brand name Saphnelo Pen
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088886
  • GCN: 59069
  • HICL (First Databank): 047512
  • AHFS class code: 90:24.28.00
  • RxCUI (RxNorm): 2565280
Why two NDCs? The FDA registers this code as 0310-3080-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00310-3080-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Type I interferon Receptor Antagonist class.

Pharmacologic class Type I interferon Receptor Antagonist
Drug family (ATC) Monoclonal antibodies
How it works Type I interferon Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name SAPHNELO 120 MG/0.8 ML PEN Ingredient Anifrolumab-Fnia
📗 Our plain-language guide HelloPharmacist
  • Saphnelo is a biologic medicine specifically designed for moderate to severe systemic lupus erythematosus, or SLE. It works by blocking a signaling pathway that's overactive in mos...
  • What exactly is Saphnelo and why has my doctor prescribed it for my lupus?
  • There are two options. One is an IV infusion given at a clinic or infusion center by a healthcare provider, once every four weeks — each session takes about 30 minutes. The other i...
  • How will I actually receive this medication — will I have to go to a clinic every time?
📖 Read our full Anifrolumab-fnia Injection guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 syringe 1 syringe
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00310-3080-01 You're viewing this Main listing 1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS 2026-04-24 — Active
00310-3080-02 0310-3080-02 1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS 2026-04-24 — Active
00310-3080-95 0310-3080-95 1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS Sample 2026-04-24 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 syringe — 1 syringe, glass in 1 carton / .8 ml in 1 syringe, glass.
How does this package differ from NDC 00310-3080-02?
Both are SAPHNELO Anifrolumab-fnia 120 mg/.8mL Injection, Solution — the drug itself is identical. This page's package is the 1 syringe one, while NDC 00310-3080-02 is the 1 syringe package.
What NDC number is used to bill for this package of SAPHNELO Anifrolumab-fnia 120 mg/.8mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Saphnelo 120 mg/.8mLthis 00310-3080-01 AstraZeneca 1 syringe — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2021
First FDA approval
Jul 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2033. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 30, 2021 ⏳ ~6.8 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Saphneloanifrolumab-fnia
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2021 2023 2025 2027 2029 2031 2033
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateJul 30, 2033
Common questions
Is there a biosimilar for SAPHNELO 120 MG/0.8 ML PEN?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII X573657P6P
    Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
  • UNII JNJ23Q2COM
    Lysine hydrochloride is an amino acid salt used in medicines as a buffer and pH stabilizer. It helps maintain the acidity level of the product to keep the active ingredient stable and effective.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 7YIN7J07X4
    A natural sugar derived from plants and microorganisms. It acts as a filler to give the medication bulk and stability, and helps preserve the active ingredient during storage and manufacturing.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAstraZeneca Pharmaceuticals LP
FDA applicationBLA761451 (BLA)
Labeler code00310
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio113 products on file

More NDCs from AstraZeneca Pharmaceuticals LP labeler code 00310

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 129 words ▾

1 INDICATIONS AND USAGE 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. Use of SAPHNELO is not recommended in these situations.

SAPHNELO is a type I interferon (IFN) receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. ( 1 ) 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. Use of SAPHNELO is not recommended in these situations.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • 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 )

2.1Important 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) ] .

2.2Recommended 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.

2.3Intravenous Preparation and Administration Instructions SAPHNELO is supplied as a single-dose vial. Prepare the diluted infusion solution using aseptic technique, by the following procedure: 1. Visually inspect the vial for particulate matter and discoloration.

SAPHNELO is a clear to opalescent, colorless to slightly yellow, solution. Discard the vial if the solution is cloudy, discolored or visible particles are observed. Do not shake the vial.

2. Withdraw and discard 2 mL of solution from a 50 mL or 100 mL 0.9% Sodium Chloride Injection, USP infusion bag. 3.

Withdraw 2 mL of solution from the vial of SAPHNELO and add it to the infusion bag. Mix the solution by gentle inversion. Do not shake.

4. Each vial is intended for one time use only. Discard any unused portion remaining in the vial.

5. Administer the infusion solution immediately after preparation. 6.

If the infusion solution is not administered immediately, store the diluted solution of SAPHNELO at room temperature 59°F to 77°F (15°C to 25°C) for up to 4 hours, or refrigerated 36°F to 46°F (2°C to 8°C) for up to 24 hours. Do not freeze. Protect from light.

If refrigerated, allow the diluted SAPHNELO solution to reach room temperature prior to administration. 7. Administer the infusion solution intravenously over a 30-minute period through an infusion line containing a sterile, low-protein binding 0.2 to 15 micron in-line or add-on filter.

8. To ensure the complete dose of SAPHNELO has been administered, flush the entire infusion line with 25 mL of 0.9% Sodium Chloride Injection, USP at the end of the infusion. 9.

Do not co-administer other medicinal products through the same infusion line. 10. Dispose of any unused medicinal product or waste material in accordance with local requirements .

2.4Subcutaneous Preparation and Administration Instructions The SAPHNELO prefilled syringe and autoinjector (SAPHNELO PEN) are for subcutaneous use. 1. Comprehensive instructions for subcutaneous administration of SAPHNELO using the prefilled syringe or autoinjector are provided in the ‘Instructions for Use’.

2. Patients/caregivers may administer SAPHNELO prefilled syringe/SAPHNELO PEN after proper training in the subcutaneous injection technique and after the healthcare provider determines it is appropriate. 3.

Prior to administration, remove SAPHNELO from the refrigerator and allow it to come to room temperature for 60 minutes. 4. Visually inspect SAPHNELO for particulate matter and discoloration prior to administration.

SAPHNELO is… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 91 words ▾

3 DOSAGE FORMS AND STRENGTHS Intravenous Infusion • Injection: 300 mg/2 mL (150 mg/mL) as a clear to opalescent, colorless to slightly yellow solution in a single-dose vial. Subcutaneous Injection • Injection: 120 mg/0.8 mL as a clear to opalescent, colorless to slightly yellow solution in a single-dose prefilled syringe or single-dose autoinjector (SAPHNELO PEN). Intravenous Infusion: • Injection: 300 mg/2 mL (150 mg/mL) in a single-dose vial.

( 3 ) Subcutaneous Injection: • Injection: 120 mg/0.8 mL in a single-dose prefilled syringe or single-dose autoinjector (SAPHNELO PEN). ( 3 )

⛔ Contraindications 36 words ▾

4 CONTRAINDICATIONS 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. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • 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 )

5.1Serious 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. Consider the benefit and risk of administering SAPHNELO in patients with a chronic infection, a history of recurrent infections, or known risk factors for infection. Instruct patients to seek medical advice if signs or symptoms of a clinically significant infection occur.

If a patient develops an infection or is not responding to standard anti-infective therapy while on SAPHNELO, monitor the patient closely and consider interrupting SAPHNELO until the infection resolves.

5.2Hypersensitivity Reactions Including Anaphylaxis Serious hypersensitivity reactions (including anaphylaxis) have been reported following SAPHNELO administration [see Contraindication (4) ] . Events of angioedema have also been reported [see Adverse Reactions (6.1) ] . Other hypersensitivity reactions and infusion-related reactions have occurred following administration of SAPHNELO [see Adverse Reactions (6.1) ] .

Consider pre-medication before infusion of SAPHNELO for patients with a history of these reactions. SAPHNELO should be administered by healthcare providers prepared to manage hypersensitivity reactions, including anaphylaxis, and infusion-related reactions. If a serious infusion-related or hypersensitivity reaction (e.g., anaphylaxis) occurs, immediately interrupt the administration of SAPHNELO and initiate appropriate therapy.

5.3Malignancy There is an increased risk of malignancies with the use of immunosuppressants. The impact of SAPHNELO treatment on the potential development of malignancies is not known. Consider the individual benefit-risk in patients with known risk factors for the development or reoccurrence of malignancy prior to prescribing SAPHNELO. In patients who develop malignancies, consider the benefit-risk of continued treatment with SAPHNELO.

5.4Immunizations Update immunizations, according to current immunization guidelines, prior to initiating SAPHNELO therapy. Avoid concurrent use of live or live-attenuated vaccines in patients treated with SAPHNELO.

5.5Not Recommended for Concomitant Use with Other Biologic Therapies SAPHNELO has not been studied in combination with other biologic therapies, including B-cell-targeted therapies. Therefore, use of SAPHNELO is not recommended for use in combination with biologic therapies.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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.

6.1Clinical 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. Adverse reactions that occurred at greater than or equal to 2% incidence are shown in Table 1.

Table 1 Adverse Reactions Occurring in ≥2% of Adults with Moderate to Severe SLE Treated with Intravenous SAPHNELO for 52 weeks in Trials 1, 2 and 3 Adverse Reaction SAPHNELO (N=459) % Placebo (N=466) % Upper respiratory tract infection Upper respiratory tract infections (including Upper respiratory tract infections, Nasopharyngitis, Pharyngitis) 34 23 Bronchitis Bronchitis (including Bronchitis, Bronchitis viral, Tracheobronchitis) 11

5.2Infusion‑related reactions 9.4

7.1Herpes Zoster 6.1

1.3Cough 5.0

3.2Respiratory tract infection Respiratory tract infection (including Respiratory tract infection, Respiratory tract infection viral, Respiratory tract infection bacterial) 3.3

1.5Hypersensitivity 2.8

0.6All patients received standard therapy. Long-term Safety Patients who completed Trials 2 and 3 (Phase III feeder trials) were eligible to continue on treatment in a randomized, double-blind, placebo-controlled long-term extension (LTE) trial, for an additional 3 years. The long-term safety of SAPHNELO was assessed in 257 patients who received SAPHNELO 300 mg every 4 weeks and 112 patients who received placebo in both a feeder trial and the LTE.

Of these, 177 patients who received SAPHNELO (68.9%) and 52 patients who received placebo (46.4%) completed a total of 4 years on treatment. The overall long-term safety profile of SAPHNELO was consistent with Trials 1, 2 and 3. Specific Adverse Reactions Infections: In the 52‑week controlled-clinical trials, infections were reported in a greater proportion of patients while on treatment with SAPHNELO compared to placebo (69.7% versus 55.4%, respectively).

Herpes Zoster: In the 52‑week controlled-clinical trials, the incidence of herpes zoster in patients while on treatment with SAPHNELO was 6.1% and 1.3% in patients on placebo. Cases with multidermatomal involvement and disseminated presentation have been reported. Of the 28 SAPHNELO-treated patients with herpes zoster, 2 experienced disseminated disease requiring hospitalization compared to none among placebo-treated patients.

Hypersensitivity Reactions Including Anaphylaxis: During the SLE intravenous development program, there was one report of an anaphylactic reaction in a patient who received SAPHNELO 150 mg, and 4 reports of angioedema after 300 mg. In general, the hypersensitivity reaction… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 11 words ▾

7 DRUG INTERACTIONS No formal drug interaction trials have been conducted.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk : Pregnant women with SLE are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. Maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia. Passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block.

Data Animal Data : In an enhanced pre- and post-natal development study, pregnant cynomolgus monkeys received anifrolumab-fnia at intravenous doses of 30 or 60 mg/kg once every 2 weeks from confirmation of pregnancy at Gestation Day 20, throughout the gestation period, and continuing until 1‑month post-partum (approximately Lactation Day 28). There was no evidence of anifrolumab-fnia related maternal toxicity, embryo-fetal toxicity, or post-natal developmental effects. No anifrolumab-fnia related effect on T-cell-dependent antibody response in the infants was noted up to Day 180 after birth.

The no observed adverse effect level (NOAEL) for maternal and developmental toxicity was identified as 60 mg/kg (approximately 28‑times the MRHD on an AUC basis). In the infants, mean serum concentrations of anifrolumab‑fnia on Day 30 after birth increased with dose and were approximately 4.2% to 9.7% of the respective maternal concentrations. The anifrolumab-fnia concentrations in the infant serum were up to approximately 22‑times the concentrations in the maternal milk, suggesting that anifrolumab-fnia had transferred via the placenta.

8.2Lactation Risk Summary No data are available regarding the presence of SAPHNELO in human milk, the effects on the breastfed child, or the effects on milk production. Anifrolumab-fnia was detected in the milk of female cynomolgus monkeys administered anifrolumab-fnia. Due to species-species differences in lactation physiology, animal data may not reliably predict drug levels in humans.

Maternal IgG is known to be present in human milk. If anifrolumab-fnia is transferred into human milk, the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to anifrolumab-fnia are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SAPHNELO and any potential adverse effects on the… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk : Pregnant women with SLE are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. Maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia. Passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block.

Data Animal Data : In an enhanced pre- and post-natal development study, pregnant cynomolgus monkeys received anifrolumab-fnia at intravenous doses of 30 or 60 mg/kg once every 2 weeks from confirmation of pregnancy at Gestation Day 20, throughout the gestation period, and continuing until 1‑month post-partum (approximately Lactation Day 28). There was no evidence of anifrolumab-fnia related maternal toxicity, embryo-fetal toxicity, or post-natal developmental effects. No anifrolumab-fnia related effect on T-cell-dependent antibody response in the infants was noted up to Day 180 after birth.

The no observed adverse effect level (NOAEL) for maternal and developmental toxicity was identified as 60 mg/kg (approximately 28‑times the MRHD on an AUC basis). In the infants, mean serum concentrations of anifrolumab‑fnia on Day 30 after birth increased with dose and were approximately 4.2% to 9.7% of the respective maternal concentrations. The anifrolumab-fnia concentrations in the infant serum were up to approximately 22‑times the concentrations in the maternal milk, suggesting that anifrolumab-fnia had transferred via the placenta.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and efficacy of SAPHNELO in pediatric patients have not been established.

🧓 Geriatric Use 48 words ▾

8.5Geriatric Use Of the 952 patients with moderate to severe SLE exposed to SAPHNELO in clinical trials, 3% (n=33) were 65 and over. The number of patients aged 65 years of age and older was not sufficient to determine whether they respond differently from younger adult patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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. Anifrolumab-fnia also induces the internalization of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly.

Blockade of receptor mediated type I IFN signaling inhibits IFN responsive gene expression as well as downstream inflammatory and immunological processes. Inhibition of type I IFN blocks plasma cell differentiation and normalizes peripheral T-cell subsets. Type I IFNs play a role in the pathogenesis of SLE.

Approximately 60-80% of adult patients with active SLE express elevated levels of type I IFN inducible genes.

12.2Pharmacodynamics In patients with moderate to severe SLE, following the administration of SAPHNELO, neutralization (≥80%) of a type I IFN gene signature was observed from Week 4 to Week 52 in blood samples of patients with elevated levels of type I IFN inducible genes and returned to baseline levels within 8 to 12 weeks following withdrawal of SAPHNELO at the end of the 52‑week treatment period. However, the clinical relevance of the type I IFN gene signature neutralization is unclear. In SLE patients with positive anti-dsDNA antibodies at baseline (Trials 2 and 3), treatment with SAPHNELO led to numerical reductions in anti-dsDNA antibodies over time through Week 52.

In patients with low complement levels (C3 and C4) at baseline (Trials 2 and 3), increases in complement levels were observed in patients receiving SAPHNELO through Week 52.

12.3Pharmacokinetics 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.

The estimated time to reach steady state is approximately 112 days for both intravenous and subcutaneous administration. Following 300 mg intravenous administrations every 4 weeks, the accumulation ratio for C max was 1.11 and for C trough was 2.37. Following 120 mg subcutaneous administration weekly, the accumulation ratio for C max was 1.85 and C trough was 1.85.

Absorption The bioavailability of anifrolumab-fnia was estimated to be 73% following subcutaneous injection. The estimated maximum serum concentration (C max ) of anifrolumab-fnia at steady state was 63.7 μg/mL. Distribution Based on population PK analysis, the estimated volume of distribution at steady state for a typical patient with SLE (68 kg) is

5.16L. Elimination From population PK analysis, anifrolumab-fnia exhibited non-linear PK due to IFNAR1-mediated drug clearance. The estimated systemic clearance (CL) for anifrolumab-fnia is 0.146 L/day.

Based on population PK analysis of patients who received SAPHNELO for one year, serum concentrations of anifrolumab-fnia were below detection in 95% of patients approximately 16 weeks after the last dose. Specific Populations There was no clinically meaningful difference in systemic clearance based on age, race, ethnicity, region, gender, IFN status or body weight, that requires dose adjustment. Age: Based on population PK analyses, age (range 18 to 70 years) did not affect anifrolumab-fnia clearance.

Limited PK data are available for geriatric patients; 3% (n=33) of the patients included in the PK analysis were 65 years or older [see Use in Specific Populations (8.5) ] . Patients with Renal Impairment: No specific clinical trials have… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 126 words ▾

12.1Mechanism of Action 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. Anifrolumab-fnia also induces the internalization of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly.

Blockade of receptor mediated type I IFN signaling inhibits IFN responsive gene expression as well as downstream inflammatory and immunological processes. Inhibition of type I IFN blocks plasma cell differentiation and normalizes peripheral T-cell subsets. Type I IFNs play a role in the pathogenesis of SLE.

Approximately 60-80% of adult patients with active SLE express elevated levels of type I IFN inducible genes.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution in a single-dose vial for intravenous infusion or a prefilled syringe or autoinjector for subcutaneous injection. SAPHNELO is available as follows: Packaging Unit and Strength Pack Size and NDC 300 mg/2 mL (150 mg/mL) single-dose vial (NDC 0310-3040-00) One vial in a carton: NDC 0310-3040-00 120 mg/0.8 mL single-dose prefilled syringe (NDC 0310-3080-75) One syringe in a carton: NDC 0310-3080-02 120 mg/0.8 mL single-dose autoinjector (SAPHNELO PEN) (NDC 0310-3080-25) One autoinjector in a carton: NDC 0310-3080-01 The prefilled syringe (including needle cover) and autoinjector (including cap) are not made with natural rubber latex.

Storage and Handling Store SAPHNELO in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. • Do not freeze. Do not shake. Do not expose to heat.

Do not use SAPHNELO past the expiration date. If needed, SAPHNELO prefilled syringe or autoinjector can be stored at room temperature 68°F to 77°F (20°C to 25°C) for up to 7 days in the original carton to protect from light. After the SAPHNELO prefilled syringe or autoinjector has reached room temperature, do not return to the refrigerator.

Discard SAPHNELO prefilled syringe or autoinjector if not used within 7 days at room temperature storage.

📋 Description 168 words ▾

11 DESCRIPTION Anifrolumab-fnia is a type I interferon (IFN) receptor antagonist, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced in mouse myeloma cells (NS0) by recombinant DNA technology. The molecular weight is approximately 148 kDa. Intravenous Infusion SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative‑free, clear to opalescent, colorless to slightly yellow, solution in a single-dose vial for intravenous use.

Each 2 mL single-dose vial contains 300 mg (150 mg/mL) of anifrolumab-fnia, L-histidine (3 mg), L-histidine hydrochloride monohydrate (6 mg), L-lysine hydrochloride (18 mg), polysorbate 80 (1 mg), trehalose dihydrate (98 mg), and Water for Injection, USP. The pH is 5.9. Subcutaneous Injection SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow, solution in a prefilled syringe or autoinjector for subcutaneous injection.

Each 0.8 mL single-dose prefilled syringe or autoinjector delivers 120 mg of anifrolumab-fnia, histidine (1 mg), L-histidine hydrochloride monohydrate (3 mg), lysine hydrochloride (7 mg), polysorbate 80 (0.4 mg), trehalose (36 mg), and Water for Injection, USP. The pH is 5.9.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Serious Infections Inform patients that SAPHNELO may decrease their ability to fight infections and that serious infections, including fatal ones, occurred in patients receiving SAPHNELO in clinical trials. Also inform patients that they are at increased risk of respiratory infections and herpes zoster during treatment with SAPHNELO [see Warnings and Precautions (5.1) ] .

Advise patients to contact their healthcare provider if they develop any symptoms of an infection. Hypersensitivity Reactions/Anaphylaxis Inform patients that serious hypersensitivity reactions, including anaphylaxis, have been reported in patients who received SAPHNELO. Instruct patients to immediately tell their healthcare provider or go to the emergency department of their nearest hospital, if they experience symptoms of an allergic reaction (e.g., anaphylaxis) during or after the administration of SAPHNELO [see Warnings and Precautions (5.2) ] .

Immunizations Inform patients that they should not receive live or live-attenuated vaccines while receiving SAPHNELO. Advise patients to discuss with their healthcare provider before seeking immunizations on their own [see Warnings and Precautions (5.4) ] . Pregnancy Advise female patients to inform their healthcare provider if they intend to become pregnant during therapy, suspect they are pregnant or become pregnant while receiving SAPHNELO [see Use in Specific Populations (8.1) ] .

Inform women that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to SAPHNELO and they can contact AstraZeneca at 1-877-693-9268 for more information or to report the pregnancy. Manufactured by: AstraZeneca AB Södertälje, Sweden SE-15185 US License No. 2059 Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 SAPHNELO is a registered trademark of AstraZeneca. ©AstraZeneca 2026

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics 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.

The estimated time to reach steady state is approximately 112 days for both intravenous and subcutaneous administration. Following 300 mg intravenous administrations every 4 weeks, the accumulation ratio for C max was 1.11 and for C trough was 2.37. Following 120 mg subcutaneous administration weekly, the accumulation ratio for C max was 1.85 and C trough was 1.85.

Absorption The bioavailability of anifrolumab-fnia was estimated to be 73% following subcutaneous injection. The estimated maximum serum concentration (C max ) of anifrolumab-fnia at steady state was 63.7 μg/mL. Distribution Based on population PK analysis, the estimated volume of distribution at steady state for a typical patient with SLE (68 kg) is

5.16L. Elimination From population PK analysis, anifrolumab-fnia exhibited non-linear PK due to IFNAR1-mediated drug clearance. The estimated systemic clearance (CL) for anifrolumab-fnia is 0.146 L/day.

Based on population PK analysis of patients who received SAPHNELO for one year, serum concentrations of anifrolumab-fnia were below detection in 95% of patients approximately 16 weeks after the last dose. Specific Populations There was no clinically meaningful difference in systemic clearance based on age, race, ethnicity, region, gender, IFN status or body weight, that requires dose adjustment. Age: Based on population PK analyses, age (range 18 to 70 years) did not affect anifrolumab-fnia clearance.

Limited PK data are available for geriatric patients; 3% (n=33) of the patients included in the PK analysis were 65 years or older [see Use in Specific Populations (8.5) ] . Patients with Renal Impairment: No specific clinical trials have been conducted to investigate the effect of renal impairment on anifrolumab-fnia. Based on population PK analyses, anifrolumab-fnia clearance was comparable in SLE patients with mild (60-89 mL/min/1.73 m 2 ) and moderate (30-59 mL/min/1.73 m 2 ) decrease in eGFR values and patients with normal renal function (≥90 mL/min/1.73 m 2 ).

There were no SLE patients with a severe decrease in eGFR or end stage renal disease (<30 mL/min/1.73 m 2 ); anifrolumab-fnia is not cleared renally. Patients with urine protein/creatinine ratio (UPCR) >2 mg/mg were excluded from the clinical trials. Based on population PK analyses, increased UPCR did not significantly affect anifrolumab-fnia clearance.

Patients with Hepatic Impairment: No specific clinical trials have been conducted to investigate the effect of hepatic impairment on anifrolumab-fnia. IgG1 monoclonal antibodies are predominantly eliminated via catabolism and are not expected to undergo hepatic metabolism; changes in hepatic function are not expected to influence anifrolumab-fnia clearance. Based on population PK analyses, baseline hepatic function biomarkers (ALT and AST ≤2.0 × ULN, and total bilirubin) had no clinically relevant effect on anifrolumab-fnia clearance.

Drug Interactions No formal drug-drug interaction trials have been conducted. Based on population PK analysis, concomitant use of oral corticosteroids, anti-malarials, immunosuppressants (azathioprine, methotrexate, mycophenolate mofetil, mycophenolic acid, and mizoribine), NSAIDs, ACE inhibitors, and HMG-CoA reductase inhibitors did not significantly affect the PK of anifrolumab-fnia.

🧬 Pharmacodynamics 137 words ▾

12.2Pharmacodynamics In patients with moderate to severe SLE, following the administration of SAPHNELO, neutralization (≥80%) of a type I IFN gene signature was observed from Week 4 to Week 52 in blood samples of patients with elevated levels of type I IFN inducible genes and returned to baseline levels within 8 to 12 weeks following withdrawal of SAPHNELO at the end of the 52‑week treatment period. However, the clinical relevance of the type I IFN gene signature neutralization is unclear. In SLE patients with positive anti-dsDNA antibodies at baseline (Trials 2 and 3), treatment with SAPHNELO led to numerical reductions in anti-dsDNA antibodies over time through Week 52.

In patients with low complement levels (C3 and C4) at baseline (Trials 2 and 3), increases in complement levels were observed in patients receiving SAPHNELO through Week 52.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Intravenous Administration in Adults with Moderate to Severe SLE Trial Design and Population The safety and efficacy of SAPHNELO were evaluated in three 52-week treatment period, multicenter, randomized, double-blind, placebo-controlled trials (Trial 1 [NCT01438489], Trial 2 [NCT02446912] and Trial 3 [NCT02446899]). Patients were diagnosed with SLE according to the American College of Rheumatology (1982 revised) classification criteria. All patients were ≥18 years of age and had moderate to severe disease, with a SLE Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points, organ level involvement based on the British Isles Lupus Assessment Group (BILAG) assessment, and a Physician’s Global Assessment [PGA] score ≥1, despite receiving standard SLE therapy consisting of either one or any combination of oral corticosteroids (OCS), antimalarials and/or immunosuppressants at baseline.

Patients continued to receive their existing SLE therapy at stable doses during the clinical trials, with the exception of OCS (prednisone or equivalent) where tapering was a component of the protocol. Patients who had severe active lupus nephritis and patients who had severe active central nervous system lupus were excluded. The use of other biologic agents and cyclophosphamide were not permitted during the trials; patients receiving other biologic therapies were required to complete a wash-out period of at least 5 half‑lives prior to enrollment.

All three trials were conducted in North America, Europe, South America and Asia. Patients received SAPHNELO or placebo, administered by intravenous infusion, every 4 weeks. Efficacy of SAPHNELO was established based on assessment of clinical response using the composite endpoints, the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) and the SLE Responder Index (SRI‑4).

BICLA response at Week 52, was defined as improvement in all organ domains with moderate or severe activity at baseline: • Reduction of all baseline BILAG A to B/C/D and baseline BILAG B to C/D, and no BILAG worsening in other organ systems, as defined by ≥1 new BILAG A or ≥2 new BILAG B; • No worsening from baseline in SLEDAI-2K, where worsening is defined as an increase from baseline of >0 points in SLEDAI-2K; • No worsening from baseline in patients’ lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point PGA visual analogue scale (VAS); • No discontinuation of treatment; • No use of restricted medication beyond the protocol-allowed threshold.

SRI‑4 response, was defined as meeting each of the following criteria at Week 52 compared with baseline: • Reduction from baseline of ≥4 points in the SLEDAI-2K; • No new organ system affected as defined by 1 or more BILAG A or 2 or more BILAG B items compared to baseline; • No worsening from baseline in the patients’ lupus disease activity defined by an increase ≥0.30 points on a 3‑point PGA VAS; • No discontinuation of treatment; • No use of restricted medication beyond the protocol-allowed threshold. Trial 1 randomized 305 patients (1:1:1) who received SAPHNELO, 300 mg or 1000 mg, or placebo once every 4 weeks for up to 52 weeks.

The primary endpoint was a combined assessment of the SRI-4 and the sustained reduction in OCS (<10 mg/day and ≤OCS dose at Week 1, sustained for 12 weeks) measured at Week 24. Trial 2 and 3 were similar in design. Trial 2 randomized 457 patients (1:2:2) who received SAPHNELO 150 mg, 300 mg once every 4 weeks or placebo.

Trial 3 randomized 362 patients (1:1) who received SAPHNELO 300 mg once every 4 weeks or placebo. The primary endpoints were improvement in disease activity evaluated at 52 weeks, measured by SRI‑4 in Trial 2 and BICLA in Trial 3 (defined above). The common secondary efficacy endpoints included in both trials were the maintenance of OCS reduction, improvement in cutaneous SLE activity, and flare rate.

During Weeks 8-40, patients with a baseline OCS ≥10 mg/day were re… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 125 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic and genotoxic potential of anifrolumab-fnia have not been evaluated. In rodent models of IFNAR1 blockade, increased carcinogenic potential has been observed. The clinical relevance of these findings is unknown.

Effects on male and female fertility have not been directly evaluated in animal studies. No anifrolumab-fnia-related adverse effects on indirect measures of male or female fertility, based on semen analysis, spermatogenesis staging, menses cycle, organ weights and histopathological findings in the reproductive organs were observed in 9-month repeat-dose toxicity studies in cynomolgus monkeys at doses up to 50 mg/kg intravenous once weekly (approximately 58‑times the MRHD on an AUC basis) and 60 mg/kg subcutaneous once weekly (approximately 52-times the subcutaneous MRHD on an AUC basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 122 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic and genotoxic potential of anifrolumab-fnia have not been evaluated. In rodent models of IFNAR1 blockade, increased carcinogenic potential has been observed. The clinical relevance of these findings is unknown.

Effects on male and female fertility have not been directly evaluated in animal studies. No anifrolumab-fnia-related adverse effects on indirect measures of male or female fertility, based on semen analysis, spermatogenesis staging, menses cycle, organ weights and histopathological findings in the reproductive organs were observed in 9-month repeat-dose toxicity studies in cynomolgus monkeys at doses up to 50 mg/kg intravenous once weekly (approximately 58‑times the MRHD on an AUC basis) and 60 mg/kg subcutaneous once weekly (approximately 52-times the subcutaneous MRHD on an AUC basis).

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION SAPHNELO ® (saf-NEH-low) (anifrolumab-fnia) injection, for intravenous or subcutaneous use What is SAPHNELO? • SAPHNELO is a prescription medicine used to treat adults with moderate to severe systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines. • SAPHNELO contains anifrolumab-fnia which is in a group of medicines called monoclonal antibodies. Lupus is a disease of the immune system (the body system that fights infection). When given together with other medicines for lupus, SAPHNELO may help to reduce your lupus disease activity more than other lupus medicines alone. • It is not known if SAPHNELO is effective in people with severe active lupus nephritis or central nervous system lupus. • It is not known if SAPHNELO is safe and effective in children.

Do not use SAPHNELO if you: • are allergic to anifrolumab-fnia or any of the ingredients in SAPHNELO. See the end of this Patient Information leaflet for a complete list of ingredients in SAPHNELO. Before you receive SAPHNELO, tell your healthcare provider about all of your medical conditions, including if you: • think you have an infection or have infections that keep coming back.

You should not receive SAPHNELO if you have an infection unless your healthcare provider tells you to. See “What are the possible side effects of SAPHNELO?” • are scheduled to receive a vaccination or if you think you may need a vaccination. You should not receive live vaccines during treatment with SAPHNELO. • have or have had any type of cancer. • are receiving other biologic medicines or monoclonal antibodies. • are pregnant or plan to become pregnant.

It is not known if SAPHNELO will harm your unborn baby. Tell your healthcare provider if you are pregnant, think you might be pregnant, or plan to become pregnant during your treatment with SAPHNELO. • Pregnancy Exposure Registry . If you become pregnant while receiving SAPHNELO, talk to your healthcare provider.

A pregnancy exposure registry monitors pregnancy outcomes in women exposed to SAPHNELO. You can find out more information about the registry by calling AstraZeneca at 1-877-693-9268. • are breastfeeding or plan to breastfeed. It is not known if SAPHNELO passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby while receiving SAPHNELO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SAPHNELO may affect the way other medicines work, and other medicines may affect how SAPHNELO works.

How will I receive SAPHNELO? SAPHNELO is intended for use under your healthcare provider’s care and may be administered as an intravenous infusion or as a subcutaneous injection. When given into a vein (intravenously) • Your healthcare provider will give you SAPHNELO through a needle placed in a vein (IV or intravenous infusion).

It takes about 30 minutes to give you the full dose of SAPHNELO. • SAPHNELO is usually given 1 time every 4 weeks. • If you miss an appointment, call your healthcare provider as soon as possible to reschedule your appointment. When given under the skin (subcutaneously) • SAPHNELO may be prescribed as a single-dose prefilled syringe or as a single-dose autoinjector (SAPHNELO PEN). • Use SAPHNELO exactly as your healthcare provider tells you to use it. • SAPHNELO is injected under your skin (subcutaneously) in your stomach (abdomen), thigh or upper arm (for caregiver administration only) 1 time every week. • Before you use SAPHNELO, your healthcare provider will train you or your caregiver how to give the injections. • Read the Instructions for Use that comes with SAPHNELO for information on how to prepare and inject SAPHNELO. • If you miss your dose of SAPHNELO inject a dose as soon as you remember.

Then, continue to inject 1 time each week based on the new day SAPHNELO was injected or at your regularly scheduled time as long as there are at least… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE SAPHNELO® (saf-NEL-low) (anifrolumab-fnia) injection, for subcutaneous use Single-dose prefilled syringe 120 mg/0.8 mL This Instructions for Use contains information on how to inject using SAPHNELO prefilled syringe. Read this Instructions for Use before you start using SAPHNELO prefilled syringe and each time you get a refill. There may be new information.

This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Your healthcare provider should show you or your caregiver how to use SAPHNELO prefilled syringe the right way. If you or your caregiver have any questions, talk to your healthcare provider.

SAPHNELO prefilled syringe is for use under the skin (subcutaneous) only. Important storage information and warnings • Store SAPHNELO prefilled syringe in a refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton until ready to use. • If needed, SAPHNELO prefilled syringe can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days in the original carton to protect from light. After SAPHNELO prefilled syringe has reached room temperature, do not return to the refrigerator.

Throw away SAPHNELO prefilled syringe if not used within 7 days at room temperature. • Each SAPHNELO prefilled syringe contains 1 dose for one time use only. Do not share SAPHNELO prefilled syringe with other people. Do not use SAPHNELO prefilled syringe if it has: • been frozen or exposed to heat. • been dropped, damaged, or appears to be tampered with.

Do not shake SAPHNELO prefilled syringe. If any of the above happens, throw away the prefilled syringe in an FDA-cleared sharps disposal container and use a new prefilled syringe. Keep SAPHNELO prefilled syringe and all medicines out of the sight and reach of children.

SAPHNELO prefilled syringe parts Do not remove the needle cover until right before injecting SAPHNELO. Do not touch the needle guard activation clips. This will keep you from activating the needle guard too soon.

Preparing to inject using SAPHNELO prefilled syringe Step 1 – Gather supplies for your injection See Step 9 for instructions on how to throw away (dispose of) the used SAPHNELO prefilled syringe. Step 2 – Inspect the carton and wait 60 minutes Select a clean, well-lit, flat work surface, such as a table. Check the expiration date (EXP) on the carton. • Do not use if the expiration date has passed.

Check the carton for damage. • Do not use if the carton looks damaged. Let SAPHNELO prefilled syringe come to room temperature for 60 minutes before injecting. • Keep SAPHNELO prefilled syringe in the original carton to protect from light. • Do not warm SAPHNELO prefilled syringe in any other way. For example, do not warm it in a microwave, hot water, direct sunlight or near other heat sources.

Step 3 – Remove the prefilled syringe from the carton and inspect Open the carton and remove SAPHNELO prefilled syringe by holding the middle of the syringe body. • Do not hold or remove by the plunger. Check the expiration date on the prefilled syringe. • Do not use if the expiration date has passed. Check the prefilled syringe for damage. • Do not use if damaged.

Check the liquid through the viewing window. • The liquid should be clear and colorless to slightly yellow. • Do not use if the liquid is cloudy, discolored, or contains visible particles. • It is normal to see small air bubbles in the liquid. Do not try to remove the air bubbles. Injecting using your SAPHNELO prefilled syringe Step 4 – Choose an injection site You or your caregiver can inject in the front of your thigh or the lower part of your stomach (abdomen).

A caregiver may also inject your upper arm. Do not try to inject yourself in the upper arm. Choose an injection site that is at least 1-inch (3 cm) away from where you last injected.

Do not inject: • into the 2-inch (5 cm) area around your belly button. • where the skin is red, warm, tender, bruised, scal… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 7 words ▾

Dosage and Administration ( 2 ) 04/2026

📄 Package Label / Principal Display Panel 136 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0310-3080-02 Rx only SAPHNELO ® (anifrolumab-fnia) Injection 120 mg/0.8 mL For Subcutaneous Injection only Do not shake, freeze or expose to heat. 1 single-dose pre-filled syringe AstraZeneca Carton_1_Sub_Cut_Inj_120mg_zero_point_8ml

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0310-3080-01 Rx Only Saphnelo® Pen 120 mg/0.8 mL (anifrolumab-fnia) Injection For Subcutaneous Injection Only Do not shake, freeze, or expose to heat. 1 single-dose autoinjector AstraZeneca Carton_2_Autoinjector_SubCut_Pen

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0310-3040-00 Rx Only SAPHNELO ® (anifrolumab-fnia) Injection 300 mg/ 2 mL (150 mg/mL) For Intravenous Infusion After Dilution Must dilute before use. See prescribing information. Single-dose vial. Discard unused portion. Store refrigerated at 2 o C to 8 o C (36 o F to 46 o F) Keep vial in original carton to protect from light. Do not shake or freeze. 1 single-dose vial AstraZeneca saphnelo_vial

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Saphnelo — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Saphnelo. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.19M
Claims incl. refills
1.1K
Beneficiaries
488
Spend / beneficiary
$12,685.05
Spend / claim
$5,430.09
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SAPHNELO (this brand).

Top reported reactions

Systemic Lupus Erythematosus149
Fatigue137
Arthralgia94
Headache93
Nausea83
Pain74
Rash72

Age at onset

Infant1
Child1
Adolescent1
Adult277
Elderly38

Reporter sex

1,745 reports
Male · 9%
Female · 91%
Unknown · 0%

Serious outcomes

Hospitalization296
Death74
Life-threatening50
Disabling17
Reports over time (by year) — tap or hover for the count & year
2025 2026 205 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by AstraZeneca Pharmaceuticals LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 syringe (00310-3080-02), 1 syringe (00310-3080-95). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
AstraZeneca Pharmaceuticals LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00310-3040-00 · AstraZeneca 00310-3200-04 · AstraZeneca →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.