Anifrolumab

SAPHNELO

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Pronunciation: an-i-FROL-yoo-mab (saf-NEL-loe)

Anifrolumab ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Anifrolumab ballicule

What it isA monoclonal antibody against the type I interferon receptor, given IV for systemic lupus erythematosus.

Why this oneIt directly suppresses the interferon signature central to lupus and is notably effective for cutaneous disease.

What limits itSerious infection, especially herpes zoster, can end treatment; avoid live vaccines. Its role in severe renal or CNS lupus is unestablished.

Anifrolumab molecular structure (skeletal formula) — Molecular structure: Anifrolumab

FDA label

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FDA dosing	Population	Start	Target	Max
Moderate–severe SLE on standard therapy	Adults	—	IV 300 mg q4wk; or SC 120 mg once weekly	—

Renal Undefined

Hepatic Undefined

Missed dose spacing: min 14 days between IV infusions; min 3 days between SC injections

Instructions

IV: infuse over 30 min through in-line filter; SC: inject in thigh/abdomen, rotate sites
Switching IV→SC: first SC ~2 wk after last IV; SC→IV: first IV ~3–4 wk after last SC
Avoid live/live-attenuated vaccines
Not recommended for use with other biologic therapies

Available strengths

inj 120 mg/.8 mL
inj 300 mg/2 mL

Contraindications

History of anaphylaxis with anifrolumab-fnia

Cautions

Serious/fatal infections (respiratory, herpes zoster); avoid initiating during active infection
Hypersensitivity reactions including anaphylaxis and angioedema
Malignancy risk with immunosuppressants
Avoid live/live-attenuated vaccines
Not recommended with other biologic therapies

Adverse reactions

Nasopharyngitis / upper respiratory tract infection
Bronchitis
Infusion-related reactions
Herpes zoster
Cough

Pregnancy Insufficient human data; monoclonal IgG crosses placenta (greater in 3rd trimester). Exposure registry available.

Lactation No human milk data; maternal IgG present in human milk.

Cost

Anifrolumab (SAPHNELO)

Strength		#/mo	generic $/unit	CostPlus
120 mg/.8 mL	inj	per unit		not offered
300 mg/2 mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Anifrolumab is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

NO BOXED WARNINGS

Principal riskSerious infections

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Sedation liability0 / 4

Direct muscarinic antagonism0 / 4

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