anifrolumab

Contraindicated in:

Hypersensitivity;
Active infection;
Concurrent use with other biologic therapies.

Use Cautiously in:

Chronic infection, history of recurrent infections, or risk factors for infection;
Risk factors for malignancy;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Resp: cough

Misc: infection, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), infusion-related reactions, MALIGNANCY

Interactions ⬆ ⬇

Drug-drug:

↑risk of adverse reactions and ↓ immune response to live vaccines or live-attenuated vaccines; avoid concurrent use.

Availability ⬆ ⬇

Solution for injection: 150 mg/mL

Route/Dosage ⬆ ⬇

IV (Adults ): 300 mg every 4 wk.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Monoclonal antibody that binds to subunit 1 of the type I interferon receptor which inhibits type I interferon signaling and reduces inflammatory and immunological processes that occur in SLE.

Therapeutic effects:

Reduction in SLE disease activity.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: monoclonal antibodies, interferon receptor antagonists

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Not widely distributed to extravascular tissues.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose of anifrolumab to patient. Advise patient to read Patient Information before starting anifrolumab and periodically during therapy in case of changes.
Advise patient to notify health care professional if signs and symptoms of infection (fever or flu-like symptoms; muscle aches; cough; shortness of breath; burning on urination or urinating more often than usual; diarrhea or stomach pain; shingles [a red skin rash that can cause pain and burning]) or hypersensitivity reactions occur.
Instruct patient to avoid live or live-attenuated vaccines during therapy.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Inform patient of pregnancy exposure registry monitors pregnancy outcomes in women exposed to anifrolumab during pregnancy. For more information about the registry or to report a pregnancy while on Saphnelo, contact AstraZeneca at 1-877-693-9268.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0310- AstraZeneca Pharmaceuticals LP
- 0310-3000-
  - 0310-3000-10- 11.7 kg in 1 POUCH (0310-3000-10)

90112- AstraZeneca Nijmegen B.V.
- 90112-3000-
  - 90112-3000-2- 1105 VIAL, GLASS in 1 BOX (90112-3000-2) / 2 mL in 1 VIAL, GLASS

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Indications ⬇

Contraind./Precautions ⬆ ⬇