anifrolumab

General

Pronunciation:
an-i-frol-ue-mab

Trade Name(s)

Saphnelo

Ther. Class.

none assigned

Pharm. Class.

monoclonal antibodies

interferon receptor antagonists

Indications

Moderate to severe systemic lupus erythematosus in patients who are receiving standard therapy.

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 systemic lupus erythematosus.

Therapeutic Effect(s):

Reduction in systemic lupus erythematosus disease activity.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Not widely distributed to extravascular tissues.

Metabolism and Excretion: Unknown.

Half-life: Unknown.

TIME/ACTION PROFILE (plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	end of infusion	unknown

Contraindication/Precautions

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.

Adverse Reactions/Side Effects

Resp: cough

Misc: INFECTION, HYPERSENSITIVITY REACTIONS (including anaphylaxis and angioedema), infusion-related reactions, MALIGNANCY

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

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

Route/Dosage

IV (Adults): 300 mg every 4 wk.

Availability

Solution for injection: 150 mg/mL

Assessment

Assess for lupus symptoms before starting and periodically during therapy.
Monitor for signs/symptoms of infections (fever, sore throat, shortness of breath, rash, urinary burning or frequency) during therapy. May require interruption of therapy.
Monitor for signs/symptoms of hypersensitivity reactions (swelling of face, tongue, or mouth; breathing difficulties; fainting; dizziness; light-headedness) during therapy.

Implementation

Update immunizations, according to current immunization guidelines, before starting therapy.

IV Administration

Intermittent Infusion: Dilution: Solution is clear to opalescent, colorless to slightly yellow; do not administer solutions that are cloudy, discolored, or contain particulate matter. Withdraw and discard 2 mL of solution from a 100-mL 0.9% NaCl infusion bag. Withdraw 2 mL of solution from vial and add it to infusion bag. Mix the solution by gentle inversion. Do not shake. Administer immediately after mixing. Diluted solution is stable for 4 hr at room temperature and up to 24 hr if refrigerated. Allow solution to reach room temperature before administering. Rate: Administer over 30 min through an infusion line containing a sterile low-protein-binding 0.2- or 0.22-micron in-line filter. Flush infusion set with 25 mL of 0.9% NaCl to ensure all solution has been administered.

Patient/Family Teaching

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Advise patient to notify health care provider if signs/symptoms of infection or hypersensitivity reactions occur.
Advise patient to avoid live or live-attenuated vaccines during therapy.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Advise patient of pregnancy exposure registry that 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.

Evaluation/Desired Outcomes