interferon receptor antagonists
Moderate to severe systemic lupus erythematosus (SLE) in patients who are receiving standard therapy.
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.
Reduction in SLE disease activity.
Absorption: IV administration results in complete bioavailability.
Distribution: Not widely distributed to extravascular tissues.
Metabolism and Excretion: Unknown.
TIME/ACTION PROFILE (plasma concentrations)
- History of anaphylaxis to anifrolumab;
- 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 breast feeding;
- Pedi: Safety and effectiveness not established in children.
Adverse Reactions/Side Effects
Misc: HYPERSENSITIVITY REACTIONS (including anaphylaxis and angioedema), INFECTION, MALIGNANCY, infusion-related reactions
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
↑ risk of adverse reactions and ↓ immune response to live vaccines or live-attenuated vaccines ; avoid concurrent use.
IV (Adults): 300 mg every 4 wk.
Solution for injection: 150 mg/mL
- Assess patient for lupus symptoms before starting and periodically during therapy.
Monitor for signs and symptoms of infections (fever, sore throat, shortness of breath, rash, urinary burning or frequency) during therapy. May require interruption of therapy.
Monitor for signs and symptoms of hypersensitivity reactions (swelling of face, tongue, or mouth, breathing difficulties, and/or fainting, dizziness, feeling lightheaded) during therapy.
- Update immunizations, according to current immunization guidelines, before starting therapy.
- 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 of anifrolumab 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.
- 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 breast feeding. 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.
Decrease in disease activity of lupus.