Saphnelo

Saphnelo

anifrolumab

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Anifrolumab
Indications/Uses
Add-on therapy for adult patients w/ moderate to severe, active autoAb +ve SLE despite standard therapy.
Dosage/Direction for Use
300 mg IV infusion over 30 min every 4 wk.
Contraindications
Special Precautions
Not to be administered by IV push or bolus inj. Interrupt therapy if serious infusion-related or hypersensitivity reaction occurs. Not to be initiated in patients w/ any clinically significant active infection eg, active TB. Severe active CNS lupus or severe active lupus nephritis; chronic infection, history of recurrent infections or known risk factors for infection; history of primary immunodeficiency; known risk factors for development or reoccurrence of malignancy. Consider anti-TB therapy prior to initiation in patients w/ untreated latent TB. Not recommended in combination w/ biologic therapies. Avoid concurrent use w/ live or attenuated vaccines. Severe renal impairment or ESRD. Women of childbearing potential should use effective contraception. Not recommended during pregnancy. Lactation. Childn & adolescents <18 yr. Elderly ≥65 yr.
Adverse Reactions
URTI; bronchitis. Herpes zoster, resp tract infection; hypersensitivity; infusion-related reaction.
Drug Interactions
Therapeutic monitoring in concomitant use of CYP substrates w/ narrow therapeutic index eg, warfarin.
MIMS Class
Immunosuppressants
ATC Classification
L04AG11 - anifrolumab ; Belongs to the class of monoclonal antibodies. Used as immunosuppressants.
Presentation/Packing
Form
Saphnelo infusion conc (vial) 300 mg/2 mL
Packing/Price
1's
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