Saphnelo

Saphnelo

anifrolumab

Manufacturer:

AstraZeneca

Distributor:

Zuellig
Concise Prescribing Info
Contents
Anifrolumab
Indications/Uses
Add-on therapy for the treatment of adult patients w/ moderate to severe, active autoantibody +ve SLE, despite standard therapy.
Dosage/Direction for Use
300 mg as IV infusion over a 30-min period, every 4 wk.
Contraindications
Special Precautions
Must not be administered as an IV push or bolus inj. Do not co-administer any other medicinal products through the same infusion line. Immediately interrupt administration in case of serious infusion-related or hypersensitivity reaction. Patients w/ history of infusion-related reactions &/or hypersensitivity may be pre-medicated (eg, antihistamine) before infusion. Not recommended in combination w/ biologic therapies. Has not been studied in patients w/ severe active CNS lupus or severe active lupus nephritis; patients w/ history of primary immunodeficiency. Increased risk of resp infections & herpes zoster. Caution in patients w/ chronic infection, history of recurrent infections, or known risk factors for infection. Do not initiate treatment in patients w/ any clinically significant active infection until the infection resolves or is adequately treated; patients w/ active TB. Complete all appropriate immunisations according to current immunisation guidelines prior to initiating therapy. Avoid concurrent use of live or attenuated vaccines. Consider individual benefit-risk in patients w/ known risk factors for the development or reoccurrence of malignancy. Exercise caution when considering continuing therapy for patients who develop malignancy. Pregnancy & lactation. Safety & efficacy in childn & adolescents <18 yr have not yet been established.
Adverse Reactions
URTI, bronchitis. Infusion-related reaction; herpes zoster, resp tract infection; hypersensitivity.
Drug Interactions
Therapeutic monitoring is recommended in patients treated w/ 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 conc for soln for infusion 300 mg/2 mL
Packing/Price
1's
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