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Enspryng

Enspryng

Manufacturer:

Chugai Pharma

Distributor:

DKSH

Marketer:

Roche
Concise Prescribing Info
Contents
Satralizumab
Indications/Uses
Monotherapy or in combination w/ immunosuppressive therapy for neuromyelitis optica spectrum disorders in adults & adolescents ≥12 yr who are anti-aquaporin-4 IgG seropositive.
Dosage/Direction for Use
SC Loading dose: 120 mg inj every 2 wk (1st dose at wk 0, 2nd dose at wk 2 & 3rd dose at wk 4). Maintenance dose: 120 mg inj every 4 wk. Delayed or missed doses Last dose administered ≥12 wk: 120 mg inj at wk 0, 2 & 4, followed by 120 mg every 4 wk; 8 to <12 wk: 120 mg inj at wk 0 & 2, followed by 120 mg every 4 wk; <8 wk during the maintenance period or missed a loading dose: 120 mg inj as soon as possible. Maintenance period: Reset to every 4 wk. Loading period: If 2nd loading dose is delayed or missed: Administer as soon as possible & 3rd final dose after 2 wk; if 3rd loading dose is delayed or missed: Administer as soon as possible & 1st maintenance dose after 4 wk. Restart of treatment after liver transaminase elevation Last dose administered ≥12 wk: Restart at 120 mg inj at wk 0, 2 & 4, followed by 120 mg every 4 wk; <12 wk: Restart at 120 mg inj every 4 wk.
Contraindications
Special Precautions
Patients w/ active infection. Monitor ALT & AST levels every 4 wk for 1st 3 mth, followed by every 3 mth for 1 yr, thereafter; neutrophil counts 4-8 wk after start of therapy & thereafter. Not to be given concurrently w/ live or live attenuated vaccines. Renal & hepatic impairment. Not recommended during pregnancy. Lactation. Ped patients <12 yr. Elderly >74 yr.
Adverse Reactions
Headache; inj-related reactions; arthralgia; decreased WBC. Migraine; musculoskeletal stiffness; rash, pruritus; insomnia; peripheral oedema; allergic rhinitis; hypofibrinogenaemia; increased blood bilirubin.
Drug Interactions
Minor impact on exposure of CYP450 substrates w/ narrow therapeutic index.
MIMS Class
Immunosuppressants
ATC Classification
L04AC19 - satralizumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Enspryng soln for inj 120 mg/mL
Packing/Price
1's
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