ENSPRYNG Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Genentech Inc.

Λέξεις κλειδιά

50242-007

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1. Indications and Usage

ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

2. Dosage and Administration

2.1 Assessments Prior to the First Dose of ENSPRYNG Hepatitis B Virus Screening Prior to initiating ENSPRYNG, perform Hepatitis B virus (HBV) screening. ENSPRYNG is contraindicated in patients with active ...

3. Dosage Forms and Strengths

Injection: 120 mg/mL clear, and colorless to slightly yellow solution in single-dose prefilled syringe.

4. Contraindications

ENSPRYNG is contraindicated in patients with: A known hypersensitivity to satralizumab or any of the inactive ingredients [see Warnings and Precautions (5.1)] Active Hepatitis B infection ...

5. Warnings and Precautions

5.1 Infections An increased risk of infections, including serious and potentially fatal infections, has been observed in patients treated with IL-6 receptor antagonists, including ENSPRYNG. The most common ...

6. Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions (5.1)] Elevated Liver Enzymes [see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...

6.2. Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...

8.1. Pregnancy

Risk Summary There are no adequate data on the developmental risk associated with the use of ENSPRYNG in pregnant women. In an animal reproduction study, no adverse effects on maternal animals or fetal ...

8.2. Lactation

Risk Summary No information is available on the presence of satralizumab-mwge in human milk, the effects of the satralizumab-mwge on the breastfed infant, or the effects of the satralizumab-mwge on milk ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

Clinical studies of ENSPRYNG did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. However, population pharmacokinetic ...

11. Description

Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino ...

12.1. Mechanism of Action

The precise mechanism by which satralizumab-mwge exerts therapeutic effects in NMOSD is unknown but is presumed to involve inhibition of IL-6-mediated signaling through binding to soluble and membrane-bound ...

12.2. Pharmacodynamics

The relationship between any of the pharmacodynamic effects of ENSPRYNG and clinical outcomes in NMOSD is unknown.

12.3. Pharmacokinetics

The pharmacokinetics of ENSPRYNG have been characterized both in Japanese and Caucasian healthy volunteers, and in NMOSD patients. The pharmacokinetics in NMOSD patients using the recommended dose were ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Carcinogenicity studies of satralizumab-mwge were not conducted. Mutagenesis Genetic toxicology studies of satralizumab-mwge were not conducted. As an antibody, satralizumab-mwge is not ...

14. Clinical Studies

The efficacy of ENSPRYNG for the treatment of NMOSD in adult patients was established in two studies. Study 1 was a randomized (2:1), placebo-controlled trial in 95 patients without concurrent IST (Study ...

16.1. How Supplied

ENSPRYNG (satralizumab-mwge) injection is available as a sterile, preservative-free, clear, colorless to slightly yellow solution in single-dose prefilled syringe (PFS) with needle safety device. ENSPRYNG ...

16.2. Storage and Handling

Refrigerate at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake. Prior to administration, ENSPRYNG, if unopened, can be removed from and returned to the refrigerator, ...

17. Patient Counseling Information

Advise the patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections Inform patients that an increased risk of infections, including serious and potentially ...