UPLIZNA Solution for injection (2020)
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Viela Bio, Inc.
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1. Indications and Usage
UPLIZNA 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 P rior to F irst D ose of UPLIZNA Hepatitis B Virus Screening Prior to initiating UPLIZNA, perform Hepatitis B virus (HBV) screening. UPLIZNA is contraindicated in patients with active ...
3. Dosage Forms and Strengths
Injection: 100 mg/10 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial.
4. Contraindications
UPLIZNA is contraindicated in patients with: A history of a life-threatening infusion reaction to UPLIZNA <em>[see Warnings and Precautions (5.1)]</em> Active hepatitis B infection <em>[see Warnings and ...
5. Warnings and Precautions
5.1 Infusion Reactions UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other signs or symptoms. During the randomized clinical trial ...
6. Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions <em>[see Warnings and Precautions (5.1)]</em> Infections <em>[see Warnings and Precautions ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Immunogenicity
As with all therapeutic proteins there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...
7. Drug Interactions
7.1 Immunosuppressive or Immune-Modulating Therapies Concomitant usage of UPLIZNA with immunosuppressant drugs, including systemic corticosteroids, may increase the risk of infection. Consider the risk ...
8.1. Pregnancy
Risk Summary UPLIZNA is a humanized IgG1 monoclonal antibody and immunoglobulins are known to cross the placental barrier. There are no adequate data on the developmental risk associated with the use of ...
8.2. Lactation
Risk Summary There are no data on the presence of ineblizumab-cdon in human milk, the effects on a breastfed infant, or the effects on milk production. Human IgG is excreted in human milk, and the potential ...
8.3. Females and Males of Reproductive Potential
Contraception Women of childbearing potential should use contraception while receiving UPLIZNA and for 6 months after the last infusion of UPLIZNA <em>[see Clinical Pharmacology (12.3)]</em>.
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
Clinical studies of UPLIZNA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
11. Description
Inebilizumab-cdon is a CD19-directed humanized afucosylated IgG1 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight ...
12.1. Mechanism of Action
The precise mechanism by which inebilizumab-cdon exerts its therapeutic effects in NMOSD is unknown but is presumed to involve binding to CD19, a cell surface antigen presents on pre-B and mature B lymphocytes. ...
12.2. Pharmacodynamics
Pharmacodynamics of UPLIZNA were assessed with an assay for CD20+ B cells, since UPLIZNA can interfere with the CD19+ B cell assay. Treatment with UPLIZNA reduces CD20+ B cell counts in blood by 8 days ...
12.3. Pharmacokinetics
The pharmacokinetics of inebilizumab-cdon in NMOSD patients following intravenous administration of UPLIZNA was biphasic with a mean terminal half-life of 18 days. The mean maximum concentration was 108 ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis No studies have been conducted to assess the carcinogenic potential of inebilizumab-cdon. Mutagenesis No studies have been conducted to assess the genotoxic potential of inebilizumab-cdon. ...
14. Clinical Studies
The efficacy of UPLIZNA for the treatment of NMOSD was established in Study 1 (NCT02200770), a randomized (3:1), double-blind, placebo-controlled trial that enrolled 213 patients with NMOSD who were anti-AQP4 ...
16.1. How Supplied
UPLIZNA (inebilizumab-cdon) injection is a clear to slightly opalescent, colorless to slightly yellow solution supplied as: One carton containing three 100 mg/10 mL single-dose vials – NDC 72677-551-01. ...
16.2. Storage and Handling
Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake. Store vials upright.
17. Patient Counseling Information
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Infusion Reactions Inform patients about the signs and symptoms of infusion reactions and advise them to ...