Uplizna 3 Vial Kit
Uplizna 3 Vial Kit Uses, Dosage, Side Effects, Food Interaction and all others data.
Inappropriate growth of or self-directed antibody production by B-cells is the etiological underpinning of a variety of conditions, including the multiple sclerosis-like neurological condition neuromyelitis optica spectrum disorder (NMOSD). Uplizna 3 Vial Kit is a humanized afucosylated monoclonal IgG1 antibody directed against the broadly expressed B-cell surface antigen CD19. Uplizna 3 Vial Kit is cytolytic, resulting in B-cell depletion and offering therapeutic benefit to patients suffering from NMOSD. Compared to the anti-CD20 antibody rituximab, which is also used to treat NMOSD, inebilizumab has broader specificity.
Uplizna 3 Vial Kit was granted FDA approval on June 11, 2020, for the treatment of anti-aquaporin 4 positive NMOSD patients. Given its mechanism of action and good safety profile, it may prove useful in the treatment of other conditions linked to autoimmune antibody production or B-cell malignancies.
Uplizna 3 Vial Kit is a CD19-directed monoclonal antibody that results in immunosuppression through B-cell depletion with sufficient efficacy to allow a six-month dosing schedule. Due to this mechanism of action, patients undergoing inebilizumab treatment may be at higher risk of infections and should be monitored for active infections and immunoglobulin levels while undergoing treatment; vaccination is not recommended during inebilizumab treatment. Also, there is a risk of severe infusion reactions. Animal data suggests the possibility of fetal harm with inebilizumab and therefore, effective contraception during and for six months following inebilizumab treatment is recommended.
| Trade Name | Uplizna 3 Vial Kit |
| Availability | Prescription only |
| Generic | Inebilizumab |
| Inebilizumab Other Names | Inebilizumab, inebilizumab-cdon |
| Related Drugs | Soliris, eculizumab, Uplizna, Enspryng, satralizumab |
| Type | |
| Weight | 149000.0 Da (approximate) |
| Groups | Approved, Investigational |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Uplizna 3 Vial Kit is a humanized anti-CD19 cytolytic monoclonal antibody for B-cell depletion in autoimmune conditions. Currently approved only for neuromyelitis optica spectrum disorder (NMOSD).
Uplizna 3 Vial Kit is indicated for the treatment of aquaporin-4 (AQP4) immunoglobulin-positive (AQP4-IgG) neuromyelitis optica spectrum disorder (NMOSD) in adult patients.
Uplizna 3 Vial Kit is also used to associated treatment for these conditions: Neuromyelitis Optica Spectrum Disorder
How Uplizna 3 Vial Kit works
Neuromyelitis optica spectrum disorder (NMOSD), formerly referred to as Devic's disease, is an antibody-mediated autoimmune condition resulting in astroglial cell death, demyelination, and central nervous system (CNS) inflammation. The presence of anti-aquaporin 4 immunoglobulin (AQP4-IgG) is the most frequent biomarker, although AQP4-IgG negative, anti-myelin oligodendrocyte glycoprotein (anti-MOG) positive, variants with similar presentation also exist. The theoretical origin of symptoms is through AQP4-IgG-mediated astrocyte cytotoxicity and subsequent infiltration of neutrophils, eosinophils, and macrophages, leading to inflammatory-mediated oligodendrocyte damage and myelin sheath loss. In general, this manifests as optic neuritis and transverse myelitis with occasional involvement of the diencephalic, brainstem, and cerebral hemisphere.
CD19 is a B-cell surface antigen expressed on most B-cells, including the expanded population of CD27high Uplizna 3 Vial Kit binds to CD19 and, through one of several potential mechanisms, results in cell death. Destruction of the specific AQP4-IgG-producing plasmablasts results in lower amounts of AQP4-IgG in the CNS and therefore slows neuronal damage and improves patient outcomes.
Toxicity
Toxicity information regarding inebilizumab is not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects such as severe infusion reactions, infections, and arthralgia. Symptomatic and supportive measures are recommended.
Food Interaction
No interactions found.Uplizna 3 Vial Kit Disease Interaction
Major: hepatitis B, tuberculosisModerate: infections, vaccination
Volume of Distribution
Uplizna 3 Vial Kit has an estimated central volume of distribution of 2.95L and a peripheral volume of distribution of 2.57L. The steady-state volume of distribution in patients administered with a range of doses between 0.1 and 10.0 mg/kg ranged from 53.7 to 71.7 mL/kg.
Elimination Route
Uplizna 3 Vial Kit is given intravenously and hence is immediately exposed to the systemic circulation. The mean reported Cmax following second dose 300 mg administration was 108 μg/mL, and the cumulative AUC following 26 weeks of treatment with two IV administrations was 2980 μg*d/mL.
In a clinical trial investigating the use of inebilizumab in relapsing multiple sclerosis, the mean Cmax corresponding to 30, 100, and 600 mg of inebilizumab was 17.9, 43.1, and 248.0 μg/mL and the AUC0-∞ was 440, 1150, and 6950 μg*d/mL. In another trial for patients with systemic sclerosis, the mean Cmax varied between 2.7 and 227.0 μg/mL and the AUC0-∞ varied between 16.1 and 2890.0 μg*d/mL for doses between 0.1 and 10.0 mg/kg.
Half Life
Uplizna 3 Vial Kit exhibits biphasic pharmacokinetics with a mean terminal half-life of 18 days. The terminal half-life reported in phase I studies varied by dose but was typically close to 18 days, with a range of 6.8 to 18.7 days.
Clearance
Uplizna 3 Vial Kit has an estimated systemic clearance of 0.19 L/day. In phase I studies, the reported clearance varied between 139-180 mL/day in one study, and 3.5-6.2 mL/kg/day in another, depending on the dose.
Innovators Monograph
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