Uplizna (inebilizumab-cdon)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Inebilizumab-cdon is a recombinant humanized kappa immunoglobulin G1 (IgG1) monoclonal antibody that targets and depletes CD19-expressing B cells.
Inebilizumab-cdon is a CD19-directed humanized IgG1 monoclonal antibody produced by recombinant DNA technology. The precise mechanism by which inebilizumab-cdon exerts its therapeutic effects in neuromyelitis optica spectrum disorder (NMOSD) is unknown but is presumed to involve binding to CD19, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, inebilizumab-cdon results in antibody-dependent cellular cytolysis.
The pharmacodynamics of inebilizumab-cdon were assessed with an assay for CD20+ B cells, because the drug can interfere with the CD19+ B cell assay. Treatment with inebilizumab-cdon reduces CD20+ B cell counts in blood by 8 days after infusion. CD20+ B-cell counts were reduced below the lower limit of normal by 4 weeks in 100% of patients treated with inebilizumab-cdon and remained below the lower limit of normal in 94% of patients for 28 weeks after initiation of treatment.
The pharmacokinetics of inebilizumab-cdon in NMOSD patients following IV administration is biphasic; mean terminal half-life is 18 days. Inebilizumab-cdon is degraded by proteolytic enzymes widely distributed in the body. The estimated systemic clearance of the first-order elimination pathway was 0.19 L/day.
USES: This medication is used to treat a certain nervous system disorder that affects the eye (optic) nerve and spinal cord (neuromyelitis optica spectrum disorder-NMOSD). Inebilizumab is also used to treat a chronic immune condition (immunoglobulin G4 related disease-IgG4-RD) and a certain muscle condition (generalized myasthenia gravis). This medication belongs to a class of drugs known as monoclonal antibodies.
It may help reduce swelling and decrease the risk of attacks.
Generic name: inebilizumab-cdon
Pronunciation: (in-EB-i-LIZ-ue-mab)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Uplizna
Indications
The following indications are listed for Uplizna:
- Anti-Acetylcholine Receptor (Achr) Antibody Positive Generalized Myasthenia Gravis
- Anti-Muscle-Specific Tyrosine Kinase (Musk) Antibody Positive Generalized Myasthenia Gravis
- Immunoglobulin G4-Related Disease
- Neuromyelitis Optica Spectrum Disorder With Anti-Aquaporin-4 (Aqp4) Antibodies
Also known as: Achr-Ab(+) Generalized Myasthenia Gravis, Anti-Aquaporin-4 (Aqp4) Antibody Positive Neuromyelitis Optica Spectrum Disorder, Anti-Aquaporin-4 Positive Devic's Disease.
Dosing
No dosing information is available for this tab.
Inebilizumab-cdon is administered as an IV infusion via an infusion pump. The commercially available injection must be diluted with 0.9% sodium chloride injection prior to administration.
Administer the drug through an IV line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
Cytochrome P-450 (CYP) enzymes and transporters are not involved in the clearance of inebilizumab-cdon; therefore, the potential risk of interactions between inebilizumab-cdon and concomitant medications that are substrates, inducers, or inhibitors of these enzymes and transporters is low.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*A history of a life-threatening infusion reaction to inebilizumab-cdon
*Active hepatitis B infection
*Active or untreated latent tuberculosis infection.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse reactions (>=10%) reported with inebilizumab-cdon in clinical studies were urinary tract infection and arthralgia.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of inebilizumab-cdon have not been established in pediatric patients.
There are no adequate data on the developmental risk associated with the use of inebilizumab-cdon in pregnant women. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy. B-cell levels in infants following maternal exposure to inebilizumab-cdon have not been studied in clinical trials. The potential duration of B-cell depletion in such infants, and the impact of B-cell depletion on vaccine safety and effectiveness, are unknown.
Inebilizumab-cdon is a humanized IgG1 monoclonal antibody and immunoglobulins are known to cross the placental barrier.
There are no data on the presence of inebilizumab-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 for absorption of inebilizumab-cdon to lead to B-cell depletion in the breastfed infant is unknown.
Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for inebilizumab-cdon and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.
Clinical studies of inebilizumab-cdon did not include sufficient numbers of patients >=65 year of age to determine whether they respond differently from younger patients.
A population pharmacokinetic analysis indicated no significant effect of age on clearance of inebilizumab-cdon.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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