Inebilizumab Brand Name– UPLIZNA
What is Inebilizumab
Inebilizumab is an intravenous CD19-directed cytolytic humanized afucosylated IgG1 monoclonal antibody indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody-positive.
In a randomized, double-blind, placebo-controlled trial of patients with NMOSD who were anti-AQP4 antibody-positive (n = 213) or anti-AQP4 antibody-negative (n = 17), the time to first adjudicated relapse was significantly longer in patients treated with inebilizumab compared to placebo (relative risk reduction 73%; HR 0.272; p less than 0.0001).
In the anti-AQP4 antibody-positive population, there was a 77.3% relative reduction (HR 0.227; p less than 0.0001).
There was no evidence of a benefit in patients who were anti-AQP4 antibody-negative. Compared to patients given placebo, inebilizumab-treated patients who were anti-AQP4 antibody-positive had reduced annualized rates of hospitalizations (0.11) vs. placebo (0.5).
Infusion-related reactions have been reported with inebilizumab.
These reactions are most common with the first infusion but may also occur during subsequent infusions.
Administration of inebilizumab requires an experienced clinician with access to appropriate medical support to manage potential severe reactions, such as serious infusion reactions.
To reduce the risk of an infusion reaction, premedication with a corticosteroid, an antihistamine, and an antipyretic is recommended.
Indications
- neuromyelitis optica spectrum disorder
Side Effects
- antibody formation
- arthralgia
- back pain
- cystitis
- headache
- infection
- influenza
- infusion-related reactions
- lymphopenia
- neutropenia
- pharyngitis
- progressive multifocal leukoencephalopathy
Monitoring Parameters
- hepatitis B serology
- serum IgG concentations
- tuberculin skin test
Contraindications
- breast-feeding
- contraception requirements
- corticosteroid therapy
- hepatitis
- hypogammaglobulinemia
- immunosuppression
- in utero exposure
- infection
- infusion-related reactions
- pregnancy
- reproductive risk
- requires an experienced clinician
- tuberculosis
- vaccination
Interactions
- Azelastine; Fluticasone
- Bacillus Calmette-Guerin Vaccine, BCG
- Beclomethasone
- Betamethasone
- Budesonide
- Budesonide; Formoterol
- Ciclesonide
- Corticosteroids
- Cortisone
- Deflazacort
- Dexamethasone
- Fludrocortisone
- Flunisolide
- Fluticasone
- Fluticasone; Salmeterol
- Fluticasone; Umeclidinium; Vilanterol
- Fluticasone; Vilanterol
- Formoterol; Mometasone
- Hydrocortisone
- Influenza Virus Vaccine
- Intranasal Influenza Vaccine
- Live Vaccines
- Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live
- Measles/Mumps/Rubella Vaccines, MMR
- Methylprednisolone
- Mometasone
- Prednisolone
- Prednisone
- Rotavirus Vaccine
- Rubella Virus Vaccine Live
- Smallpox and Monkeypox Vaccine, Live, Nonreplicating
- Smallpox Vaccine, Vaccinia Vaccine
- Triamcinolone
- Typhoid Vaccine
- Varicella-Zoster Virus Vaccine, Live
- Yellow Fever Vaccine, Live
