What is Uplizna (inebilizumab-cdon) used for?

Uplizna (inebilizumab-cdon) is a CD19-targeting monoclonal antibody used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who test positive for anti-aquaporin-4 (AQP4) antibodies.[1]
It comes in a single-dose vial containing 100 mg/10 mL of inebilizumab-cdon.[1]

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How does Uplizna work?

NMOSD is a rare autoimmune condition of the central nervous system where the immune system attacks healthy nerve cells, particularly those expressing the aquaporin-4 (AQP4) protein. This can lead to damage in the optic nerves, spinal cord, and brain.[2]

Uplizna is a type of immunotherapy known as a monoclonal antibody, designed to bind to CD19, a protein found on B cells (a type of white blood cell). B cells are believed to play a significant role in the disease process of NMOSD.[3]
Once in the bloodstream, Uplizna attaches to CD19 on B cells and triggers their destruction, thereby helping to reduce disease activity.[3]

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Where is Uplizna approved?

Uplizna was approved by the U.S. Food and Drug Administration (FDA) on June 11, 2020, for adults with NMOSD who are anti-AQP4 antibody positive.[2]
The FDA has also granted UpliznaBreakthrough Therapy and Orphan Drug designations.[2]

It may also be approved in other countries or regions. Please contact our support team if you need details on its availability in a specific country.

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How is Uplizna administered?

The recommended treatment schedule includes:[1]

• Initial phase: 300 mg IV infusion, followed two weeks later by another 300 mg IV infusion
• Maintenance: Starting six months after the first dose, a single 300 mg IV infusion every six months

Before starting Uplizna, patients should undergo screening for infections like hepatitis B and tuberculosis.
Any necessary vaccinations should be administered at least 4 weeks prior to the first infusion.[1]

Before each dose, patients should be checked for active infections. If an infection is present, treatment should be postponed until recovery.[1]

Premedication may be given prior to each infusion to reduce the risk of infusion-related side effects.[1]
For full dosing and administration details, refer to the official prescribing information.[1]

Important: Always consult your treating physician for personalized medical guidance.

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What are the possible side effects of Uplizna?

Common side effects (≥10% of patients) may include:[1]

• Urinary tract infections (UTIs)
• Joint pain (arthralgia)

Serious side effects listed include:[1]

• Infusion-related reactions
• Reactivation of Hepatitis B
• Progressive multifocal leukoencephalopathy (PML), a rare brain infection
• Tuberculosis (TB)

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Use in Special Populations

Uplizna may cause harm to the fetus if used during pregnancy. It is advised to avoid pregnancy and breastfeeding while on this medication.[1]

For a detailed list of potential side effects, please consult the official prescribing information.[1]

References

1. Full prescribing information [FDA]: Uplizna (inebilizumab-cdon) [PDF]
Viela Bio, Jun 2020

2. Viela Bio Announces U.S. FDA Approval of UPLIZNA™ (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD)
Globe News Wire press release, June 11, 2020

3. B cell-based therapies in CNS autoimmunity: differentiating CD19 and CD20 as therapeutic targets
Forsthuber TG, Ther Adv NeurolDisord, Mar 21, 2018