Inebilizumab-cdon

What is inebilizumab-cdon?

• Inebilizumab-cdon (Uplizna) is a CD19-directed cytolytic antibody used to treat adults with neuromyelitis optic spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

What are the uses of this medicine?

• This medicine is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

How does this medicine work?

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. Following cell surface binding to B lymphocytes, inebilizumab-cdon results in antibody-dependent cellular cytolysis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients if:

• had a life-threatening infusion reaction to UPLIZNA.
• an active hepatitis B virus infection.
• active or untreated inactive (latent) tuberculosis.

What drug interactions can this medicine cause?

• Avoid co-administration of UPLIZNA with immunosuppressant drugs, including systemic corticosteroids, may increase the risk of infection.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• Prior to initiating UPLIZNA, perform Hepatitis B virus (HBV) screening. UPLIZNA is contraindicated in patients with active HBV .
• Prior to initiating UPLIZNA, evaluate for active tuberculosis and test for latent infection.
• Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA for live or live-attenuated vaccines.
• Prior to every infusion of UPLIZNA, determine whether there is an active infection. In case of active infection, delay infusion of UPLIZNA until the infection resolves
• Premedicate with a corticosteroid, an antihistamine, and an antipyretic.
• UPLIZNA must be diluted in 250 mL of 0.9% Sodium Chloride Injection, USP prior to administration.

The recommended dose is:

• Initial dose: 300 mg intravenous infusion followed two weeks later by a second 300 mg intravenous infusion
• Subsequent doses (starting 6 months from the first infusion): single 300 mg intravenous infusion every 6 months

Administration

• UPLIZNA is given through a needle placed in a vein (IV or intravenous infusion) in your arm.
• Before treatment with UPLIZNA, your healthcare provider will give you a corticosteroid medicine, an antihistamine, and a fever prevention medicine to help infusion reactions become less frequent and less severe. See “What is the most important information I should know about UPLIZNA?”
• Your first dose of UPLIZNA will be given as 2 separate infusions, 2 weeks apart.
• Your next doses of UPLIZNA will be given as one infusion every 6 months.
• Each infusion will last about 1 hour and 30 minutes. After each infusion, you will be monitored by a healthcare provider for at least 1 hour.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial

This medicine is available in fallowing brand namesː

• UPLIZNA

What side effects can this medication cause?

Common possible side effects of this medicine include:

• urinary tract infection
• arthralgia
• Headache
• Back pain

UPLIZNA can cause serious side effects, including:

• Infusion reactions
• Hepatitis B virus (HBV) reactivation
• Progressive Multifocal Leukoencephalopathy (PML)

What special precautions should I follow?

• UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other signs or symptoms.
• Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.
• Management recommendations for infusion reactions depend on the type and severity of the reaction. For life-threatening infusion reactions, immediately and permanently stop UPLIZNA and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
• Delay UPLIZNA administration in patients with an active infection until the infection is resolved.
• Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.
• Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion. Consider discontinuing UPLIZNA if a patient develops a serious opportunistic infection or recurrent infections if immunoglobulin levels indicate immune compromise.
• Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of UPLIZNA in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Inebilizumab-cdon
• FDA Inebilizumab-cdon

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