Uplizna Side Effects Center

Last updated on RxList: 1/22/2021
Uplizna Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Uplizna?

Uplizna (inebilizumab-cdon) is a CD19-directed cytolytic antibody used to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

What Are Side Effects of Uplizna?

Side effects of Uplizna include:

Dosage for Uplizna

Uplizna is administered as an intravenous infusion titrated to completion, approximately 90 minutes. The recommended initial dose is: 300 mg intravenous infusion followed two weeks later by a second 300 mg intravenous infusion. Subsequent doses (starting 6 months from the first infusion) are a single 300 mg intravenous infusion every 6 months.

Uplizna In Children

Safety and effectiveness of Uplizna in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Uplizna?

Uplizna may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Uplizna During Pregnancy and Breastfeeding

Uplizna is not recommended for use during pregnancy; it may harm a fetus. Females of reproductive potential are advised to use effective contraception while receiving Uplizna and for at least 6 months after the last dose. It is unknown if Uplizna passes into breast milk or how it would affect a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Uplizna (inebilizumab-cdon) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Uplizna Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel drowsy, nauseated, feverish, or have a headache, skin rash, muscle pain, or trouble breathing.

Inebilizumab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Call your doctor at once if you have:

  • fever, chills, body aches;
  • stuffy nose, cough, sore throat;
  • pain or burning when you urinate;
  • urinating more than usual; or
  • right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well.

Your doses may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • painful urination; or
  • joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Uplizna (Inebilizumab-cdon Injection)

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Uplizna Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Infusion Reactions [see WARNINGS AND PRECAUTIONS]
  • Infections [see WARNINGS AND PRECAUTIONS]
  • Reduction in Immunoglobulins [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of UPLIZNA was evaluated in Study 1, in which 161 patients were exposed to UPLIZNA at the recommended dosage regimen during the randomized, controlled treatment period; during which 52 patients received placebo [see DOSAGE AND ADMINISTRATION and Clinical Studies]. Subsequently, 198 patients were exposed to UPLIZNA during an open-label treatment period.

Two-hundred and eight patients in the randomized and open-label treatment periods had a total of 324 person-years of exposure to UPLIZNA, including 165 patients with exposure for at least 6 months and 128 with exposure for one year or more.

Table 3 lists adverse reactions that occurred in at least 5% of patients treated with UPLIZNA and at a greater incidence than in patients who received placebo in Study 1. The most common adverse reactions (incidence of at least 10% in patients treated with UPLIZNA and at a greater incidence than placebo) were urinary tract infection and arthralgia.

Table 3 Adverse Reactions in Patients with NMOSD with an Incidence of at Least 5% with UPLIZNA and a Greater Incidence than Placebo in Study 1

Adverse ReactionsUPLIZNA
N = 161
%
Placebo
N = 52
%
Urinary tract infection1110
Arthralgia104
Headache88
Back pain74

Across both the randomized and open-label treatment in Study 1, the most common adverse reactions (greater than 10%) were urinary tract infection (20%), nasopharyngitis (13%), infusion reaction (12%), arthralgia (11%), and headache (10%).

Laboratory Abnormalities

Decreased Immunoglobulins

At the end of the 6.5-month randomized, controlled period, relative to baseline, the total immunoglobulin level was reduced approximately 8% from baseline for patients treated with UPLIZNA as compared to an increase of 6% in patients treated with placebo. The mean decreases from baseline in immunoglobulin G (IgG) and immunoglobulin M (IgM) were approximately 4% and 32%, respectively, in patients treated with UPLIZNA, whereas IgG was increased by 6% and IgM was increased by approximately 13% in placebo-treated patients. The proportion of patients treated with UPLIZNA who had IgG levels below the lower limit of normal at year 1 was 6.6% and at year 2 was 13%. The proportion of patients treated with UPLIZNA who had IgM levels below the lower limit of normal at year 1 was 31% and at year 2 was 42%.

Decreased Neutrophil Counts

Neutrophil counts between 1.0-1.5 x109/L were observed in 6.9% of UPLIZNA-treated patients versus 1.9% of patients who received placebo. Neutrophil counts between 0.5-1.0 x109/L were observed in 1.9% of patients treated with UPLIZNA compared to no patients who received placebo. At the end of the 6.5-month randomized, controlled period, the proportion of patients with a neutrophil count below the limit of normal was 12% for patients treated with UPLIZNA compared to 4.2% for patients who received placebo.

Decreased Lymphocyte Counts

A reduction in lymphocyte counts was observed more frequently in patients treated with UPLIZNA compared to those who received placebo. At the end of the 6.5-month randomized, controlled period, the proportion of patients with a lymphocyte count below the limit of normal was 5.3% for patients treated with UPLIZNA compared to 4.2% for patients who received placebo.

Immunogenicity

As with all therapeutic proteins there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other inebilizumab products may be misleading.

In Study 1, treatment-emergent antibodies (those that appeared or significantly increased from baseline after administration of UPLIZNA), were detected in 5.6% patients receiving UPLIZNA. Although these data do not demonstrate an impact of anti-inebilizumab-cdon antibody development on the efficacy or safety of UPLIZNA in these patients, the available data are too limited to make definitive conclusions.

Read the entire FDA prescribing information for Uplizna (Inebilizumab-cdon Injection)

© Uplizna Patient Information is supplied by Cerner Multum, Inc. and Uplizna Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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