Inebilizumab-cdon
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alara Ece Dagsali, M.D.
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Overview
Inebilizumab-cdon is a humanized monoclonal antibody against CD19 that is FDA approved for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Immunoglobulin G4-Related Disease (IgG4-RD) UPLIZNA is indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.. Common adverse reactions include The following clinically significant adverse reactions are described elsewhere in the labeling:
- Infusion Reactions
- Infections
- Reduction in Immunoglobulins.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Neuromyelitis Optica Spectrum Disorder (NMOSD) UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Immunoglobulin G4-Related Disease (IgG4-RD) UPLIZNA is indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.
DOSAGE Injection: 100 mg/10 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Inebilizumab-cdon in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Inebilizumab-cdon in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Inebilizumab-cdon FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Inebilizumab-cdon in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Inebilizumab-cdon in pediatric patients.
Contraindications
UPLIZNA is contraindicated in patients with:
- A history of a life-threatening infusion reaction to UPLIZNA
- Active hepatitis B infection
- Active or untreated latent tuberculosis
Warnings
Infusion Reactions UPLIZNA can cause infusion reactions, including anaphylaxis. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. During the randomized clinical trial period, infusion reactions were observed with the first course of UPLIZNA in 9.3% of NMOSD patients. Infusion reactions of UPLIZNA were observed in 7.4% of IgG4-RD patients during the randomized controlled period. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions.
Reducing the Risk of Infusion Reactions and Managing Infusion Reactions
Administer pre-medication with a corticosteroid, an antihistamine, and an antipyretic.
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.
Infections An increased risk of infections has been observed with other B-cell depleting therapies. The most common infections reported by UPLIZNA-treated patients in the randomized and open-label clinical trial periods for NMOSD included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD randomized controlled and open-label periods, the most common infections reported by UPLIZNA-treated patients were upper respiratory tract infection (11%), nasopharyngitis (10%), urinary tract infection (9%), and influenza (6%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.
Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants
UPLIZNA has not been studied in combination with other immunosuppressants. If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects.
Hepatitis B Virus (HBV) Reactivation
Risk of HBV reactivation has been observed with other B-cell depleting antibodies. There have been no cases of HBV reactivation in patients treated with UPLIZNA, but patients with chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer UPLIZNA to patients with active hepatitis. For patients who are chronic carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment.
Progressive Multifocal Leukoencephalopathy (PML)
PML is an opportunistic viral infection of the brain caused by the JC virus that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. Although no confirmed cases of PML were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell depleting antibodies and other therapies that affect immune competence. In UPLIZNA clinical trials one subject died following the development of new brain lesions for which a definitive diagnosis could not be established, though the differential diagnosis included an atypical NMOSD relapse, PML, or acute disseminated encephalomyelitis. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Tuberculosis
Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA. Consider anti-tuberculosis therapy prior to initiation of UPLIZNA in patients with a history of latent active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment.
Vaccinations
Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA. The safety of immunization with live or live-attenuated vaccines following UPLIZNA therapy has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with UPLIZNA During Pregnancy
In infants of mothers exposed to UPLIZNA during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B-cells in these exposed infants may increase the risks from live or live-attenuated vaccines. Non-live vaccines, as indicated, may be administered prior to recovery from B-cell and immunoglobulin level depletion, but consultation with a qualified specialist should be considered to assess whether a protective immune response was mounted.
Reduction in Immunoglobulins There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment [see Adverse Reactions (6.1)]. Monitor the levels of quantitative serum immunoglobulins during treatment with UPLIZNA, especially in patients with opportunistic or recurrent infections, and until B-cell repletion after discontinuation of therapy. Consider discontinuing UPLIZNA therapy if a patient with low immunoglobulin G or M develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
Fetal Risk Based on animal data, UPLIZNA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to UPLIZNA even after B-cell repletion. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving UPLIZNA and for at least 6 months after the last dose
Adverse Reactions
Clinical Trials 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.
NMOSD
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. 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.
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%).
IgG4-RD
The safety of UPLIZNA was evaluated in Study 2, in which 68 patients were exposed to UPLIZNA at the recommended dosage regimen during the randomized, controlled treatment period; during which 67 patients received placebo.
Table 4 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 2. 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 lymphopenia.
Postmarketing Experience
There is limited information regarding Inebilizumab-cdon Postmarketing Experience in the drug label.
Drug Interactions
Immunosuppressive or Immune-Modulating Therapies Concomitant usage of UPLIZNA with immunosuppressant drugs, including systemic corticosteroids, may increase the risk of infection. Consider the risk of additive immune system effects when co-administering immunosuppressive therapies with UPLIZNA.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Inebilizumab-cdon in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Inebilizumab-cdon in women who are pregnant.
Labor and Delivery
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to UPLIZNA during pregnancy or shortly before conception. Healthcare providers are encouraged to advise their patients to register by contacting the UPLIZNA Pregnancy Registry by calling the coordinating center at 1 (303) 724-4644 or www.upliznapregnancyregistry.com.
Nursing Mothers
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 UPLIZNA to lead to B-cell depletion in the breastfed infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for UPLIZNA and any potential adverse effects on the breastfed infant from UPLIZNA or from the underlying maternal condition.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatic Use
NMOSD
Clinical studies of UPLIZNA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
IgG4-RD
Twenty-nine percent (32 out of 112) of patients 65 years of age or older, were treated with UPLIZNA. There were no overall age-related differences in safety or efficacy observed compared to younger patients.
Gender
Contraception
Women of childbearing potential should use contraception while receiving UPLIZNA and for 6 months after the last infusion of UPLIZNA
Race
There is no FDA guidance on the use of Inebilizumab-cdon with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Inebilizumab-cdon in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Inebilizumab-cdon in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Inebilizumab-cdon in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Inebilizumab-cdon in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Inebilizumab-cdon Administration in the drug label.
Monitoring
Monitor the patient closely for infusion reactions during and for at least one hour after the completion of the infusion.
IV Compatibility
There is limited information regarding the compatibility of Inebilizumab-cdon and IV administrations.
Overdosage
There is limited information regarding Inebilizumab-cdon overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Inebilizumab-cdon Pharmacology in the drug label.
Mechanism of Action
The precise mechanism by which inebilizumab-cdon exerts its therapeutic effects in NMOSD and IgG4-RD 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.
Structure
There is limited information regarding Inebilizumab-cdon Structure in the drug label.
Pharmacodynamics
Pharmacodynamics of UPLIZNA were assessed with an assay for CD20+ B-cells, since UPLIZNA can interfere with the CD19+ B-cell assay. Treatment with UPLIZNA 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 UPLIZNA and remained below the lower limit of normal in 94% of patients for 28 weeks after initiation of treatment.
CD20+ B-cell counts were reduced below the lower limit of normal by week 2 in 100% of patients treated with UPLIZNA and remained below the lower limit of normal in 85% of patients for up to 52 weeks after initiation of treatment.
Pharmacokinetics
The pharmacokinetics of inebilizumab-cdon in NMOSD patients following intravenous administration of UPLIZNA was biphasic with a mean terminal half-life of 18 days. The mean maximum concentration was 108 µg/mL (300 mg, second dose on Day 15), and the cumulative AUC of the 26-week treatment period in which NMOSD patients received two intravenous administrations 2 week apart was 2980 µg∙d/mL.
The pharmacokinetics of inebilizumab-cdon in IgG4-RD patients following intravenous administration of UPLIZNA was biphasic with a mean terminal half-life of 18 days. The mean maximum concentration was 127 µg/mL (300 mg, second dose on Day 15), and the cumulative AUC of the 52-week treatment period in which IgG4-RD patients received two intravenous administrations 2 weeks apart, followed by a third dose at week 26 was 4290 µg×d/mL.
Distribution
Based on population pharmacokinetic analysis, the estimated typical central and peripheral volume of distribution of inebilizumab-cdon was 2.95 L and 2.57 L, respectively.
Metabolism
Inebilizumab-cdon is a humanized IgG1 monoclonal antibody that is degraded by proteolytic enzymes widely distributed in the body.
Elimination
The results of population pharmacokinetic analysis indicated that the estimated inebilizumab-cdon systemic clearance of the first-order elimination pathway was 0.19 L/day. At low exposure levels, inebilizumab-cdon was likely subject to the receptor (CD19)-mediated clearance, which decreased with time presumably because of the depletion of B-cells by UPLIZNA treatment.
Specific Populations
Gender, Race, Geriatric Use
A population pharmacokinetic analysis indicated that there was no significant effect of gender, race, and age on inebilizumab-cdon clearance.
Renal/Hepatic Impairment
No formal clinical studies have been conducted to investigate the effect of renal impairment or hepatic impairment on inebilizumab-cdon pharmacokinetic parameters.
Drug Interaction Studies
Cytochrome P450 enzymes and transporters are not involved in the clearance of inebilizumab-cdon; therefore, the potential risk of interactions between UPLIZNA and concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes and transporters is low.
Nonclinical Toxicology
Carcinogenesis
No studies have been conducted to assess the carcinogenic potential of inebilizumab-cdon.
Mutagenesis
No studies have been conducted to assess the genotoxic potential of inebilizumab-cdon.
Impairment of Fertility
Intravenous administration of inebilizumab-cdon (0, 3, or 30 mg/kg/week) to human CD19 transgenic male and female mice prior to and during mating and continuing in females through gestation day 15 resulted in reduced fertility at both doses tested. A no-effect dose for adverse effects on fertility was not identified.
Clinical Studies
Neuromyelitis Optica Spectrum Disorder (NMOSD)
The efficacy of UPLIZNA for the treatment of NMOSD was established in Study 1 (NCT02200770), a randomized (3:1), double-blind, placebo-controlled trial that enrolled 213 patients with NMOSD who were anti-AQP4 antibody positive and 17 who were anti-AQP4 antibody negative.
Patients met the following eligibility criteria:
A history of one or more relapses that required rescue therapy within the year prior to screening, or 2 or more relapses that required rescue therapy in 2 years prior to screening. Expanded Disability Status Scale (EDSS) score of 7.5 or less. Patients with an EDSS score of 8.0 were eligible if they were deemed capable of participating. Patients were excluded if previously treated with immunosuppressant therapies within an interval specified for each such therapy. The use of immunosuppressants during the blinded phase of the trial was prohibited.
The use of oral or intravenous corticosteroids during the blinded phase of the trial was prohibited, with the exception of premedication for investigational treatment and treatment for a relapse.
Of the 213 enrolled anti-AQP4 antibody positive patients, a total of 161 were randomized to receive treatment with UPLIZNA, and 52 were randomized to receive placebo.
The baseline demographic and disease characteristics were balanced between the treatment groups. Females accounted for 94% of the study population. Fifty-two percent of patients were White, 21% Asian, and 9% Black or African American. The mean age was 43 years (range 18 to 74 years). The mean EDSS score was 4.0. The number of relapses in the two years prior to randomization was 2 or more in 83% of the patients.
UPLIZNA was administered according to the recommended dosage regimen.
All potential relapses were evaluated by a blinded, independent, adjudication committee, who determined whether the relapse met protocol-defined criteria. Patients who experienced an adjudicated relapse in the randomized-controlled period (RCP), or who completed the Day 197 visit without a relapse, exited the RCP.
The primary efficacy endpoint was the time to the onset of the first adjudicated relapse on or before Day 197.
The time to the first adjudicated relapse was significantly longer in patients treated with UPLIZNA compared to patients who received placebo (relative risk reduction 73%; hazard ratio: 0.272; p < 0.0001). In the anti-AQP4 antibody positive population there was a 77.3% relative reduction (hazard ratio: 0.227, p < 0.0001). There was no evidence of a benefit in patients who were anti-AQP4 antibody negative.
Compared to placebo-treated patients, patients treated with UPLIZNA who were anti-AQP4 antibody positive had reduced annualized rates of hospitalizations (0.11 for UPLIZNA versus 0.50 for placebo).
Immunoglobulin G4-Related Disease (IgG4-RD) The efficacy of UPLIZNA for the treatment of IgG4-RD was established in Study 2 (NCT04540497), a randomized, double-blind, multicenter, 52-week placebo-controlled trial that enrolled 135 adult patients who met the following eligibility criteria:
- Newly diagnosed or recurrent IgG4-RD that required glucocorticoid (GC) treatment at screening.
- Confirmed history of organ involvement at any time in the course of disease.
The concomitant use of biologic and non-biologic immunosuppressive agents was prohibited during the blinded phase of the trial. Of the 135 enrolled IgG4-RD patients, 68 patients were randomized to receive UPLIZNA and 67 were randomized to receive placebo. The baseline demographic and disease characteristics were generally balanced between the treatment groups. Females accounted for 35% of the study population. Thirty-nine percent of patients were White, 47% Asian, and 1% Black or African American. The mean age was 58 years (range 24 to 80 years). The median disease duration was 0.9 years. Forty-six percent of patients were newly diagnosed with IgG4-RD and 54% had recurrent disease.
Patients were at a uniform 20 mg per day dose of glucocorticoids at the time of randomization and then began a prespecified taper of 5 mg dose every two weeks until discontinuation at the end of 8 weeks. The use of glucocorticoids during the trial was permitted for premedication for investigational treatment, treatment for a relapse and in certain situations other than an IgG4-RD flare. UPLIZNA was administered according to the recommended dosage regimen.
Disease flare was defined as new/worsening signs or symptoms that were positively adjudicated and warranted treatment by the investigator. All potential flares were assessed by the investigator and subsequently reviewed by a blinded, independent, adjudication committee, who determined whether the flare met one or more of the protocol-defined, organ-specific flare diagnostic criteria.
The primary efficacy endpoint was the time to First Treated and Adjudication Committee (AC)-determined IgG4-RD flare within the 52-week RCP. The time to the First Treated and AC determined IgG4-RD flare was significantly longer in the UPLIZNA group, compared with the placebo group (Figure 2). UPLIZNA reduced the risk of treated and AC-determined IgG4-RD flare by 87%, compared with placebo (hazard ratio: 0.13; p < 0.0001).
For all patients in the trial, the mean (SD) total GC use for IgG4-RD control per patient other than the planned GC taper was lower in the UPLIZNA-treated group compared with the placebo- treated group, with a mean (SD) of 118.25 (438.97) mg prednisone equivalent versus 1384.53 (1723.26) mg prednisone equivalent, respectively during the RCP. Forty-two (62.7%) placebo-treated patients and 7 (10.3%) UPLIZNA-treated patients received GC for IgG4-RD control other than the planned GC taper. The mean (SD) total GC use per patient for the 42 placebo-treated patients was 2202.76 (1709) mg prednisone equivalent and for the 7 UPLIZNA-treated patients was 1148.71 (878) mg prednisone equivalent.
How Supplied
UPLIZNA (inebilizumab-cdon) injection is a clear to slightly opalescent, colorless to slightly yellow solution supplied as:
- One carton containing three 100 mg/10 mL single-dose vials – NDC 75987-150-03
Storage
- 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.
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Patient Counseling Information
Advise the patient and/or caregiver to read the FDA-approved patient labeling.
Infusion Reactions
Inform patients about the signs and symptoms of infusion reactions, including anaphylaxis, and advise them to contact their healthcare provider immediately if they observe signs or symptoms of infusion reactions.
Infections
Advise patients to contact their healthcare provider for any signs of infection during treatment or after the last dose. Signs include fever, chills, constant cough, or dysuria.
Advise patients that UPLIZNA may cause reactivation of hepatitis B infection and that monitoring will be required if they are at risk .
Advise patients that PML has happened with drugs that are similar to UPLIZNA and may happen with UPLIZNA. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their healthcare provider if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Vaccinations
Advise patients to complete any required vaccinations at least 4 weeks prior to initiation of UPLIZNA. Administration of live-attenuated or live vaccines is not recommended during UPLIZNA treatment and until B-cell recovery.
Pregnancy
Instruct patients that if they are pregnant or plan to become pregnant while taking UPLIZNA, they should inform their healthcare provider. Advise females of reproductive potential that they should use effective contraception during treatment and for 6 months after UPLIZNA therapy. Advise patients to register with the UPLIZNA pregnancy exposure registry.
Precautions with Alcohol
Alcohol-Inebilizumab-cdon interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
UPLIZNA
Look-Alike Drug Names
There is limited information regarding Inebilizumab-cdon Look-Alike Drug Names in the drug label.
Price
References
The contents of this FDA label are provided by the National Library of Medicine.