HELP YOUR ADULT PATIENTS WITH NMOSD
BE UP FOR
grabbing tomorrow
AND MAKING IT THEIRS
HELP YOUR ADULT PATIENTS WITH NMOSD
BE UP FOR
grabbing tomorrow
AND MAKING IT THEIRS
EFFICACY
Relapse reduction
89%
of patients on UPLIZNA® (inebilizumab-cdon) were relapse-free at 28 weeks
58%
for placebo¹
Significantly longer time to first adjudicated neuromyelitis optica spectrum disorder (NMOSD) relapse for UPLIZNA vs placebo in the randomized-controlled period (ITT* population; anti-aquaporin-4 [AQP4] antibody positive patients)
Reduced hospitalizations
UPLIZNA reduced the annualized rate of hospitalization for anti-AQP4 antibody positive patients vs placebo¹
78%
relative reduction in the annualized rate of hospitalization for UPLIZNA vs placebo (0.11 vs 0.5 for placebo)¹
SAFETY
UPLIZNA has a favorable safety profile
UPLIZNA is contraindicated in patients with¹:
- A history of life-threatening infusion reactions to UPLIZNA
- Active hepatitis B infection
- Active or untreated latent tuberculosis
UPLIZNA has a similar adverse event rate compared to placebo1,2
Adverse reactions in adult patients with NMOSD with an incidence of at least 5% with UPLIZNA and a greater incidence than placebo¹
| Adverse Reactions | UPLIZNA (n=161) % | Placebo (n=52) % |
|---|---|---|
| Urinary tract infection | 11 | 10 |
| Arthralgia | 10 | 4 |
| Headache | 8 | 8 |
| Back pain | 7 | 4 |
| Adverse Reactions Urinary tract infection UPLIZNA (n=161) % Placebo (n=52) % |
| Adverse Reactions Arthralgia UPLIZNA (n=161) % Placebo (n=52) % |
| Adverse Reactions Headache UPLIZNA (n=161) % Placebo (n=52) % |
| Adverse Reactions Back pain UPLIZNA (n=161) % Placebo (n=52) % |
UPLIZNA can cause serious adverse events, including infusion reactions, infections, reduction in immunoglobulins and fetal risk. For more information about possible serious adverse events, please see Prescribing Information.
Additional safety considerations
- Consider the risk for increased immunosuppressive effects when used in combination with other immunosuppressant therapies¹
- Women of childbearing age should use contraception while receiving UPLIZNA and for six months after the last infusion¹
- Infusion reactions were most common with the first infusion (9.3%), but were also observed during subsequent infusions¹
- Most infusion reactions were mild to moderate. Symptoms included headache, nausea, somnolence, dyspnea, fever, myalgia, rash or other signs or symptoms1,3
Infection was reported in 39% of UPLIZNA patients and 44% of placebo patients during the randomized-controlled period³
Immunoglobulins¹
- Consistent with its mechanism of action, average immunoglobulin levels decreased with UPLIZNA use
- The proportion of UPLIZNA-treated patients with immunoglobulin G (IgG) levels below the lower limit of normal at year one was 7.5% and at year two was 14%
- The relationship between reduced immunoglobulin levels and infection has not been assessed with UPLIZNA
Neutropenia¹
- Neutropenia was generally transient and was not associated with serious infections
Access and Support
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Resources for Your Patients
Conversation guides and downloadable materials to help inform and educate your patients about UPLIZNA.
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INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
UPLIZNA® (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
IMPORTANT SAFETY INFORMATION
UPLIZNA is contraindicated in patients with:
- A history of life-threatening infusion reaction to UPLIZNA
- Active hepatitis B infection
- Active or untreated latent tuberculosis
WARNINGS AND PRECAUTIONS
Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.
Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.
Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.
The risk of hepatitis B virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.
Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (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. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.
Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.
Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.
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. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.
Fetal Risk: May cause fetal harm based on animal data. 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.
Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.
References: 1. UPLIZNA (Inebilizumab-cdon) [prescribing information] Horizon. 2. Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised, placebo-controlled phase 2/3 trial. Lancet. 2019;394:1352-1363. doi: 10.1016/S0140-6736(19)31817-3. 3. Data on File. Horizon, June 2020.