Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Horizon Therapeutics Ireland DAC, 70 St. Stephens Green, Dublin 2, D02 E2X4, Ireland
Uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive (see section 5.1).
Treatment should be initiated under the supervision of a physician experienced in the treatment of NMOSD and with access to appropriate medical support to manage potential severe reactions such as serious infusion-related reactions.
The patient should be monitored for infusion reactions during and for at least one hour after the completion of the infusion (see section 4.4).
Prior to initiating treatment, testing should be performed for:
All immunisations should be administered according to immunisation guidelines at least 4 weeks prior to initiation of inebilizumab for live or live-attenuated vaccines (see section 4.4).
If loss of efficacy is thought to be caused by immunogenicity, the physician should follow B-cell counts as a direct measure of clinical impact (see section 5.1).
The recommended loading dose is 300 mg (3 vials of 100 mg) intravenous infusion followed 2 weeks later by a second 300 mg intravenous infusion.
The recommended maintenance dose is 300 mg intravenous infusion every 6 months. Inebilizumab is for chronic treatment.
If an infusion of inebilizumab is missed, it should be administered as soon as possible and not delayed until the next planned dose.
Prior to every infusion of inebilizumab, it should be determined whether there is a clinically significant infection. In case of infection, infusion of inebilizumab should be delayed until the infection resolves.
Premedication with a corticosteroid (e.g. methylprednisolone 80-125 mg intravenous or equivalent) should be administered approximately 30 minutes prior to each inebilizumab infusion; and an antihistamine (e.g. diphenhydramine 25-50 mg orally or equivalent) and an anti-pyretic (e.g. paracetamol 500-650 mg orally or equivalent) approximately 30-60 minutes prior to each inebilizumab infusion (see section 4.4).
Inebilizumab has been administered to 6 elderly patients (≥65 years of age) in clinical studies. Based on the limited data available, no dose adjustment is considered necessary in patients over 65 years old (see section 5.2).
Inebilizumab has not been studied in patients with severe renal or hepatic impairment. However, dose adjustment based on renal or hepatic function is not warranted because immunoglobulin (Ig) G monoclonal antibodies are not primarily cleared via renal or hepatic pathways (see section 5.2).
The safety and efficacy of inebilizumab in children and adolescents aged 0 to 18 years has not yet been established. No data are available.
For intravenous use.
Vials should not be shaken.
Vials should be stored upright.
The prepared solution should be administered intravenously via an infusion pump at an increasing rate to completion (approximately 90 minutes) through an intravenous line containing a sterile, low protein-binding 0.2 or 0.22 micron in-line filter according to the schedule in Table 1.
Table 1. Recommended infusion rate for administration when diluted in a 250 mL intravenous bag:
| Elapsed time (minutes) | Infusion rate (mL/hour) |
|---|---|
| 0-30 | 42 |
| 31-60 | 125 |
| 61-completion | 333 |
For instructions on dilution of the medicinal product before administration, see section 6.6.
The highest dose of inebilizumab tested in autoimmune patients was 1200 mg, administered as two 600 mg intravenous infusions separated by 2 weeks. The adverse reactions were similar to what was observed in the inebilizumab pivotal clinical study.
There is no specific antidote in the event of an overdose; the infusion should be interrupted immediately and the patient should be observed for infusion-related reactions (see section 4.4). The patient should be closely monitored for signs or symptoms of adverse reactions and supportive care instituted as required.
5 years.
Shelf life after dilution: The prepared infusion solution should be administered immediately. If not administered immediately, store up to 24 hours in a refrigerator at 2°C to 8°C or 4 hours at room temperature prior to the start of the infusion.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Store in the original package to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
10 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a mist gray flip-off aluminium seal.
Pack size of 3 vials.
Prior to the start of the intravenous infusion, the prepared infusion solution should be at room temperature between 20°C and 25°C.
The concentrate should be visually inspected for particulate matter and discolouration. The vial should be discarded if the solution is cloudy, discoloured, or it contains discrete foreign particulate matter.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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