ULTOMIRIS CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/ML [SIN17026P]

Product Info

ULTOMIRIS CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/ML

[SIN17026P]

Indication

4.1 Therapeutic indications

Paroxysmal Nocturnal Hemoglobinuria

ULTOMIRIS is indicated for the treatment of adult and pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH)

• who presents with clinical symptom(s) indicative of high disease activity.

• who are clinically stable after having been treated with eculizumab for at least the past 6 months.

Atypical Hemolytic Uremic Syndrome

ULTOMIRIS is indicated for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).

Limitations of Use:
ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Generalized Myasthenia Gravis

ULTOMIRIS is indicated as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

Neuromyelitis Optica Spectrum Disorder

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

Dosing

4.2 Posology and method of administration

Posology

Intravenous (IV) use

Adult and pediatric patients with PNH or aHUS with body weight greater than or equal to 5 kg.

The recommended ULTOMIRIS maintenance dosing in adult and pediatric patients with PNH or aHUS with a body weight greater than or equal to 5 kg is based on the patient’s body weight, as shown in Table 1, with maintenance doses administered every 4 or 8 weeks, starting 2 weeks after loading dose.

Refer to Table 2 for treatment initiation instructions in patients who are complement inhibitor treatment-naïve or switching treatment from SOLIRIS.

Dosing schedule is allowed to occasionally vary by ± 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS), but the subsequent dose should be administered according to the original schedule.

Adult patients with gMG or NMOSD with body weight greater than or equal 40 kg.

The recommended ULTOMIRIS maintenance dosing in adult patients with gMG or NMOSD with a body weight greater than or equal to 40 kg is based on the patient’s body weight, as shown in Table 1, with maintenance doses administered every 8 weeks, starting 2 weeks after loading dose.

Refer to Table 2 for treatment initiation instructions in patients who are complement inhibitor treatment-naïve or switching treatment from SOLIRIS.

Dosing schedule is allowed to occasionally vary by ± 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS) but the subsequent dose should be administered according to the original schedule.

Supplemental dosing following treatment with plasma exchange (PE), plasmapheresis (PP), or intravenous immunoglobulin (IVIg).

PE, PP, and IVIg have been shown to reduce ULTOMIRIS serum levels. A supplemental dose of ULTOMIRIS is required in the setting of PE, PP, or IVIg (Table 3).

Method of administration

Intravenous (IV) use

ULTOMIRIS is for administration by a healthcare provider and is not intended for subcutaneous administration.

This medicinal product must be administered through a 0.2 micrometre filter and should not be administered as an intravenous push or bolus injection.

For instructions on dilution of the medicinal product before administration, see Section 7.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

ULTOMIRIS 100 mg/mL

ULTOMIRIS 100 mg/mL must be diluted to a final concentration of 50 mg/mL.

Following dilution, ULTOMIRIS 100 mg/mL is to be administered by intravenous infusion based on body weight as shown in Table 4 and Table 5.

Special populations

Women of childbearing potential

Women of childbearing potential should use effective contraception methods during treatment and up to 8 months after treatment.

Pediatric population/use in children

Use of ULTOMIRIS in pediatric patients for treatment of PNH is supported by evidence from a pediatric clinical study (13 patients aged 9 to 17 years). The safety and efficacy of ULTOMIRIS for the treatment of pediatric and adult patients with PNH appear similar. See Section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Use of ULTOMIRIS in pediatric patients for treatment of aHUS is supported by evidence from a pediatric clinical study (24 patients in Cohort 1 and 10 patients in Cohort 2 aged 10 months to 17 years). The safety and efficacy of ULTOMIRIS for the treatment of aHUS is consistent in pediatric and adult patients.

ULTOMIRIS has not been studied in PNH patients below 9 years of age. The posology to be used in pediatric patients with PNH is identical to the weight-based dosing recommendations provided for pediatric patients with aHUS, with maintenance dosing starting 2 weeks after loading dose administration. Based on the pharmacokinetic (PK)/pharmacodynamic (PD) data available in aHUS and PNH patients treated with ULTOMIRIS, this dosing regimen is expected to result in an efficacy and safety profile similar to that in adults, for all pediatric patients starting at 5 kg.

ULTOMIRIS has not been evaluated in pediatric patients with gMG or NMOSD.

Elderly population

ULTOMIRIS may be administered to patients aged 65 years and over. There is no evidence indicating any special precautions are required for treating a geriatric population.

Patients with aplastic anemia

ULTOMIRIS may be administered to patients with PNH treated with concomitant medications for aplastic anemia (including immunosuppressive therapies). There is no evidence indicating any special precautions are required in patients with aplastic anemia.

Renal and hepatic impairment

Studies have not been conducted to examine the effects of hepatic impairment; however, pharmacokinetic data suggest that no dose adjustment is required in patients with hepatic impairment.

No dose adjustment is required for patients with renal impairment, see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

The clinical trials of ULTOMIRIS in patients with aHUS included patients with other complement-mediated thrombotic microangiopathy (Cm-TMA) conditions (patients with renal impairment, some of whom were receiving dialysis). No dose adjustment is required in this population, see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

4.3 Contraindications

Do not initiate ULTOMIRIS therapy in patients:

• with unresolved Neisseria meningitidis infection.

• who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).