Oxlumo

Therapy should be initiated and supervised by a physician experienced in the management of hyperoxaluria. Posology Oxlumo is administered by subcutaneous injection. The recommended dose of Oxlumo consists of loading doses given once a month for 3 doses, followed by maintenance doses beginning one month after the last loading dose, as shown in Table 1.

Dosing is based on body weight.

The patient dose (in mg) and volume (in mL) should be calculated as follows:

Patient body weight (kg)×dose (mg/kg)=total amount (mg) of medicinal product to be administered. Total amount (mg) divided by concentration (189 mg/mL)=total volume of medicinal product (mL) to be injected. 3 Table 1: Oxlumo weight-based dosing regimen Body weight Loading dose Maintenance dose (beginning one month after the last loading dose) less than 10 kg 6 mg/kg once monthly for 3 doses 3 mg/kg once monthly, beginning one month after the last loading dose 10 kg to less than 20 kg 6 mg/kg once monthly for 3 doses 6 mg/kg once every 3 months (quarterly), beginning one month after the last loading dose 20 kg and above 3 mg/kg once monthly for 3 doses 3 mg/kg once every 3 months (quarterly), beginning one month after the last loading dose Patients on haemodialysis Administer Oxlumo following haemodialysis if administered on dialysis days.

Missed dose If a dose is delayed or missed, treatment should be administered as soon as possible. Prescribed monthly or quarterly dosing should be resumed from the most recently administered dose. 2). Hepatic impairment Oxlumo has not been studied in patients with hepatic impairment.

5×ULN). 2). 73 m2) including end-stage renal disease (ESRD), or those on dialysis. 2). Paediatric population In patients under 1 year of age, limited data are available. 2). Method of administration For subcutaneous use only. This medicinal product is provided as a ready-to-use solution in a single use vial.

• The required volume of Oxlumo should be calculated based on the recommended weight-based dose as shown in Table 1. 5 mg), more than one vial will be needed. 5 mL. 5 mL should be administered as multiple injections (the total dose divided equally between syringes with each injection containing approximately the same volume) to minimise potential injection site discomfort due to injection volume.

4 • Having the medicinal product on the needle tip before the needle is in the subcutaneous space should be avoided. • This medicinal product should be injected subcutaneously into the abdomen, upper arms, or thighs. • For subsequent injections or doses, rotating the injection site is recommended.

Summary of the safety profile The most frequently reported adverse reactions were injection site reaction (35%) and abdominal pain (16%). Tabulated list of adverse reactions Adverse reactions associated with lumasiran obtained from clinical studies and spontaneous reporting are tabulated below.

The adverse reactions are coded to preferred terms (PTs) under the MedDRA system organ class (SOC) and are presented by frequency. The frequency of the adverse reactions is expressed according to the following categories: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

Table 2:

Adverse reactions System organ class Adverse reaction Frequency Immune system disorders Hypersensitivitya Not known Gastrointestinal disorders Abdominal painb Very common General disorders and administration site conditions Injection site reactionc Very common a Adverse reaction reported during post-marketing use.

b Includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort, and abdominal tenderness. c Includes injection site reaction, injection site erythema, injection site pain, injection site pruritus, injection site swelling, injection site discomfort, injection site discolouration, injection site mass, injection site induration, injection site rash, injection site bruising, injection site haematoma and injection site exfoliation.

7%). The most commonly reported symptoms were erythema, swelling, pain, haematoma, pruritus, and discolouration. The majority of injection site reactions started on the day of administration, with < 2% of injection site reactions occurring 5 or more days after administration.

6 Injection site reactions were generally mild, resolved within two days, and did not result in interruption or discontinuation of treatment. 4%) lumasiran-treated patients. 3%) reported abdominal pain, including upper or lower abdominal pain, abdominal discomfort, or abdominal tenderness.

Severe or end-stage renal impairment Treatment with lumasiran increases plasma glycolate levels, which may increase the risk of metabolic acidosis or worsening of pre-existing metabolic acidosis in patients with severe or end-stage renal disease.

These patients should therefore be monitored for signs and symptoms of metabolic acidosis. Moderate or severe hepatic impairment In patients with moderate or severe hepatic impairment there is a potential for decreased efficacy. 2). Excipient with known effect Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium-free’.

1.