OXLUMO Solution for injection Ref.[10953] Active ingredients: Lumasiran

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 months, followed by maintenance doses, 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.

Table 1. Oxlumo weight-based dosing regimen:

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.

Special populations

Elderly

No dose adjustment is necessary in patients ≥65 years of age (see section 5.2).

Hepatic impairment

Oxlumo has not been studied in patients with hepatic impairment. No dose adjustment is necessary in patients with transient elevation in total bilirubin (total bilirubin >1.0 to 1.5×ULN). Caution is required when treating patients with moderate or severe hepatic impairment (see sections 4.4 and 5.2).

Renal impairment

No dose adjustment is necessary in patients with mild (estimated glomerular filtration rate (eGFR) 60 to <90 mL/min/1.73 m²) or moderate (eGFR 30 to <60 mL/min/1.73 m²) renal impairment (see section 5.2). Limited clinical data are available in patients with severe renal impairment (eGFR 15 to <30 mL/min/1.73 m²), end-stage renal disease (eGFR <15 mL/min/1.73 m²), or who are on dialysis. Safety monitoring is warranted when treating patients with severe or end-stage renal impairment (see sections 4.4 and 5.2).

Paediatric population

In patients under 1 year of age, limited data are available. Caution should be used when treating these patients (see section 5.2).

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.
• If the dose is more than 0.5 mL (94.5 mg), more than one vial will be needed.
• The maximum acceptable single injection volume is 1.5 mL. Doses requiring more than 1.5 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.
• 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.
• This medicinal product should not be administered into scar tissue or areas that are reddened, inflamed, or swollen.

Oxlumo should be administered by a healthcare professional. For instructions on the medicinal product before administration, see section 6.6.

In case of overdose, it is recommended that the patient be monitored as medically indicated for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted.

3 years.

Once the vial is opened, the medicinal product should be used immediately.

Do not store above 30°C.

Keep vial in the outer carton to protect from light.

Glass vial with a fluoropolymer-coated rubber stopper and an aluminium overseal with a flip-off button. Each vial contains 0.5 mL solution for injection.

Pack size of one vial.

This medicinal product is ready-to-use and for single use only. For subcutaneous use only

• Before administration, materials not included in the pack that are needed for administration should be collected, which will include a sterile syringe (0.3 mL, 1 mL, or 3 mL), an 18-gauge (G) needle, and a 25 G to 31 G needle.
• The required volume of Oxlumo should be calculated based on the recommended weight-based dose (see section 4.2).
• An 18-gauge needle should be used to withdraw Oxlumo from the vial. The vial should be held upright or tilted at a slight angle, and the flat edge of the needle should be pointed downwards.
• For volumes less than 0.3 mL, a sterile 0.3 mL syringe is recommended.
• The medicinal product should be administered with a sterile 25- to 31-G needle with a 13 mm or 16 mm needle length for subcutaneous injection.
• Note: This medicinal product should not be pushed into the 25 G to 31 G needle.
• Syringes, transfer needles, and injection needles should only be used once.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.