Posology : מינונים

4.2    Posology and method of administration

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.


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 mg/kg once monthly, beginning 3 doses                          one month after the last loading dose 
10 kg to less than 20 kg   6 mg/kg once monthly for         6 mg/kg once every 3 months (quarterly), 3 doses                          beginning one month after the last loading dose

20 kg and above            3 mg/kg once monthly for         3 mg/kg once every 3 months (quarterly),
3 doses                          beginning one month after the last loading dose


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). OXLUMO has not been studied in patients with an eGFR <30 mL/min/1.73 m2 or patients 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.