Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Lumasiran sodium
Alnylam Netherlands B.V.
A16AX18
Lumasiran
Other alimentary tract and metabolism products,
Hyperoxaluria, Primary
Treatment of primary hyperoxaluria type 1 (PH1) in all age groups.
Revision: 4
Authorised
2020-11-19
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OXLUMO 94.5 MG/0.5 ML SOLUTION FOR INJECTION lumasiran This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Oxlumo is and what it is used for 2. What you need to know before you are given Oxlumo 3. How Oxlumo is given 4. Possible side effects 5. How to store Oxlumo 6. Contents of the pack and other information 1. WHAT OXLUMO IS AND WHAT IT IS USED FOR WHAT OXLUMO IS Oxlumo contains the active substance lumasiran. WHAT OXLUMO IS USED FOR Oxlumo is used to treat primary hyperoxaluria type 1 (PH1) in adults and children of all ages. WHAT PH1 IS PH1 is a rare illness in which the liver produces too much of a substance called oxalate. Your kidneys remove oxalate from the body and it is passed out in the urine. In people with PH1, the extra oxalate can build up in the kidneys and cause kidney stones, and can stop the kidney from working as well as they should. A build-up of oxalate can also damage other parts of the body such as eyes, heart, skin, and bone. This is called oxalosis. HOW OXLUMO WORKS Lumasiran, the active substance in Oxlumo, reduces the amount of an enzyme called glycolate oxidase that the liver makes. Glycolate oxidase is one of the enzymes involved in producing oxalate. By lowering the amount of the enzyme, the liver produces less oxalate and the levels of oxalate in the urine and blood also fall. This can help to reduce the effects of the illness. 2 Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Oxlumo 94.5 mg/0.5 mL solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains lumasiran sodium equivalent to 189 mg lumasiran. Each vial contains 94.5 mg lumasiran in 0.5 mL. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to yellow solution (pH of approximately 7; osmolality 240 to 360 mOsm/kg). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups. 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. 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 Read the complete document