Oxlumo

Land: Europäische Union

Sprache: Englisch

Quelle: EMA (European Medicines Agency)

Wirkstoff:

Lumasiran sodium

Verfügbar ab:

Alnylam Netherlands B.V.

ATC-Code:

A16AX18

INN (Internationale Bezeichnung):

Lumasiran

Therapiegruppe:

Other alimentary tract and metabolism products,

Therapiebereich:

Hyperoxaluria, Primary

Anwendungsgebiete:

Treatment of primary hyperoxaluria type 1 (PH1) in all age groups.

Produktbesonderheiten:

Revision: 4

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2020-11-19

Gebrauchsinformation

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

Fachinformation

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