ENSPRYNG

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

SATRALIZUMAB

Disponible desde:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

Código ATC:

L04AC19

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

SATRALIZUMAB 120 MG / 1 ML

Vía de administración:

S.C

tipo de receta:

Required

Fabricado por:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Área terapéutica:

SATRALIZUMAB

indicaciones terapéuticas:

Enspryng is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.

Fecha de autorización:

2022-02-01

Información para el usuario

INJECTING ENSPRYNG
13. Hold the barrel of the syringe between your thumb
and forefinger. With the help of the other hand, pull the
needle cap straight off. You may see a drop of liquid at
the tip of the needle. This is normal and will not affect
your dose )SEE FIGURE K(.
•
USE THE SYRINGE WITHIN 5 MINUTES OF REMOVING
THE CAP, OTHERWISE THE NEEDLE MAY GET BLOCKED.
• Do not remove the needle cap until you are ready to
inject Enspryng.
• Do not put the needle cap back on after it has been
removed as it might damage the needle.
• Do not touch the needle and do not allow it to come
into contact with other surfaces after the needle cap
has been removed.
14. Dispose of the needle cap immediately in the sharps
container. See step 21 ”Disposing of Enspryng“.
15. Hold the barrel of the syringe with your thumb and
forefinger. With the other hand, pinch the skin in the
area which you cleaned )SEE FIGURE L(.
16. Use a fast and sharp movement to insert the needle at
an angle between 45° and 90° )SEE FIGURE L(.
•
Do not change the injection angle during the injection.
• Do not insert the needle again.
17. After the needle is inserted, release the pinched skin.
18. Slowly inject all of the medicine by gently pressing the
plunger downward until it touches the activation guards
)SEE FIGURE M(.
19. Gently release the plunger and allow the needle to exit
the skin at the same angle at which it was inserted (SEE
FIGURE N(.
•
NOW THE NEEDLE WILL BE COVERED BY THE AUTOMATIC
NEEDLE GUARD. If the needle is not covered, carefully
place the syringe in the sharps container to prevent
injury. See step 21 ”Disposing of Enspryng“.
TAKING CARE OF THE INJECTION SITE
20. A little bleeding may occur at the injection site. You can
press with a cotton ball or gauze pad on the injection
site until the bleeding stops, but DO NOT massage the
area. If needed, a small bandage can be placed on the
injection site. If the medicine comes into contact with
the skin, wash the area with water.
DISPOSING OF ENSPRYNG
21. Do not try to cover

Ficha técnica

1
Enspryng PI_version 1
ENSPRYNG
®

SATRALIZUMAB_ _
Solution for injection
1.
NAME OF THE MEDICINAL PRODUCT
Enspryng
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe (PFS) contains 120 mg of satralizumab in 1 mL.
Satralizumab is_ _produced in Chinese hamster ovary cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Colourless to slightly yellow liquid. The solution has a pH of
approximately 6.0 and an osmolality of
approximately 310 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Enspryng is indicated as a monotherapy or in combination with
immunosuppressive therapy (IST) for
the treatment of neuromyelitis optica spectrum disorders (NMOSD) in
adult and adolescent patients
from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG)
seropositive.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the treatment of
neuromyelitis optica (NMO) or NMOSD.
Posology
Enspryng can be used as a monotherapy or in combination with oral
corticosteroids (OCs),
azathioprine (AZA) or mycophenolate mofetil (MMF) (see section 5.1).
The posology in adolescent
patients ≥12 years of age with body weight ≥ 40 kg and adult
patients is the same.
2
_Loading doses _
_ _
The recommended loading dose is 120 mg subcutaneous (SC) injection
every two weeks for the first
three administrations (first dose at week 0, second dose at week 2 and
third dose at week 4).
_ _
_Maintenance doses _
_ _
The recommended maintenance dose is 120 mg SC injection every four
weeks.
_Duration of treatment _
_ _
Enspryng is intended for long-term treatment.
_ _
_Delayed or missed doses _
_ _
If an injection is missed, for any reason other than increases in
liver enzymes, it should be
administered as described in table 1.
TABLE 1: RECOMMENDED DOSAGE FOR DELAYED OR MISSED DOSES
LAST DOSE ADMINISTERED
RECOMMENDED DOSAGE FOR DELAYED OR MISSED DOSES
Missed a loading do