Aspaveli

国家: 欧盟

语言: 英文

来源: EMA (European Medicines Agency)

有效成分:

Pegcetacoplan

可用日期:

Swedish Orphan Biovitrum AB (publ)

ATC代码:

L04

INN（国际名称）:

pegcetacoplan

治疗组:

Immunosuppressants

治疗领域:

Hemoglobinuria, Paroxysmal

疗效迹象:

Aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months.

產品總結:

Revision: 3

授权状态:

Authorised

授权日期:

2021-12-13

资料单张

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
ASPAVELI 1 080 MG SOLUTION FOR INFUSION
pegcetacoplan
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 START USING 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 pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ASPAVELI is and what it is used for
2.
What you need to know before you use ASPAVELI
3.
How to use ASPAVELI
4.
Possible side effects
5.
How to store ASPAVELI
6.
Contents of the pack and other information
1.
WHAT ASPAVELI IS AND WHAT IT IS USED FOR
WHAT IS ASPAVELI
ASPAVELI is a medicine that contains the active substance
pegcetacoplan. Pegcetacoplan has been
designed to attach to the C3 complement protein, which is a part of
the body’s defence system called
the ‘complement system’. Pegcetacoplan prevents your body’s
immune system from destroying your
red blood cells.
WHAT IS ASPAVELI USED FOR
ASPAVELI is used to treat adult patients with a disease called
paroxysmal nocturnal haemoglobinuria
(PNH) who are still anaemic after treatment with another type of PNH
medicine, called a C5 inhibitor,
for at least 3 months.
In patients with PNH, the ‘complement system’ is overactive and
attacks their red blood cells, which
can lead to low blood counts (anaemia), tiredness, difficulty in
functioning, pain, abdominal pain, dark
urine, shortness of breath, difficulty swallowing, erectile
d

产品特点

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
ASPAVELI 1 080 mg solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mL vial contains 1 080 mg of pegcetacoplan.
Each mL contains 54 mg of pegcetacoplan.
Excipients with known effect
Each mL contains 41 mg of sorbitol.
Each vial contains 820 mg of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless to slightly yellowish aqueous solution with pH 5.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASPAVELI is indicated in the treatment of adult patients with
paroxysmal nocturnal haemoglobinuria
(PNH) who are anaemic after treatment with a C5 inhibitor for at least
3 months.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated under the supervision of a healthcare
professional experienced in the
management of patients with haematological disorders.
Self-administration and home infusion should
be considered for patients who have tolerated treatment well in
experienced treatment centres. The
decision of a possibility of self-administration and home infusions
should be made after evaluation and
recommendation from the treating physician.
Posology
Pegcetacoplan can be given by a healthcare professional, or
administered by the patient or caregiver
following proper instruction.
Pegcetacoplan is administered twice weekly as a 1 080 mg subcutaneous
infusion with a commercially
available syringe system infusion pump that can deliver doses up to 20
mL. The twice weekly dose
should be administered on Day 1 and Day 4 of each treatment week.
PNH is a chronic disease and treatment with ASPAVELI is recommended to
continue for the patient’s
lifetime, unless the discontinuation of this m