Lartruvo
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
02-09-2019
Fachinformation
(SPC)
02-09-2019
Öffentlichen Beurteilungsberichts
(PAR)
02-09-2019
Wirkstoff:
Olaratumab
Verfügbar ab:
Eli Lilly Nederland B.V.
ATC-Code:
L01XC27
INN (Internationale Bezeichnung):
olaratumab
Therapiegruppe:
Antineoplastic agents
Therapiebereich:
Sarcoma
Anwendungsgebiete:
Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin (see section 5.1).
Produktbesonderheiten:
Revision: 3
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2016-11-09
Gebrauchsinformation
30
B. PACKAGE LEAFLET
Medicinal product no longer authorised
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
LARTRUVO
10 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
olaratumab
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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lartruvo is and what it is used for
2.
What you need to know before you are given Lartruvo
3.
How you are given Lartruvo
4.
Possible side effects
5.
How to store Lartruvo
6.
Contents of the pack and other information
1.
WHAT LARTRUVO IS AND WHAT IT IS USED FOR
Lartruvo contains the active substance olaratumab, which belongs to a
group of medicines called
monoclonal antibodies.
Olaratumab recognises and attaches specifically to a protein known as
platelet-derived growth factor
receptor-α (PDGFR-α). PDGFR-α is found in large amounts on some
cancer cells where it stimulates
the cells to grow and divide. When olaratumab attaches to PDGFR-α it
may prevent cancer cell growth
and survival.
Lartruvo is used in combination with another anti-cancer medicine
called doxorubicin for the
treatment of adults with advanced soft tissue sarcoma who have not
been previously treated with
doxorubicin. Soft tissue sarcoma is a cancer that starts in the soft
tissues, such as the muscles, fat,
cartilage and blood vessels.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LARTRUVO
_ _
YOU MUST NOT BE GIVEN LARTRUVO
-
if you are allergic to olaratumab or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
You should t
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
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
Lartruvo 10 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of concentrate for solution for infusion contains 10 mg of
olaratumab.
Each 19 mL vial contains 190 mg of olaratumab.
Each 50 mL vial contains 500 mg of olaratumab.
Olaratumab is a human IgG1 monoclonal antibody produced in murine
(NS0) cells by recombinant
DNA technology.
Excipient with known effect
Each 19mL vial contains approximately 22 mg (1 mmol) sodium.
Each 50 mL vial contains approximately 57 mg (2.5 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is clear to slightly opalescent and colourless to
slightly yellow solution without visible
particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lartruvo is indicated in combination with doxorubicin for the
treatment of adult patients with
advanced soft tissue sarcoma who are not amenable to curative
treatment with surgery or radiotherapy
and who have not been previously treated with doxorubicin (see section
5.1).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Olaratumab therapy must be initiated and supervised by physicians
experienced in oncology. Patients
should be monitored during the infusion for signs and symptoms of
infusion-related reactions (IRRs)
in a setting with available resuscitation equipment (see section 4.4).
Posology
The recommended dose of olaratumab is 15 mg/kg administered by
intravenous infusion on days 1
and 8 of each 3 week cycle until disease progression or unacceptable
toxicity. Lartruvo is administered
in combination with doxorubicin for up
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