Pontevia 120 mg solution for injection in pre-filled syringe

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Galcanezumab

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

Galcanezumab

Units in package:

1 ml

Manufactured by:

ELI LILLY AND COMPANY

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PONTEVIA 120MG SOLUTION FOR
INJECTION IN PRE-FILLED PEN
PONTEVIA 120MG SOLUTION FOR
INJECTION IN PRE-FILLED SYRINGE
Galcanezumab 120 mg
WHAT IS IN THIS LEAFLET
1.
What Pontevia is used for
2.
How Pontevia works
3.
Before you use Pontevia
4.
How to use Pontevia
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Pontevia
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT PONTEVIA IS USED FOR
Pontevia is a prescription medicine used
to prevent migraine in adult patients who
have at least 4 migraines days per month.
HOW PONTEVIA WORKS
Pontevia
contains
galcanezumab,
a
medicine
that
stops
the
activity
of
a
naturally occurring substance in the body
called
calcitonin
gene-related
peptide
(CGRP). People with migraine may have
increased levels of CGRP.
Pontevia
can
reduce
the
frequency
of
migraine
headache
and
improve
your
quality of life. It starts working in about a
week.
BEFORE YOU USE PONTEVIA
-
_When you must not use it _
If you are allergic to galcanezumab or any
of the other ingredients of this medicine
(see
PRODUCT DESCRIPTION
section).
-
_Before you start to use it _
Talk to your doctor, nurse or pharmacist
before using Pontevia.
Pontevia
can
potentially
cause
serious
allergic reactions. You must look out for
signs of these reactions while you are
using Pontevia (see
SIDE EFFECTS
).
_Children _
_and _
_adolescents: _
Pontevia
should
not
be
given
to
children
and
adolescents under 18 years of age
because it has not been studied in this age
group.
_Pregnancy and lactation_
: If you are a
woman able to have children, you are
advised to avoid becoming pregnant while
using Pontevia.
If you are pregnant, think you may be
pregnant or are planning to have a baby,
ask your doctor for advice before taking
this medicine. It is preferable to avoid the
use of Pontevia in pregnancy as the effects
of this medicine in pregnant women are
not known.
If you are breast-feeding or are planning
to breast-

Summary of Product characteristics

Pontevia 120mg Pre- Pen and Syringe USPI August 2022
Page 1 of 13
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PONTEVIA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR PONTEVIA.
PONTEVIA (GALCANEZUMAB) INJECTION, FOR SUBCUTANEOUS USE --------
-------------------- INDICATIONS AND USAGE ---------------------------
PONTEVIA is indicated for the prophylaxis of migraine in adults who
have at least 4 migraine days per month. (1.1)
------------------------DOSAGE AND
ADMINISTRATION-----------------------
•
For subcutaneous use only. (2.1, 2.2, 2.3)
•
The
recommended
dose
is
120
mg
galcanezumab
injected
subcutaneously once monthly, with a 240 mg loading dose as the initial
dose. (2.1)
•
Administer in the abdomen, thigh, back of the upper arm, or buttocks
subcutaneously. (2.3)
----------------------DOSAGE FORMS AND STRENGTHS---------------------
•
Injection: 120 mg/mL solution in a single-dose prefilled pen (3)
•
Injection: 120 mg/mL solution in a single-dose prefilled syringe (3)
------------------------------- CONTRAINDICATIONS
------------------------------
PONTEVIA is contraindicated in patients with serious hypersensitivity
to galcanezumab or to any of the excipients. (4)
------------------------ WARNINGS AND PRECAUTIONS
-----------------------
Serious
hypersensitivity
reactions
including
cases
of
anaphylaxis,
angioedema and urticaria have been reported (see section 6.3). If a
serious
hypersensitivity reaction occurs, administration of galcanezumab
should be
discontinued immediately and appropriate therapy initiated (see
section 4).
Patients
should
be
informed
on
the
possibility
of
a
delayed
onset
hypersensitivity reaction and instructed to contact their physician.
------------------------------- ADVERSE
REACTIONS------------------------------
The most common adverse reactions (incidence ≥2% and at least 2%
greater than placebo) in PONTEVIA clinical studies were injection site
reactions. (6.1)
REVISED: 23 AUG 2022
FULL PRESCRIBING INFO