Pasurta 70mgml Solution for Injection in a Prefilled Syringe

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ERENUMAB

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ERENUMAB

Unit dalam pakej:

1 Pre-Filled Syringes

Dikeluarkan oleh:

Alcon-Couvreur NV

Risalah maklumat

PASURTA
® INJECTION
Erenumab (70 mg/ml & 140 mg/ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
WHAT PASURTA IS USED FOR
2.
HOW PASURTA WORKS
3.
BEFORE YOU USE PASURTA
4.
HOW TO USE PASURTA
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF PASURTA
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
12.
INSTRUCTION FOR USE OF PASURTA
WHAT PASURTA IS USED FOR
Pasurta is a medicine used to prevent
migraine in adults who have at least 4
migraine days per month. It contains the
active substance erenumab, which
belongs to a group of medicines called
anti-Calcitonin Gene-Related Peptide
(CGRP) receptor antibody.
HOW PASURTA WORKS
Pasurta works by blocking the activity of
CGRP molecule, which has been linked
to migraine.
BEFORE YOU USE PASURTA
-
_When you must not use it _
If you have had an allergic reaction to
Pasurta or to any of its ingredients. See
“
PRODUCT DESCRIPTION
” section below
for all ingredients. Ask your doctor if
you are not sure.
TELL YOUR HEALTHCARE PROVIDER OR GET
EMERGENCY MEDICAL HELP IMMEDIATELY:
If you get any symptoms of a serious
allergic reaction, such as rash or swelling
usually of the face, mouth, tongue, or
throat; or difficulty breathing. Serious
allergic reactions can happen within
minutes, but some may happen more
than one week after using Pasurta.
If you have severe constipation or
constipation associated with symptoms
such as severe or constant belly pain,
vomiting, swelling of belly or bloating.
Severe constipation can happen after
receiving Pasurta. In some cases, patients
have been hospitalized or needed surgery.
-
_Before you start to use it _
_Children and adolescents (below 18 _
_years) _
The use of Pasurta has not been studied
in children under 18 years of age.
_Older people (65 years or above) _
You can use Pasurta if you are aged 65
years or over at the same dose as for
other adults.
_Pregnancy and lactation _
Pasurta has not been studied in pregnant
women. It is

Ciri produk

Novartis
Page 2
Malaysia Package Leaflet
23-Mar-2022
PASURTA
®
PASURTA
®
Anti-Calcitonin Gene-Related Peptide Receptor (anti-CGRPR) monoclonal
antibody
ATC code: N02CD01
_ _
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
70 mg erenumab in 1.0 mL (70 mg/mL) solution is a solution that is
clear, colorless to
yellowish, and practically free from particles.

70 mg/mL solution for injection in a pre-filled syringe, subcutaneous
use.
140 mg erenumab in 1.0 mL (140 mg/mL) solution is a solution that is
clear, colorless to
yellowish, and practically free from particles.

140 mg/mL solution for injection in a pre-filled syringe, subcutaneous
use.
ACTIVE SUBSTANCE
Erenumab.
EXCIPIENTS
Sucrose, Glacial acetic acid, Polysorbate 80, Water for injection,
Sodium hydroxide.
INDICATIONS
Pasurta is indicated for prophylaxis of migraine in adults who have at
least 4 migraine days per
month.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE
The recommended dose of Pasurta is 70 mg administered once monthly.
Some patients may benefit from a dosage of 140 mg administered once
monthly [see section
CLINICAL STUDIES]
If Pasurta dose is missed, administer as soon as possible. Thereafter,
Pasurta can be scheduled
monthly from the date of the last dose.
SPECIAL POPULATIONS
PEDIATRICS
The safety and effectiveness of Pasurta has not been studied in
pediatric patients.
GERIATRICS
Clinical studies of Pasurta did not include sufficient numbers of
patients aged 65 and over to
determine whether they respond differently from younger patients. No
dose adjustment is
required as the pharmacokinetics of erenumab are not affected by age.
RENAL IMPAIRMENT
No dose adjustment is necessary in patients with mild to moderate
renal impairment. Population
pharmacokinetic analysis of integrated data from the Pasurta clinical
trials did not reveal a
Novartis
Page 3
Malaysia Package Leaflet
23-Mar-2022
PASURTA
®
difference in the pharmacokinetics of erenumab in patients with mild
or moderate renal
impairment relative to those with normal renal function. Patients