QULIPTA 60 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

ATOGEPANT AS MONOHYDRATE

Tilgængelig fra:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC-kode:

N02CD07

Lægemiddelform:

TABLETS

Sammensætning:

ATOGEPANT AS MONOHYDRATE 60 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

FOREST LABORATORIES IRELAND, LIMITED, IRELAND

Terapeutisk område:

ATOGEPANT

Terapeutiske indikationer:

Qulipta is indicated for the preventive treatment of migraine in adults

Autorisation dato:

2022-09-28

Indlægsseddel

QUL_APL_ENG_NOV 23_CL
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only
QULIPTA
®
10 mg
Tablets
QULIPTA
®
30 mg
Tablets
QULIPTA
®
60 mg
Tablets
Each tablet contains:
atogepant
10
mg
(equivalent
to
10.3 mg of atogepant free base
monohydrate).
Each tablet contains:
atogepant
30
mg
(equivalent
to
30.9 mg of atogepant free base
monohydrate).
Each tablet contains:
atogepant
60
mg
(equivalent
to
61.8 mg of atogepant free base
monohydrate).
For the list of inactive ingredients, please see section 6 “Further
Information” in this leaflet. See also “Important
information about some of the medicine’s ingredients” in section
2.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains concise information
about the medicine. If you have further questions, refer to the doctor
or pharmacist.
This medicine has been prescribed for your ailment/for you. Do not
pass it on to others. It may harm them even
if it seems to you that their ailment/medical condition is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
QULIPTA is indicated for the preventive treatment of migraine in
adults.
Therapeutic group:
Antimigraine preparations, calcitonin gene related peptide (CGRP)
receptor antagonist.
How QULIPTA works
QULIPTA works by blocking the activity of the calcitonin gene-related
peptide (CGRP) molecule which has been
linked to migraine. This reduction in CGRP’s activity reduces
migraine.
2.
BEFORE USING THE MEDICINE
Do not use the medicine:

If you are sensitive (allergic) to the active substance atogepant or
any of the other ingredients of this
medicine (for the list of inactive ingredients, see section 6).
Allergic reactions may include: life-threatening
allergic reaction (anaphylaxis) and difficulty breathing (see below
“Special warnings about using this
medicine”).
Special warnings about using this medicine:
Before starting treatment with QULIPTA, tell your doctor if:


Produktets egenskaber

QUL API NOV 2023 CL
QULIPTA 10 mg
QULIPTA 30 mg
QULIPTA 60 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
QULIPTA 10 mg
Each tablet contains 10 mg of atogepant (equivalent to 10.3 mg of
atogepant free base monohydrate).
QULIPTA 30 mg
Each tablet contains 30 mg of atogepant (equivalent to 30.9 mg of
atogepant free base monohydrate).
QULIPTA 60 mg
Each tablet contains 60 mg of atogepant (equivalent to 61.8 mg of
atogepant free base monohydrate).
1
INDICATIONS AND USAGE
QULIPTA is indicated for the preventive treatment of migraine in
adults.
2
DOSAGE AND ADMINISTRATION
2.1
Recommended Dosage
QULIPTA is taken orally with or without food.
Episodic Migraine
The recommended dosage of QULIPTA for episodic migraine is 10 mg, 30
mg, or 60 mg taken once daily.
Chronic Migraine
The recommended dosage of QULIPTA for chronic migraine is 60 mg taken
once daily.
2.2
Dosage Modifications
Dosing modifications for concomitant use of specific drugs and for
patients with renal impairment are provided
in Table 1.
Table 1: Dosage Modifications for Drug Interactions and for Specific
Populations
Dosage Modifications
Recommended
Once Daily Dosage
for Episodic
Migraine
Usage and
Recommended
Once Daily Dosage
for Chronic
Migraine
Concomitant Drug [see Drug Interactions (7)]
Strong CYP3A4 Inhibitors (7.1)
10 mg
Avoid use
Strong, Moderate or Weak CYP3A4 Inducers (7.2)
30 mg or 60 mg
Avoid use
OATP Inhibitors (7.3)
10 mg or 30 mg
30 mg
Renal Impairment [see Use in Specific Populations (8)]
Severe Renal Impairment and End-Stage Renal Disease
(CLcr <30 mL/min) (8.6)
10 mg
Avoid use
QUL API NOV 2023 CL
3
DOSAGE FORMS AND STRENGTHS
QULIPTA 10 mg is supplied as white to off-white, round biconvex
tablets debossed with “A” and “10” on one
side.
QULIPTA 30 mg is supplied as white to off-white, oval biconvex tablets
debossed with “A30” on one side.
QULIPTA 60 mg is supplied as white to off-white, oval biconvex tablets
debossed with “A60” on one side.
4
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
l