UBRELVY 50 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

UBROGEPANT AS TRIHYDRATE

Dostupné z:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

Forma lieku:

TABLETS

Zloženie:

UBROGEPANT AS TRIHYDRATE 50 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

FOREST LABORATORIES IRELAND, LIMITED, IRELAND

Terapeutické indikácie:

Ubrelvy is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults.Limitations of UseUbrelvy is not indicated for the preventive treatment of migraine.

Dátum Autorizácia:

2022-06-03

Príbalový leták

UBR APL TIK JUL 23 CL P4
UBR APL TIK JUL 23 CL P4
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS( – 1986
This medicine is dispensed with a doctor’s
prescription only
UBRELVY 50 mg, tablets
UBRELVY 100 mg, tablets
The active ingredient and its quantity:
Each tablet contains:
UBRELVY 50 mg, tablets
ubrogepant 50.0 mg/tablet )equivalent to 54.9 mg
of ubrogepant free base trihydrate(
UBRELVY 100 mg, tablets
ubrogepant 100.0 mg/tablet )equivalent to 109.8 mg
of ubrogepant free base trihydrate(
For the full list of inactive ingredients, please see
section 6 “Further Information” in this leaflet.
See also “Important information about some of this
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.
This medicine is intended for use in adults above
the age of 18.
1. WHAT IS THE MEDICINE INTENDED FOR?
UBRELVY
contains
the
active
substance
ubrogepant, a calcitonin gene-related peptide
)CGRP( receptor antagonist. UBRELVY is used
for the acute treatment of migraine attacks with or
without aura in adults.
Limitations of Use
UBRELVY is not indicated for the preventive
treatment of migraine.
Therapeutic group: antimigraine preparations,
calcitonin gene-related peptide )CGRP( antagonist.
2. BEFORE USING THE MEDICINE
Do not use the medicine:
- if you are sensitive )allergic( to the active
substance ubrogepant or to any of the
other ingredients of this medicine )listed in
section 6(. Serious allergic reactions may
include life-threatening allergic reaction
)anaphylaxis(,
difficulty
breathing,
and
swelling
of the face, mouth, tongue, or throat. See
section “Special warnings about using this
medicine” and section 4 �

Súhrn charakteristických

UBR API MAR 23 CL
Page
1
of
14
UBRELVY 50 MG
UBRELVY 100 MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
UBRELVY 50 mg
Each tablet contains 50 mg of ubrogepant (equivalent to 54.9 mg of
ubrogepant free base trihydrate)
UBRELVY 100 mg
Each tablet contains 100 mg of ubrogepant (equivalent to 109.8 mg of
ubrogepant free base trihydrate)
1
INDICATIONS AND USAGE
UBRELVY is a calcitonin gene-related peptide receptor antagonist
indicated for the acute treatment of migraine
with or without aura in adults.
Limitations of Use
UBRELVY is not indicated for the preventive treatment of migraine.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSAGE
The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with
or without food.
If needed, a second dose may be taken at least 2 hours after the
initial dose. The maximum dose in a 24-hour
period is 200 mg. The safety of treating more than 8 migraines in a
30-day period has not been established.
2.2
DOSAGE MODIFICATIONS
Dosing modifications for concomitant use of specific drugs and for
patients with hepatic or renal impairment
are provided in Table 1.
TABLE 1: DOSE MODIFICATIONS FOR DRUG INTERACTIONS AND FOR SPECIFIC
POPULATIONS
DOSAGE MODIFICATIONS
INITIAL DOSE
SECOND DOSE
a
(IF NEEDED)
CONCOMITANT DRUG _[SEE DRUG INTERACTIONS (7)]_
Moderate CYP3A4 Inhibitors
_ (7.1)_
50 mg
Avoid within 24
hours
Weak CYP3A4 Inhibitors
_(7.1)_
50 mg
50 mg
Strong CYP3A4 Inducers
_(7.2)_
Avoid concomitant use
Weak & Moderate CYP3A4 Inducers
_ (7.2)_
100 mg
100 mg
BCRP and/or P-gp only Inhibitors
_(7.3)_
50 mg
50 mg
UBR API MAR 23 CL
Page
2
of
14
SPECIFIC POPULATIONS _[SEE USE IN SPECIFIC POPULATIONS (8)]_
Severe Hepatic Impairment (Child-Pugh Class C)
_(8.6)_
50 mg
50 mg
Severe Renal Impairment (CLcr 15-29 mL/min)
_(8.7)_
50 mg
50 mg
End-Stage Renal Disease (CLcr <15 mL/min)
_ (8.7)_
Avoid use
a
Second dose may be taken at least 2 hours after the initial dose
3
DOSAGE FORMS AND STRENGTHS
UBRELVY 50 mg is supplied as white to off-white, capsule-shaped,
biconvex tablets debossed with “U50” on
one sid