FIRDAPSE- amifampridine phosphate tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

amifampridine phosphate (UNII: 8HF8FIN815) (amifampridine - UNII:RU4S6E2G0J)

から入手可能:

Catalyst Pharmaceuticals, Inc.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

FIRDAPSE® is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. FIRDAPSE is contraindicated in patients with: - A history of seizures [see Warnings and Precautions (5.1)] - Hypersensitivity to amifampridine phosphate or another aminopyridine [see Warnings and Precautions (5.2)] Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FIRDAPSE during pregnancy. Physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves in the registry by calling 855-212-5856 (toll-free), using the Fax number 877-867-1874 (toll-free), by contacting the Pregnancy Coordinating Center at [e-mail], or by visiting the study website www.firdapsepregnancystudy.com. Risk Summary There are no data on the developmental risk associated with the use of FIRDAPSE in pregnant women. In animal studies, administration of amifampridine phosph

製品概要:

FIRDAPSE 10 mg tablets are white to off white, round, and functionally scored. Each tablet is debossed on the non-scored side with "CATALYST" and on the scored side with "211" above the score and "10" below the score. Tablets can be divided in half at the score. FIRDAPSE is supplied as follows: Child Resistant Blister Pack Bottles Store FIRDAPSE tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. See Dosage and Administration (2.5) for storage instructions for FIRDAPSE prepared suspension.

認証ステータス:

New Drug Application

情報リーフレット

Catalyst Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
FIRDAPSE® (FIR-DAPSE)
(AMIFAMPRIDINE)
TABLETS, FOR ORAL USE
This Medication Guide has been approved by the U.S. Food and
Drug Administration
Revised: 09/2022
Read this Medication Guide before you start taking FIRDAPSE and each
time you get a refill. There may
be new information. This information does not take the place of
talking with your doctor about your
medical condition or your treatment.
What is the most important information I should know about FIRDAPSE?
FIRDAPSE can cause seizures.
•
You could have a seizure even if you never had a seizure before.
•
Do not take FIRDAPSE if you have ever had a seizure.
Stop taking FIRDAPSE and call your doctor right away if you have a
seizure while taking FIRDAPSE.
What is FIRDAPSE?
FIRDAPSE is a prescription medicine used to treat Lambert-Eaton
myasthenic syndrome (LEMS) in
people 6 years of age and older.
It is not known if FIRDAPSE is safe or effective in children less than
6 years of age.
Do not take FIRDAPSE if you:
•
have ever had a seizure.
•
are allergic to amifampridine phosphate, or another aminopyridine.
Before you take FIRDAPSE, tell your doctor about all of your medical
conditions. including if you:
•
are taking another aminopyridine, such as compounded
3,4-diaminopyridine (3,4-DAP)
•
have had a seizure
•
have kidney problems
•
have liver problems
•
are pregnant or plan to become pregnant. It is not known if FIRDAPSE
will harm your unborn
baby. You and your doctor will decide if you should take FIRDAPSE
while you are pregnant.
•
There is a registry for women who become pregnant during treatment
with FIRDAPSE. The
purpose of this registry is to collect information about your health
and your baby's health. Contact
the registry as soon as you learn that you are pregnant, or ask your
doctor to contact for you by
calling 855-212-5856 (toll free), contacting the Fax number
877-867-1874 (toll free), emailing the
Pregnancy Coordinating Center at [e-mail], or
visiti

製品の特徴

FIRDAPSE- AMIFAMPRIDINE PHOSPHATE TABLET
CATALYST PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FIRDAPSE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FIRDAPSE .
FIRDAPSE (AMIFAMPRIDINE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2018
RECENT MAJOR CHANGES
Indications and Usage (1) 9/2022
Dosage and Administration (2.1, 2.2, 2.3, 2.4, 2.5) 9/2022
INDICATIONS AND USAGE
FIRDAPSE is a potassium channel blocker indicated for the treatment of
Lambert-Eaton myasthenic
syndrome (LEMS) in adults and pediatric patients 6 years of age and
older. (1)
DOSAGE AND ADMINISTRATION
Administer orally in divided doses (3 to 4 times daily). (2.1)
The recommended starting dosage for adults (any weight) and pediatric
patients weighing 45 kg or
more is 15 mg to 30 mg daily, in divided doses. (2.1)
Dosage can be increased by 5 mg daily every 3 to 4 days. (2.1)
The maximum single dose is 20 mg. (2.1)
Dosage is not to exceed a maximum of 80 mg daily. (2.1)
The recommended starting dosage for pediatric patients weighing less
than 45 kg is 5 mg to 15 mg
daily, in divided doses. (2.1)
Dosage can be increased by 2.5 mg daily every 3 to 4 days. (2.1)
The maximum single dose is 10 mg. (2.1)
Dosage is not to exceed a maximum of 40 mg daily. (2.1)
The recommended starting dosage for adult and pediatric patients with
renal impairment, hepatic
impairment, and in known N-acetyltransferase 2 (NAT2) poor
metabolizers is the lowest recommended
initial daily dosage (2.1, 2.2, 2.3, 2.4)
For patients with a dosage adjustment of less than 5 mg increments, or
who have difficulty swallowing,
or require feeding tube, a l mg/mL suspension can be prepared. (2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, functionally scored. (3)
CONTRAINDICATIONS
FIRDAPSE is contraindicated in patients with:
A history of seizures (4)
Hypersensitivity to amifampridine or another aminopyridine (4)
WARNINGS AND PRECAUTIONS
Seizures: FIRDAPSE can cause seizures. Consider disco