RUZURGI- amifampridine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Amifampridine (UNII: RU4S6E2G0J) (Amifampridine - UNII:RU4S6E2G0J)

Available from:

Jacobus Pharmaceutical Company,Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

RUZURGI is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. RUZURGI is contraindicated in patients with: - A history of seizures [see Warnings and Precautions (5.1)] - Hypersensitivity to amifampridine or another aminopyridine [see Warnings and Precautions (5.2)] Risk Summary There are no data on the developmental risk associated with the use of RUZURGI in pregnant women. Animal studies to assess the potential adverse effects of amifampridine on embryofetal development have not been conducted. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Risk Summary There are no data on the presence of amifampridine or the 3-N-acetyl-amifampridine metabolite in human milk, the effects on the breastfed infant, or the effects on mi

Product summary:

RUZURGI (amifampridine) 10 mg functionally scored tablets are oval, white to off-white, and debossed “10 │ 110” on one side and “JACOBUS” on the other side. RUZURGI is supplied as follows: Prior to Dispensing: Store tablets in a refrigerator between 2°C to 8°C (36°F to 46°F). Keep container tightly closed with desiccant canister inside after opening. Protect from moisture and light. After Dispensing: Store tablets at 20°C to 25°C (68°F to 77°F) for up to 3 months; excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].

Authorization status:

New Drug Application

Patient Information leaflet

RUZURGI- AMIFAMPRIDINE TABLET
Jacobus Pharmaceutical Company,Inc
----------
MEDICATION GUIDE
RUZURGI® (rew-ZUR-jee)
(amifampridine) tablets, for oral use
Read this Medication Guide before you start taking RUZURGI 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 RUZURGI?
RUZURGI can cause seizures.
•
You could have a seizure even if you never had a seizure before.
•
Do not take RUZURGI if you have ever had a seizure.
Stop taking RUZURGI and call your doctor right away if you have a
seizure while taking RUZURGI.
What is RUZURGI?
RUZURGI is a prescription medicine used to treat Lambert-Eaton
myasthenic syndrome (LEMS) in
children 6 to less than 17 years of age.
It is not known if RUZURGI is safe or effective in children less than
6 years of age.
Do not take RUZURGI if you:
•
have ever had a seizure.
•
are allergic to amifampridine or another aminopyridine. Talk to your
doctor if you are not sure.
Before you take RUZURGI, tell your doctor about all of your medical
conditions including if you:
•
are taking another aminopyridine, such as as compounded
3,4-diaminopyridine (3,4-DAP), 4-
aminopyridine, or pyridostigmine.
•
have had a seizure.
•
have kidney problems.
•
have liver problems.
•
are pregnant or planning to become pregnant. It is not known if
RUZURGI can harm your unborn
baby. You and your doctor should decide if you will take RUZURGI while
you are pregnant.
•
are breastfeeding or plan to breastfeed. It is not known if RUZURGI
passes into your breastmilk.
Talk to your doctor about the best way to feed your baby while taking
RUZURGI.
Tell your doctor about all the medicines you take, including
prescription and over-the-counter medicines,
vitamins, and herbal supplements.
How should I take RUZURGI?
•
See the detailed “Instructions for Use” on how to take and prepare
a suspension of RUZURGI if
your dos

Summary of Product characteristics

RUZURGI- AMIFAMPRIDINE TABLET
JACOBUS PHARMACEUTICAL COMPANY,INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RUZURGI SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RUZURGI.
RUZURGI (AMIFAMPRIDINE) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2018
INDICATIONS AND USAGE
RUZURGI is a potassium channel blocker indicated for the treatment of
Lambert-Eaton myasthenic syndrome (LEMS) in
patients 6 to less than 17 years of age. (1)
DOSAGE AND ADMINISTRATION
Patients 6 to less than 17 years of age weighing 45 kg or more:
Initial dosage is 15 mg to 30 mg daily, in divided doses
Increase daily in 5 mg to 10 mg increments, divided in up to 5 doses
daily
Maximum single dose is 30 mg; maximum daily dosage is 100 mg (2.1)
Patients 6 to less than 17 years of age weighing less than 45 kg:
Initial dosage is 7.5 mg to 15 mg daily, in divided doses
Increase daily in 2.5 mg to 5 mg increments, divided in up to 5 doses
daily
Maximum single dose is 15 mg; maximum daily dosage is 50 mg (2.1)
When patients require a dosage in less than 5 mg increments, have
difficulty swallowing, or require feeding tubes, a 1
mg/mL suspension can be prepared. (2.2)
For patients with renal or hepatic impairment or who are known
N-acetyltransferase 2 poor metabolizers, use the lowest
recommended initial dosage. (2.3, 2.4, 2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, functionally scored (3)
CONTRAINDICATIONS
History of seizures (4)
Hypersensitivity to amifampridine or other aminopyridine (4)
WARNINGS AND PRECAUTIONS
RUZURGI can cause seizures. Consider discontinuation or dose-reduction
of RUZURGI in patients who have a seizure
while on treatment. (5.1)
Hypersensitivity reactions: If a hypersensitivity reaction such as
anaphylaxis occurs, RUZURGI should be discontinued
and appropriate therapy initiated. (5.2)
ADVERSE REACTIONS
The most common adverse reactions (incidence at least 10% and at least
2% greater than placebo) are
paresthesia/dysesthesia, abdominal pain, dyspeps