PRIFTIN- rifapentine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RIFAPENTINE (UNII: XJM390A33U) (RIFAPENTINE - UNII:XJM390A33U)

Available from:

sanofi-aventis U.S. LLC

INN (International Name):

rifapentine

Composition:

rifapentine 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PRIFTIN® (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis . PRIFTIN must always be used in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible [see Dosage and Administration (2.1) and Clinical Studies (14.1)]. Limitations of Use Do not use PRIFTIN monotherapy in either the initial or the continuation phases of active antituberculous treatment. PRIFTIN should not be used once weekly in the continuation phase regimen in combination with isoniazid (INH) in HIV-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin (RIF)-resistant organisms [see Warnings and Precautions (5.4) and Clinical Studies (14.1)]. PRIFTIN has not been studied as part of the initial phase treatment regimen in HIV-infected patients with active pulmonary tuberculosis. PRIFTIN is indicated in adults and children 2 years an

Product summary:

How Supplied PRIFTIN is supplied as 150 mg round normal convex dark-pink film-coated tablets debossed "Priftin" on top and "150" on the bottom, packaged in aluminum formable foil blister strips inserted into an aluminum foil laminated pouch. Carton of 32 tablets (4 strips of 8 tablets) NDC 0088-2100-32 Carton of 24 tablets (3 strips of 8 tablets) NDC 0088-2100-24 Storage Store at 25°C (77°F); excursions permitted 15–30°C (59–86°F) (see USP Controlled Room Temperature). Protect from excessive heat and humidity.

Authorization status:

New Drug Application

Patient Information leaflet

sanofi-aventis U.S. LLC
----------
MEDICATION GUIDE
PRIFTIN (PRIF - TIN)
(RIFAPENTINE)
TABLETS
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: June 2020
Read this Medication Guide before you start taking PRIFTIN 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 PRIFTIN?
PRIFTIN may cause serious side effects, including:
•
Liver problems. PRIFTIN may cause serious liver problems. Your doctor
may do a blood test to
check your liver function before and while you take PRIFTIN. Stop
taking PRIFTIN and call your
doctor right away if you have any of the following signs and symptoms
of liver problems:
•
nausea
•
stomach pain
•
tiredness, yellowing skin or whites of your eyes
•
vomiting
•
loss of appetite
•
dark urine
•
Allergic reactions and flu-like symptoms. Allergic reactions and
flu-like symptoms have happened in
some people taking PRIFTIN. Signs and symptoms of an allergic reaction
may include:
•
low blood pressure (hypotension)
•
hives
•
cough with wheezing
•
difficulty breathing
•
red eyes (conjunctivitis)
•
lower blood platelet levels
Signs and symptoms of a flu-like reaction may include:
•
weakness
•
nausea and vomiting
•
chills
•
itching
•
shortness of breath
•
fainting
•
tiredness
•
headache
•
aches
•
sweats
•
chest pain
•
fast heartbeat
•
muscle pain
•
fever
•
rash
•
dizziness
•
cough
•
Severe skin reactions. Serious skin reactions such as Stevens-Johnson
syndrome (SJS) and drug
reaction with eosinophilia and systemic symptoms (DRESS) syndrome have
happened in some
people taking PRIFTIN.
Stop taking PRIFTIN right away and call your doctor or get emergency
help if you have any of the
MEDICATION GUIDE
PRIFTIN (PRIF - TIN)
(RIFAPENTINE)
TABLETS
following symptoms:
•
rash
•
red and painful
skin
•
peeling or bleeding s

Summary of Product characteristics

PRIFTIN- RIFAPENTINE TABLET, FILM COATED
SANOFI-AVENTIS U.S. LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRIFTIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PRIFTIN.
PRIFTIN (RIFAPENTINE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions (5.3)
6/2020
INDICATIONS AND USAGE
PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12
years of age and older for the treatment of active
pulmonary tuberculosis (TB) caused by _Mycobacterium tuberculosis_ in
combination with one or more antituberculosis
(anti-TB) drugs to which the isolate is susceptible. (1.1)
PRIFTIN is indicated for the treatment of latent tuberculosis
infection (LTBI) caused by _M. tuberculosis _in combination
with isoniazid in patients 2 years of age and older at high risk of
progression to TB disease. (1.2)
See Full Prescribing Information for Limitations of Use. (1.1, 1.2)
DOSAGE AND ADMINISTRATION
ACTIVE PULMONARY TUBERCULOSIS: PRIFTIN should be used in regimens
consisting of an initial 2 month phase followed
by a 4 month continuation phase. (2.1)
INITIAL PHASE (2 MONTHS): 600 mg twice weekly for two months as
directly observed therapy (DOT), with no less than
72 hours between doses, in combination with other antituberculosis
drugs. (2.1)
CONTINUATION PHASE (4 MONTHS): 600 mg once weekly for 4 months as
directly observed therapy with isoniazid or
another appropriate antituberculosis agent. (2.1)
LATENT TUBERCULOSIS INFECTION: PRIFTIN should be administered in
combination with isoniazid once weekly for 12
weeks as directly observed therapy. (2.2)
Adults and children ≥12 years: PRIFTIN (based on weight, see table
below) and isoniazid 15 mg/kg (900 mg maximum).
(2.2)
Children 2 to 11 years: PRIFTIN (based on weight, see table below) and
isoniazid 25 mg/kg (900 mg maximum). (2.2)
WEIGHT RANGE
PRIFTIN DOSE
NUMBER OF PRIFTIN TABLETS
10–14 kg
300 mg
2
14.1–25 kg
450 mg
3
25.1–32 kg
600 mg
4
32.1–50