PRIFTIN- rifapentine tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

A-S Medication Solutions

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 and older for the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in patients at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph) [see Clinical Studies (14.2)] . Limitations of Use Active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection. PRIFTIN must always be used in combination with isoniazid as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection [see Dosage and Administration (2.2) and Clinical Studies (14.2)] . - PRIFTIN in combination with isoniazid is not recommended for individuals presumed to be exposed to rifamycin-resistant or isoniazid-resistant M. tuberculosis . PRIFTIN is contraindicated in patients with a history of hypersensitivity to rifamycins. Risk Summary Based on animal data, PRIFTIN may cause fetal harm when administered to a pregnant woman. Available data from clinical trials, case reports, epidemiology studies and postmarketing experience with PRIFTIN use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, adverse maternal or fetal outcomes. In two clinical trials, a total of 59 patients who were treated with rifapentine in combination with other anti-tuberculosis drugs became pregnant. Overall, the reported rate of miscarriage following rifapentine exposure in these two clinical trials did not represent an increase over the background rate of miscarriage reported in the general population (see Data) . There are risks associated with active tuberculosis during pregnancy. When administered during the last few weeks of pregnancy, PRIFTIN may be associated with maternal postpartum hemorrhage and bleeding in the exposed neonates (see Clinical Considerations) . In animal reproduction and developmental toxicity studies, adverse developmental outcomes (including cleft palate or mal-positioned aortic arches) were observed following administration of rifapentine to pregnant rats and rabbits at doses approximately 0.6 and 0.3 to 1.3 times, respectively, of the recommended human dose based on body surface area comparisons (see Data) . Based on animal data, advise pregnant women of the risk for fetal harm. As rifapentine is always used in combination with other antituberculosis drugs such as isoniazid, ethambutol, and pyrazinamide, refer to the prescribing information of the other drug(s) for more information on their associated risks of use during pregnancy. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo-fetal risk Active tuberculosis in pregnancy is associated with adverse maternal and neonatal outcomes including maternal anemia, cesarean delivery, preterm birth, low birth weight, birth asphyxia, and perinatal infant death. Labor or delivery When administered during the last few weeks of pregnancy, PRIFTIN may increase the risk for maternal postpartum hemorrhage and bleeding in the exposed neonate. Monitor prothrombin time of pregnant women and neonates who are exposed to PRIFTIN during the last few weeks of pregnancy. Treatment with Vitamin K may be indicated. Data Human data Fourteen patients with active tuberculosis treated with multiple antituberculosis drugs including PRIFTIN became pregnant during clinical studies. Six delivered normal infants, four had first trimester spontaneous abortions (of these, one patient abused ethanol and another patient was HIV-infected), one had an elective abortion, and outcome was unknown in three patients. These data are, however, limited by the quality of reporting and confounded by comorbid medical conditions and multiple antituberculosis drug exposures. In the trial that compared the safety and effectiveness of PRIFTIN in combination with isoniazid to isoniazid alone for the treatment of latent tuberculosis infection, a total of 45 (2.5%) women in the PRIFTIN/isoniazid arm and 71 (4.1%) women in the isoniazid arm became pregnant. Among the 46 total pregnancies in the PRIFTIN/isoniazid arm, there were 31 live births, 6 elective abortions, 7 spontaneous abortions, and 2 unknown outcomes. Of the 31 live infants, 21 were reported healthy while in the other ten cases no further details were available. The rate of spontaneous abortion in the PRIFTIN/isoniazid arm (15%) and the rate of spontaneous abortion in the isoniazid arm (19%) did not represent an increase over the background rate of 15 to 20 percent reported in the general population. Further interpretation of these results is limited by the quality of adverse event reporting. Animal data Animal studies in rats and rabbits revealed malformations and other adverse developmental outcomes in both species. Pregnant rats given oral rifapentine during organogenesis (gestational days 5 through 15) at 40 mg/kg/day (0.6 times the human dose of 600 mg based on body surface area comparisons) produced pups with cleft palates and mal-positioned aortic arches, delayed ossification, increased number of ribs, a decrease in litter size and mean litter weight, an increase in number of stillbirths, and an increase in mortality during lactation. When rifapentine was administered orally to mated female rats late in gestation, at 20 mg/kg/day (0.3 times the human dose based on body surface area), pup weights and gestational survival (live pups born/pups born) were reduced compared to controls. Increased resorptions and postimplantation loss, decreased mean fetal weights, increased numbers of stillborn pups, and slightly increased pup mortality during lactation were also noted. When pregnant rabbits received oral rifapentine at 10 mg/kg to 40 mg/kg (0.3 times to 1.3 times the human dose based on body surface area) during organogenesis (GD6 to GD18), major fetal malformations occurred including: ovarian agenesis, pes varus, arhinia, microphthalmia, and irregularities of the ossified facial tissues. At 40 mg/kg/day, there were increases in postimplantation loss and the incidence of stillborn pups. Risk Summary There are no data on the presence of rifapentine or its metabolite in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Since PRIFTIN may produce a red-orange discoloration of body fluids, there is a potential for discoloration of breast milk. Monitor infants exposed to rifapentine through breast milk for signs of hepatotoxicity (see Clinical Considerations) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PRIFTIN and any potential adverse effects on the breastfed infant from PRIFTIN or from the underlying maternal condition. Clinical Considerations Monitor infants exposed to rifapentine through breast milk for signs of hepatotoxicity to include irritability, prolonged unexplained crying, yellowing of the eyes, loss of appetite, vomiting, and changes in color of the urine (darkening) or stool (lightening, pale or light brown). Contraception Use of PRIFTIN may reduce the efficacy of hormonal contraceptives. Advise patients using hormonal contraceptives to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment with PRIFTIN [see Warnings and Precautions (5.5) and Drug Interactions (7.3)] . The safety and effectiveness of PRIFTIN in the treatment of active pulmonary tuberculosis have not been established in pediatric patients under the age of 12. The safety and effectiveness of PRIFTIN in combination with isoniazid once-weekly regimen has been evaluated in pediatric patients (2 to 17 years of age) for the treatment of latent tuberculosis infection. In clinical studies, the safety profile in children was similar to that observed in adult patients [see Adverse Reactions (6.1) and Clinical Studies (14.2)] . In a pharmacokinetic study conducted in 2 to 11-year-old pediatric patients with latent tuberculosis infection, PRIFTIN was administered once weekly based on weight (15 mg/kg to 30 mg/kg, up to a maximum of 900 mg). Exposures (AUC) in children 2 to 11 years old with latent tuberculosis infection were higher (average 31%) than those observed in adults receiving PRIFTIN 900 mg once weekly [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)] . Clinical studies with PRIFTIN did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In a pharmacokinetic study with PRIFTIN, no substantial differences in the pharmacokinetics of rifapentine and 25-desacetyl metabolite were observed in the elderly compared to younger adults [see Clinical Pharmacology (12.3)] .

Produkt oppsummering:

Product: 50090-5063 NDC: 50090-5063-0 8 TABLET, FILM COATED in a BLISTER PACK / 3 in a CARTON

Autorisasjon status:

New Drug Application

Informasjon til brukeren

A-S Medication Solutions
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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
MEDICATION GUIDE
PRIFTIN (PRIF - TIN)
(RIFAPENTINE)
TABLETS
of the following symptoms:
•
rash
•
red and painful skin
•
peeling or bleeding

Preparatomtale

PRIFTIN- RIFAPENTINE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
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
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 kg
750 mg
5
>50 kg
900 mg
6
For Latent Tuberculosis Infec