Priftin

Name: Priftin

How should this medicine be used?

Rifapentine comes as a tablet to take by mouth. When rifapentine is used to treat active TB, it is usually taken with food twice weekly, with doses at least 3 days apart, for the first 2 months and then once weekly for 4 months. When rifapentine is used to treat latent TB infection, it should be with food taken once every week. Take rifapentine at around the same time every scheduled day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rifapentine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are unable to swallow the tablets, you can crush them and mix the medication in a small amount of semisolid food such as pudding or applesauce. Swallow the mixture right away; do not store it for later use.

Continue to take rifapentine until you finish the prescription even if you feel better, and be careful not to miss doses. If you stop taking rifapentine too soon, your infection may not be completely treated and the bacteria may become resistant to antibiotics. If you miss doses of rifapentine, you may develop uncomfortable or serious symptoms when you begin to take the medication again.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

  • Myambutol
  • Rifadin
  • Rifamate
  • Rifater
  • Tice
  • Trecator

© Priftin Patient Information is supplied by Cerner Multum, Inc. and Priftin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Priftin Overview

Priftin is a prescription medication used to treat active and latent tuberculosis. Priftin belongs to a group of medications called antibiotics which work by killing or slowing the growth of bacteria that cause infections.

Priftin is available as a tablet and is usually taken 1 to 2 times per week, with food. The number of times a week you take your medication will depend on what point of therapy you are at and it you are treating active or latent tuberculosis.

Common side effects of Priftin include change in blood counts, joint pain, headache, vomiting, and nausea.

Priftin Drug Class

Priftin is part of the drug class:

  • Antibiotics for Treatment of Tuberculosis

Priftin (rifapentine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • diarrhea that is watery or bloody;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  • low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing.

Rifapentine can cause changes in the color of your skin or body fluids. You may notice a red-orange appearance of your skin, tears, sweat, saliva, urine, or stools. Your teeth, tongue, or the inside of your mouth may also appear red-orange. This discoloration can permanently stain contact lenses or dentures.

Common side effects may include:

  • nausea, vomiting, diarrhea, loss of appetite;

  • flu symptoms;

  • headache, joint pain;

  • itching or rash;

  • eye redness; or

  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Introduction

Antituberculosis agent; semisynthetic cyclopentylpiperazinyl derivative of rifamycin SV.1 11 12 13

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C); protect from excessive heat and humidity.1

Uses For Priftin

Rifapentine is used in combination with other medicines to treat active tuberculosis in adults and children 12 years of age and older. It is also used to treat inactive (latent) tuberculosis in adults and children 2 years of age and older. Rifapentine is an antibiotic and works to kill or prevent the growth of bacteria. It will not help against viruses.

This medicine is available only with your doctor's prescription.

Priftin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Blood in the urine
  • joint pain
  • lower back or side pain
  • swelling of the feet or lower legs
Less common
  • Aggressive reaction
  • black, tarry stools
  • blood in the stools
  • nausea
  • pinpoint red spots on the skin
  • severe abdominal or stomach pain
  • sore throat and fever
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin
Rare
  • Diarrhea
  • dizziness
  • increase in blood pressure
  • severe or continuing headaches

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acne
  • constipation
  • loss of appetite

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Use in specific populations

Pregnancy

Pregnancy Category C:

Risk Summary

There are no adequate and well controlled trials of Priftin in pregnant women; however, there are limited pregnancy outcome data reported from women enrolled in clinical trials of various Priftin treatment regimens for active tuberculosis and latent tuberculosis infection. The reported rate of spontaneous abortion following Priftin exposure did not represent an increase over the background rate of spontaneous abortion reported in the general population. Further interpretation of these data is limited by the quality of clinical trial adverse event reporting. In animal reproduction and developmental toxicity studies, rifapentine produced fetal harm and was teratogenic at doses less than and similar to the recommended human dose. Because animal studies are not always predictive of human response, Priftin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Clinical Considerations

Labor or Delivery

When administered during the last few weeks of pregnancy, rifampin, another rifamycin product, 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.

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, six elective abortions, seven spontaneous abortions, and two unknown outcomes. Of the 31 live infants, 21 were reported healthy while in the other ten cases no further details were available. No congenital anomalies were reported. 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 embryofetal toxicity in both species. Pregnant rats given oral rifapentine during organogenesis at 40 mg/kg/day (0.6 times the human dose of 600 mg based on body surface area), produced pups with cleft palates, right aortic arch, increased incidence of delayed ossification, and increased numbers of ribs. 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 post implantation 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), major fetal malformations occurred including: ovarian agenesis, pes varus, arhinia, microphthalmia and irregularities of the ossified facial tissues. At the higher dose, there were increases in post-implantation loss and the incidence of stillborn pups.

Nursing Mothers

It is not known whether Priftin is present in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother [see Nonclinical Toxicology (13.1)]. Since Priftin may produce a red-orange discoloration of body fluids, there is a potential for discoloration of breast milk.

A slight increase in rat pup mortality was observed during lactation when dams were dosed late in gestation through lactation.

Pediatric Use

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 (2–17 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-year-old 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)].

Geriatric Use

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)].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Hepatocellular carcinomas were increased in male NMRI mice (Harlan Winklemann) which were treated orally with rifapentine for two years at or above doses of 5 mg/kg/day (0.04 times the recommended human dose based on body surface area conversions). In a two year rat study, there was an increase in nasal cavity adenomas in Wistar rats treated orally with rifapentine at 40 mg/kg/day (0.6 times human dose based on body surface area conversions).

Rifapentine was negative in the following genotoxicity tests: in vitro gene mutation assay in bacteria (Ames test); in vitro point mutation test in Aspergillus nidulans; in vitro gene conversion assay in Saccharomyces cerevisiae; host-mediated (mouse) gene conversion assay with Saccharomyces cerevisiae; in vitro Chinese hamster ovary cell/hypoxanthine-guanine phosphoribosyltransferase (CHO/HGPRT) forward mutation assay; in vitro chromosomal aberration assay utilizing rat lymphocytes; and in vivo mouse bone marrow micronucleus assay.

The 25-desacetyl metabolite of rifapentine was positive in the in vitro mammalian chromosome aberration test in V79 Chinese hamster cells, but was negative in the in vitro gene mutation assay in bacteria (Ames test), the in vitro Chinese hamster ovary cell/hypoxanthine-guanine phosphoribosyltransferase (CHO/HGPRT) forward mutation assay, and the in vivo mouse bone marrow micronucleus assay. Fertility and reproductive performance were not affected by oral administration of rifapentine to male and female rats at doses of up to 20 mg/kg/day (one-third of the human dose based on body surface area conversions).

For Healthcare Professionals

Applies to rifapentine: oral tablet

General

In general, there are no data concerning the adverse effects of rifapentine (the active ingredient contained in Priftin) in monotherapy. The following adverse effects have been reported during treatment in the intensive phase (i.e., rifapentine 2 times a week and isoniazid, pyrazinamide and ethambutol daily for 2 months) and the continuation phase (i.e., rifapentine and isoniazid once a week for 4 months) in a clinical study in which 361 patients were randomized to the rifapentine regimen.[Ref]

Hematologic

Hematologic side effects have included neutropenia (12.5%), lymphopenia (12.7%), anemia (12.2%), leukopenia (6.6%), thrombocytosis (5.5%), leukocytosis (3%), neutrophilia (2.5%), thrombocytopenia (2.5%), polycythemia (2.2%), and lymphadenopathy (1.1%). Lymphocytosis, hematoma, purpura, hypochromic anemia, normocytic anemia, and thrombosis have been reported in less than 1% of patients.[Ref]

Metabolic

Metabolic side effects have included hyperuricemia (31.9), hypoglycemia (10%), hyperkalemia (9.1%), increased nonprotein nitrogen (3.9%), hyperglycemia (3.6%), increased lactate dehydrogenase (1.4%), and hyperphosphatemia (1.4%). Weight decrease, diabetes mellitus, increased alkaline phosphatase, hypophosphatemia, hypercalcemia, hypovolemia, and weight increase have been reported in less than 1% of patients.[Ref]

Hyperuricemia was most likely related to pyrazinamide as only 2 cases were reported during the continuation phase, when pyrazinamide was no longer part of the regimen.[Ref]

Genitourinary

Genitourinary side effects have included proteinuria (13%), pyuria (21.6%), urinary tract infection (13.3%), urinary casts (8%), cystitis (1.7%), and hematuria (17.7%). Urethral disorder, dysuria, pyelonephritis, urinary incontinence, urination disorder, penis disorder, vaginitis, vaginal hemorrhage, positive cervical smear test, leukorrhea, male mastitis, prostatic disorder, and abortion have been reported in less than 1% of patients.[Ref]

Respiratory

Respiratory side effects have included hemoptysis (8.3%), coughing (8%), upper respiratory tract infection (4.7%), bronchitis (2.5%), pharyngitis (1.9%), epistaxis (1.4%), and pleuritis (1.1%). Abnormal breath sounds, pneumothorax, pneumonia, pleural effusion, rhinitis, dyspnea, pneumonitis, sinusitis, increased sputum, pulmonary fibrosis, upper respiratory congestion, asthma, abnormal chest x-ray, bronchospasm, laryngeal edema, laryngitis, and respiratory disorder have been reported in less than 1% of patients.

Immunologic

Immunologic side effects have included influenza (7.8%), tuberculosis infection (2.5%), infection (1.4%), and herpes zoster (1.1%). Fungal infection, parasitic infection, and protozoan infection have been reported in less than 1% of patients.

Hepatic

Hepatic side effects have included elevated ALT (6.9%) and AST (5.8%). Bilirubinemia, hepatomegaly, jaundice, and hepatitis have been reported in less than 1% of patients.[Ref]

Other

Other side effects have included back pain (6.9%), pain (6.1%), chest pain (5.5%), accident injury (4.7%), abdominal pain (1.9%), fever (1.4%), fatigue (1.1%), dependent edema (1.1%), at least one case of influenza-like syndrome, and orange-red discoloration of body tissues and/or fluids (e.g., skin, teeth, tongue, urine, tears, sputum, saliva, feces, sweat, and cerebral spinal fluid). Abnormal laboratory test, legs edema, asthenia, face edema, abscess, peripheral edema, malaise, ear disorder not specified, otitis media, earache, otitis externa, and tympanic membrane perforation have been reported in less than 1% of patients.[Ref]

Dermatologic

Dermatologic side effects have included increased sweating (6.4%), rash (6.1%), pruritus (3.6%), acne (2.5%), skin disorder (1.4%), maculopapular rash (1.7%), and eczema (1.1%). Skin ulceration, urticaria, dry skin, furunculosis, skin discoloration, fungal dermatitis, nail disorder, alopecia, and erythematous rash have been reported in less than 1% of patients.[Ref]

Gastrointestinal

Clostridium difficile should be suspected in any patient who develops persistent or severe diarrhea following rifapentine (the active ingredient contained in Priftin) therapy.[Ref]

Gastrointestinal side effects have included anorexia (5.8%), nausea (2.5%), vomiting (2.5%), dyspepsia (2.8%), constipation (1.9%), diarrhea (1.9%), and hemorrhoids (1.4%). Tooth disorder, gastroenteritis, gastritis, esophagitis, cheilitis, dry mouth, pancreatitis, proctitis, salivary gland enlargement, tenesmus, and gastrointestinal disorder not specified have been reported in less than 1% of patients. Clostridium difficile associated diarrhea has been reported with almost all antibiotics, including the rifamycins.[Ref]

Nervous system

Nervous system side effects have included headache (3.9%), dizziness (1.7%), tremor (1.4%), and insomnia (1.1%). Somnolence, seizure not specified, dysphonia, hypoesthesia, torticollis, hypertonia, hyporeflexia, meningitis, migraine headache, stupor, and taste loss have been reported in less than 1% of patients.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia (4.4%), arthritis (1.1%), arthrosis (1.1%), and gout (1.1%). Myalgia, myositis, bone fracture, muscle weakness, and muscle spasm have been reported in less than 1% of patients.

Cardiovascular

Cardiovascular side effects have included hypertension (1.7%). Syncope, tachycardia, palpitation, orthostatic hypotension, pericarditis, deep thrombophlebitis, vascular disorder, and vasodilation have been reported in less than 1% of patients.

Ocular

Ocular side effects have included conjunctivitis (2.5%). Eye pain and eye abnormality have been reported in less than 1% of patients.

Psychiatric

Psychiatric side effects have included anxiety, confusion, drug abuse, aggressive reaction, and agitation in less than 1% of patients.

Oncologic

Oncologic side effects have included pulmonary carcinoma, neoplasm not specified, carcinoma, and lipoma in less than 1% of patients.

Renal

Renal side effects have included increased BUN (less than 1%).

Some side effects of Priftin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Rifapentine Breastfeeding Warnings

There are no data on the excretion of rifapentine into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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