Priftin

PRIFTIN- rifapentine tablet, film coated
A-S Medication Solutions

1 INDICATIONS AND USAGE

1.1 Active Pulmonary Tuberculosis

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.

1.2 Latent Tuberculosis Infection

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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Active Pulmonary Tuberculosis

PRIFTIN is only recommended for the treatment of active pulmonary tuberculosis caused by drug-susceptible organisms as part of regimens consisting of a 2-month initial phase followed by a 4-month continuation phase.

PRIFTIN should not be used in the treatment of active pulmonary tuberculosis caused by rifampin-resistant strains.

Initial phase (2 Months): PRIFTIN should be administered at a dose of 600 mg twice weekly for two months as directly observed therapy (DOT), with an interval of no less than 3 consecutive days (72 hours) between doses, in combination with other antituberculosis drugs as part of an appropriate regimen which includes daily companion drugs such as isoniazid (INH), ethambutol (EMB) and pyrazinamide (PZA).

Continuation phase (4 Months): Following the initial phase (2 months), continuation phase (4 months) treatment consists of PRIFTIN 600 mg once weekly for 4 months in combination with isoniazid or another appropriate antituberculosis agent for susceptible organisms administered as directly observed therapy.

2.2 Dosage in Latent Tuberculosis Infection

PRIFTIN should be administered once weekly in combination with isoniazid for 12 weeks as directly observed therapy.

Adults and children 12 years and older: The recommended dose of PRIFTIN should be determined based on weight of the patient up to a maximum of 900 mg once weekly (see Table 1). The recommended dose of isoniazid is 15 mg/kg (rounded to the nearest 50 mg or 100 mg) up to a maximum of 900 mg once weekly for 12 weeks.

Children 2 to 11 years: The recommended dose of PRIFTIN should be determined based on weight of the patient up to a maximum of 900 mg once weekly (see Table 1). The recommended dose of isoniazid is 25 mg/kg (rounded to the nearest 50 mg or 100 mg) up to a maximum of 900 mg once weekly for 12 weeks.

Table 1: Weight Based Dose of PRIFTIN in the Treatment of Latent Tuberculosis Infection

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

2.3 Administration

Take PRIFTIN with meals. Administration of PRIFTIN with a meal increases oral bioavailability and may reduce the incidence of gastrointestinal upset, nausea, and/or vomiting [see Clinical Pharmacology (12.3)].

For patients who cannot swallow tablets, the tablets may be crushed and added to a small amount of semi-solid food, all of which should be consumed immediately [see Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

PRIFTIN is supplied as 150 mg round normal convex dark-pink film-coated tablets debossed “F” on one side of tablet.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

PRIFTIN is contraindicated in patients with a history of hypersensitivity to rifamycins.

5 WARNINGS AND PRECAUTIONS

5.1 Hepatotoxicity

Elevations of liver transaminases may occur in patients receiving PRIFTIN [see Adverse Reactions (6.1)]. Patients on PRIFTIN should be monitored for symptoms of liver injury.

Patients with abnormal liver tests and/or liver disease or patients initiating treatment for active pulmonary tuberculosis should only be given PRIFTIN in cases of necessity and under strict medical supervision. In such patients, obtain serum transaminase levels prior to therapy and every 2 to 4 weeks while on therapy. Discontinue PRIFTIN if evidence of liver injury occurs.

5.2 Hypersensitivity and Related Reactions

Hypersensitivity reactions may occur in patients receiving PRIFTIN. Signs and symptoms of these reactions may include hypotension, urticaria, angioedema, acute bronchospasm, conjunctivitis, thrombocytopenia, neutropenia or flu-like syndrome (weakness, fatigue, muscle pain, nausea, vomiting, headache, fever, chills, aches, rash, itching, sweats, dizziness, shortness of breath, chest pain, cough, syncope, palpitations). There have been reports of anaphylaxis [see Patient Counseling Information (17)].

Monitor patients receiving PRIFTIN therapy for signs and/or symptoms of hypersensitivity reactions. If these symptoms occur, administer supportive measures and discontinue PRIFTIN.

5.3 Severe Cutaneous Adverse Reactions

Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in association with the use of rifapentine (PRIFTIN) treatment regimens in patients with active and latent tuberculosis. Discontinue PRIFTIN at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Patient Counseling Information (17)].