PRIFTIN is indicated for the treatment of pulmonary tuberculosis. This indication is based on the 6 month follow-Up treatment outcome observed in the controlled clinical trial as a surrogate for the 2 year follow up generally accepted as evidence of efficacy in the treatment of pulmonacy tuberculosis. PRIFTIN must always be used in conjunction with at least one other antituberculosis drug to which the isolate is susceptible. In the intensive phase of the short-course treatment of pulmonary tuberculosis. PRIFTIN should be administered twice weekly for two months, with an interval of no less than 3 days (72 hours) between doses, as part of an appropriate regimen which includes daily companion drugs (Table 2-1). It may also be necessary to add either streptomycin or ethambutol until the results of susceptibility testing are known. Compliance with all drugs in the Intensive Phase (i.e., PRIFTIN, isoniazid, pyrazinamide, ethambutol or streptomycin) is imperative to assure early sputum conversion and protection against relapse. Following the intensive phase, Continuation Phase treatment should be continued with PRIFTIN for 4 months. During this phase, PRIFTIN should be administered on a once-weekly basis in combination with an appropriate antituberculous agent for susceptible organisms (Table 2-1) (see DOSAGE AND ADMINISTRATION section).

In the treatment of tuberculosis the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Consequently, clinical samples for mycobacterial culture and susceptibility testing should be obtained prior to the initiation of therapy, as well as during treatment to monitor therapeutic response. The susceptibility of M.tuberculosis organisms to isoniazid, rifampin, pyrazinamide, ethambutol, rifapentine and other appropriate agents should be measured. If test results show resistance to any of these drugs and the patient is not responding to therapy, the drug regimen should be modified.

PRIFTIN should not be used alone, in initial treatment or in retreatment of pulmonary tuberculosis. In the intensive phase of short-course therapy which is to continue for 2 months, 600mg (four 150mg tablets) of PRIFTIN should be given twice weekly with an interval of not less than 3 days (72 hours) between doses. For those patients with propensity to nausea, vomiting or gastrointestinal upset, administration of PRIFTIN with food may be useful. In the Intensive Phase, PRIFTIN must be administered in combination as part of an appropriate regimen which includes daily companion drugs. Compliance with all drugs in the Intensive phase (i.e. PRIFTIN, isoniazid, pyrazinamide, ethambutol, or streptomycin). Especially on days when rifapentine is not administered is imperative to assure early sputum conversion and protection against relapse. The Advisory Council for the Elimination of Tuberculosis, the Americal Thoracic Society and the Centers for disease Control and Prevention also recommend that either streptomycin or ethambutolbe added to the regimen unless the likelihood of isoniazid resistance is very low. The need for streptomycin or ethambutol should be reassessed when the results of susceptibility testing are known. An initial treatment regimen with less than four drugs may be considered if there is little possibility of drug resistance (that is, less than 4% primary resistance to isoniazid in the community, and the patient has had no previous treatment with antituberculosis medications, is not from a country with a high prevalence of drug resistance, and has no known exposure to a drug-resistant case) (See Reference 2).

Following the intensive phase, treatment should be continued with PRIFTIN once weekly for 4 months in combination with isoniazid or an appropriate agent for susceptible organisms. If the patient is still sputum smear or culture positive, if resistant organisms are present, or if the patient is HIV positive, follow the ATS/CDC treatment guidelines (See Reference 2).

Concomitant administration of pyridoxine (Vitamin B₆) us recommended in the malnourished, in those predisposed to neuropathy (e.g., alcoholics and diabetics), and in adolescents.

The above recommendations apply to patients with drug-susceptible organisms. Patients with drug-resistant organisms may require longer duration of treatment with other drug regimens.

PRIFTIN (rifapentine) 150 mg pink film coated tablets are packaged in aluminum foil blisters in cartons of 32 tablets (NDC 0088-2100-03).

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.

Draft Prescribing Information as of June 1998

Manufactured by: GRUPPO LEPITIT S.p.A. 20020 Lainate, Italy

Manufactured for: Hoechst Marion Roussel, Inc. Kansas City, MO 64137 USA

REFERENCES:

1.Update on US Public Health Service (USPHS) Study 22: A trial of once weekly isoniazid (INH) & rifapentine(RPT) in the continuation phase of TB treatment. The USPHS Rifapentine Trial Group, A Vernon, et al. Am J Repir Crit Care Med. 157: (suppl) A467 (abstract), March 1998

2. American Thoracic Society , CDC Treatment of tuberculosis and tuberculosis infection in adults and children. Am J Respir Crit Care Med. 149: 1359-1374, 1994

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