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Priftin

Clinical Pharmacology
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Clinical Pharmacology

Patient Weight

<50 kg

≥ 50 kg

600

600

300

300

1500

2000

800

1200

Continuation Phase

Rifapentine (mg)

Isoniazid (mg)    

Once Weekly

Once Weekly  

Patient Weight

<50 kg

≥ 50 kg

 

600

600

 

600

900

Rifapentine Combination Treatment

Intensive Phase

Rifapentine (mg)

Isoniazid (mg)

Pyrazinamide (mg)

Ethambutol (mg)  

Daily

Daily

Daily

Daily

Patient Weight

<50 kg

≥ 50 kg

 

450

600

 

300

300

 

1500

2000

 

800

1200

Continuation Phase

Rifapentine (mg)

Isoniazid (mg)    

Twice Weekly

Twice Weekly  

Patient Weight

<50 kg

≥ 50 kg

 

450

600

 

600

900

* Ethambutol was to be discontinued once baseline susceptiblity test results were available.

Priftin Proposed Text of the Labeling (Annotated)

Table 2-2 presents clinical outcome in study 008.

Table 2-2 presents clinical outcome in study 008.

 

Rifapentine Combination

Rifapentine Combination

Status at End of Treatment:

   

Converted

67% (249/286)

81% (229/284)

Not Converted

1% (4/286)

3% (8/284)

Lost to Follow-up

12% (33/286)

17% (47/284)

Status in follow up.

   

Relapsed

Brand Name: Priftin
Generic Name: Rifapentine
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