• Treatment of pulmonary tuberculosis (must be used in combination with other agents)
• Treatment of latent tuberculosis in patients at high risk of progression to tuberculosis (with isoniazid)

Contraindicated in:

• Hypersensitivity to rifapentine or other rifamycins (rifampin or rifabutin)
• Patients with HIV and active tuberculosis
• Porphyria (may worsen condition)
• OB: Pregnancy (may cause fetal harm).

Use Cautiously in:

• History of liver disease
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Children <12 yr (safety and effectiveness not established).

Exercise Extreme Caution in:

• Concurrent use of protease inhibitor.

CV: hypertension.

Derm: acne, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), pruritus, rash, STEVENS-JOHNSON SYNDROME.

EENT: red-orange discoloration of tears.

GI: ↑liver enzymes, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), anorexia, diarrhea, dyspepsia, nausea, red-orange discoloration of saliva, vomiting.

GU: hematuria, proteinuria, pyuria, red-orange discoloration of urine, urinary casts.

Hemat: anemia, leukopenia, lymphopenia, neutropenia, thrombocytosis.

MS: arthralgia.

Neuro: dizziness, headache.

Resp: hemoptysis.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), pain.

Drug-Drug:

• ↑metabolism and may ↓ levels of phenytoin, disopyramide, mexiletine, quinidine, chloramphenicol, clarithromycin, dapsone, doxycycline, fluoroquinolones, warfarin, fluconazole, itraconazole, ketoconazole, some sedative/hypnotics (benzodiazepines and barbiturates), some beta blockers, some calcium channel blockers, corticosteroids, digoxin, hormonal contraceptives, haloperidol, protease inhibitors (ritonavir, nelfinavir), sulfonylurea oral hypoglycemic agents, cyclosporine, tacrolimus, levothyroxine, some opioids, progestins, quinine, sildenafil, theophylline, some reverse transcriptase inhibitors, and tricyclic antidepressants; dosage adjustments may be necessary.
• Antacids↓ absorption.

Drug-Food:

• Food ↑ absorption.

• Tablets: 150 mg;

Tuberculosis

• PO (Adults): Intensive phase: 600 mg twice weekly (not less than 72 hr between doses) for 2 mo as directly observed therapy;Continuation phase: 600 mg once weekly for 4 mo.

Latent Tuberculosis

• PO (Adults and Children 2 yr and >50 kg): 900 mg once weekly for 12 wk.
• PO (Adults and Children 2 yr and >32.1–50 kg): 750 mg once weekly for 12 wk.
• PO (Adults and Children 2 yr and >25.1–32 kg): 600 mg once weekly for 12 wk.
• PO (Adults and Children 2 yr and >14.1–25 kg): 450 mg once weekly for 12 wk.
• PO (Adults and Children 2 yr and >10–14 kg): 300 mg once weekly for 12 wk.

Priftin

• Inhibits DNA-dependent RNA polymerase.

• Bactericidal action against intracellular and extracellular susceptible strains of Mycobacterium tuberculosis.

Therapeutic Classification: antituberculars

Absorption: 70% absorbed following oral administration.

Distribution: Widely distributed in body tissues and fluids.

Protein Binding: Rifapentine: 97.7%;desacetyl rifapentine: 93.2%.

Metabolism/Excretion: Mostly metabolized by the liver; 17% excreted by the kidneys; some conversion to another active compound (25-desacetyl rifapentine).

Half-life: 13 hr (rifapentine and desacetyl rifapentine).

(blood levels)

• Advise patient to take medication as directed; not to skip doses or double up on missed doses of daily companion medications. Emphasize the importance of continuing therapy even after symptoms have subsided. Length of therapy for tuberculosis depends on regimen being used and underlying disease states.
• Advise patient to notify health care professional promptly if fever, malaise, darkened urine, yellow eyes and skin, nausea, vomiting, anorexia, or pain or swelling of joints occur.
• Instruct patient to notify health care professional signs and symptoms of severe skin reactions (rash, peeling or bleeding skin, swollen face, lips, mouth tongue or throat, sores or blisters on the inside of mouth or lips, flu-like symptoms, red and painful skin) or if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
• Caution patient to avoid the use of alcohol during this therapy; may increase the risk of hepatotoxicity.
• Rifapentine may occasionally cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Inform patient that saliva, sputum, teeth, tongue, sweat, tears, CSF, urine, and feces may become red-orange, and that soft contact lenses may become permanently discolored.
• Rep: Advise patient that rifepentine is teratogenic and may decrease the effectiveness of oral contraceptives. Counsel patient to use a nonhormonal form of contraception during therapy and to avoid breastfeeding. Monitor infants exposed to rifapentine through breast milk for signs of hepatotoxicity (irritability, prolonged unexplained crying, yellowing of the eyes, loss of appetite, vomiting, darkening of the urine, pale stool).
• Emphasize the importance of regular follow-up exams to monitor progress and to check for side effects.

rif-a-PEN-teen

NDC Code^*

• 0088- sanofi-aventis U.S. LLC
  • 0088-2100- Priftin
    • 0088-2100-24- 3 POUCH in 1 CARTON (0088-2100-24) > 8 BLISTER PACK in 1 POUCH > 1 TABLET, FILM COATED in 1 BLISTER PACK

• 0088- sanofi-aventis U.S. LLC
  • 0088-2100- Priftin
    • 0088-2100-32- 4 POUCH in 1 CARTON (0088-2100-32) > 8 BLISTER PACK in 1 POUCH > 1 TABLET, FILM COATED in 1 BLISTER PACK

• 0088- sanofi-aventis U.S. LLC
  • 0088-2102- Priftin
    • 0088-2102-24- 3 BLISTER PACK in 1 CARTON (0088-2102-24) > 8 TABLET, FILM COATED in 1 BLISTER PACK (0088-2102-01)