rifapentine (Rx)

Brand and Other Names:Priftin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 150mg
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Pulmonary Tuberculosis

Indicated for treatment of pulmonary TB caused by Mycobacterium tuberculosis in combination with 1 or more antituberculosis drugs

Initial phase (2 months): 600 mg PO 2x/week for 2 months; interval between doses not <3 d (in combination with other antiTB drugs) THEN

Continuation phase (4 months): 600 mg PO qWeek for 4 months by direct observation therapy with isoniazid or another appropriate antiTB drug

Administration: take with meal

Latent Tuberculosis

Indicated for treatment of latent TB infection caused by M. tuberculosis in adults and children aged ≥2 yr at high risk of progression to TB disease (including those in close contact with active TB patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph)

Once weekly rifapentine PO (weight based dosing below) plus isoniazid once-weekly for 12 weeks as directly observed therapy (DOT)

≥12 years and >50 kg: 900 mg

≥12 years and 32.1-50 kg: 750 mg

Isoniazid dose: 15 mg/kg (rounded to nearest 50 mg or 100 mg); not to exceed 900 mg once-weekly for 12 weeks

References: CDC MMWR 2011;60:1650-3 and NEJM 2011;365:2155-2166

Limitations of use

  • Active TB disease should be ruled out before initiating
  • Must always be used in combination with isoniazid as a 12-wk once-weekly regimen
  • Rifapentine in combination with isoniazid is not recommended for rifamycin or isoniazid resistant M tuberculosis

MAC Prophylaxis (Orphan)

Prophylactic treatment of Mycobacterium avium complex (MAC) in patients with AIDS and a CD4+ count less than or equal to 75/cu.mm

Orphan indication sponsor

  • Hoechst Marion Roussel, Inc; P.O. Box 9627, Mail Station: H3-M2516; Kansas City, MO 64134-0627

MAC Treatment (Orphan)

Treatment of Mycobacterium avium complex (MAC) in patients with AIDS

Orphan indication sponsor

  • Hoechst Marion Roussel, Inc; P.O. Box 9627, Mail Station: H3-M2516; Kansas City, MO 64134-0627

Dosage Forms & Strengths

tablet

  • 150mg
more...

Latent Tuberculosis

Indicated for treatment of latent TB infection caused by M. tuberculosis in adults and children aged ≥2 yr at high risk of progression to TB disease (including those in close contact with active TB patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph)

<2 years: Safety and efficacy not established

2-11 years

  • Once weekly rifapentine PO (weight based dosing below) plus isoniazid once-weekly for 12 weeks as directly observed therapy (DOT)
  • 10-14 kg: 300 mg
  • >14-25 kg: 450 mg
  • >25-32 kg: 600 mg
  • >32-49.9 kg: 750 mg
  • ≥50 kg: Not to exceed 900 mg
  • Isoniazid dose: 25 mg/kg (rounded to nearest 50 mg or 100 mg); not to exceed 900 mg once-weekly for 12 weeks
  • References: CDC MMWR 2011;60:1650-3 and NEJM 2011;365:2155-2166

Limitations of use

  • Active TB disease should be ruled out before initiating
  • Must always be used in combination with isoniazid as a 12-wk once-weekly regimen
  • Rifapentine in combination with isoniazid is not recommended for rifamycin or isoniazid resistant M tuberculosis
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Interactions

Interaction Checker

and rifapentine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Hyperuricemia (most likely d/t pyrazinamide from initial phase combo Tx)

            1-10%

            Hypertension

            Headache

            Dizziness

            Rash

            Pruritus

            Acne

            Anorexia

            Nausea/vomiting

            Dyspepsia

            Diarrhea

            Neutropenia

            Lymphopenia

            Anemia

            Leukopenia

            Thrombocytosis

            Increased ALT/AST

            Arthralgia

            Pain

            Pyuria

            Proteinuria

            Hematuria

            Urinary casts

            Hemoptysis

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            Warnings

            Contraindications

            Hypersensitivity to rifamycins

            Cautions

            May increase liver enzymes; initiation in patients with existing abnormal liver tests and/or liver disease only in cases of necessity and under strict medical supervision; monitor LFTs every 2-4 week and discontinue if evidence of liver injury occurs

            Hypersensitivity or anaphylaxis reported including hypotension, urticaria, angioedema, acute bronchospasm, conjunctivitis, thrombocytopenia, neutropenia, or flu-like syndrome

            Not for use as initial phase treatment in HIV-infected individuals with active pulmonary TB

            Higher relapse rate may occur in patients with cavitary pulmonary lesions and/or positive sputum cultures after the initial phase of active TB treatment, and in patients with bilateral pulmonary disease

            Induces CYP450 isoenzymes; coadministration with drugs metabolized by these enzymes (eg, protease inhibitors, certain NRTIs, hormonal contraception) may result in significant decreased plasma concentrations and loss of therapeutic effect

            May produce a red-orange discoloration of body tissues/fluids (eg, skin, teeth, tongue, urine, feces, saliva, sputum, tears, sweat, CSF); contact lenses or dentures may become permanently stained

            As with the use of nearly all systemic antibacterial agents, Clostridium difficile-associated diarrhea (CDAD) reported; discontinue if CDAD confirmed

            Porphyria reported in patients receiving rifampin, attributed to induction of delta amino levulinic acid synthetase; rifapentine may have similar enzyme induction properties; avoid in patients with history of porphyria

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: unknown

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits RNA polymerase in M. tuberculosis

            Absorption

            Peak Plasma Time: 5-6 hr

            Distribution

            Protein Bound: 98%

            Metabolism

            Enzymes induced: CYP3A4, CYP2C9/10

            Elimination

            Half-Life: 13 hr

            Excretion: feces (70%); urine

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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