Priftin

rifapentine

Priftin

Pharmacologic class: Rifamycin derivative

Therapeutic class: Antitubercular

Pregnancy risk category C

Action

Inhibits RNA synthesis by blocking RNA transcription in susceptible organisms (mycobacteria and some gram-positive and gram-negative bacteria)

Availability

Tablets: 150 mg

Indications and dosages

Pulmonary tuberculosis (TB)

Adults: Intensive-phase treatment-600 mg P.O. twice weekly for 2 months, with doses spaced 72 hours apart; must be given with at least one other antitubercular. Continuation-phase treatment-600 mg P.O. once weekly for 4 months, given with another antitubercular.

Off-label uses

Mycobacterium avium intracellulare complex infection

Contraindications

• Hypersensitivity to drug or other rifamycin derivatives

Precautions

Use cautiously in:

• hepatic disorders, porphyria

• concurrent protease inhibitor therapy for human immunodeficiency virus infection

• elderly patients

• pregnant or breastfeeding patients

• children younger than age 12.

Administration

• Know that drug is given with at least one other antitubercular.

• Expect to give drug with pyridoxine to adolescents, malnourished patients, and patients at risk for neuropathy.

Adverse reactions

CNS: headache, fatigue, anxiety, dizziness, aggressive behavior

CV: hypertension, peripheral edema

EENT: visual disturbances; discolored tears, sputum, and saliva

GI: nausea, vomiting, diarrhea, dyspepsia, esophagitis, gastritis, discolored feces, anorexia, pancreatitis

GU: hematuria, pyuria, proteinuria, urinary casts, discolored urine

Hematologic: anemia, thrombocytosis, hematoma, purpura, eosinophilia, neutropenia, leukopenia

Hepatic: hepatitis

Metabolic: hyperuricemia, hypovolemia, hyperkalemia

Musculoskeletal: gout, arthritis, joint pain

Skin: rash, pruritus, acne, urticaria, discolored skin and sweat

Other: edema

Interactions

Drug-drug. Amitriptyline, anticoagulants, barbiturates, beta-adrenergic blockers, chloramphenicol, clofibrate, cortico-steroids, cyclosporine, dapsone, delavirdine, diazepam, digoxin, diltiazem, disopyramide, doxycycline, fentanyl, fluconazole, fluoroquinolones, haloperidol, hormonal contraceptives, indinavir, itraconazole, ketoconazole, methadone, mexiletine, nelfinavir, nifedipine, nortriptyline, oral hypoglycemics, phenothiazines, progestin, quinidine, quinine, ritonavir, saquinavir, sildenafil, tacrolimus, theophylline, thyroid preparations, tocainide, verapamil, warfarin, zidovudine: decreased actions of these drugs

Antiretroviral drugs: decreased efficacy of these drugs

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, eosinophils, lactate dehydrogenase, potassium, uric acid: increased levels

Folate, vitamin B12 assays: interference with standard assays

Hemoglobin, neutrophils, platelets, white blood cells: decreased values

Patient monitoring

• Monitor CBC, uric acid level, and liver function tests. Watch for signs and symptoms of blood dyscrasias and hepatitis.

• Assess vital signs and fluid intake and output. Stay alert for hypertension and edema.

• Closely monitor nutritional status and hydration.

Patient teaching

Instruct patient to immediately report fever, malaise, appetite loss, nausea, vomiting, or yellowing of skin or eyes.

• Emphasize importance of taking with companion drugs, as prescribed, to prevent growth of resistant TB strains.

• Tell patient drug may color tears, urine, and other body fluids reddish or brownish orange. Instruct him not to wear contact lenses during therapy, because drug may stain them permanently.

• Advise patient to take with meals and to minimize GI upset by eating small, frequent servings of healthy food and drinking plenty of fluids.

• Tell patient to monitor his weight and report sudden gains. Also tell him to report swelling.

Instruct patient to immediately report rash or unusual bleeding or bruising.

Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, vision, and alertness.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

rifapentine

(rif-a-pen-teen) ,

Priftin

(trade name)

Classification

Therapeutic: antituberculars
Pregnancy Category: C

Indications

Treatment of pulmonary tuberculosis:
  • Must be used in combination with other agents.

Action

Inhibits DNA-dependent RNA polymerase.

Therapeutic effects

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

Pharmacokinetics

Absorption: 70% absorbed following oral administration.
Distribution: Widely distributed in body tissues and fluids.
Protein Binding: Rifapentine—97.7%;desacetyl rifapentine—93.2%.
Metabolism and 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).

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POunknown5–6 hrunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity to rifapentine or other rifamycins (rifampin or rifabutin).
Use Cautiously in: History of liver disease; Obstetric / Lactation / Pediatric: Pregnancy, lactation, or children <12 yr (safety not established).
Exercise Extreme Caution in: Concurrent protease inhibitor therapy.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache

Respiratory

  • hemoptysis

Cardiovascular

  • hypertension

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • anorexia
  • diarrhea
  • dyspepsia
  • ↑ liver enzymes
  • nausea
  • vomiting

Genitourinary

  • hematuria
  • proteinuria
  • pyuria
  • urinary casts

Dermatologic

  • acne
  • pruritus
  • rash

Hematologic

  • anemia
  • leukopenia
  • lymphopenia
  • neutropenia
  • thrombocytosis

Musculoskeletal

  • arthralgia

Miscellaneous

  • pain

Interactions

Drug-Drug interaction

↑ 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 (indinavir, ritonavir, nelfinavir, saquinavir ), sulfonylurea oral hypoglycemic agents, cyclosporine, tacrolimus, levothyroxine, some opioids, progestins, quinine, reverse transcriptase inhibitors (delavirdine, zidovudine ), sildenafil, theophylline, some reverse transcriptase inhibitors, and tricyclicantidepressants ; dosage adjustments may be necessary.Antacids ↓ absorption.Food ↑ absorption.

Route/Dosage

Must be used in combination with other antituberculars
Oral (Adults) Intensive phase—600 mg twice weekly (not less than 72 hr between doses) for 2 mo;continuation phase—600 mg once weekly for 4 mo.

Availability

Tablets: 150 mg

Nursing implications

Nursing assessment

  • Mycobacterial studies and susceptibility tests should be performed prior to and periodically throughout therapy to detect possible resistance.
  • Assess lung sounds and character and amount of sputum periodically throughout therapy.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several weeks following cessation of therapy.
  • Lab Test Considerations: Assess hepatic enzymes, bilirubin, CBC, and platelet count prior to therapy. Monitor at least monthly, especially in relation to adverse reactions. Patients with liver disease or abnormal liver tests should have liver tests (especially AST and ALT) monitored every 2–4 weeks. Signs of worsening disease may require discontinuation.
    • May interfere with methods for determining serum folate and vitamin B levels and with urine tests based on color reaction.
    • Hyperuricemia is common during intensive phase, especially when combined with pyrazinamide.

Potential Nursing Diagnoses

Risk for infection (Indications)
Noncompliance (Patient/Family Teaching)

Implementation

  • Rifapentine is not administered alone. When used with isoniazid, pyridoxine (vitamin B) is administered concurrently in patients who are malnourished, predisposed to neuropathy (patients with alcoholism or diabetes), or adolescents to prevent neuropathy.
  • Oral: May be administered with food to minimize nausea, vomiting, or GI upset.
    • Antacids should not be administered within 1 hr before or 2 hr after rifapentine.

Patient/Family Teaching

  • Advise patient to take medication exactly 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 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, because this 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.
  • Advise patient that this medication has teratogenic properties and may decrease the effectiveness of oral contraceptives. Counsel patient to use a nonhormonal form of contraception throughout therapy.
  • Emphasize the importance of regular follow-up exams to monitor progress and to check for side effects.

Evaluation/Desired Outcomes

  • Decreased fever and night sweats.
    • Diminished cough and sputum production.
    • Negative sputum cultures.
    • Increased appetite.
    • Weight gain.
    • Reduced fatigue.
    • Increased sense of well-being in patients with tuberculosis.

Priftin®

Rifapentine, see there.
Mentioned in ?
References in periodicals archive ?
M2 EQUITYBITES-December 4, 2014-Sanofi receives approval for Priftin from US Food and Drug Administration
Sanofi, a global healthcare company, has received approval from the US Food and Drug Administration for Priftin, an antimycobacterial, in combination with isoniazid for a new indication to treat latent tuberculosis infection in patients two years of age and older at high risk of progression to tuberculosis disease, it was reported yesterday.
The trial compared a 12-week, once-weekly regimen of Priftin plus INH (3RPT/INH), using Direct Observation Therapy, with nine months of self-administered daily INH (9INH).
The new approval for Priftin exemplifies the commitment to treating TB upheld by Sanofi for more than a half century.
M2 PHARMA-December 4, 2014-Sanofi receives approval for Priftin from US Food and Drug Administration
M2 EQUITYBITES-December 3, 2014-Sanofi announces the US FDA's approval for Priftin in combination with isoniazid (INH) for treating latent tuberculosis infection
Healthcare company Sanofi (NYSE:SNY) on Tuesday reported the approval of Priftin in combination with isoniazid (INH) for a new indication for the treatment of latent tuberculosis infection (LTBI) in patients two years of age and older at high risk of progression to tuberculosis (TB) disease following a priority review by the US Food and Drug Administration.
The company said Priftin (rifapentine) is an antimycobacterial that has been approved in combination with one or more antituberculosis drugs for the treatment of active pulmonary TB caused by Mycobacterium tuberculosis.
This new approval for Priftin was based in part on the PREVENT TB study conducted by the CDC-Tuberculosis Trials Consortium (TBTC).
M2 PHARMA-December 3, 2014-Sanofi announces the US FDA's approval for Priftin in combination with isoniazid (INH) for treating latent tuberculosis infection