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Flucytosine: Drug information

Flucytosine: Drug information
(For additional information see "Flucytosine: Patient drug information" and see "Flucytosine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Monitoring:

Use with extreme caution in patients with renal impairment. Close monitoring of hematologic, renal, and hepatic status of all patients is essential.

Brand Names: US
  • Ancobon
Pharmacologic Category
  • Antifungal Agent, Oral
Dosing: Adult

Usual dosage range: Oral: 50 to 150 mg/kg/day in divided doses every 6 hours.

Candidiasis

Candidiasis:

Cardiac infection, native or prosthetic valve endocarditis, or device infection (eg, implantable cardiac defibrillator, pacemaker, ventricular assist device): Oral: 25 mg/kg/dose 4 times daily (in combination with an amphotericin B lipid formulation). For device infection without endocarditis, duration is 4 weeks after device removal for generator pocket infections and ≥6 weeks after device removal for wire infections. For endocarditis, duration is ≥6 weeks after valve replacement surgery, with longer durations for perivalvular abscesses or other complications. Note: May transition to step-down therapy with fluconazole in patients with fluconazole-susceptible isolates who are clinically stable with negative repeat blood cultures (IDSA [Pappas 2016]).

Central nervous system (eg, meningitis): Oral: 25 mg/kg/dose 4 times daily (in combination with amphotericin B [liposomal]) until step-down therapy is clinically appropriate (IDSA [Pappas 2016]).

Endophthalmitis (with or without vitritis): Fluconazole- or voriconazole-resistant isolates: Oral: 25 mg/kg/dose 4 times daily (in combination with amphotericin B [liposomal]) for ≥4 to 6 weeks until examination indicates resolution; for patients with vitritis or with macular involvement, intravitreal antifungal therapy is also recommended (IDSA [Pappas 2016]).

Urinary tract infection:

Cystitis, symptomatic: Oral: Fluconazole-resistant C. glabrata: 25 mg/kg/dose 4 times daily for 7 to 10 days as monotherapy (IDSA [Pappas 2016]).

Pyelonephritis: Fluconazole-resistant C. glabrata: Oral: 25 mg/kg/dose 4 times daily in combination with amphotericin B deoxycholate for 1 to 7 days or as monotherapy for 14 days (IDSA [Pappas 2016]).

Vulvovaginal, caused by C. glabrata (alternative agent) (off-label use): Intravaginal: 16% extemporaneously compounded cream: 1 applicatorful (~5 g) once daily (at bedtime) for 14 days (Horowitz 1986; IDSA [Pappas 2016]; Sobel 2003; Sobel 2022). Note: Reserve for patients with no other clear cause of symptoms (Sobel 2022). May also be used in combination with intravaginal amphotericin B (IDSA [Pappas 2016]; White 2001).

Cryptococcal meningitis, disseminated disease, or severe pulmonary infection

Cryptococcal meningitis, disseminated disease, or severe pulmonary infection:

Oral: Induction: 25 mg/kg/dose 4 times daily, as part of an appropriate combination regimen. Duration of induction therapy is ≥2 weeks, but should be extended in patients with evidence of neurological complications; for cerebral cryptococcomas, recommended duration is ≥6 weeks. Induction therapy is followed by consolidation and maintenance therapy with fluconazole (AST-IDCOP [Baddley 2019]; HHS [OI adult 2022]; IDSA [Perfect 2010]).

Dosing: Kidney Impairment: Adult

The manufacturer recommends dose reduction for elevated BUN or serum creatinine (or other signs of renal impairment); however, no specific dosage adjustments are provided. The following adjustments have been recommended (based on a usual dose of 25 mg/kg/dose every 6 hours):

CrCl >40 mL/minute: No dosage adjustment necessary (HHS [OI adult 2022]; IDSA [Perfect 2010]).

CrCl 21 to 40 mL/minute: 25 mg/kg/dose every 12 hours (HHS [OI adult 2022]).

CrCl 10 to 20 mL/minute: 25 mg/kg/dose every 24 hours (HHS [OI adult 2022]).

CrCl <10 mL/minute: 25 mg/kg/dose every 48 hours (HHS [OI adult 2022]).

End-stage renal disease on intermittent hemodialysis: 25 to 50 mg/kg/dose every 48 to 72 hours; administer dose after hemodialysis (Drew 1999; HHS [OI adult 2022]).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Pediatric

(For additional information see "Flucytosine: Pediatric drug information")

Note: In general, administer in combination with amphotericin B or another susceptible antifungal due to development of resistance.

General dosing, susceptible infections: Infants, Children, and Adolescents: Oral: 50 to 150 mg/kg/day in divided doses every 6 hours (Red Book [AAP 2015])

Aspergillosis, endocarditis

Aspergillosis, endocarditis: Limited data available: Children and Adolescents: Oral: 37.5 mg/kg/dose every 6 hours in combination with amphotericin B (AHA [Baltimore 2015])

Candidiasis

Candidiasis:

Chorioretinitis: Infants, Children, and Adolescents: Oral: 25 mg/kg/dose every 6 hours in combination with amphotericin B (IDSA [Pappas 2016])

CNS disease, treatment: Infants, Children, and Adolescents: Oral: 25 mg/kg/dose every 6 hours in combination with amphotericin B (IDSA [Pappas 2016])

Endocarditis or implanted cardiovascular device:

Infants: Oral: 25 mg/kg/dose every 6 hours in combination with amphotericin B; valve replacement or removal of hardware is strongly recommended (IDSA [Pappas 2016])

Children and Adolescents: Oral: 25 to 37.5 mg/kg/dose every 6 hours in combination with amphotericin B; valve replacement or removal of hardware is strongly recommended (AHA [Baltimore 2015]; IDSA [Pappas 2016])

Urinary tract infection: Infants, Children, and Adolescents: Oral:

Cystitis, symptomatic: 25 mg/kg/dose every 6 hours for 7 to 10 days (IDSA [Pappas 2016])

Pyelonephritis: 25 mg/kg/dose every 6 hours for 2 weeks with or without amphotericin B (IDSA [Pappas 2016]); if fungal balls present, use in combination with amphotericin B and treatment duration should be until symptom resolution and clear urine culture

Cryptococcal disease; disseminated; treatment

Cryptococcal disease; disseminated (including CNS disease); treatment (independent of HIV status): Infants, Children, and Adolescents: Oral: 25 mg/kg/dose every 6 hours in combination with amphotericin B or fluconazole; minimum treatment duration: ≥2 weeks; full treatment duration dependent upon: HIV status, source of infection and concomitant antifungal therapy (HHS [OI pediatric 2013]; HHS [OI Adult 2015]; Perfect 2010; Tunkel 2008)

Dosing: Kidney Impairment: Pediatric

Monitor serum concentrations.

Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; however, the following guidelines have been used by some clinicians:

Aronoff 2007: Infants, Children, and non-HIV-exposed/-positive Adolescents: Based on a usual dose of 100 to 150 mg/kg/day divided every 6 hours

GFR >50 mL/minute/1.73 m2: No adjustment recommended

GFR 30 to 50 mL/minute/1.73 m2: 25 to 37.5 mg/kg/dose every 8 hours

GFR 10 to 29 mL/minute/1.73 m2: 25 to 37.5 mg/kg/dose every 12 hours

GFR <10 mL/minute/1.73 m2: 25 to 37.5 mg/kg/dose every 24 hours

Hemodialysis or peritoneal dialysis: 25 to 37.5 mg/kg/dose every 24 hours

Continuous renal replacement therapy: 25 to 37.5 mg/kg/dose every 8 hours; monitor serum concentrations

HHS [OI adult] 2015: HIV-exposed/-positive: Adolescents: Based on a usual dose of 25 mg/kg every 6 hours:

CrCl >40 mL/minute: No adjustment recommended

CrCl 20 to 40 mL/minute: 25 mg/kg/dose every 12 hours

CrCl 10 to <20 mL/minute: 25 mg/kg/dose every 24 hours

CrCl <10 mL/minute: 25 mg/kg/dose every 48 hours

Hemodialysis: Administer dose after hemodialysis: 25 to 50 mg/kg every 48 to 72 hours

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, flucytosine has minimal hepatic metabolism; use caution.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Ancobon: 250 mg, 500 mg

Generic: 250 mg, 500 mg

Generic Equivalent Available: US

Yes

Administration: Adult

Oral: To reduce or avoid nausea and vomiting, administer a few capsules at a time over 15 minutes until full dose is taken.

Vaginal (off-label route): Gently insert full applicator of cream and press plunger to release the medication (Horowitz 1986).

Administration: Pediatric

Oral: Administer around-the-clock to promote less variation in peak and trough serum levels; to avoid nausea and vomiting, administer a few capsules at a time over 15 minutes until full dose is taken.

Use: Labeled Indications

Candida/Cryptococcus infections: Treatment of systemic fungal infections (eg, bloodstream infection, endocarditis, urinary tract infection, meningitis, pulmonary) caused by susceptible strains of Candida or Cryptococcus, in combination with other antifungal agents.

Use: Off-Label: Adult

Candidiasis, vulvovaginal, caused by Candida glabrata

Medication Safety Issues
Sound-alike/look-alike issues:

Flucytosine may be confused with fludarabine, fluorouracil

Ancobon may be confused with Oncovin

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Cardiovascular: Cardiotoxicity, chest pain, ventricular dysfunction

Central nervous system: Ataxia, confusion, fatigue, hallucination, headache, paresthesia, parkinsonian-like syndrome, peripheral neuropathy, psychosis, sedation, seizure, vertigo

Dermatologic: Pruritus, skin photosensitivity, skin rash, toxic epidermal necrolysis, urticaria

Endocrine & metabolic: Hypoglycemia, hypokalemia

Gastrointestinal: Abdominal pain, anorexia, diarrhea, duodenal ulcer, enterocolitis, gastrointestinal hemorrhage, nausea, ulcerative colitis, vomiting, xerostomia

Genitourinary: Azotemia, crystalluria

Hematologic & oncologic: Agranulocytosis, anemia, aplastic anemia, bone marrow aplasia, eosinophilia, leukopenia, pancytopenia, thrombocytopenia

Hepatic: Hepatic injury (acute), hepatic insufficiency, hepatic necrosis, increased liver enzymes, increased serum bilirubin, jaundice

Hypersensitivity: Hypersensitivity reaction

Neuromuscular & skeletal: Weakness

Otic: Hearing loss

Renal: Increased blood urea nitrogen, increased serum creatinine, renal failure

Respiratory: Dyspnea

Miscellaneous: Fever

Contraindications

Hypersensitivity to flucytosine or any component of the formulation; known complete dihydropyrimidine dehydrogenase enzyme deficiency.

Warnings/Precautions

Disease-related concerns:

• Hematologic disease: Use with caution in patients with bone marrow depression, hematologic disease, or those who have been treated with radiation or drugs that suppress the bone marrow; bone marrow toxicity may be dose related and irreversible.

• Hepatic impairment: Use with caution in patients with hepatic impairment; hepatotoxicity that appears to be dose related may occur.

• Renal impairment: Dosage adjustment recommended in patients with renal impairment.

Special populations:

• Dihydropyrimidine dehydrogenase enzyme deficiency: Severe toxicity, including diarrhea, mucositis, neurotoxicity, and neutropenia, may be increased in patients with dihydropyrimidine dehydrogenase enzyme deficiency; consider determination of dihydropyrimidine dehydrogenase enzyme deficiency in patients who develop drug toxicity.

Other warnings/precautions:

• Monotherapy: Generally should not be used as monotherapy, as resistance can rapidly develop.

Warnings: Additional Pediatric Considerations

Serum flucytosine concentrations are highly variable in neonates; monitor closely (Pasqualotte 2007); serum concentrations tended to be higher in children <12 years of age; monitor closely (Soltani 2006).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Amphotericin B: May enhance the adverse/toxic effect of Flucytosine. Amphotericin B may increase the serum concentration of Flucytosine. Risk C: Monitor therapy

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

Brivudine [INT]: May enhance the adverse/toxic effect of Flucytosine. Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Cytarabine (Conventional): May diminish the therapeutic effect of Flucytosine. Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Gimeracil: May increase serum concentrations of the active metabolite(s) of Flucytosine. Specifically, gimeracil may increase concentrations of fluorouracil. Risk X: Avoid combination

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination

Food Interactions

Food decreases the rate, but not the extent of absorption.

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Flucytosine is metabolized to fluorouracil which may cause adverse events if administered during pregnancy; refer to the Fluorouracil (Systemic) monograph for additional information.

Breastfeeding Considerations

It is not known if flucytosine is present in breast milk. Due to the potential for serious adverse reactions in the breastfeeding infant, a decision should be made whether to discontinue breastfeeding or the drug, taking into account the importance of treatment to the mother.

Monitoring Parameters

Pretreatment: Electrolytes (especially potassium), CBC with differential, BUN, renal function.

During treatment: CBC with differential and LFTs (eg, alkaline phosphatase, AST/ALT) frequently; renal function; serum flucytosine concentrations (2 hours after administration of a dose) after 3 to 5 doses and as clinically indicated (eg, following dosage adjustment, change in renal function, bone marrow toxicity) (BSMM [Ashbee 2014]; HHS [OI adult 2022]); if serum flucytosine concentrations cannot be monitored, monitor CBC at least twice weekly (HHS [OI adult 2022]).

Reference Range

Target serum concentration: 30 to 80 mcg/mL; serum concentrations should not exceed 100 mcg/mL to avoid bone marrow toxicity and hepatotoxicity (AST-IDCOP [Baddley 2019]; IDSA [Perfect 2010]). Serum concentrations should be measured after 3 to 5 doses (HHS [OI adult 2022]), 2 hours after administration of a dose (AST-IDCOP [Baddley 2019]; HHS [OI adult 2022]; IDSA [Perfect 2010]). Repeat serum concentrations should be obtained following dosage adjustment, change in renal function, or if bone marrow toxicity occurs (BSMM [Ashbee 2014]).

Mechanism of Action

Penetrates fungal cells and is converted to fluorouracil which competes with uracil interfering with fungal RNA and protein synthesis

Pharmacokinetics

Absorption: Rapid; serum concentrations are highly variable in neonates; monitor closely (Pasqualotto 2007); serum concentrations tended to be higher in children <12 years of age; monitor closely (Soltani 2006)

Distribution: Into CSF, aqueous humor, joints, peritoneal fluid; Vd: 0.6 L/kg

Protein binding: 3% to 4%

Metabolism: Minimally hepatic; deaminated both in yeasts and possibly via gut bacteria to 5-fluorouracil

Bioavailability: 78% to 89%; decreased in neonates

Half-life elimination:

Neonates: 4 to 34 hours (Baley 1990)

Infants: 7.4 hours

Adults: 2 to 5 hours

Anuria: 85 hours (range: 30 to 250)

End-stage renal disease (ESRD): 75 to 200 hours

Time to peak, serum: ~1 to 2 hours

Neonates: 2.5 ± 1.3 hours

Adults: ~1 to 2 hours

Excretion: Urine (>90% as unchanged drug)

Pharmacokinetics: Additional Considerations

Altered kidney function: Prolonged half-life (29.9 to 250 hours in anuric or nephrectomized patients).

Pricing: US

Capsules (Ancobon Oral)

250 mg (per each): $92.21

500 mg (per each): $178.43

Capsules (Flucytosine Oral)

250 mg (per each): $82.07

500 mg (per each): $158.81

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Alcobon (AE, BH, CY, EG, IL, IQ, IR, JO, LB, LY, NZ, OM, SA, SY, YE);
  • Ancobon (HK);
  • Ancotil (AE, AT, AU, BG, BH, BR, CH, CY, DE, EG, FR, GB, GR, HR, IE, IL, IQ, IR, IT, JO, LB, LY, NL, NO, OM, PL, SA, SE, SG, SY, YE);
  • Ancotyl (RU);
  • Cocol (JP);
  • Flusine (TW)


For country code abbreviations (show table)
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