Vfend (voriconazole) Antifungal Side Effects, Dosage, Warnings


Generic drug: voriconazole

Brand name: Vfend

What is Vfend (voriconazole), and how does it work?

Vfend (voriconazole) is a prescription medicine used to treat certain serious fungal infections in your blood and body. These infections are called “aspergillosis,” “esophageal candidiasis,” “Scedosporium,” “Fusarium,” and “candidemia”. It is not known if Vfend is safe and effective in children younger than 2 years old.

What are the side effects of Vfend?

Vfend may cause serious side effects including:

Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

The most common side effects of
Vfend in adults include:

The most common side effects of
Vfend in children include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of
Vfend.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Vfend?

Important Administration Instructions For Use In All Patients

  • Administer Vfend Tablets or Oral Suspension at least one hour before or after a meal.
  • Vfend I.V. for Injection requires reconstitution to 10 mg/mL and subsequent dilution to 5 mg/mL or less prior to administration as an infusion, at a maximum rate of 3 mg/kg per hour over 1 to 2 hours.  

Administer diluted Vfend I.V. by intravenous infusion over 1 to 2 hours only. Do not administer as an IV bolus injection.

Use Of
Vfend I.V. With Other Parenteral Drug Products

Blood Products And Concentrated Electrolytes
  • Vfend I.V. must not be infused concomitantly with any blood product or short-term infusion of concentrated electrolytes, even if the two infusions are running in separate intravenous lines (or cannulas).
  • Electrolyte disturbances such as hypokalemia, hypomagnesemia and
    hypocalcemia should be corrected prior to initiation of and during Vfend
    therapy.
Intravenous Solutions Containing (non-concentrated) Electrolytes
  • Vfend I.V. can be infused at the same time as other intravenous solutions containing (non-concentrated) electrolytes, but must be infused through a separate line.
Total Parenteral Nutrition (TPN)
  • Vfend I.V. can be infused at the same time as total parenteral nutrition, but must be infused in a separate line. If infused through a multiple-lumen catheter, TPN needs to be administered using a different port from the one used for
    Vfend I.V.

Recommended Dosing Regimen In Adults

Invasive Aspergillosis And Serious Fungal Infections Due To Fusarium spp. And Scedosporium apiospermum
  • See Table 1. Therapy must be initiated with the specified loading dose
    regimen of intravenous Vfend on Day 1 followed by the recommended
    maintenance dose (RMD) regimen. Intravenous treatment should be continued
    for at least 7 days.
  • Once the patient has clinically improved and can tolerate medication
    given by mouth, the oral tablet form or oral suspension form of Vfend may be
    utilized.
  • The recommended oral maintenance dose of 200 mg achieves a voriconazole
    exposure similar to 3 mg/kg intravenously; a 300 mg oral dose achieves an
    exposure similar to 4 mg/kg intravenously.
  • Switching between the intravenous and oral formulations is appropriate
    because of the high bioavailability of the oral formulation in adults.
Candidemia In Non-Neutropenic Patients And Other Deep Tissue Candida Infections
  • See Table 1. Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Esophageal Candidiasis
  • See Table 1. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms.

Table 1: Recommended Dosing Regimen (Adults)

InfectionLoading DoseMaintenance Dosea,bIntravenous infusionIntravenous infusionOralcInvasive Aspergillosisd6 mg/kg every 12 hours for the first 24 hours4 mg/kg every 12 hours200 mg every 12 hoursCandidemia in nonneutropenic patients and other deep tissue Candida infections6 mg/kg every 12 hours for the first 24 hours3-4 mg/kg every 12 hourse200 mg every 12 hoursEsophageal CandidiasisNot EvaluatedfNot Evaluatedf200 mg every 12 hoursScedosporiosis and Fusariosis6 mg/kg every 12 hours for the first 24 hours4 mg/kg every 12 hours200 mg every 12 hoursa Increase dose when
Vfend is co-administered with phenytoin or efavirenz (7); Decrease dose in patients with hepatic impairment (2.5)
b In healthy volunteer studies, the 200 mg oral every 12 hours dose provided an exposure (AUCτ) similar to a 3 mg/kg intravenous infusion every 12 hours dose; the 300 mg oral every 12 hours dose provided an exposure (AUCτ) similar to a 4 mg/kg intravenous infusion every 12 hours dose (12).
cAdult patients who weigh less than 40 kg should receive half of the oral maintenance dose.
d In a clinical study of IA, the median duration of intravenous
Vfend therapy was 10 days (range 2 to 85 days). The median duration of oral
Vfend therapy was 76 days (range 2 to 232 days) (14.1).
e In clinical trials, patients with candidemia received 3 mg/kg intravenous infusion every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg every 12 hours as salvage therapy. Appropriate dose should be based on the severity and nature of the infection.
f Not evaluated in patients with EC.

Method For Adjusting the Dosing Regimen In Adults
  • If patient’s response is inadequate, the oral maintenance dose may be increased from 200 mg every 12 hours (similar to 3 mg/kg intravenously every 12 hours) to 300 mg every 12 hours (similar to 4 mg/kg intravenously every 12 hours).
  • For adult patients weighing less than 40 kg, the oral maintenance dose may be increased from 100 mg every 12 hours to 150 mg every 12 hours.
  • If patient is unable to tolerate 300 mg orally every 12 hours, reduce the oral maintenance dose by 50 mg steps to a minimum of 200 mg every 12 hours (or to 100 mg every 12 hours for adult patients weighing less than 40 kg).
  • If patient is unable to tolerate 4 mg/kg intravenously every 12 hours, reduce the intravenous maintenance dose to 3 mg/kg every 12 hours.

Recommended Dosing Regimen In Pediatric Patients

  • The recommended dosing regimen for pediatric patients 2 to less than 12
    years of age and 12 to 14 years of age with body weight less than 50 kg is
    shown in Table 2.
  • For pediatric patients 12 to 14 years of age with a body weight greater
    than or equal to 50 kg and those 15 years of age and above regardless of
    body weight, administer the adult dosing regimen of Vfend.

Table 2: Recommended Dosing Regimen for Pediatric Patients 2 to less than 12 years of age and 12 to 14 years of age with body weight less than 50 kg^

Loading DoseMaintenance DoseIntravenous infusionIntravenous infusionOralInvasive Aspergillosis*9 mg/kg every 12 hours for the first 24 hours8 mg/kg every 12 hours after the first 24 hours9 mg/kg every 12 hours (maximum dose of 350 mg every 12 hours)Candidemia in nonneutropenics and other deep tissue Candida infections†Scedosporiosis and FusariosisEsophageal Candidiasis†Not Evaluated4 mg/kg every 12 hours9 mg/kg every 12 hours (maximum dose of 350 mg every 12 hours)^ Based on a population pharmacokinetic analysis in 112 immunocompromised pediatric patients aged 2 to less than 12 years of age and 26 immunocompromised pediatric patients aged 12 to less than 17 years of age.
* In the Phase 3 clinical trials, patients with IA received intravenous (IV) treatment for at least 6 weeks and up to a maximum of 12 weeks. Patients received IV treatment for at least the first 7 days of therapy and then could be switched to oral
Vfend therapy.
† Study treatment for primary or salvage invasive candidiasis and candidemia (ICC) or EC consisted of intravenous
Vfend, with an option to switch to oral therapy after at least 5 days of IV therapy, based on subjects meeting switch criteria. For subjects with primary or salvage ICC,
Vfend was administered for at least 14 days after the last positive culture. A maximum of 42 days of treatment was permitted. Patients with primary or salvage EC were treated for at least 7 days after the resolution of clinical signs and symptoms. A maximum of 42 days of treatment was permitted.

  • Initiate therapy with an intravenous infusion regimen. Consider an oral regimen only after there is a significant clinical improvement. Note that an 8 mg/kg intravenous dose will provide voriconazole exposure approximately 2-fold higher than a 9 mg/kg oral dose.
  • The oral dose recommendation for children is based on studies in which
    Vfend was administered as the powder for oral suspension formulation. Bioequivalence between the
    Vfend powder for oral suspension and Vfend tablets has not been investigated in a pediatric population.
  • Oral bioavailability may be limited in pediatric patients 2 to 12 years with malabsorption and very low body weight for age. In that case, intravenous
    Vfend administration is recommended.
Method For Adjusting The Dosing Regimen In Pediatric Patients

Pediatric Patients 2 To Less Than 12 Years Of Age And 12 To 14 Years Of Age With Body Weight Less Than 50 kg

  • If patient response is inadequate and the patient is able to tolerate the initial intravenous maintenance dose, the maintenance dose may be increased by 1 mg/kg steps.
  • If patient response is inadequate and the patient is able to tolerate the oral maintenance dose, the dose may be increased by 1 mg/kg steps or 50 mg steps to a maximum of 350 mg every 12 hours.
  • If patients are unable to tolerate the initial intravenous maintenance dose, reduce the dose by 1 mg/kg steps.
  • If patients are unable to tolerate the oral maintenance dose, reduce the dose by 1 mg/kg or 50 mg steps.

Pediatric Patients 12 To 14 Years Of Age Weighing Greater Than Or Equal To 50 kg And 15 Years Of Age And Older Regardless Of Body Weight

  • Use the optimal method for titrating dosage recommended for adults.

Dosage Modifications In Patients With Hepatic Impairment

Adults
  • The maintenance dose of Vfend should be reduced in adult patients with mild to moderate hepatic impairment, Child-Pugh Class A and B. There are no PK data to allow for dosage adjustment recommendations in patients with severe hepatic impairment (Child-Pugh Class C).
  • Duration of therapy should be based on the severity of the patient’s underlying disease, recovery from immunosuppression, and clinical response.
  • Adult patients with baseline liver function tests (ALT, AST) of up to 5 times
    the upper limit of normal (ULN) were included in the clinical program. Dose
    adjustments are not necessary for adult patients with this degree of abnormal
    liver function, but continued monitoring of liver function tests for further
    elevations is recommended.
  • It is recommended that the recommended Vfend
    loading dose regimens be used, but that the maintenance dose be halved in adult
    patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B).
  • Vfend has not been studied in adult patients with severe hepatic cirrhosis (Child-Pugh Class C) or in patients with chronic hepatitis B or chronic hepatitis C disease.
  • Vfend has been associated with elevations in liver function tests and with clinical signs of liver damage, such as jaundice.
  • Vfend should only be used in patients with severe hepatic impairment if the benefit outweighs the potential risk. Patients with hepatic impairment must be carefully monitored for drug toxicity.
Pediatric Patients
  • Dosage adjustment of Vfend in pediatric patients with hepatic impairment has not
    been established.

Dosage Modifications In Patients With Renal Impairment

Adult Patients
  • The pharmacokinetics of orally administered Vfend are not significantly affected
    by renal impairment. Therefore, no adjustment is necessary for oral dosing in
    patients with mild to severe renal impairment.
  • In patients with moderate
    or severe renal impairment (creatinine clearance <50 mL/min) who are receiving
    an intravenous infusion of Vfend, accumulation of the intravenous vehicle,
    SBECD, occurs.
  •  Oral voriconazole should be administered to these patients,
    unless an assessment of the benefit/risk to the patient justifies the use of
    intravenous Vfend. Serum creatinine levels should be closely monitored in these
    patients, and, if increases occur, consideration should be given to changing to
    oral Vfend therapy.
  • Voriconazole is hemodialyzed with clearance of 121 mL/min. The intravenous vehicle, SBECD, is hemodialyzed with clearance of 55 mL/min. A 4-hour hemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment.
Pediatric Patients
  • Dosage adjustment of Vfend in pediatric patients with renal impairment has not
    been established.

Dosage Adjustment When Co-Administered With Phenytoin Or Efavirenz

  • The maintenance dose of voriconazole should be increased when co-administered
    with phenytoin or efavirenz. Use the optimal method for titrating dosage.





QUESTION

Bowel regularity means a bowel movement every day.
See Answer

What drugs interact with Vfend?

Voriconazole is metabolized by, and inhibits the activity of, cytochrome P450 isoenzymes, CYP2C19, CYP2C9, and CYP3A4. Inhibitors or inducers of these isoenzymes may increase or decrease voriconazole plasma concentrations, respectively, and there is potential for voriconazole to increase the plasma concentrations of substances metabolized by these CYP450 isoenzymes.

Tables 10 and 11 provide the clinically significant interactions between voriconazole and other medical products.

Table 10: Effect of Other Drugs on Voriconazole Pharmacokinetics

Drug/Drug Class (Mechanism of Interaction by the Drug)Voriconazole Plasma Exposure (Cmax and AUCτ after 200 mg every 12 hours)Recommendations for Voriconazole Dosage Adjustment/CommentsRifampin* and Rifabutin* (CYP450 Induction)Significantly ReducedContraindicatedEfavirenz (400 mg every 24 hours)** (CYP450 Induction)Significantly ReducedContraindicatedEfavirenz (300 mg every 24 hours)** (CYP450 Induction)Slight Decrease in AUCτWhen voriconazole is coadministered with efavirenz, voriconazole oral maintenance dose should be increased to 400 mg every 12 hours and efavirenz should be decreased to 300 mg every 24 hours.High-dose Ritonavir (400 mg every 12 hours)** (CYP450 Induction)Significantly ReducedContraindicatedLow-dose Ritonavir (100 mg every 12 hours)** (CYP450 Induction)ReducedCoadministration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.Carbamazepine (CYP450 Induction)Not Studied In Vivo or In Vitro, but Likely to Result in Significant ReductionContraindicatedLong Acting Barbiturates (CYP450 Induction)Not Studied In Vivo or In Vitro, but Likely to Result in Significant ReductionContraindicatedPhenytoin* (CYP450 Induction)Significantly ReducedIncrease voriconazole maintenance dose from 4 mg/kg to 5 mg/kg IV every 12 hours or from 200 mg to 400 mg orally every 12 hours (100 mg to 200 mg orally every 12 hours in patients weighing less than 40 kg).Letermovir (CYP2C9/2C19 Induction)ReducedIf concomitant administration of voriconazole with letermovir cannot be avoided, monitor for reduced effectiveness of voriconazole.St. John’s Wort (CYP450 inducer; P-gp inducer)Significantly ReducedContraindicatedOral Contraceptives** containing ethinyl estradiol and norethindrone (CYP2C19 Inhibition)IncreasedMonitoring for adverse events and toxicity related to voriconazole is recommended when coadministered with oral contraceptives.Fluconazole** (CYP2C9, CYP2C19 and CYP3A4 Inhibition)Significantly IncreasedAvoid concomitant administration of voriconazole and fluconazole. Monitoring for adverse events and toxicity related to voriconazole is started within 24 hours after the last dose of fluconazole.Other HIV Protease Inhibitors (CYP3A4 Inhibition)In Vivo Studies Showed No Significant Effects of Indinavir on Voriconazole Exposure In Vitro Studies Demonstrated Potential for Inhibition of Voriconazole Metabolism (Increased Plasma Exposure)No dosage adjustment in the voriconazole dosage needed when coadministered with indinavir. Frequent monitoring for adverse events and toxicity related to voriconazole when coadministered with other HIV protease inhibitors.Other NNRTIs*** (CYP3A4 Inhibition or CYP450 Induction)In Vitro Studies Demonstrated Potential for Inhibition of Voriconazole Metabolism by Delavirdine and Other NNRTIs (Increased Plasma Exposure) A Voriconazole-Efavirenz Drug Interaction Study Demonstrated the Potential for the Metabolism of Voriconazole to be Induced by Efavirenz and Other NNRTIs (Decreased Plasma Exposure)Frequent monitoring for adverse events and toxicity related to voriconazole. Careful assessment of voriconazole effectiveness.* Results based on in vivo clinical studies generally following repeat oral dosing with 200 mg every 12 hours voriconazole to healthy subjects
** Results based on in vivo clinical study following repeat oral dosing with 400 mg every 12 hours for 1 day, then 200 mg every 12 hours for at least 2 days voriconazole to healthy subjects
*** Non-Nucleoside Reverse Transcriptase Inhibitors

Table 11: Effect of Voriconazole on Pharmacokinetics of Other Drugs

Drug/Drug Class (Mechanism of Interaction by Voriconazole)Drug Plasma Exposure (Cmax and AUCτ)Recommendations for Drug Dosage Adjustment/CommentsSirolimus* (CYP3A4 Inhibition)Significantly IncreasedContraindicatedRifabutin* (CYP3A4 Inhibition)Significantly IncreasedContraindicatedEfavirenz (400 mg every 24 hours)** (CYP3A4 Inhibition)Significantly IncreasedContraindicatedEfavirenz (300 mg every 24 hours)** (CYP3A4 Inhibition)Slight Increase in AUCτWhen voriconazole is coadministered with efavirenz, voriconazole oral maintenance dose should be increased to 400 mg every 12 hours and efavirenz should be decreased to 300 mg every 24 hours.High-dose Ritonavir (400 mg every 12 hours)**(CYP3A4 Inhibition) Low-dose Ritonavir (100 mg every 12 hours)**No Significant Effect of Voriconazole on Ritonavir Cmax or AUCτ Slight Decrease in Ritonavir Cmax and AUCτContraindicated because of significant reduction of voriconazole Cmax and AUCτ. Coadministration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided (due to the reduction in voriconazole Cmax and AUCτ) unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.Cisapride, Pimozide, Quinidine (CYP3A4 Inhibition)Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be IncreasedContraindicated because of potential for QT prolongation and rare occurrence of torsade de pointes.Ergot Alkaloids (CYP450 Inhibition)Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be IncreasedContraindicatedNaloxegol (CYP3A4 Inhibition)Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased which may Increase the Risk of Adverse ReactionsContraindicatedTolvaptan (CYP3A4 Inhibition)Although Not Studied Clinically, Voriconazole is Likely to Significantly Increase the Plasma Concentrations of TolvaptanContraindicatedCyclosporine* (CYP3A4 Inhibition)AUCt Significantly Increased; No Significant Effect on CmaxWhen initiating therapy with
Vfend in patients already receiving cyclosporine, reduce the cyclosporine dose to one-half of the starting dose and follow with frequent monitoring of cyclosporine blood levels. Increased cyclosporine levels have been associated with nephrotoxicity. When
Vfend is discontinued, cyclosporine concentrations must be frequently monitored and the dose increased as necessary.Methadone*** (CYP3A4 Inhibition)IncreasedIncreased plasma concentrations of methadone have been associated with toxicity including QT prolongation. Frequent monitoring for adverse events and toxicity related to methadone is recommended during coadministration. Dose reduction of methadone may be needed.Fentanyl (CYP3A4 Inhibition)IncreasedReduction in the dose of fentanyl and other long-acting opiates metabolized by
CYP3A4 should be considered when coadministered with Vfend. Extended and
frequent monitoring for opiate-associated adverse events may be necessary.Alfentanil (CYP3A4 Inhibition)Significantly IncreasedReduction in the dose of alfentanil and other opiates metabolized by CYP3A4
(e.g., sufentanil) should be considered when coadministered with Vfend. A longer
period for monitoring respiratory and other opiate-associated adverse events may
be necessary.Oxycodone (CYP3A4 Inhibition)Significantly IncreasedReduction in the dose of oxycodone and other long-acting opiates metabolized by
CYP3A4 should be considered when coadministered with Vfend. Extended and
frequent monitoring for opiate-associated adverse events may be necessary.NSAIDs**** including. ibuprofen and diclofenac (CYP2C9 Inhibition)IncreasedFrequent monitoring for adverse events and toxicity related to NSAIDs. Dose
reduction of NSAIDs may be needed.Tacrolimus* (CYP3A4 Inhibition)Significantly IncreasedWhen initiating therapy with
Vfend in patients already receiving tacrolimus, reduce the tacrolimus dose to one-third of the starting dose and follow with frequent monitoring of tacrolimus blood levels. Increased tacrolimus levels have been associated with nephrotoxicity. When
Vfend is discontinued, tacrolimus concentrations must be frequently monitored and the dose increased as necessary.Phenytoin* (CYP2C9 Inhibition)Significantly IncreasedFrequent monitoring of phenytoin plasma concentrations and frequent monitoring of adverse effects related to phenytoin.Oral Contraceptives containing ethinyl estradiol and norethindrone (CYP3A4 Inhibition)**IncreasedMonitoring for adverse events related to oral contraceptives is recommended during coadministration.Prednisolone and other corticosteroids (CYP3A4 Inhibition)In Vivo Studies Showed No Significant Effects of
Vfend on Prednisolone Exposure Not Studied In vitro or In vivo for Other Corticosteroids, but Drug Exposure Likely to be IncreasedNo dosage adjustment for prednisolone when coadministered with
Vfend. Monitor
for potential adrenal dysfunction when Vfend is administered with other
corticosteroids.Warfarin* (CYP2C9 Inhibition)Prothrombin Time Significantly IncreasedMonitor PT or other suitable anticoagulation tests. Adjustment of warfarin dosage may be needed.Ivacaftor (CYP3A4 Inhibition)Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased which may Increase the Risk of Adverse ReactionsDose reduction of ivacaftor is recommended. Refer to the prescribing information for ivacaftorOmeprazole* (CYP2C19/3A4 Inhibition)Significantly IncreasedWhen initiating therapy with
Vfend in patients already receiving omeprazole doses of 40 mg or greater, reduce the omeprazole dose by one-half. The metabolism of other proton pump inhibitors that are CYP2C19 substrates may also be inhibited by voriconazole and may result in increased plasma concentrations of other proton pump inhibitors.Other HIV Protease Inhibitors (CYP3A4 Inhibition)In Vivo Studies Showed No Significant Effects on Indinavir Exposure In Vitro Studies Demonstrated Potential for Voriconazole to Inhibit Metabolism (Increased Plasma Exposure)No dosage adjustment for indinavir when coadministered with
Vfend. Frequent monitoring for adverse events and toxicity related to other HIV protease inhibitors.Other NNRTIs***** (CYP3A4 Inhibition)A Voriconazole-Efavirenz Drug Interaction Study Demonstrated the Potential for Voriconazole to Inhibit Metabolism of Other NNRTIs (Increased Plasma Exposure)Frequent monitoring for adverse events and toxicity related to NNRTI.Benzodiazepines (CYP3A4 Inhibition)In Vitro Studies Demonstrated Potential for Voriconazole to Inhibit Metabolism (Increased Plasma Exposure)Frequent monitoring for adverse events and toxicity (i.e., prolonged sedation) related to benzodiazepines metabolized by CYP3A4 (e.g., midazolam, triazolam, alprazolam). Adjustment of benzodiazepine dosage may be needed.HMG-CoA Reductase Inhibitors (Statins) (CYP3A4 Inhibition)In Vitro Studies Demonstrated Potential for Voriconazole to Inhibit Metabolism (Increased Plasma Exposure)Frequent monitoring for adverse events and toxicity related to statins. Increased statin concentrations in plasma have been associated with rhabdomyolysis. Adjustment of the statin dosage may be needed.Dihydropyridine Calcium Channel Blockers (CYP3A4 Inhibition)In Vitro Studies Demonstrated Potential for Voriconazole to Inhibit Metabolism (Increased Plasma Exposure)Frequent monitoring for adverse events and toxicity related to calcium channel blockers. Adjustment of calcium channel blocker dosage may be needed.Sulfonylurea Oral Hypoglycemics (CYP2C9 Inhibition)Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be IncreasedFrequent monitoring of blood glucose and for signs and symptoms of hypoglycemia. Adjustment of oral hypoglycemic drug dosage may be needed.Vinca Alkaloids (CYP3A4 Inhibition)Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be IncreasedFrequent monitoring for adverse events and toxicity (i.e., neurotoxicity) related to vinca alkaloids. Reserve azole antifungals, including voriconazole, for patients receiving a vinca alkaloid who have no alternative antifungal treatment options.Everolimus (CYP3A4 Inhibition)Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be IncreasedConcomitant administration of voriconazole and everolimus is not recommended.* Results based on in vivo clinical studies generally following repeat oral dosing with 200 mg BID voriconazole to healthy subjects
** Results based on in vivo clinical study following repeat oral dosing with 400 mg every 12 hours for 1 day, then 200 mg every 12 hours for at least 2 days voriconazole to healthy subjects
*** Results based on in vivo clinical study following repeat oral dosing with 400 mg every 12 hours for 1 day, then 200 mg every 12 hours for 4 days voriconazole to subjects receiving a methadone maintenance dose (30-100 mg every 24 hours)
**** Non-Steroidal Anti-Inflammatory Drug
***** Non-Nucleoside Reverse Transcriptase Inhibitors

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Is Vfend safe to use while pregnant or breastfeeding?

  • Voriconazole can cause fetal harm when administered to a pregnant woman.
  • There are no available data on the use of Vfend in pregnant women.
  • No data are available regarding the presence of voriconazole in human milk, the effects of voriconazole on the breastfed infant, or the effects on milk production.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
    Vfend and any potential adverse effects on the breastfed child from Vfend or from the underlying maternal condition.

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