Voriconazole intravenous
Other products: Voriconazole
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Handling and access
NIOSH hazardous drug
Table 2NIOSH lists voriconazole as a hazardous drug. AHFS class: 8:14.08 azoles.
- Meets the NIOSH definition of a hazardous drug (carcinogenicity, developmental or reproductive toxicity, organ toxicity at low doses, or genotoxicity) without MSHI or a Group 1 or 2A carcinogen classification.
- Only a developmental and/or reproductive hazard: precautions matter most for workers who are pregnant, breastfeeding, or trying to conceive.
Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.
Azole Antifungal
Dosing in kidney impairment
Dosage Modifications in Patients With Renal Impairment Adult Patients The pharmacokinetics of orally administered voriconazole are not significantly affected by renal impairment. Therefore, no adjustment is necessary for oral dosing in patients with mild to severe renal impairment [see Clinical Pharmacology ] . In patients with moderate or severe renal impairment (creatinine clearance <50 mL/min) who are receiving an intravenous infusion of voriconazole, 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 voriconazole. Serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to changing to oral voriconazole therapy [see Warnings and Precautions ] .
Voriconazole and the intravenous vehicle, SBECD, are dialyzable. A 4-hour hemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment [see Clinical Pharmacology ] . Pediatric Patients Dosage adjustment of voriconazole for injection in pediatric patients with renal impairment has not been established [see Use in Specific Populations ] .
Dosing in liver impairment
Dosage Modifications in Patients With Hepatic Impairment Adults The maintenance dose of voriconazole for injection 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 [see Warnings and Precautions ] .
It is recommended that the recommended voriconazole for injection 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) [see Clinical Pharmacology ] . Voriconazole for injection 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.
Voriconazole for injection has been associated with elevations in liver function tests and with clinical signs of liver damage, such as jaundice. Voriconazole for injection 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 voriconazole for injection in pediatric patients with hepatic impairment has not been established [see Use in Specific Populations ] .
| a Increase dose when voriconazole for injection is coadministered 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). | ||||
| c Adult 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 voriconazole therapy was 10 days (range 2 to 85 days). The median duration of oral voriconazole 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. | ||||
| Infection | Loading Dose | Maintenance Dosea,b | ||
| Intravenous infusion | Intravenous infusion | Oral tabletsc | Oral suspension | |
| Invasive Aspergillosisd | 6 mg/kg every 12 hours for the first 24 hours | 4 mg/kg every 12 hours | 200 mg every 12 hours | 5 mL every 12 hours |
| Candidemia in nonneutropenic patients and other deep tissue Candida infections | 6 mg/kg every 12 hours for the first 24 hours | 3-4 mg/kg every 12 hourse | 200 mg every 12 hours | 5 mL every 12 hours |
| Esophageal Candidiasis | Not Evaluatedf | Not Evaluatedf | 200 mg every 12 hours | 5 mL every 12 hours |
| Scedosporiosis and Fusariosis | 6 mg/kg every 12 hours for the first 24 hours | 4 mg/kg every 12 hours | 200 mg every 12 hours | 5 mL every 12 hours |
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Preparation and administration
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Important Administration Instructions for Use in All Patients Voriconazole for injection requires reconstitution to 10 mg per mL and subsequent dilution to 5 mg per mL or less prior to administration as an infusion, at a maximum rate of 3 mg/kg per hour over 1 to 3 hours. Administer diluted voriconazole for injection by intravenous infusion over 1 to 3 hours only.
Do not administer as an IV bolus injection.
Preparation and Intravenous Administration of Voriconazole for Injection Reconstitution The powder is reconstituted with 19 mL of Water for Injection to obtain an extractable volume of 20 mL of clear concentrate containing 10 mg per mL of voriconazole. It is recommended that a standard 20 mL (non-automated) syringe be used to ensure that the exact amount (19 mL) of Water for Injection is dispensed.
Discard the vial if a vacuum does not pull the diluent into the vial. Shake the vial until all the powder is dissolved. Dilution Voriconazole must be infused over 1 to 3 hours, at a concentration of 5 mg per mL or less. Therefore, the required volume of the 10 mg per mL voriconazole concentrate should be further diluted as follows (appropriate diluents listed below): Calculate the volume of 10 mg per mL voriconazole concentrate required based on the patient's weight (see Table 3 ).
In order to allow the required volume of voriconazole concentrate to be added, withdraw and discard at least an equal volume of diluent from the infusion bag or bottle to be used. The volume of diluent remaining in the bag or bottle should be such that when the 10 mg per mL voriconazole concentrate is added, the final concentration is not less than 0.5 mg per mL nor greater than 5 mg per mL.
Using a suitable size syringe and aseptic technique, withdraw the required volume of voriconazole concentrate from the appropriate number of vials and add to the infusion bag or bottle. Discard Partially Used Vials . The final voriconazole solution must be infused over 1 to 3 hours at a maximum rate of 3 mg/kg per hour. [See table below.] 4 mL - 8 mL 9 mL 15 - 6 mL - 12 mL 13.5 mL 20 - 8 mL - 16 mL 18 mL 25 - 10 mL - 20 mL 22.5 mL 30 9 mL 12 mL 18 mL 24 mL 27 mL 35 10.5 mL 14 mL 21 mL 28 mL 31.5 mL 40 12 mL 16 mL 24 mL 32 mL 36 mL 45 13.5 mL 18 mL 27 mL 36 mL 40.5 mL 50 15 mL 20 mL 30 mL 40 mL 45 mL 55 16.5 mL 22 mL 33 mL 44 mL 49.5 mL 60 18 mL 24 mL 36 mL 48 mL 54 mL 65 19.5 mL 26 mL 39 mL 52 mL 58.5 mL 70 21 mL 28 mL 42 mL - - 75 22.5 mL 30 mL 45 mL - - 80 24 mL 32 mL 48 mL - - 85 25.5 mL 34 mL 51 mL - - 90 27 mL 36 mL 54 mL - - 95 28.5 mL 38 mL 57 mL - - 100 30 mL 40 mL 60 mL - - Voriconazole for injection is a single-dose unpreserved sterile lyophile.
Therefore, from a microbiological point of view, once reconstituted, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2° to 8°C (36° to 46°F). This medicinal product is for single use only and any unused solution should be discarded.
Only clear solutions without particles should be used. The reconstituted solution can be diluted with: 0.9% Sodium Chloride USP Lactated Ringers USP 5% Dextrose and Lactated Ringers USP 5% Dextrose and 0.45% Sodium Chloride USP 5% Dextrose USP 5% Dextrose and 20 mEq Potassium Chloride USP 0.45% Sodium Chloride USP 5% Dextrose and 0.9% Sodium Chloride USP The compatibility of voriconazole for injection with diluents other than those described above is unknown (see Incompatibilities below) .
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Incompatibilities Voriconazole for injection must not be diluted with 4.2% Sodium Bicarbonate Infusion. The mildly alkaline nature of this diluent caused slight degradation of voriconazole after 24 hours storage at room temperature.
Although refrigerated storage is recommended following reconstitution, use of this diluent is not recommended as a precautionary measure. Compatibility with other concentrations is unknown.
| Infection | Loading dose | Maintenance Dose | ||
| Intravenous infusion | Intravenous infusion | Oral tablets | Oral suspension | |
| Invasive Aspergillosis | 6 mg/kg every 12 hours for the first 24 hours | 4 mg/kg every 12 hours | 200 mg every 12 hours | 5 mL every 12 hours |
| Candidemia in nonneutropenics and other deep tissue Candida infections | 3-4 mg/kg every 12 hours | 200 mg every 12 hours | 5 mL every 12 hours | |
| Scedosporiosis and Fusariosis | 4 mg/kg every 12 hours | 200 mg every 12 hours | 5 mL every 12 hours | |
| Esophageal Candidiasis | Not Evaluated | Not Evaluated | 200 mg every 12 hours | 5 mL every 12 hours |
| Infection | Loading Dose | Maintenance Dose | ||
| Intravenous infusion | Intravenous infusion | Oral tablets | Oral suspension | |
| Invasive Aspergillosis | 9 mg/kg every 12 hours for the first 24 hours | 8 mg/kg every 12 hours after the first 24 hours | 9 mg/kg every 12 hours (maximum dose of 350 mg every 12 hours) | 0.225 mL/kg every 12 hours[maximum dose of 8.75 mL (350 mg) every 12 hours] |
| Candidemia in nonneutropenics and other deep tissue Candida infections | ||||
| Scedosporiosis and Fusariosis | ||||
| Esophageal Candidiasis | Not Evaluated | 4 mg/kg every 12 hours | 9 mg/kg every 12 hours (maximum dose of 350 mg every 12 hours) | 0.225 mL/kg every 12 hours[maximum dose of 8.75 mL (350 mg) every 12 hours] |
| a Increase dose when voriconazole for injection is coadministered 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). | ||||
| c Adult 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 voriconazole therapy was 10 days (range 2 to 85 days). The median duration of oral voriconazole 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. | ||||
| Infection | Loading Dose | Maintenance Dosea,b | ||
| Intravenous infusion | Intravenous infusion | Oral tabletsc | Oral suspension | |
| Invasive Aspergillosisd | 6 mg/kg every 12 hours for the first 24 hours | 4 mg/kg every 12 hours | 200 mg every 12 hours | 5 mL every 12 hours |
| Candidemia in nonneutropenic patients and other deep tissue Candida infections | 6 mg/kg every 12 hours for the first 24 hours | 3-4 mg/kg every 12 hourse | 200 mg every 12 hours | 5 mL every 12 hours |
| Esophageal Candidiasis | Not Evaluatedf | Not Evaluatedf | 200 mg every 12 hours | 5 mL every 12 hours |
| Scedosporiosis and Fusariosis | 6 mg/kg every 12 hours for the first 24 hours | 4 mg/kg every 12 hours | 200 mg every 12 hours | 5 mL every 12 hours |
Drug interactions
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- Voriconazole intravenous
Label text (2 paragraphs)
Voriconazole is metabolized by cytochrome P450 isoenzymes, CYP2C19, CYP2C9, and CYP3A4. Therefore, inhibitors or inducers of these isoenzymes may increase or decrease voriconazole plasma concentrations, respectively. Voriconazole is a strong inhibitor of CYP3A4, and also inhibits CYP2C19 and CYP2C9. Therefore, voriconazole may increase the plasma concentrations of substances metabolized by these CYP450 isoenzymes. Table 10 and Table 11 provide listings of clinically significant drug interactions, including contraindicated drugs [see Contraindications ( 4 )] .
Drugs listed in Table 10 and Table 11 are a guide and not considered a comprehensive list of all possible drugs and herbal products that are contraindicated or may interact with voriconazole. Table 10: Effect of Other Drugs on Voriconazole Pharmacokinetics [see Clinical Pharmacology ( 12.3 )] * 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 Drug/Drug Class (Mechanism of Interaction by the Drug) Voriconazole Plasma Exposure (C max and AUC τ after 200 mg every 12 hours) Prevention or Management Recommendations Rifampin* and Rifabutin* (CYP450 Induction) Significantly Reduced Contraindicated Efavirenz (400 mg every 24 hours)** (CYP450 Induction) Efavirenz (300 mg every 24 hours)** (CYP450 Induction) Significantly Reduced Slight Decrease in AUC τ Contraindicated When voriconazole is concomitantly administered 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) Low-dose Ritonavir (100 mg every 12 hours)** (CYP450 Induction) Significantly Reduced Reduced Contraindicated Concomitant administration 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 Reduction Contraindicated Long Acting Barbiturates (e.g., phenobarbital, mephobarbital) (CYP450 Induction) Not Studied In Vivo or In Vitro , but Likely to Result in Significant Reduction Contraindicated Phenytoin* (CYP450 Induction) Significantly Reduced Increase 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) Reduced If 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 Reduced Contraindicated Oral Contraceptives** containing ethinyl estradiol and norethindrone (CYP2C19 Inhibition) Increased Monitoring for adverse reactions and toxicity related to voriconazole is recommended for concomitant administration with oral contraceptives. Fluconazole** (CYP2C9, CYP2C19 and CYP3A4 Inhibition) Significantly Increased Avoid concomitant administration of voriconazole and fluconazole. Monitoring for adverse reactions 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 for concomitant administration with indinavir. Frequent monitoring for adverse reactions and toxicity related to voriconazole for concomitant administration 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 reactions and toxicity related to voriconazole. Careful assessment of voriconazole effectiveness. Table 11: Effect of Voriconazole on Pharmacokinetics of Other Drugs [see Clinical Pharmacology ( 12.3 )] * 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 Drug/Drug Class (Mechanism of Interaction by Voriconazole) Drug Plasma Exposure (C max and AUC τ ) Prevention or Management Recommendations Sirolimus* (CYP3A4 Inhibition) Significantly Increased Contraindicated Rifabutin* (CYP3A4 Inhibition) Significantly Increased Contraindicated Efavirenz (400 mg every 24 hours)** (CYP3A4 Inhibition) Efavirenz (300 mg every 24 hours)** (CYP3A4 Inhibition) Significantly Increased Slight Increase in AUC τ Contraindicated When voriconazole is concomitantly administered 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 C max or AUC τ Slight Decrease in Ritonavir C max and AUC τ Contraindicated because of significant reduction of voriconazole C max and AUC τ . Concomitant administration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided (due to the reduction in voriconazole C max and AUC τ ) unless an assessment of the benefit/risk to the patient justifies the use of voriconazole. Pimozide, Quinidine, Ivabradine (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Drug Plasma Exposure Likely to be Increased Contraindicated 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 Increased Contraindicated Naloxegol (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Drug Plasma Exposure Likely to be Increased which may Increase the Risk of Adverse Reactions Contraindicated Tolvaptan (CYP3A4 Inhibition) Although Not Studied Clinically, Voriconazole is Likely to Significantly Increase the Plasma Concentrations of Tolvaptan Contraindicated Lurasidone (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Voriconazole is Likely to Significantly Increase the Plasma Concentrations of Lurasidone Contraindicated Finerenone (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Voriconazole is Likely to Significantly Increase the Plasma Concentrations of Finerenone Contraindicated Eplerenone (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Voriconazole is Likely to Significantly Increase the Plasma Concentrations of Eplerenone Contraindicated Voclosporin (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Voriconazole is Likely to Significantly Increase the Plasma Concentrations of Voclosporin Contraindicated Venetoclax (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Venetoclax Plasma Exposure Likely to be Significantly Increased Concomitant administration of voriconazole is contraindicated at initiation and during the ramp-up phase in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Refer to the venetoclax labeling for safety monitoring and dose reduction in the steady daily dosing phase in CLL/SLL patients. For patients with acute myeloid leukemia (AML), dose reduction and safety monitoring are recommended across all dosing phases when concomitantly administered voriconazole with venetoclax. Refer to the venetoclax prescribing information for dosing instructions. Lemborexant (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Drug Plasma Exposure Likely to be Increased Avoid concomitant use of voriconazole with lemborexant. Glasdegib (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Drug Plasma Exposure Likely to be Increased Consider…
Contraindications
Voriconazole is contraindicated in patients with known hypersensitivity to voriconazole or its excipients [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6.1 , 6.2 )] . There is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. Refer to the prescribing information for other azole antifungal agents. • Concomitant use of voriconazole with the interacting drugs described and listed below in this section are a guide and not considered a comprehensive list of all possible drugs that may be contraindicated with voriconazole. 1.
Concomitant use of voriconazole is contraindicated with drugs that are highly dependent on CYP3A4 for metabolism, and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see Drug Interactions ( 7 )] : • Eplerenone • Ergot alkaloids (e.g., ergotamine, dihydroergotamine) • Finerenone • Ivabradine • Lurasidone • Naloxegol • Pimozide • Quinidine • Rifabutin [see Clinical Pharmacology ( 12.3 )] • Sirolimus [see Clinical Pharmacology ( 12.3 )] • Tolvaptan • Venetoclax: Coadministration at initiation and during the ramp-up phase is contraindicated in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) due to the potential for increased risk of tumor lysis syndrome [see Drug Interactions ( 7 )] . • Voclosporin 2. Concomitant use of voriconazole is contraindicated with drugs and herbal products that induce CYP2C19, CYP2C9, and/or CYP3A4 and for which significantly reduced voriconazole plasma concentrations may be associated with loss of efficacy [see Drug Interactions ( 7 )] : • Carbamazepine • Efavirenz Concomitant use with efavirenz dosages of 400 mg every 24 hours or higher is contraindicated [see Clinical Pharmacology ( 12.3 )] . • Long-acting barbiturates • Rifabutin • Rifampin • Ritonavir Concomitant use with high-dose ritonavir (400 mg every 12 hours) is contraindicated. Concomitant use with 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 [see Clinical Pharmacology ( 12.3 )] • St. John’s Wort [see…
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
BLikelihood score B: Likely cause of clinically apparent liver injury.
Voriconazole is a triazole antifungal agent used primarily in the treatment or prevention of aspergillosis and candidal infections. Voriconazole therapy is associated with transient, asymptomatic serum aminotransferase elevations and is a known cause of clinically apparent acute drug induced liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Voriconazole can cause fetal harm when administered to a pregnant woman. There are no available data on the use of voriconazole in pregnant women. In animal reproduction studies, oral voriconazole was associated with fetal malformations in rats and fetal toxicity in rabbits. Cleft palates and hydronephrosis/hydroureter were observed in rat pups exposed to voriconazole during organogenesis at and above 10 mg/kg (0.3 times the RMD of 200 mg every 12 hours based on body surface area comparisons).
In rabbits, embryomortality, reduced fetal weight and increased incidence of skeletal variations, cervical ribs and extrasternal ossification sites were observed in pups when pregnant rabbits were orally dosed at 100 mg/kg (6 times the RMD based on body surface area comparisons) during organogenesis. Rats exposed to voriconazole from implantation to weaning experienced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose [see Data ] .
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus [see Warnings and Precautions (5.9) ] . The background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20% respectively. Data Animal Data Voriconazole was administered orally to pregnant rats during organogenesis (gestation days 6-17) at 10, 30, and 60 mg/kg/day.
Voriconazole was associated with increased incidences of the malformations hydroureter and hydronephrosis at 10 mg/kg/day or greater, approximately 0.3 times the recommended human dose (RMD) based on body surface area comparisons, and cleft palate at 60 mg/kg, approximately 2 times the RMD based on body surface area comparisons. Reduced ossification of sacral and caudal vertebrae, skull, pubic, and hyoid bone, supernumerary ribs, anomalies of the sternebrae, and dilatation of the ureter/renal pelvis were also observed at doses of 10 mg/kg or greater. There was no evidence of maternal toxicity at any dose.
Voriconazole was administered orally to pregnant rabbits during the period of organogenesis (gestation days 7-19) at 10, 40, and 100 mg/kg/day. Voriconazole was associated with increased post-implantation loss and decreased fetal body weight, in association with maternal toxicity (decreased body weight gain and food consumption) at 100…
Breastfeeding (LactMed)
No information is available on the use of voriconazole during breastfeeding. If voriconazole is required by the mother, it is not a reason to discontinue breastfeeding. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
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