Posaconazole

Posaconazole is an azole antifungal agent [ see Clinical Pharmacology (12.4) ].

• Posaconazole is an azole antifungal indicated as follows: Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: ( 1.2 ) o Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see Clinical Studies (14.2) ] as follows: Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh gr…

• Known hypersensitivity to posaconazole or other azole antifungal agents. ( 4.1 ) Coadministration of posaconazole with the following drugs is contraindicated; posaconazole increases concentrations and toxicities of: Sirolimus ( 4.2 , 5.1 , 7.1 ) CYP3A4 substrates (pimozide, quinidine): can result in QTc interval prolongation and cases of torsades de pointes (TdP) ( 4.3 , 5.2 , 7.2 ) HMG-CoA Reductase Inhibitors Primarily Metabolized through CYP3A4 ( 4.4 , 7.3 ) Ergot alkaloids ( 4.5 , 7.4 ) Venetoclax: In patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) at initiation and during the ramp-up phase ( 4.6 , 5.11 , 7.16 ) 4.1 Hypersensitivity Posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents.contraindicated

Noxafil ® oral suspension is not substitutable with posaconazole delayed-release tablets or Noxafil ® PowderMix for delayed-release oral suspension due to the differences in the dosing of each formulation. Therefore, follow the specific dosage recommendations for each of the formulations. ( 2.1 , 2.2 , 2.3 ) Administer posaconazole delayed-release tablets with or without food. ( 2.1 ) Table 1: Recommended Dosage in Adult Patients Indication Dosage Form, Dose, and Duration of Therapy Prophylaxis of invasive Aspergillus and Candida infections Delayed-Release Tablets: Loading dose: 300 mg (three 100 mg delayed-release tablets) twice a day on the first day. Maintenance dose: 300 mg (three 100 mg delayed-release tablets) once a day, starting on the second day. Duration of therapy is based on recovery from neutropenia or immunosuppression. ( 2.2 , 2.3 ) For pediatric patients, see the Full Prescribing Information for dosing recommendations for posaconazole delayed-release tablets ( 1.2 , 2.1 , 2.3 ) 2.1 Important Administration Instructions Non-substitutable Noxafil ® oral suspension is not substitutable with posaconazole delayed-release tablets or Noxafil ® PowderMix for delayed-release oral suspension due to the differences in the dosing of each formulation.Therefore, follow the specific dosage recommendations for each of the formulations [see Dosage and Administration (2.2, 2.3 )]. Posaconazole delayed-release tablets Swallow tablets whole. Do not divide, crush, or chew. Administer with or without food [ see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ].

Calcineurin-Inhibitor Toxicity : Posaconazole increases concentrations of cyclosporine or tacrolimus; reduce dose of cyclosporine and tacrolimus and monitor concentrations frequently. ( 5.1 ) Arrhythmias and QTc Prolongation : Posaconazole has been shown to prolong the QTc interval and cause cases of TdP. Administer with caution to patients with potentially proarrhythmic conditions. Do not administer with drugs known to prolong QTc interval and metabolized through CYP3A4. ( 5.2 ) Electrolyte Disturbances : Monitor and correct, especially those involving potassium (K + ), magnesium (Mg ++ ), and calcium (Ca ++ ), before and during posaconazole therapy. ( 5.3 ) Pseudoaldosteronism : Manifested by the onset or worsening of hypertension, and abnormal laboratory findings. Monitor blood pressure and potassium levels, and manage as necessary. ( 5.4 ) Hepatic Toxicity : Elevations in liver tests may occur. Discontinuation should be considered in patients who develop abnormal liver tests or monitor liver tests during treatment. ( 5.5 ) Concomitant Use with Midazolam : Posaconazole can prolong hypnotic/sedative effects. Monitor patients and benzodiazepine receptor antagonists should be available. ( 5.7, 7.5 ) Vincristine Toxicity : Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with neurotoxicity and other serious adverse reactions; reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.

The following serious and otherwise important adverse reactions are discussed in detail in another section of the labeling: Hypersensitivity [ see Contraindications (4.1) ] Arrhythmias and QT Prolongation [ see Warnings and Precautions (5.2) ] Hepatic Toxicity [ see Warnings and Precautions (5.5) ] Adult Patients: Common adverse reactions in studies with posaconazole in adults are diarrhea, nausea, fever, vomiting, headache, coughing, and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of posaconazole cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial Experience in Adults Clinical Trial Experience with Posaconazole Delayed-Release Tablets for Prophylaxis The safety of posaconazole delayed-release tablets has been assessed in 230 patients in clinical trials. Patients were enrolled in a non-comparative pharmacokinetic and safety trial of posaconazole delayed-release tablets when given as antifungal prophylaxis (Posaconazole Delayed-Release Tablet Study). Patients were immunocompromised with underlying conditions including hematological malignancy, neutropenia post-chemotherapy, GVHD, and post HSCT.

Pregnancy : Based on animal data, may cause fetal harm. ( 8.1 ) Pediatrics : Safety and effectiveness in patients younger than 2 years of age have not been established. ( 8.4 ) Severe Renal Impairment : Monitor closely for breakthrough fungal infections. ( 8.6 ) 8.1 Pregnancy Risk Summary Based on findings from animal data, posaconazole may cause fetal harm when administered to pregnant women. Available data for use of posaconazole in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, skeletal malformations (cranial malformations and missing ribs) and maternal toxicity (reduced food consumption and reduced body weight gain) were observed when posaconazole was dosed orally to pregnant rats during organogenesis at doses ≥1.4 times the 400 mg twice daily oral suspension regimen based on steady-state plasma concentrations of posaconazole in healthy volunteers. In pregnant rabbits dosed orally during organogenesis, increased resorptions, reduced litter size, and reduced body weight gain of females were seen at doses 5 times the exposure achieved with the 400 mg twice daily oral suspension regimen. Doses of ≥ 3 times the clinical exposure caused an increase in resorptions in these rabbits (see Data).

Metabolism

General Pharmacokinetic Characteristics Posaconazole delayed-release tablets exhibit dose proportional pharmacokinetics after single and multiple dosing up to 300 mg. The mean pharmacokinetic parameters of posaconazole at steady state following administration of posaconazole delayed-release tablets 300 mg twice daily on Day 1, then 300 mg once daily thereafter in healthy volunteers and in neutropenic patients who are receiving cytotoxic chemotherapy for AML or MDS or HSCT recipients with GVHD are shown in Table 20.

There is no experience with overdosage of posaconazole delayed-release tablets. During the clinical trials, some patients received Noxafil ® oral suspension up to 1600 mg/day with no adverse reactions noted that were different from the lower doses. In addition, accidental overdose was noted in one patient who took 1200 mg twice daily Noxafil ® oral suspension for 3 days. No related adverse reactions were noted by the investigator. Posaconazole is not removed by hemodialysis.

• Sep 15, 2006NDANDA022003Schering
• Nov 25, 2013NDANDA205053Merck Sharp Dohme
• Mar 13, 2014NDANDA205596Merck Sharp Dohme
• Aug 21, 2019ANDAANDA212411Sinotherapeutics Inc
• May 15, 2020ANDAANDA208773Hikma
• Feb 1, 2021ANDAANDA213454Aet Pharma
• May 31, 2021NDANDA214770Msd Merck Co
• Feb 4, 2022ANDAANDA214476Biocon Pharma

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Noxafil, Injection, 18 mg/1 mL (NDC 0085-4331-01)To be discontinued
  Sponsor: Merck Sharp & Dohme Corp.
  Updated Dec 2, 2025

1. 1Off Label Use1,59310%
2. 2Drug Ineffective1,4579.3%
3. 3Febrile Neutropenia1,0396.6%
4. 4Product Use In Unapproved Indication9776.2%
5. 5Death9586.1%
6. 6Drug Interaction9526.1%
7. 7Pyrexia8705.5%
8. 8Neutropenia7244.6%
9. 9Pneumonia6644.2%
10. 10Thrombocytopenia5153.3%
11. 11Diarrhoea5073.2%
12. 12Nausea4923.1%
13. 13Septic Shock4502.9%
14. 14Condition Aggravated4322.7%
15. 15Acute Kidney Injury4192.7%

The 10 most recently updated of 115 ClinicalTrials.gov registrations naming Posaconazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML
  Not yet recruiting · Phase 2 · Interventional · 88 enrolled · UNC Lineberger Comprehensive Cancer Center
  NCT07605949updated 2026-06-09
• Amphotericin Versus Posaconazole for Pulmonary Mucormycosis
  Completed · Phase 2 · Interventional · 82 enrolled · Post Graduate Institute of Medical Education and Research, Chandigarh
  NCT05468372updated 2026-05-22
• Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression
  Recruiting · Phase 1 · Phase 2 · Interventional · 84 enrolled · AstraZeneca
  NCT07155226updated 2026-05-19
• Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)
  Not yet recruiting · Phase 3 · Interventional · 664 enrolled · University of Minnesota
  NCT07261150updated 2026-05-08
• A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients
  Recruiting · Phase 2 · Interventional · 160 enrolled · Chinese PLA General Hospital
  NCT06928376updated 2026-05-08
• Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant
  Recruiting · Phase 1 · Phase 2 · Interventional · 20 enrolled · Benjamin Tomlinson
  NCT06129734updated 2026-04-27
• A Study of BGB-11417 in Participants With Myeloid Malignancies
  Recruiting · Phase 1 · Phase 2 · Interventional · 260 enrolled · BeiGene
  NCT04771130updated 2026-04-23
• Imetelstat Combinations in Relapsed AML
  Recruiting · Phase 1 · Interventional · 36 enrolled · Douglas Tremblay
  NCT07320235updated 2026-04-22
• Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
  Completed · Phase 3 · Interventional · 602 enrolled · Mundipharma Research Limited
  NCT04368559updated 2026-04-13
• A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)
  Recruiting · Phase 1 · Phase 2 · Interventional · 606 enrolled · Sumitomo Pharma America, Inc.
  NCT04988555updated 2026-03-24

Frequently asked questions

How does Posaconazole work?

Posaconazole is an azole antifungal agent [ see Clinical Pharmacology (12.4) ].

What is Posaconazole used for?

According to FDA labeling, Posaconazole carries indications including: Posaconazole is an azole antifungal indicated as follows: Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: ( 1.2 ) o Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see Clinical Studies (14.2) ] as follows: Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh gr…. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Posaconazole?

Posaconazole is classified as Triazole and tetrazole derivatives, Azole Antifungal, 14-alpha Demethylase Inhibitors, Ergosterol Synthesis Inhibitors, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Decreased Cell Membrane Integrity.

What are the brand names for Posaconazole?

Posaconazole is marketed under brand names including Mometamax Single, Noxafil, Posatex.

What are the contraindications for Posaconazole?

Posaconazole labeling lists contraindications including: Known hypersensitivity to posaconazole or other azole antifungal agents. ( 4.1 ) Coadministration of posaconazole with the following drugs is contraindicated; posaconazole increases concentrations and toxicities of: Sirolimus ( 4.2 , 5.1 , 7.1 ) CYP3A4 substrates (pimozide, quinidine): can result in QTc interval prolongation and cases of torsades de pointes (TdP) ( 4.3 , 5.2 , 7.2 ) HMG-CoA Reductase Inhibitors Primarily Metabolized through CYP3A4 ( 4.4 , 7.3 ) Ergot alkaloids ( 4.5 , 7.4 ) Venetoclax: In patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) at initiation and during the ramp-up phase ( 4.6 , 5.11 , 7.16 ) 4.1 Hypersensitivity Posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents.. Always consult the full prescribing information and a clinician.