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Noxafil

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Posaconazole

Treatment option: Aspergillosis,Aspergilloma, Fungal Infection, Infection, Candidiasis,Vaginal, Coccidioidomycosis, Leukemia, Myelodysplastic Diseases, Neutropenia, Acute Nonlymphocytic Leukemia, Fusariosis

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Noxafil

Quick Facts

Property	Description
Active ingredient	Posaconazole (INN)
Form	Delayed-release tablet, Oral suspension, IV Injection
Pharmacological class	Triazole Antifungal (Azole)
Common use	Prevention and treatment of serious fungal infections
Origin	Synthetic (Chemically synthesized)

What Type of Medicine is Posaconazole (Noxafil)?

Noxafil is the brand name for the prescription drug posaconazole, which is classified as a synthetic triazole antifungal agent. This single-ingredient medicine belongs to a class of powerful agents used systemically to fight invasive fungal infections. Posaconazole has an extended spectrum of activity, providing coverage against many yeasts and molds, including species that may show resistance to older antifungal agents.

What Forms Does Noxafil Come In?

Noxafil is available in three primary formulations: an oral suspension, a delayed-release tablet, and an intravenous (IV) injection solution. This range of dosage forms is a unique feature, ensuring that patients—even those critically ill or unable to swallow—can receive the medicine reliably. The active component is posaconazole, which is formulated with excipients designed to provide more consistent absorption in the bloodstream, particularly with the newer delayed-release tablets.

What is the General Purpose of This Antifungal Medicine?

The overall therapeutic purpose of Noxafil is to serve as a critical tool for the prevention and treatment of severe, life-threatening fungal infections in individuals with highly weakened immune systems. It is primarily used for prophylaxis (prevention) in high-risk patient populations, such as those undergoing intensive chemotherapy or stem cell transplantation. This targeted use makes it an essential part of supportive care, protecting patients whose bodies cannot adequately fight these dangerous pathogens alone.

What side effects are possible with Noxafil?

Noxafil (posaconazole) is an antifungal medication, and like all drugs, it can cause side effects. Patients should be closely monitored by their healthcare provider throughout the course of treatment.

Common Side Effects

The most frequently reported adverse reactions include gastrointestinal issues such as diarrhea, nausea, and vomiting. Other common side effects include fever, headache, and low potassium levels (hypokalemia).

Serious Warnings and Precautions

1. Hepatic Toxicity: Noxafil may cause elevated liver function tests (LFTs), which are usually reversible upon discontinuation. Serious liver damage, including liver failure, has been reported. Liver function should be monitored before and during therapy.

2. Arrhythmias and QTc Prolongation: Noxafil has been shown to prolong the QTc interval, a measure of heart rhythm, and may lead to rare, serious heart rhythm abnormalities like Torsade de Pointes. It is crucial to administer with caution in patients with proarrhythmic conditions (e.g., history of QTc prolongation, heart failure). Electrolyte levels (potassium, magnesium, calcium) should be corrected before and during treatment.

3. Drug Interactions: Posaconazole is known to interact with many other medications, significantly increasing the concentration of certain drugs, which can lead to serious toxicities. Specifically, Noxafil is contraindicated with drugs like sirolimus, pimozide, quinidine, certain HMG-CoA reductase inhibitors (statins), and ergot alkaloids. Healthcare providers must review all concomitant medications.

4. Allergic Reactions: Severe hypersensitivity reactions are possible. Patients should seek immediate medical attention if they experience signs of an allergic reaction, such as swelling of the face, lips, tongue, or throat, or a widespread rash.

Patients with severe diarrhea or vomiting must be monitored closely for breakthrough fungal infections, as these conditions may reduce the absorption and effectiveness of oral posaconazole formulations.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for posaconazole (Noxafil) provides specific guidance for management in cases of known or suspected overexposure.

Overdose Scope

Domain	Official Regulatory Statement
Documented overdose presentations	No adverse reactions were noted in a documented case of accidental overdosage, nor were high-dose reactions different from those reported at standard therapeutic doses.
Physiological systems affected	Adverse reactions observed at doses up to 1,600 mg/day were not different from those seen at the recommended lower doses.
Emergency-response statements	Treatment mandated is symptomatic and supportive care.
When immediate medical help is required	Emergency medical care is required when overexposure is known or suspected.

Overdose Management Constraints (high-level)

Classification	Official Regulatory Statement
Antidote information	No specific antidote is known for posaconazole.
Removal technique	The medicine is not removed by haemodialysis.

Resulting Overdose Structure

Official overdose statements:

Treatment for confirmed or suspected overdosage must be symptomatic and supportive.
The medicine is not removed by haemodialysis, and no specific antidote is known.

Connection to the overall overdose profile: The official documents define the overdose profile primarily through mandated emergency response actions, given the limited documented specific acute symptoms associated with high-dose exposure. This profile confirms that immediate, specialized medical assistance is required for any suspected overexposure to initiate symptomatic and supportive treatment and account for the constraints of drug removal.

Therapeutic Uses of Noxafil

What Noxafil Treats: Main Uses and Benefits

Noxafil (posaconazole) is generally a triazole antifungal agent used in situations involving certain distressing symptoms caused by fungal infections where functional stability becomes affected. Its main uses fall into the primary therapeutic domains of prophylaxis (prevention) and the therapeutic management of specific invasive fungal infections (IFIs).

Noxafil is commonly used across conditions presenting with acute episodes, specifically to prevent invasive fungal infections like Aspergillus and Candida in patients who are severely immunocompromised (e.g., those undergoing chemotherapy for blood cancers or receiving stem cell transplants). This provides support that helps ease the overall symptom burden in these high-risk groups.

For treatment, Noxafil may assist with managing various invasive fungal infections, including aspergillosis, fusariosis, coccidioidomycosis, chromoblastomycosis, and mycetoma. It is also applied in addressing oropharyngeal candidiasis (thrush), particularly in cases that are refractory to standard topical therapy. This contributes to improved comfort during periods of heightened symptoms, and it is considered relevant when supportive symptom management is appropriate.

Quick Fact: Relief for Symptoms related to systemic imbalance

Regulatory References

European Medicines Agency's overview of Noxafil

Eligibility and Restrictions for Use

The eligibility for Noxafil (posaconazole) is defined by strict criteria outlined in official regulatory documents, focusing on patient status, age, and organ function.

Contraindicated Populations

Use of Noxafil is contraindicated (absolutely prohibited) in persons with:

Known Hypersensitivity: Allergy to posaconazole or to any other azole antifungal agents [1.6, 2.6].
Hereditary Fructose Intolerance (HFI): Contraindicated for the PowderMix formulation [2.1].

Age-Related Eligibility

Age Group	Eligibility Status (Varies by Formulation)
Under 2 Years	Safety and effectiveness have not been established [1.3, 3.4].
2 Years and Older	Eligible for IV injection and delayed-release tablets (depending on weight) [1.3, 3.4].
Under 18 Years	The oral suspension is not recommended in this age group, per the EMA [1.2].
Older Adults ( ge 65 years)	No dosage adjustment is necessary based on age [1.3].

Conditional Use and Restrictions

Specific clinical conditions require caution or restriction:

Pregnancy and Lactation: Use during pregnancy must not be used unless the benefit outweighs the risk; women of childbearing potential are required to use effective contraception. Breastfeeding must be stopped upon initiation of therapy [1.2, 4.3].
Renal Impairment: The IV injection should be avoided in patients with moderate to severe renal impairment (creatinine clearance <50 mL/min) due to the accumulation risk of the intravenous vehicle [3.1]. Patients with severe renal impairment using oral forms must be monitored closely [2.4].
Cardiovascular Conditions: Administer with caution to patients with potentially proarrhythmic conditions, such as those with QTc prolongation [1.1, 2.7].

What should I know about interactions with other medicines?

Interactions with other medicines and products

Posaconazole (Noxafil) is documented to be a strong inhibitor of Cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp), which is the primary basis for its pharmacokinetic interactions. This inhibitory action can significantly increase the plasma concentration and exposure of co-administered medicinal products metabolized by these enzymes.

Official Interaction Restrictions

Formal restrictions govern the co-administration of Noxafil due to the risk of toxicity:

Classification	Interacting Substances	Official Restriction Basis
Contraindicated	Sirolimus, Statins (e.g., Simvastatin, Lovastatin), Ergot Alkaloids, QTc Prolonging Agents (e.g., Pimozide, Quinidine)	Risk of toxicity (e.g., rhabdomyolysis, QTc prolongation) due to increased exposure of co-administered drug.
Use with Caution	Calcineurin Inhibitors (e.g., Cyclosporine, Tacrolimus), Benzodiazepines, Digoxin	Posaconazole increases their plasma levels; monitoring or dose adjustment is required.

Co-administration with strong CYP450 Inducers (e.g., Rifabutin, Phenytoin) is cautioned against, as these agents significantly reduce posaconazole plasma concentrations. Additionally, the Oral Suspension formulation must be administered with a full meal or nutritional supplement, as food is required to achieve adequate drug absorption. Formulation-specific constraints include the contraindication of the IV injection in severe renal impairment due to excipient accumulation and the PowderMix formulation in Hereditary Fructose Intolerance.

Mechanism of Action

Targeted Inhibition of Fungal Sterol Metabolism

Posaconazole is an inhibitor of Lanosterol 14-alpha-demethylase (CYP51), a fungal enzyme necessary for the production of ergosterol. By binding to the enzyme's active site, the drug blocks the conversion of lanosterol, leading to the dual effect of ergosterol depletion and the accumulation of toxic intermediate sterols. This mechanistic cascade critically compromises the integrity and fluidity of the fungal cell membrane.

️ Mechanistic Limitations and Cellular Evasion

This mechanism can be functionally constrained by the fungal pathogen itself, primarily through mutations in the cyp51A gene that reduce Posaconazole's binding affinity to the target enzyme, or by the overexpression of efflux pump proteins. These evasion mechanisms actively limit the drug concentration at the site of action, preventing sufficient enzyme inhibition of the ergosterol synthesis pathway.

Dosage and Administration Information

How to Use Noxafil

Noxafil (posaconazole) must be used strictly according to the administration rules, as the different formulations are not interchangeable. The choice of dosage form—Delayed-Release Tablet, Oral Suspension, PowderMix, or Intravenous (IV) Injection—determines the exact administration requirements.

Administration Scope

Feature	Delayed-Release Tablet / Injection / PowderMix	Oral Suspension
Route of Administration	Oral / Intravenous Infusion	Oral
Timing in Relation to Meals	Administer with or without food	Administer with a full meal
Dosing Schedule	Loading dose (e.g., 300 mg twice daily) on Day 1, followed by maintenance dose (e.g., 300 mg once daily) starting Day 2	Varies by indication (e.g., 200 mg three times daily)

Procedural Instructions

Delayed-Release Tablets must be swallowed whole; they must not be divided, crushed, or chewed.
Oral Suspension must be shaken well before each use. If a patient cannot eat a full meal, the suspension should be taken with a liquid nutritional supplement or an acidic carbonated beverage (e.g., ginger ale).
IV Injection must be administered as an infusion over approximately 90 minutes via a central venous line. It must not be given as a rapid bolus injection.
PowderMix for Delayed-Release Oral Suspension must be mixed with the provided mixing liquid and used within one hour of preparation.

Missed Doses

If a dose is missed, take the dose as soon as possible and continue the regular dosing schedule; however, if it is close to the time for the next scheduled dose, skip the missed dose and return to the regular schedule. Do not take two doses to make up for a missed one.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Noxafil

The evaluation of posaconazole (Noxafil) was studied for its role in preventing and treating specific, serious fungal infections. This overview focuses strictly on the structure of the available research, describing the populations, measured outcomes, and documented study limitations, without offering any clinical advice or interpretation.

Evidence for Use in Preventing Invasive Fungal Infections (Prophylaxis)

Studies exploring the preventative use of posaconazole primarily involved Randomized Controlled Trials (RCTs). This type of research design is applied in studies examining comparative outcomes. These trials were observed in highly vulnerable populations, specifically adults and adolescents (typically age 13 and older) who are severely immunocompromised. This includes patients with prolonged neutropenia following intensive chemotherapy and individuals who have undergone Hematopoietic Stem Cell Transplant (HSCT) and developed Graft-versus-Host Disease (GVHD).

Researchers monitored several critical outcomes related to systemic or functional imbalance. The main outcomes were the measured incidence of proven or probable IFIs (specifically Aspergillus and Candida infections), all-cause mortality, and infection-related mortality over defined time intervals. Studies monitored for patterns related to the incidence of IFIs and patient survival in comparison to other antifungal agents.

Key Uncertainties and Research Gaps in the Evidence

One major limitation in the foundational research is related to the historical use of the original oral suspension formulation. Findings indicate that this formulation had variable and inconsistent oral absorption in patients, often influenced by the patient’s diet, gastric health, or co-existing conditions. This pharmacokinetic variability was associated with difficulty in achieving consistent drug levels.

Data for certain groups remain insufficient. Specifically, the evidence base for prophylactic use is less characterized in children under 13 years of age in the original pivotal trials. Additionally, the evidence consistency varies across studies for the treatment of rare invasive mycoses. The reliance on non-comparative salvage studies means that randomized comparisons against other agents are lacking in these areas. The results apply only to the populations studied, and research does not determine whether an individual will respond similarly.

How should Noxafil be stored and disposed of?

Storage and Disposal Instructions for Noxafil (Posaconazole)

Noxafil must be stored strictly according to its formulation and kept out of the sight and reach of children.

Formulation	Required Storage Condition
Delayed-Release Tablets & Oral Suspension	Controlled room temperature: 20 C to 25 C (68 F to 77 F), kept tightly closed in the original container.
IV Injection (Unopened Vial)	Refrigerated at 2 C to 8 C (36 F to 46 F).

Do not freeze the oral suspension or the IV injection. The IV injection is a single-dose solution; any unused portion must be discarded. Once diluted, the IV solution should be administered immediately or may be stored under refrigeration for a maximum of 24 hours. All unused or expired product must be disposed of according to local requirements for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.