Noxafil (posaconazole)

Posaconazole oral suspension and delayed-release tablets are not interchangeable and cannot be substituted for each other without a change in dosage and frequency of administration. (See Dispensing and Dosage and Administration Precautions under Administration: Oral Administration, in Dosage and Administration.)

Dosage recommendations for the specific posaconazole preparation must be followed.

Posaconazole is administered orally or by slow IV infusion.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Posaconazole is contraindicated in patients with known hypersensitivity to posaconazole or other azole antifungals.

Concomitant use with sirolimus is contraindicated. (See Drug Interactions: Immunosuppressive Agents.)

Concomitant use with ergot alkaloids (e.g., ergotamine, dihydroergotamine) is contraindicated. (See Drug Interactions: Ergot Alkaloids.)

Concomitant use with drugs that are substrates for cytochrome P-450 (CYP) 3A4 and for which elevated plasma concentrations may be associated with prolonged QT interval corrected for rate (QTc) and rare occurrences of torsades de pointes (e.g., pimozide, quinidine) is contraindicated. (See Drug Interactions: Drugs that Prolong the QT Interval.)

Concomitant use with HMG-CoA reductase inhibitors (statins) principally metabolized by CYP3A4 (e.g., atorvastatin, lovastatin, simvastatin) is contraindicated. (See Drug Interactions: HMG-CoA Reductase Inhibitors.)

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in 5% or more of patients receiving posaconazole include GI effects (nausea, vomiting, diarrhea, abdominal pain, anorexia, constipation, dry mouth, dyspepsia, flatulence, decreased appetite ), fever, headache, increased sweating, rigors, chills, mucosal inflammation, dizziness, fatigue, edema (legs), asthenia, weakness, decreased weight, dehydration, hypertension, and hypotension. Vaginal hemorrhage, tachycardia, bacteremia, pneumonia, herpes simplex infection, cytomegalovirus infection, oral candidiasis, pharyngitis, musculoskeletal pain, arthralgia, back pain, petechiae, insomnia, coughing, dyspnea, epistaxis, rash, and pruritus also were reported in 5% or more of patients. Anemia, neutropenia, thrombocytopenia, hypocalcemia, hypokalemia, hypomagnesemia, hyperglycemia, increased AST, increased ALT, increased gamma-glutamyltransferase (GGT, gamma-glutamyl transpeptidase, GGPT), increased alkaline phosphatase, and bilirubinemia were reported in 2% or more of patients. Serious adverse effects, including fever and neutropenia, were reported more frequently when the drug was used in patients with refractory oropharyngeal candidiasis (especially in those severely immunocompromised by advanced HIV infection) than when used for prophylaxis.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy of posaconazole oral suspension and delayed-release tablets have not been established in children younger than 13 years of age.

Safety and efficacy of IV posaconazole have not been established in patients younger than 18 years of age.

The manufacturer states that use of posaconazole oral suspension or delayed-release tablets in pediatric patients 13-17 years of age is supported by evidence from adequate and well-controlled studies in adults.

Data from a limited number of pediatric patients 13-17 years of age who received posaconazole oral suspension (200 mg 3 times daily) for prophylaxis of invasive fungal infections indicate that the safety profile and mean steady-state plasma posaconazole concentrations in this age group are similar to those reported in adults 18 years of age or older.

Comparison of pharmacokinetic data from a limited number of pediatric patients 8-17 years of age who received posaconazole oral suspension (400 mg 2 times or 200 mg 4 times daily) for the treatment of invasive fungal infections+ with pharmacokinetic data from adults 18 years of age or older indicates that mean steady-state plasma posaconazole concentrations in pediatric patients and adults are similar.

Posaconazole oral suspension has been used in a limited number of children 7 years of age+ or older without unusual adverse effects.

The US Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), IDSA, and American Academy of Pediatrics (AAP) state that data are insufficient to date to make recommendations regarding use of posaconazole in HIV-infected infants and children.

There are no adequate and well-controlled studies in pregnant women. Posaconazole should be used during pregnancy only when potential benefits outweigh possible risks to the fetus.

The Infectious Diseases Society of America (IDSA) states that use of posaconazole should be avoided during pregnancy, especially during the first trimester.

Posaconazole has been shown to cause skeletal malformations (cranial malformations and missing ribs) when given to rats at dosages at least 1.4 times greater than a human dosage of the oral suspension of 400 mg twice daily (based on steady-state plasma concentrations). No malformations were seen in rabbits given a posaconazole dosage of 80 mg/kg (exposure levels 5.2 times higher than human exposures achieved with a dosage of the oral suspension of 400 mg twice daily); however, this dosage was associated with an increase in resorptions, reduction in body weight gain of females, and reduction in litter size.

Posaconazole is distributed into milk in rats; it is not known whether the drug is distributed into milk in humans.

Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or posaconazole, taking into account the importance of the drug to the woman.

Dosage adjustments are not necessary when oral or IV posaconazole is used in geriatric adults 65 years of age or older.

Although no overall differences in safety and pharmacokinetics were observed between geriatric and younger adults in clinical studies evaluating posaconazole oral suspension, posaconazole delayed-release tablets, or IV posaconazole, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.