NEWS HIGHLIGHTS
Published Studies Related to Noxafil (Posaconazole)
Lack of pharmacokinetic drug interaction between oral posaconazole and caspofungin or micafungin. [2011.01]
The objective of this phase 1, open-label, parallel, randomized study was to determine the effect of posaconazole on the pharmacokinetics of caspofungin and micafungin in 67 healthy subjects. Caspofungin (70 mg on day 1, 50 mg on days 2-14 once daily; 1-hour intravenous infusion) (cohort 1) or micafungin (150 mg once daily days 1-7; 1-hour IV infusion) (cohort 2) was administered alone or with posaconazole oral suspension 400 mg twice daily, on days 1 to 14 (cohort 1) or days 1 to 7 (cohort 2).
Economic evaluation of posaconazole versus fluconazole prophylaxis in patients with graft-versus-host disease (GVHD) in the Netherlands. [2010.09]
The objective of this study was to evaluate the cost-effectiveness of posaconazole versus fluconazole for the prevention of invasive fungal infections (IFI) in graft-versus-host disease (GVHD) patients in the Netherlands. A decision analytic model was developed based on a double-blind randomized trial that compared posaconazole with fluconazole antifungal prophylaxis in recipients of allogeneic HSCT with GVHD who were receiving immunosuppressive therapy (Ullmann et al., N Engl J Med 356:335-347, 2007)...
Exposure-response of posaconazole used for prophylaxis against invasive fungal infections: evaluating the need to adjust doses based on drug concentrations in plasma. [2010.07]
The purpose of this article is to report the exposure-response (E-R) relationship of posaconazole oral suspension (POS) for prophylaxis against invasive fungal infections (IFIs), on the basis of the US Food and Drug Administration (FDA) clinical pharmacology review of two randomized, active-controlled clinical studies...
[Economic evaluation of posaconazole in prophylaxis of invasive fungal infections in Italian neutropenic patients with acute myeloid leukaemia or myelodysplastic syndrome]. [2010.06]
The objective of this study was to assess the costs and effectiveness (avoided invasive fungal infections - IFIs; overall mortality) of prophylaxis with posaconazole 200 mg per os TID and standard azoles (fluconazole 400 mg per os OD, itraconazole 200 mg per os BID) in neutropenic patients with acute myelogenous leukaemia or myelodysplastic syndromes.
Skin concentrations and pharmacokinetics of posaconazole after oral administration. [2010.05]
A randomized, single-center, open-label study of posaconazole (POS) was performed to determine the concentration of POS in the skin of 30 healthy adult human subjects receiving 400 mg POS oral suspension twice daily for 8 days with a high-fat meal. Blood samples for plasma POS level determination were collected at prespecified times on day 1 and day 8...
Clinical Trials Related to Noxafil (Posaconazole)
A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2) [Active, not recruiting]
Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension in Subjects at High Risk for Invasive Fungal Infections (Study P05520AM1) [Recruiting]
The purpose of this study is to collect pharmacokinetic (PK) information related to how well
intravenous Posaconazole (POS IV), is distributed in the body and to determine the safety
and tolerability of this new formulation. In addition, the PK, safety, and tolerability of
switching from taking POS IV to taking Posaconazole Oral Suspension (POS Oral) will be
evaluated. The data collected in this study will be compared to data collected in previous
studies.
Individuals who have been diagnosed by their physicians with a blood disease or cancer that
can affect their infection-fighting white blood cells will be asked to participate in the
trial. Since these blood diseases and their treatments can weaken the immune system, they
may put these individuals at a high risk for getting a serious fungal infection of their
internal organs or blood (invasive fungal infection). As these fungal infections can be
hard to detect early and can be life-threatening, many physicians believe that individuals
diagnosed with these diseases should receive antifungal therapy to try to lower their risk
of getting this type of infection.
Enrollment into this study will take place in several stages (cohorts). The determination
of which cohort an individual will be asked to participate in is based on which cohort is
open at the site at the time the individual is approached to consider study participation.
Overall, about 250 individuals (subjects) are expected to take part in this study from
approximately 48 centers around the world.
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome [Recruiting]
The purpose of this study is to compare the effects, good and/or bad, of posaconazole and
micafungin in preventing fungal infections after chemotherapy for acute leukemia or
myelodysplastic syndrome. When people take chemotherapy, they are more likely to get
infections. Posaconazole has been approved for the prevention of fungal infections in
patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome.
Posaconazole is available only as an oral suspension and has to be given with food. After
chemotherapy, many patients are not able to tolerate food or oral medication because of
severe mucositis. Patients unable to tolerate food and oral medications cannot take
posaconazole.
Micafungin is an antifungal medication that is given only intravenously. Micafungin is
approved for the treatment of certain fungal infections and for preventing fungal infections
in patients who receive bone marrow transplant. The investigators know that micafungin is
safe. Micafungin has not been tested for the prevention of fungal infections in patients
receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin
is given by vein, it can be given even in patients who cannot take food or medications by
mouth after chemotherapy. In this study the investigators want to compare micafungin to
posaconazole when given for the prevention of fungal infections in leukemia and
myelodysplastic syndrome patients.
Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia [Recruiting]
The goal of this clinical research study is to learn the amount of posaconazole that is in
the body at different time points when given to patients with leukemia. The safety of this
drug will also be studied.
Primary Objective:
To study the plasma pharmacokinetics of posaconazole in patients with newly diagnosed acute
myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) undergoing
induction chemotherapy or relapsed or refractory patients who will receive salvage
chemotherapy.
Secondary Objective:
To evaluate the safety of posaconazole given as prophylaxis..
A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105 AM1) [Recruiting]
This single site study will examine plasma and alveolar compartment (AC) levels of
posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant
recipients receiving routine post-operative anti-fungal prophylaxis. Fungal infection rates
will be assessed following transplantation.
Reports of Suspected Noxafil (Posaconazole) Side Effects
Drug Interaction (14),
Sinoatrial Block (7),
Atrioventricular Block Second Degree (6),
Myositis (6),
Nodal Arrhythmia (5),
Septic Shock (5),
Sinus Tachycardia (5),
Sinus Bradycardia (4),
Diabetes Mellitus (3),
Neuropathy Peripheral (3), more >>
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