POSACONAZOLE
Generic: POSACONAZOLE
Basic Information
Manufacturer
Lupin Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
548124ce-8050-46a9-967b-ff23dfb18633
Indications & Usage
1 INDICATIONS AND USAGE 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 ) ○ 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 as follows: Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg.
Adverse Reactions
6 ADVERSE REACTIONS The following serious and otherwise important adverse reactions are discussed in detail in another section of the labeling: Arrhythmias and QT Prolongation [see Warnings and Precautions ( 5.2 )] Electrolyte Disturbances [see Warnings and Precautions ( 5.3 )] Pseudoaldosteronism [see Warnings and Precautions ( 5.4 )] Hepatic Toxicity [see Warnings and Precautions ( 5.5 )] Adult Patients: Common adverse reactions in studies with posaconazole are diarrhea, nausea, fever, vomiting, headache, coughing, and hypokalemia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AET Pharma US Inc, USA at 1 833-610-1604 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 with Posaconazole Delayed-Release Tablets for Prophylaxis of Invasive Aspergillus and Candida Infections 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.
This patient population was 62% male, had a mean age of 51 years (range 19-78 years, 17% of patients were ≥65 years of age), and were 93% White and 16% Hispanic.
Posaconazole therapy was given for a median duration of 28 days .
In this study, 20 adult patients received 200 mg daily dosage (this is not a recommended dosage [see Dosage and Administration ( 2.2 )] ) and 210 adult patients received 300 mg daily dosage (following twice daily dosing on Day 1 in each cohort).
Table 9 presents adverse reactions (incidence of ≥10%) observed in patients treated with posaconazole delayed-release tablets 300 mg daily dosage in the Posaconazole Delayed-Release Tablet Study.
The most frequently reported adverse reactions (>25%) in patients treated with posaconazole delayed-release tablets 300 mg once daily were diarrhea, pyrexia, and nausea.
The most common adverse reaction leading to discontinuation of posaconazole delayed-release tablets 300 mg once daily was nausea (2%).
Table 9: Adverse Reactions in at least 10% of Adults Receiving Posaconazole Delayed-Release Tablets (300 mg Daily Dosage) for the Prophylaxis of Invasive Aspergillus and Candida infections Adverse Reactions Posaconazole delayed-release tablet (300 mg) n=210 (%) Percentage of Patients Reporting any Adverse Reaction 99 Diarrhea 29 Pyrexia 28 Nausea 27 Hypokalemia 22 Cough 17 Edema Peripheral 16 Rash 16 Epistaxis 14 Headache 14 Mucosal Inflammation 14 Thrombocytopenia 14 Vomiting 13 Abdominal Pain 11 Hypertension 11 Anemia 10 Asthenia 10 Chills 10 Constipation 10 Hypomagnesemia 10 6.2 Postmarketing Experience The following adverse reaction has been identified during the post-approval use of posaconazole.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Endocrine Disorders: Pseudoaldosteronism
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AET Pharma US Inc, USA at 1 833-610-1604 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 with Posaconazole Delayed-Release Tablets for Prophylaxis of Invasive Aspergillus and Candida Infections 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.
This patient population was 62% male, had a mean age of 51 years (range 19-78 years, 17% of patients were ≥65 years of age), and were 93% White and 16% Hispanic.
Posaconazole therapy was given for a median duration of 28 days .
In this study, 20 adult patients received 200 mg daily dosage (this is not a recommended dosage [see Dosage and Administration ( 2.2 )] ) and 210 adult patients received 300 mg daily dosage (following twice daily dosing on Day 1 in each cohort).
Table 9 presents adverse reactions (incidence of ≥10%) observed in patients treated with posaconazole delayed-release tablets 300 mg daily dosage in the Posaconazole Delayed-Release Tablet Study.
The most frequently reported adverse reactions (>25%) in patients treated with posaconazole delayed-release tablets 300 mg once daily were diarrhea, pyrexia, and nausea.
The most common adverse reaction leading to discontinuation of posaconazole delayed-release tablets 300 mg once daily was nausea (2%).
Table 9: Adverse Reactions in at least 10% of Adults Receiving Posaconazole Delayed-Release Tablets (300 mg Daily Dosage) for the Prophylaxis of Invasive Aspergillus and Candida infections Adverse Reactions Posaconazole delayed-release tablet (300 mg) n=210 (%) Percentage of Patients Reporting any Adverse Reaction 99 Diarrhea 29 Pyrexia 28 Nausea 27 Hypokalemia 22 Cough 17 Edema Peripheral 16 Rash 16 Epistaxis 14 Headache 14 Mucosal Inflammation 14 Thrombocytopenia 14 Vomiting 13 Abdominal Pain 11 Hypertension 11 Anemia 10 Asthenia 10 Chills 10 Constipation 10 Hypomagnesemia 10 6.2 Postmarketing Experience The following adverse reaction has been identified during the post-approval use of posaconazole.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Endocrine Disorders: Pseudoaldosteronism