Posaconazole

Posaconazole Brand Name– Noxafil

What is Posaconazole

Posaconazole (SCH 56592) is a broad-spectrum oral triazole antifungal agent, structurally similar to itraconazole.

Posaconazole is significantly more potent at inhibiting 14-alpha demethylase than itraconazole and is more effective than itraconazole against invasive molds, including Aspergillus and Fusarium spp.

Also, effective against strains of Cryptococcus neoformans and Scedosporium apiospermum. 

Posaconazole is the first agent approved for prophylaxis of invasive Aspergillus and Candida in severely immunocompromised adults and adolescents (e.g., hematopoietic stem cell transplant recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy).

Posaconazole oral suspension was approved by the FDA on September 15, 2006 for prophylaxis of invasive Aspergillus and Candida infections.

An NDA was submitted May 2004 for the oral suspension for treatment of invasive fungal infections in patients with refractory disease or who are intolerant to other therapy; the FDA accepted the NDA July 13, 2004.

In Italy, preclinical studies have also been performed but data are not yet available. On October 27, 2005, the European Commission approved Noxafil (posaconazole) oral suspension for treatment of certain serious invasive fungal infections in adult patients with disease that is refractory to, or who are intolerant of, commonly used antifungal agents.

The oral suspension also received FDA approval for the treatment of oropharyngeal candidiasis on February 19, 2009.

Subsequently, two additional formulations have been approved by the FDA for prophylaxis of invasive Aspergillus and Candida infections, a delayed-release tablet on November 25, 2013 and an injection for infusion on March 13, 2014.

Indications

1. allergic bronchopulmonary aspergillosis
2. aspergillosis
3. aspergillosis prophylaxis
4. Aspergillus fumigatus
5. Candida albicans
6. candidiasis prophylaxis
7. cellulitis
8. Coccidioides immitis
9. coccidioidomycosis
10. coccidioidomycosis prophylaxis
11. cryptococcosis
12. Cryptococcus neoformans
13. endocarditis
14. endophthalmitis
15. esophageal candidiasis
16. fungal keratitis
17. fusariosis
18. Fusarium sp.
19. histoplasmosis
20. histoplasmosis prophylaxis
21. infectious arthritis
22. meningitis
23. Mucor sp.
24. myocarditis
25. oropharyngeal candidiasis (thrush)
26. osteomyelitis
27. pericarditis
28. Rhizopus sp.
29. Scedosporium sp.
30. sinusitis
31. tracheobronchitis

Side Effects

1. abdominal pain
2. anemia
3. anorexia
4. arthralgia
5. asthenia
6. back pain
7. candidiasis
8. chills
9. cholestasis
10. constipation
11. cough
12. dehydration
13. diarrhea
14. dizziness
15. dyspepsia
16. dyspnea
17. edema
18. elevated hepatic enzymes
19. epistaxis
20. fatigue
21. fever
22. headache
23. hemolytic-uremic syndrome
24. hepatic failure
25. hepatitis
26. hepatomegaly
27. hyperbilirubinemia
28. hyperglycemia
29. hyperhidrosis
30. hypertension
31. hypocalcemia
32. hypokalemia
33. hypomagnesemia
34. hypotension
35. infection
36. insomnia
37. jaundice
38. musculoskeletal pain
39. nausea
40. neutropenia
41. pancreatitis
42. paresthesias
43. peripheral edema
44. petechiae
45. pharyngitis
46. phlebitis
47. pruritus
48. pulmonary embolism
49. QT prolongation
50. rash
51. renal failure (unspecified)
52. sinus tachycardia
53. stomatitis
54. thrombocytopenia
55. thrombotic thrombocytopenic purpura (TTP)
56. torsade de pointes
57. vaginal bleeding
58. vomiting
59. weakness
60. weight loss

Monitoring Parameters

• LFTs
• serum creatinine
• serum electrolytes

Contraindications

• apheresis
• AV block
• azole antifungals hypersensitivity
• bradycardia
• breast-feeding
• cardiomyopathy
• celiac disease
• children
• diarrhea
• electrolyte imbalance
• females
• fever
• geriatric
• heart failure
• hepatic disease
• hepatitis
• human immunodeficiency virus (HIV) infection
• hyperparathyroidism
• hypocalcemia
• hypokalemia
• hypomagnesemia
• hypothermia
• hypothyroidism
• infants
• long QT syndrome
• myocardial infarction
• neonates
• obesity
• pheochromocytoma
• pregnancy
• QT prolongation
• renal impairment
• rheumatoid arthritis
• sickle cell disease
• sleep deprivation
• stroke
• systemic lupus erythematosus (SLE)
• vomiting

Interactions

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