Oxandrolone (OxandrinOxandrolone (Oxandrin®®) ) and the Risk of and the Risk of Peliosis HepatisPeliosis Hepatis
Troy Kish, Pharm.D.Troy Kish, Pharm.D.Pharmacy Practice Resident (PGY-1)Pharmacy Practice Resident (PGY-1)
Department of PharmacyDepartment of PharmacyKingsbrook Jewish Medical CenterKingsbrook Jewish Medical Center
Brooklyn, NYBrooklyn, NY
Clinical Instructor of Pharmacy Practice Clinical Instructor of Pharmacy Practice Arnold & Marie Schwartz College of Pharmacy andArnold & Marie Schwartz College of Pharmacy and
Health Sciences of Long Island UniversityHealth Sciences of Long Island UniversityBrooklyn, NYBrooklyn, NY
Peliosis Hepatis (PH) DefinedPeliosis Hepatis (PH) Defined
Blood filled cysts ranging from <1 cm to Blood filled cysts ranging from <1 cm to several centimeters in sizeseveral centimeters in size
Seen in parenchymal cellsSeen in parenchymal cellsOften occurs in liver, but can also develop Often occurs in liver, but can also develop
in lung, spleen, bone marrow, and lymph in lung, spleen, bone marrow, and lymph nodesnodes
Peliosis HepatisPeliosis Hepatis
Causes of PHCauses of PH
IdiopathicIdiopathicKidney or heart transplantationKidney or heart transplantationHIVHIVMalignancyMalignancy
Hodgkin’sHodgkin’sMultiple myelomaMultiple myeloma
BacterialBacterialBartonella spp.Bartonella spp.
Drug Induced PHDrug Induced PH
Androgenic-anabolic steroidsAndrogenic-anabolic steroidsTamoxifen (NolvadexTamoxifen (Nolvadex®®))Oral contraceptivesOral contraceptivesAzathioprineAzathioprineCorticosteroidsCorticosteroidsArsenicArsenic
Overview of Overview of Oxandrolone (OxandrinOxandrolone (Oxandrin®®))
Synthetic testosterone derivativeSynthetic testosterone derivative1717ββ-hydroxy-17-hydroxy-17αα-methyl-2-oxa-5-methyl-2-oxa-5αα--
androstan-3oneandrostan-3one1/6 of testosterone’s androgenic activity1/6 of testosterone’s androgenic activity6.3x anabolic activity of methyltestosterone6.3x anabolic activity of methyltestosterone
Indications for Oxandrolone UseIndications for Oxandrolone Use
Adjunctive therapy to promote weight gain Adjunctive therapy to promote weight gain in patients who:in patients who:Undergo extensive surgeryUndergo extensive surgeryHave chronic infectionsHave chronic infectionsSuffer severe traumaSuffer severe traumaFail to maintain normal weightFail to maintain normal weight
Offset corticosteroid induced protein Offset corticosteroid induced protein catabolism in chronic therapycatabolism in chronic therapy
Relief of bone pain associated with Relief of bone pain associated with osteoporosisosteoporosis
Reports of PH with Androgen TherapyReports of PH with Androgen TherapyPatientPatient DrugDrug Total Dose Total Dose
(g)(g)
DurationDuration
(months)(months)
DeathDeath
70 yo M70 yo M OxymetholoneOxymetholone 2222 1919 YesYes
64 yo F64 yo F OxymetholoneOxymetholone 55 1.51.5 YesYes
31 yo F31 yo F Oxymetholone;Oxymetholone;
Methyltestost-Methyltestost-eroneerone
1414
n/an/a
33
44
YesYes
74 yo M74 yo M Oxymetholone; Oxymetholone; TestosteroneTestosterone
1010
n/an/a
1010
1313
YesYes
68 yo F68 yo F OxymetholoneOxymetholone 4141 1818 YesYes
1 yo M1 yo M OxymetholoneOxymetholone 5656 1717 YesYes
31 yo M31 yo M OxymetholoneOxymetholone 3030 77 YesYes
Nadell et al Arch Pathol Lab Med 1977;101:405-410
Reports of PH with Androgen TherapyReports of PH with Androgen Therapycont….cont….
PatientPatient DrugDrug Total Dose Total Dose
(g)(g)
DurationDuration
(months)(months)
DeathDeath
41 yo M41 yo M OxymetholoneOxymetholone 1414 66 YesYes
27 yo M27 yo M TestosteroneTestosterone
OxymetholoneOxymetholone
86862020
141466
YesYes
50 yo F50 yo F OxymetholoneOxymetholone 3535 1111 YesYes
n/a Mn/a M FluoxymesteroneFluoxymesterone n/an/a n/an/a YesYes
24 yo M24 yo M OxymetholoneOxymetholone 33 4848 YesYes
Nadell et al Arch Pathol Lab Med 1977;101:405-410
Reports of PH with Androgen TherapyReports of PH with Androgen Therapycont….cont….
PatientPatient DrugDrug Total Dose Total Dose
(g)(g)
DurationDuration
(months)(months)
DeathDeath
67 yo M67 yo M11 OxymetholoneOxymetholone ~143~143 2424 NoNo
54 yo M54 yo M22 Unknown “sex Unknown “sex hormone pill”hormone pill”
n/an/a n/an/a YesYes
3 FA pts3 FA pts33
1 non-FA1 non-FA
OxymetholoneOxymetholone 4, 3, 1.5 (g/kg)4, 3, 1.5 (g/kg)
0.7 (g/kg)0.7 (g/kg)
n/an/a n/an/a
1. Arnold et al American Journal of Gastroenterology 1979; 71:213-216
2. Yap et al Ann Acad med Singapore 1993;22(3):381-383
3. Altay Clin Genet 1997;51:296-302
FA= Fanconi’s Anemia
Oxandrolone and PHOxandrolone and PH
MEDLINE search from 1964 to 2009 using MEDLINE search from 1964 to 2009 using search terms “Peliosis hepatis” and search terms “Peliosis hepatis” and “Oxandrolone” yielded 0 reports“Oxandrolone” yielded 0 reports
Clinical ApplicationClinical Application
Baseline monitoring parametersBaseline monitoring parametersAST, ALT, bilirubin, alkaline phosphataseAST, ALT, bilirubin, alkaline phosphataseMonitor Monitor weeklyweekly following therapy initiation following therapy initiation
Continually assess need for therapyContinually assess need for therapyPatient’s weight, nutritional status, wound sizePatient’s weight, nutritional status, wound size
Adjust dose in renal dysfunctionAdjust dose in renal dysfunctionStart at 5 mg BID when CrCl <60 mL/min or Start at 5 mg BID when CrCl <60 mL/min or
patient on dialysispatient on dialysis
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