Version May 2024
Peliosis hepatis, a condition in which liver and, sometimes, splenic tissue is replaced with blood-filled cysts, has occurred in patients receiving androgenic anabolic steroids. These cysts are sometimes present with minimal hepatic dysfunction and have been associated with liver failure. Often, they are not recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Withdrawal of drug usually results in complete disappearance of lesions.
Most often these tumors are benign and androgen-dependent, but fatal malignant tumors have occurred. Withdrawal of drug often results in regression or cessation of tumor progression. However, hepatic tumors associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be silent until life-threatening, intra-abdominal hemorrhage develops.
Blood lipid changes associated with increased risk of atherosclerosis are seen in patients treated with androgens and anabolic steroids. These changes include decreased high-density lipoprotein (HDL) and, sometimes, increased low-density lipoprotein (LDL). The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.
Note: Anadrol-50 has been discontinued in the United States for >1 year.
Erythropoietic effects: Oral: 1 to 5 mg/kg/day once daily; usual effective dose: 1 to 2 mg/kg/day; give for a minimum trial of 3 to 6 months because response may be delayed.
Fanconi anemia (alternative agent) (off-label use): Limited data available: Oral: Initial: 2 mg/kg/day (median dose reported); most patients had a documented dose reduction although exact doses were not provided; duration of therapy: 4.1 years (median for responders); 1.3 years (median for nonresponders) (Paustian 2016) or Initial: ~2 mg/kg/day; if response observed, slowly taper in 10% to 20% decrements every 3 to 4 months to achieve the lowest effective dose; doses up to 5 mg/kg/day may be required; discontinue if no response in blood counts (in the absence of other causes such as infection) after 3 to 4 months (FARF [Sroka 2020]).
No dosage adjustment provided in manufacturer’s labeling. Use with caution due to risk of edema in patients with renal impairment.
Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling.
Severe impairment: Use is contraindicated.
Refer to adult dosing.
(For additional information see "Oxymetholone (United States: Not available): Pediatric drug information")
Note: Anadrol-50 has been discontinued in the United States for >1 year.
Anemia, treatment (erythropoietic effect [eg, Fanconi anemia, bone marrow failure syndromes]):
Children and Adolescents: Oral: Initial: ~2 mg/kg/day, rounded to nearest 12.5 mg (ie, 1/4 of the 50 mg tablet); usual range: 1 to 5 mg/kg/day once daily; some have suggested higher dosing initially (2 to 5 mg/kg/day) and after response, a slow taper (eg, decrease dose by 10% to 20% every 3 to 4 months) to lowest effective dose with minimal side effects; typically, therapeutic response of stabilization or improvement in hemoglobin or platelet counts is observed within 3 to 6 months (Camitta 1979; FARF 2014). Note: The National Kidney Foundation recommends against the use of androgens as an adjuvant to erythropoiesis-stimulating agent treatment in anemic patients with chronic kidney disease (KDIGO 2012; KDOQI 2006). Although an FDA-approved indication, oxymetholone use in the treatment of aplastic anemia has been replaced by newer therapies with improved outcomes (eg, hematopoietic stem cell transplantation, immunosuppressive therapy) (BSH [Samarasinghe 2017]; NAPAAC [Rogers 2019]).
Children and Adolescents: There are no dosage adjustments provided in manufacturer's labeling. Use with caution due to risk of edema in patients with renal impairment; use is contraindicated in patients with nephrosis or patients in the nephrotic phase of nephritis.
Children and Adolescents:
Mild to moderate hepatic impairment: There are no dosage adjustments provided in manufacturer's labeling. Use with caution in patients with liver dysfunction because of its hepatotoxic potential.
Severe hepatic impairment: Use is contraindicated
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined:
Cardiovascular: Coronary artery disease, peripheral edema
Central nervous system: Chills, deepening of the voice (females), excitement, insomnia
Dermatologic: Acne vulgaris, androgenetic alopecia (postpubertal males, females), hyperpigmentation
Endocrine & metabolic: Amenorrhea, change in libido (decreased/increased), decreased glucose tolerance, decreased HDL cholesterol, gynecomastia, hirsutism (women), hypercalcemia, hyperchloremia, hyperkalemia, hypernatremia, hyperphosphatemia, increased LDL cholesterol, menstrual disease
Gastrointestinal: Diarrhea, nausea, vomiting
Genitourinary: Benign prostatic hypertrophy (elderly males), clitoromegaly, decreased ejaculate volume, epididymitis, erectile dysfunction (increased erections; prepubertal males), impotence, irritable bladder, oligospermia, phallic enlargement, priapism, testicular atrophy, testicular disease, virilization (females)
Hematologic & oncologic: Clotting factors suppression (II, V, VII, X), hemorrhage, increased INR, iron deficiency anemia, leukemia, malignant neoplasm of prostate, prolonged prothrombin time
Hepatic: Cholestatic hepatitis, cholestatic jaundice, hepatic failure, hepatic necrosis, hepatocellular neoplasm (including carcinoma), increased serum alkaline phosphatase, increased serum bilirubin, increased serum transaminases, peliosis hepatitis
Neuromuscular & skeletal: Increased creatine phosphokinase, premature epiphyseal closure (children)
Renal: Increased serum creatinine
Respiratory: Hoarseness (females)
<1%, postmarketing, and/or case reports: Hepatotoxicity (idiosyncratic; Chalasani 2014)
Hypersensitivity to oxymetholone or any component of the formulation; breast cancer in men; breast cancer in women with hypercalcemia; prostate cancer; severe hepatic dysfunction; nephrosis or nephrotic phase of nephritis; pregnancy or use in women who may become pregnant
Concerns related to adverse effects:
• Blood lipid changes: [US Boxed Warning]: Anabolic steroids may cause changes in blood lipids (decreased high density lipoproteins and sometimes increased low density lipoproteins), increasing the risk of arteriosclerosis and coronary artery disease.
• Clotting factor alterations: Anabolic steroids may suppress factors II, V, VII, and X; prothrombin time may be increased.
• Hepatic effects: [US Boxed Warning]: Androgenic anabolic steroid treatment may cause peliosis hepatis, which occurs when splenic or hepatic tissue is replaced by cysts (blood-filled); may only cause minimal hepatic dysfunction although has been associated with hepatic failure. Androgenic liver cell tumors, which may be benign, although malignant tumors have also been reported; generally regress when anabolic steroid treatment is withdrawn. Both conditions (peliosis and tumors) may not be apparent until liver failure or intra-abdominal hemorrhage develops. Androgen use (low doses) has also been associated with cholestatic hepatitis and jaundice; may be associated with hepatomegaly and right upper-quadrant pain; jaundice is typically reversible upon discontinuation (continuing treatment has been associated with coma and death). Monitor liver function periodically.
• Prostate conditions: Androgenic anabolic steroid use may cause prostatic hypertrophy or prostate cancer in elderly men.
Disease-related concerns:
• Breast cancer: May cause hypercalcemia in women with breast cancer by stimulating osteolysis.
• Diabetes: Use with caution in patients with diabetes mellitus; insulin or oral hypoglycemic needs may be altered; monitor carefully.
• Edematous conditions: Use with caution in patients with conditions influenced by edema (eg, cardiovascular disease, migraine, seizure disorder, renal impairment); may cause fluid retention.
Special populations:
• Pediatric: May accelerate bone maturation without producing compensatory gain in linear growth in children; effect may continue for 6 months after treatment discontinuation; in prepubertal children perform radiographic examination of the hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers.
• Women: Discontinue with evidence of mild virilization in women.
Other warnings/precautions:
• Appropriate use: Oxymetholone should not replace other anemia treatment supportive measures such as transfusion, correction of iron, folic acid, vitamin B12 or pyridoxine deficiency, antibacterial therapy, and the appropriate use of corticosteroids.
In children, androgens are not recommended for management of anemia associated with chronic kidney disease and should not be used (KDIGO 2006).
Oxymetholone may cause virilization in females; monitor for signs of virilization (eg, deepening of voice, hirsutism, acne, and clitoromegaly); discontinue use if evidence of mild virilization; discontinuation may prevent irreversible virilization.
Anadrol-50 has been discontinued in the United States for >1 year.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
Anadrol-50: 50 mg [DSC] [scored]
No
Tablets (Anadrol-50 Oral)
50 mg (per each): $50.96
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C-III
Oral: May administer without regard to meals; tablets may be cut to achieve partial doses (FARF 2014).
Anemia: Treatment of anemias caused by deficient red cell production. Note: Androgen therapy (eg, oxymetholone) is generally not appropriate for the treatment of anemias except in certain rare situations (eg, Fanconi anemia).
Fanconi anemia (alternative agent)
Oxymetholone may be confused with oxymetazoline, oxyMORphone
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Blood Glucose Lowering Effects: Androgens may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Ajmaline: Androgens may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy
C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Risk C: Monitor therapy
Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Risk C: Monitor therapy
CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Management: Consider avoiding concomitant use of androgens and cyclosporine. If concomitant use is unavoidable, monitor serum cyclosporine concentrations and for signs and symptoms of hepatotoxicity. Cyclosporine dose reductions may be required. Risk D: Consider therapy modification
Hypertension-Associated Agents: May enhance the hypertensive effect of Androgens. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Management: Monitor for increased effects of vitamin K antagonists if an androgen is initiated/dose increased, or decreased effects if androgen is discontinued/dose decreased. Significant reductions in vitamin K antagonist dose are likely required. Risk D: Consider therapy modification
Use is contraindicated in women who may become pregnant.
Oligospermia or amenorrhea may occur resulting in an impairment of fertility.
Use is contraindicated in women who are pregnant.
It is not known if oxymetholone is excreted in breast milk. Breastfeeding is not recommended by the manufacturer.
Periodic liver function tests, lipid profile, hemoglobin and hematocrit; iron studies; serum glucose (may be decreased by testosterone, monitor patients with diabetes); radiologic examination of bones every 6 months (when using in prepubertal children); monitor urine and serum calcium and signs of virilization in women treated for breast cancer
Enhances production of erythropoietin in patients with anemias which are due to bone marrow failure; stimulates erythropoiesis in anemias due to deficient red cell production
Onset of action: Response is not often immediate; a minimum trial of 3 to 6 months is recommended
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