Anadrol-50 – NC Standard

Restricted Product(s)

• Anadrol® -50 (oxymetholone)

FDA Approved Use

• Anadrol tablets is indicated in the treatment of anemias caused by deficient red cell production. Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and the hypoplastic anemias due to the administration of myelotoxic drugs often respond. Anadrol tablets should not replace other supportive measures such as transfusion, correction of iron, folic acid, vitamin B12 or pyridoxine deficiency, antibacterial therapy and the appropriate use of corticosteroids.

Criteria for Approval of Restricted Product(s)

1. The patient has a diagnosis of anemia caused by deficient red cell production associated with the following conditions: 
   1. Acquired aplastic anemia; 
   2. Congenital aplastic anemia; 
   3. Anemia of chronic renal failure; 
   4. Pure red cell aplasia; 
   5. Myelofibrosis; 
   6. Fanconi’s anemia; 
   7. Hypoplastic anemias caused by the administration of myelotoxic drugs, or myelosuppression due to chemotherapy; OR 
2. The patient has a diagnosis of HIV cachexia (unintentional weight loss of at least 10% of baseline weight, or body mass index less than 20 kg/m2 , not attributable to other causes, when optimal antiviral therapy has been instituted); OR 
3. The patient has a diagnosis of hereditary angioedema (C1 esterase inhibitor deficiency); AND 
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

Duration of Approval: 1095 (3 years)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Feb 2021: Criteria update: Annual criteria review. No change.
Oct 2019: Criteria update: Reformat criteria. Changed duration of approval to 3 years.
Oct 2018: Annual review; No change
Oct 2017: Annual review; No change
Oct 2016: Annual review; No change
Oct 2015: Annual review; No change
Oct 2014: Annual review; No change
Oct 2013: Annual review; No change
Oct 2012: Annual review; No change
April 2011: Original utilization management criteria issued.