Prolia (Denosumab) Hair and Skin Changes: What Patients and Clinicians Need to Know

What skin effects does the Prolia label list?

The label's dermatologic warnings section states that dermatitis, rashes and eczema have been reported and that discontinuing Prolia should be considered if severe symptoms develop [1]. A separate section covers serious infections, including skin infections such as cellulitis, notes that some led to hospitalization, and tells patients to seek prompt medical attention if signs or symptoms of infection appear [1].

In the label's trial table of reactions occurring in at least 2% of women and more often than placebo, rash was reported in 96 of 3,886 women on Prolia (2.5%) versus 79 of 3,876 on placebo (2.0%), and pruritus in 87 (2.2%) versus 82 (2.1%) [1]. Eczema is not a line in that table; it is named in the warnings section without a percentage [1]. Those figures come from FREEDOM, a 3-year randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women with osteoporosis, all instructed to take at least 1,000 mg calcium and 400 IU vitamin D daily [1].

How common are serious infections, including skin infections?

The whole-trial numbers for nonfatal serious infections were 4.0% on Prolia and 3.3% on placebo [1]. The adverse reaction table does not give a cellulitis-specific rate, so how much of that difference is skin infection is not spelled out in numbers [1].

The label links the infection risk to RANKL, which is expressed on activated T and B lymphocytes and in lymph nodes, and says a RANKL inhibitor such as Prolia may increase the risk of infection [1].

Hair loss: what is actually documented

Alopecia is in the Prolia label's postmarketing experience list, together with lichenoid eruptions, vasculitis and DRESS [1]. A postmarketing listing means the reports were submitted after approval rather than counted in the FREEDOM table [1].

Stopping Prolia: what the label says about transition

The label warns that multiple vertebral fractures can follow discontinuation and says patients should be transitioned to another antiresorptive agent if Prolia is stopped [1]. One option has been studied: in a 2-year crossover study, 115 of 126 women (91%) randomized to denosumab moved to weekly oral alendronate in year 2. Bone mineral density rose 3% to 6% on denosumab in year 1 and 0% to 1% on alendronate in year 2, and 15.9%, 7.6% and 21.7% lost density at the lumbar spine, total hip and femoral neck respectively [5].

Prolia is not Xgeva

Prolia (60 mg every 6 months for osteoporosis) and Xgeva (120 mg every 4 weeks for cancer-related bone disease) are separate products, and the label says patients receiving Prolia should not receive other denosumab products [1]. On the Xgeva label, rash appears among the most common adverse reactions (10% or more) in patients with multiple myeloma [6].