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Delestrogen® ( valerate) – Drug Shortage • The drug shortage of Par’s Delestrogen (estradiol valerate) and Perrigo’s generic estradiol valerate products are ongoing. Both products have been unavailable for at least 90 days.

— Estimated availability of Delestrogen is the first quarter of 2017. — Estimated availability of generic estradiol valerate 20 mg/mL injection is early November 2016. Estimated availability of estradiol valerate 40 mg/mL injection is mid-November 2016.

• Delestrogen is indicated for the following:

— Treatment of moderate to severe vasomotor symptoms associated with the . — Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. — Treatment of due to , or primary ovarian failure. — Treatment of advanced -dependent carcinoma of the prostate (for palliation only).

Manufacturer Product Description Strength NDC# 10 mg/mL (5 mL); 42023-110-01; Delestrogen (estradiol valerate) 20 mg/mL (5 mL); Par 42023-111-01; injection 40 mg/mL (5 mL) 42023-112-01 multiple dose vials 20 mg/mL (5 mL); 0574-0870-05; Perrigo Estradiol valerate injection 40 mg/mL (5 mL) 0574-0872-05 multiple dose vials

Action Plan • Information about the long-term drug shortage of Delestrogen and estradiol valerate injection will be communicated with clients. Formulary changes may be made, as appropriate.

• Information regarding Delestrogen and estradiol valerate injection will be posted on the optumrx.com portals.

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