How to use Elestrin

Patient Instructions for Use

Elestrin comes in a pump that is designed to deliver the amount of estrogen that patients have been prescribed.

You can use the step-by-step instructions and diagrams below to remind your patients how to apply Elestrin.

For more complete instructions, please refer to Patient Information in the Full Prescribing Information including BOXED WARNING.

Remove Cap

1.Remove the cap.

Activate the pump

2.Activate the pump.

  • Unlock the pump by turning the spout on top of the bottle a quarter turn to the left or the right.
Prime the pump

3.Prime the pump (get the pump ready) before using the pump for the first time.

  • Push the head of the pump down slowly and allow it to spring back automatically. Repeat this until gel comes out. Throw away the first amount of gel as it will not be a full dose. Once the pump head has come all the way back up, the pump is now primed and ready to use. Throw away the unused gel by placing it in the trash to avoid another person or a pet from accidental contact with the gel or eating or drinking it.
  • After priming, the pump is ready to use.
  • One complete pump depression will dispense the same amount of ELESTRIN each time. After each daily dose, return the spout to the locked position and replace the cap before you put it away.

Applying Elestrin

Dry application area

4a.Dry skin completely before applying ELESTRIN.

  • You should apply your daily dose of gel to clean, dry, unbroken skin. If you take a bath or shower or use a sauna, apply ELESTRIN after your bath, shower, or sauna. If you go swimming, try to leave as much time as possible, at least 2 hours, between applying your ELESTRIN dose and going into the water.
Apply to dry area

4b.Apply ELESTRIN at the same time each day.

  • To apply the dose, hold the pump with the tip facing the application area of the arm. For each pump depression needed, press the pump firmly and fully with a continuous motion without hesitation.
spread over dry area

4c.Gently spread the gel using only 2 fingers.

  • Spread and gently rub in the gel over the entire area of your upper arm and shoulder area, as illustrated.
Wash hands

5.Wash your hands with soap and water.

More Important Safety Information

Warning: Endometrial cancer, cardiovascular disorders, breast cancer and probable dementia

Estrogen-Alone Therapy

  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
  • The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)
  • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Estrogen Plus Progestin Therapy

  • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
  • The WHI estrogen plus progestin substudy reported increased risk of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI)
  • The WHI estrogen plus progestin study reported increased risks of invasive breast cancer
  • The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

ELESTRIN should not be used in women with any of the following conditions:

  • Undiagnosed abnormal genital bleeding
  • Known, suspected, or history of breast cancer
  • Known or suspected estrogen-dependent neoplasia
  • Active DVT, PE, or history of these conditions
  • Active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions
  • Known anaphylactic reaction or angioedema to ELESTRIN
  • Known liver impairment or disease
  • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
  • Known or suspected pregnancy

Estrogens increase the risk of gallbladder disease.

Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or choloestatic jaundice occurs.

Monitor thyroid function in women on thyroid replacement therapy.

In a placebo-controlled trial that included a total of 484 postmenopausal women, the most common adverse reactions (≥ 5 percent) are breast tenderness, metrorrhagia, nasopharyngitis, and upper respiratory tract infections.

Inducers and/or inhibitors of CYP3A4 may effect estrogen drug metabolism.

Indications

ELESTRIN (estradiol gel) is used for the treatment of moderate to severe vasomotor symptoms due to menopause.

You are encouraged to report suspected adverse reactions. To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional information, please see Full Prescribing Information including BOXED WARNING for Elestrin.