17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Advise patients that AROMASIN lowers the level of estrogen in the body. This may lead to reduction in bone mineral density (BMD) over time. The lower the BMD, the greater the risk of osteoporosis and fracture [see Warnings and Precautions (5.1)].
Other Estrogen-Containing Agents
Advise patients that they should not take estrogen-containing agents while they are taking AROMASIN as these could interfere with its pharmacologic action [see Warnings and Precautions (5.3)].
Use in Premenopausal Women
Advise patients that AROMASIN is not for use for the treatment of breast cancer in premenopausal women [see Warnings and Precautions (5.5)].
Advise pregnant women and females of reproductive potential that exposure during pregnancy or within 1 month prior to conception can result in fetal harm. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception while taking AROMASIN and for 1 month after the last dose [see Use in Specific Populations (8.3)].
Advise women not to breastfeed during treatment with AROMASIN and for 1 month after the last dose [see Use in Specific Populations (8.2)].
AROMASIN® (ah ROME ah sin)
|This Patient Information has been approved by the U.S. Food and Drug Administration||Revised: 10/2016|
AROMASIN is used in women who are past menopause for the treatment of:
It is not known if AROMASIN is safe and effective in children.
Do not take AROMASIN if you are allergic to AROMASIN or any of the ingredients in AROMASIN. See the end of this leaflet for a complete list of ingredients in AROMASIN.
Before you take AROMASIN, tell your doctor about all your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take medicines that contain estrogen, including other hormone replacement therapy or birth control pills or patches. AROMASIN should not be taken with medicines that contain estrogen as they could affect how well AROMASIN works.
AROMASIN may cause serious side effects, including:
The most common side effects of AROMASIN in women with early breast cancer include:
The most common side effects of AROMASIN in women with advanced breast cancer include:
Your doctor will do blood tests to check your vitamin D level before starting treatment with AROMASIN.
AROMASIN may cause decreased fertility in males and females. Talk to your doctor if you have concerns about fertility.
These are not all the possible side effects of AROMASIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of AROMASIN.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AROMASIN for a condition for which it was not prescribed. Do not give AROMASIN to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about AROMASIN that is written for health professionals.
Active ingredient: exemestane
Inactive ingredients: mannitol, crospovidone, polysorbate 80, hypromellose, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, simethicone, polyethylene glycol 6000, sucrose, magnesium carbonate, titanium dioxide, methylparaben, and polyvinyl alcohol.
For more information, go to www.AROMASIN.com or call 1-888-AROMASIN (1-888-276-6274).