AROMASIN® (exemestane) 8 USE IN SPECIFIC POPULATIONS

(exemestane)

Prescribing Information

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings in animal studies and its mechanism of action, AROMASIN can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. Limited human data from case reports are insufficient to inform a drug-associated risk. In animal reproduction studies, administration of exemestane to pregnant rats and rabbits caused increased incidence of abortions, embryo-fetal toxicity, and prolonged gestation with abnormal or difficult labor [see Data]. Advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

In animal reproduction studies in rats and rabbits, exemestane caused embryo-fetal toxicity, and was abortifacient. Radioactivity related to 14C-exemestane crossed the placenta of rats following oral administration of 1 mg/kg exemestane. The concentration of exemestane and its metabolites was approximately equivalent in maternal and fetal blood. When rats were administered exemestane from 14 days prior to mating until either days 15 or 20 of gestation, and resuming for the 21 days of lactation, an increase in placental weight was seen at 4 mg/kg/day (approximately 1.5 times the recommended human daily dose on a mg/m2 basis). Increased resorptions, reduced number of live fetuses, decreased fetal weight, retarded ossification, prolonged gestation and abnormal or difficult labor was observed at doses equal to or greater than 20 mg/kg/day (approximately 7.5 times the recommended human daily dose on a mg/m2 basis). Daily doses of exemestane, given to rabbits during organogenesis, caused a decrease in placental weight at 90 mg/kg/day (approximately 70 times the recommended human daily dose on a mg/m2 basis) and in the presence of maternal toxicity, abortions, an increase in resorptions, and a reduction in fetal body weight were seen at 270 mg/kg/day. No malformations were noted when exemestane was administered to pregnant rats or rabbits during the organogenesis period at doses up to 810 and 270 mg/kg/day, respectively (approximately 320 and 210 times the recommended human dose on a mg/m2 basis, respectively).

8.2 Lactation

Risk Summary

There is no information on the presence of exemestane in human milk, or on its effects on the breastfed infant or milk production. Exemestane is present in rat milk at concentrations similar to maternal plasma [see Data]. Because of the potential for serious adverse reactions in breast-fed infants from AROMASIN, advise a woman not to breastfeed during treatment with AROMASIN and for 1 month after the final dose.

Data

Radioactivity related to exemestane appeared in rat milk within 15 minutes of oral administration of radiolabeled exemestane. Concentrations of exemestane and its metabolites were approximately equivalent in the milk and plasma of rats for 24 hours after a single oral dose of 1 mg/kg 14C-exemestane.

8.3 Females and Males of Reproductive Potential

Pregnancy Testing

Pregnancy testing is recommended for females of reproductive potential within seven days prior to initiating AROMASIN.

Contraception

Females

AROMASIN can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with AROMASIN and for 1 month after the final dose.

Infertility

Based on findings in animals, male and female fertility may be impaired by treatment with AROMASIN [see Nonclinical Toxicology (13.1)].

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.6 Hepatic Impairment

The AUC of exemestane was increased in subjects with moderate or severe hepatic impairment (Childs-Pugh B or C) [see Clinical Pharmacology (12.3)]. However, based on experience with exemestane at repeated doses up to 200 mg daily that demonstrated a moderate increase in non life-threatening adverse reactions, dosage adjustment does not appear to be necessary.

8.7 Renal Impairment

The AUC of exemestane was increased in subjects with moderate or severe renal impairment (creatinine clearance <35 mL/min/1.73 m2) [see Clinical Pharmacology (12.3)]. However, based on experience with exemestane at repeated doses up to 200 mg daily that demonstrated a moderate increase in non life-threatening adverse reactions, dosage adjustment does not appear to be necessary.

Medication Guide

MEDICATION GUIDE

Patient Information AROMASIN® (ah ROME ah sin) (exemestane) tablets
What is AROMASIN? AROMASIN is used in women who are past menopause for the treatment of:
	• Early breast cancer (cancer that has not spread outside the breast) in women who: o have cancer that needs the female hormone estrogen to grow, and o have had other treatments for breast cancer, and o have taken tamoxifen for 2 to 3 years, and o are switching to AROMASIN to complete 5 years in a row of hormonal therapy. • Advanced breast cancer (cancer that has spread) after treatment with tamoxifen, and it did not work or is no longer working.
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:
	• are still having menstrual periods (are not past menopause). AROMASIN is only for women who are past menopause. • have weak or brittle bones (osteoporosis) • are pregnant or plan to become pregnant. Taking AROMASIN during pregnancy or within 1 month of becoming pregnant can harm your unborn baby. o Females who are able to become pregnant should have a pregnancy test within 7 days before starting treatment with AROMASIN. o Females who are able to become pregnant should use effective birth control (contraceptive) during treatment with AROMASIN and for 1 month after your last dose of AROMASIN. Tell your doctor right away if you become pregnant or think you may be pregnant. • are breastfeeding or plan to breastfeed. It is not known if AROMASIN passes into your breast milk. Do not breast-feed during treatment with AROMASIN and for 1 month after your last dose of AROMASIN. • Have liver or kidney problems.
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.
How should I take AROMASIN? • Take AROMASIN exactly as your doctor tells you. • Take AROMASIN 1 time each day after a meal. • If you take too much AROMASIN, call your doctor right away or go to nearest hospital emergency room.
What are the possible side effects of AROMASIN? AROMASIN may cause serious side effects, including:
	• Bone loss. AROMASIN decreases the amount of estrogen in your body which may reduce your bone mineral density (BMD) over time. This may increase your risk for bone fractures or weak and brittle bones (osteoporosis). Your doctor may check your bones during treatment with AROMASIN if you have osteoporosis or at risk for osteoporosis.
The most common side effects of AROMASIN in women with early breast cancer include:
	• hot flashes • headache	• feeling tired • trouble sleeping	• joint pain • increased sweating
The most common side effects of AROMASIN in women with advanced breast cancer include:
	• hot flashes • increased sweating	• nausea • increased appetite	• feeling tired
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.
How should I store AROMASIN? • Store AROMASIN at room temperature 68°F to 77°F (20°C to 25°C). • Keep AROMASIN and all medicines out of the reach of children.
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.
What is in AROMASIN? 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. LAB-0399-10.0 For more information, go to www.AROMASIN.com or call 1-888-AROMASIN (1-888-276-6274).
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 12/2024

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