Important Safety Information and Indication
AROMASIN® (exemestane tablets) is contraindicated in patients with known hypersensitivity to the drug or to any of the excipients.
Warnings and Precautions
AROMASIN should not be co-administered with estrogen-containing agents as these could interfere with its pharmacologic action.
Reductions in bone mineral density (BMD): Reductions in BMD over time are seen with AROMASIN use. In the IES study, clinical fractures were reported in 4.2% of patients receiving AROMASIN and in 3.1% of patients receiving tamoxifen. Therefore, women with osteoporosis or at risk of osteoporosis should have their BMD formally assessed at the commencement of treatment. Patients treated with exemestane should be carefully monitored for BMD loss and treated as appropriate.
Vitamin D Assessment: Prior to initiation of aromatase inhibitor treatment, a routine assessment of 25-hydroxy vitamin D levels should be performed due to the high prevalence of vitamin D deficiency in women with early breast cancer (EBC). Women with vitamin D deficiency should receive supplementation with vitamin D.
Embryo-Fetal Toxicity: AROMASIN can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, exemestane caused increased incidence of abortions and embryo-fetal toxicity in pregnant rats and rabbits. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with AROMASIN and for 1 month after the last dose.
AROMASIN is not indicated in the treatment of breast cancer in premenopausal women.
Early breast cancer: AEs occurring in ≥10% of patients in any treatment group (AROMASIN vs tamoxifen) were hot flushes (21.2% vs 19.9%), fatigue (16.1% vs 14.7%), arthralgia (14.6% vs 8.6%), headache (13.1% vs 10.8%), insomnia (12.4% vs 8.9%), and increased sweating (11.8% vs 10.4%). Discontinuation rates due to AEs were similar between AROMASIN and tamoxifen. The incidence of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were 1.6% with AROMASIN, and 0.6% with tamoxifen. The incidence of cardiac failure was 0.4% with AROMASIN, and 0.3% with tamoxifen.
Advanced breast cancer: The most common AEs (AROMASIN vs megestrol acetate) were hot flushes (13% vs 5%), nausea (9% vs 5%), fatigue (8% vs 10%), increased sweating (4% vs 8%), and increased appetite (3% vs 6%).
Strong CYP 3A4 inhibitors: Dose modification is recommended for patients co-medicated with a potent CYP 3A4 inducer such as rifampin, phenytoin, carbamazepine, phenobarbital, or St. John’s wort as they may significantly decrease exposure to exemestane.
The safety of chronic dosing in patients with moderate or severe hepatic or renal impairment has not been studied.
Use in Specific Populations
Lactation: Advise women not to breastfeed during treatment with AROMASIN.
IndicationAROMASIN is an aromatase inhibitor indicated for:
- the adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received 2 to 3 years of tamoxifen and are switched to AROMASIN for completion of a total of 5 consecutive years of adjuvant hormonal therapy
- the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy
Terms and ConditionsBy using the AROMASIN Savings Card (the "Card"), you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- The Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico [formerly known as "La Reforma de Salud"])
- The Card is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs which reimburse you for the entire cost of your prescription drugs
- With the Card you may pay as low as $4 per prescription of AROMASIN for a maximum savings of $300 per 30-day fill. The offer can be used once per month. Patients can receive a maximum savings of $3,600 per year
- You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
- The Card is not valid for Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance, or where otherwise prohibited by law
- This program cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription
- The Card will be accepted only at participating pharmacies
- This Card is not health insurance. Offer good only in the U.S. and Puerto Rico. The Card is limited to 1 per person during this offering period and is not transferable
- Pfizer reserves the right to rescind, revoke, or amend the program without notice. No membership fees. Card and Program expire 12/31/2018
- To learn more about the AROMASIN Savings Card, visit www.AROMASIN.com, call
1-866-562-6151or write to: Pfizer Inc, PO Box 29387, Mission, KS 66201-9618