Aromasin 25MG

Aromasin 25MG: Femara is a prescription medicine used to treat the symptoms of breast cancer. Femara may be used alone or with other medications.

Femara belongs to a class of drugs called Antineoplastics, Aromatase Inhibitor.

It is not known if Femara is safe and effective in children.

What are the possible side effects of Femara?

Femara may cause serious side effects including:

• hives,
• difficulty breathing, and
• swelling of your face, lips, tongue or throat

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Femara include:

• hot flashes,
• warmth or redness in your face or chest,
• headache,
• dizziness,
• weakness,
• bone pain,
• muscle or joint pain,
• swelling,
• weight gain,
• increased sweating, and
• increased cholesterol in your blood

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Femara. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Aromasin 25MG: Femara tablets for oral administration contains 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4′-(1H-1,2,4-Triazol-1-ylmethylene) dibenzonitrile, and its structural formula.

Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31, empirical formula C₁₇H₁₁N₅, and a melting range of 184°C to 185°C.

Femara is available as 2.5 mg tablets for oral administration.

Inactive Ingredients

Colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.

 DOSAGE AND ADMINISTRATION

Recommended Dose

Aromasin 25MG: The recommended dose of Femara is one 2.5 mg tablet administered once a day, without regard to meals.

Use In Adjuvant Treatment Of Early Breast Cancer

In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. In both the adjuvant study and the post approval adjuvant study, median treatment duration was 5 years. Treatment should be discontinued at relapse [see Clinical Studies].

Use In Extended Adjuvant Treatment Of Early Breast Cancer

In the extended adjuvant setting, the optimal treatment duration with Femara is not known. The planned duration of treatment in the study was 5 years. In the final updated analysis, conducted at a median follow-up of 62 months, the median treatment duration for Femara was 60 months. Seventy-one (71%) percent of patients were treated for at least 3 years and 58% of patients completed at least 4.5 years of extended adjuvant treatment. The treatment should be discontinued at tumor relapse [see Clinical Studies].

Use In First And Second-Line Treatment Of Advanced Breast Cancer

In patients with advanced disease, treatment with Femara should continue until tumor progression is evident [see Clinical Studies].

Use In Hepatic Impairment

No dosage adjustment is recommended for patients with mild to moderate hepatic impairment, although Femara blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of Femara in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [see WARNINGS AND PRECAUTIONS]. The recommended dose of Femara for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on Femara exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined.

Use In Renal Impairment

No dosage adjustment is required for patients with renal impairment if creatinine clearance is greater than or equal to 10 mL/min [see CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

Aromasin 25MG: 2.5 mg tablets: dark yellow, film-coated, round, slightly biconvex, with beveled edges (imprinted with the letters FV on one side and CG on the other side).

Storage And Handling

Packaged in HDPE bottles with a safety screw cap.

2.5 mg tablets

Bottles of 30 tablets – NDC 0078-0249-15

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].