Description
Femara Tablets 2.5mg (1 Strip = 10 Tablets)
Product Overview
Femara Tablets 2.5mg is a prescription oral medication containing the active ingredient Letrozole. Manufactured by Novartis Pharma Stein AG in Switzerland, this advanced, nonsteroidal aromatase inhibitor is specifically designed for the treatment of breast cancer in postmenopausal women. Femara works by significantly reducing estrogen production in the body, thereby hindering the growth of hormone-sensitive breast cancer cells. Administered as a simple, once-daily oral tablet, Femara offers a convenient and effective treatment option for various stages of breast cancer, including early, advanced, and metastatic disease. Each box contains 3 strips of 10 tablets each (total 30 tablets, 2.5mg each) .
This advanced hormonal therapy delivers effective breast cancer treatment and prevention:
Effective Cancer Treatment: Indicated for adjuvant treatment of early breast cancer, extended adjuvant treatment after tamoxifen therapy, and first/second-line treatment of advanced breast cancer.
Hormone Receptor Positive Action: Specifically targets hormone receptor-positive breast cancers, which rely on estrogen for growth.
Aromatase Inhibition: As a nonsteroidal aromatase inhibitor, it effectively blocks estrogen synthesis, leading to a significant reduction in plasma estrogen levels.
Once-Daily Dosing: Simple, once-daily oral administration for convenient and consistent treatment.
Prescription Medication: Requires a prescription from a qualified healthcare professional.
What are the Primary Uses and Key Features of Femara Tablet?
Femara Tablet serves as a specialized therapeutic solution for managing hormone receptor-positive breast cancer in postmenopausal women across various stages of the disease.
Core Uses of This Medication
Adjuvant Treatment of Early Breast Cancer: For postmenopausal women with hormone receptor-positive invasive early breast cancer, to reduce the risk of recurrence.
Extended Adjuvant Treatment: For postmenopausal women with early breast cancer who have completed approximately 5 years of prior standard adjuvant tamoxifen therapy.
First-Line Treatment of Advanced Breast Cancer: For postmenopausal women with hormone-dependent advanced (metastatic) breast cancer.
Second-Line Treatment: For advanced breast cancer after relapse or disease progression in postmenopausal women previously treated with anti-estrogens.
Neoadjuvant Treatment: For postmenopausal women with hormone receptor-positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery is not indicated.
Standout Product Features
| Feature | Description |
|---|---|
| Active Ingredient: Letrozole | A potent, nonsteroidal aromatase inhibitor that blocks estrogen synthesis. |
| Strength: 2.5mg | Each film-coated tablet contains 2.5mg of letrozole. |
| Manufacturer: Novartis | Manufactured by a globally renowned pharmaceutical company. |
| Oral Administration | Convenient once-daily tablet that can be taken with or without food. |
| Hormonal Therapy | Targets hormone receptor-positive breast cancers effectively. |
| Prescription Required | Available only with a prescription from a qualified healthcare professional. |
| Blister Packaging | Each box contains 3 strips of 10 tablets. |
What Key Ingredients are in Femara Tablet and How Does It Work?
Composition
| Component | Description |
|---|---|
| Letrozole | Each film-coated tablet contains 2.5 mg of letrozole. |
| Other Ingredients | Contains pharmaceutical excipients including lactose monohydrate (61.5mg per tablet). |
Mechanism of Action
Letrozole is a nonsteroidal aromatase inhibitor. It works by binding to the heme group of the aromatase enzyme, a cytochrome P450 enzyme that catalyzes the conversion of androgens to estrogens (specifically, androstenedione to estrone and testosterone to estradiol). By inhibiting this enzyme, letrozole significantly reduces plasma estrogen levels. This estrogen deprivation inhibits the growth of hormone-sensitive breast cancer cells, as approximately 30% of human breast cancers are sensitive to this mechanism.
Key Benefits
Effectively treats hormone receptor-positive breast cancer.
Reduces the risk of breast cancer recurrence.
Convenient once-daily oral administration.
Can be taken with or without food.
How Should I Use Femara Tablet Correctly?
Femara Tablet must be taken orally as prescribed by a healthcare professional. Do not self-adjust the dose.
Dosage and Administration
| Parameter | Details |
|---|---|
| Recommended Dose | 2.5 mg once daily. |
| Adjuvant/Extended Adjuvant | Continue for 5 years or until disease relapse/recurrence, whichever comes first. |
| Metastatic Disease | Continue until tumor progression is evident. |
| Hepatic Impairment | No dose adjustment for mild to moderate impairment; severe impairment: 2.5 mg every other day. |
| Renal Impairment | No dose adjustment required for CLcr ≥10 mL/min. |
| Method of Administration | Take orally, with or without food. |
Method of Administration
Oral: Take the tablet orally with or without food.
Consistency: Take at the same time each day for consistent treatment.
Missed Dose: Take as soon as remembered. If almost time for next dose, skip the missed dose and resume regular schedule. Do not double the dose.
Important Considerations
Prescription Only: This medication is available only with a prescription.
Not for Premenopausal Women: Contraindicated in premenopausal women.
Pregnancy and Lactation: Can cause fetal harm; do not use during pregnancy or breastfeeding.
Monitoring: Bone mineral density and cholesterol levels should be monitored during treatment.
What Precautions Should I Be Aware of Before Taking This Medication?
While generally safe and well-tolerated, specific conditions and interactions require awareness and caution.
Key Warnings and Contraindications
Pregnancy: Contraindicated; can cause fetal harm when administered to pregnant women.
Premenopausal Women: Not indicated for use in premenopausal women.
Hypersensitivity: Contraindicated in patients with known hypersensitivity to letrozole or any excipients.
Lactation: Breastfeeding is strictly prohibited while using letrozole.
Bone Effects: Decreases in bone mineral density may occur; consider bone mineral density monitoring.
Cholesterol: Increases in total cholesterol may occur; consider cholesterol monitoring.
Fatigue and Dizziness: May cause fatigue, dizziness, and somnolence; exercise caution when driving or operating machinery.
Hepatic Impairment: Patients with severe hepatic impairment require close supervision.
Renal Impairment: Insufficient data for CLcr <10 mL/min.
Drug Interactions
| Interaction | Recommendation |
|---|---|
| Tamoxifen | Sequential treatment schedules (e.g., letrozole followed by tamoxifen) may be considered. |
| Other Anticancer Drugs | Consult healthcare provider for potential interactions with other medications. |
When to Seek Immediate Medical Attention
Severe Allergic Reaction: Difficulty breathing, swelling of the face/lips/tongue/throat.
Signs of Bone Fracture: Unexplained bone pain or fractures.
Signs of Liver Dysfunction: Yellowing of skin or eyes, dark urine, severe nausea.
Severe Fatigue or Dizziness: Affecting daily activities or causing falls.
Are There Any Potential Side Effects of Femara Tablet?
As with all medications, Femara Tablet may cause side effects, although not everyone experiences them.
Side Effects by Frequency
| Frequency | Side Effects |
|---|---|
| Very Common (≥10%) | Hot flashes (12%), arthralgia/joint pain (12%), headache (10%), bone pain (22%), back pain (18%), nausea (15%), dyspnea (13%), fatigue (9%), hypercholesterolemia. |
| Common (≥1% to <10%) | Flushing, asthenia, edema, dizziness, sweating increased, constipation, vomiting, diarrhea, hypertension, abdominal pain, peripheral edema, appetite changes. |
| Uncommon (≥0.1% to <1%) | Urinary tract infection, tumor pain, leukopenia. |
| Rare/Unknown | Hypersensitivity reactions, angioedema, anaphylactic reactions. |
When to Seek Immediate Medical Attention
Severe Allergic Reaction: Difficulty breathing, swelling of the face/lips/tongue/throat.
Signs of Bone Fracture: Unexplained bone pain or fractures.
Signs of Liver Dysfunction: Yellowing of skin or eyes, dark urine.
Severe Fatigue or Dizziness: Affecting daily activities.
How Should I Store This Medication?
Proper storage is essential for maintaining the stability, efficacy, and safety of Femara Tablets.
Optimal Storage Conditions
Temperature Control: Store at room temperature, between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Do not store above 30°C.
Protect from Moisture: Store in the original package to protect from moisture.
Keep Out of Reach: Keep the medication out of reach of children and pets.
Check Solution: Do not use the medication if the expiry date has passed.
Who Manufactures Femara Tablet?
Femara Tablet is manufactured by Novartis Pharma Stein AG in Switzerland, a globally renowned and well-established pharmaceutical company. Novartis is known for producing high-quality medications for various medical conditions, with state-of-the-art manufacturing facilities.
Commitment to Quality and Safety
Regulatory Approval: Registered with relevant national drug regulatory authorities worldwide.
GMP Compliance: Manufactured in facilities that follow strict Good Manufacturing Practices.
Quality Assurance: Each batch undergoes rigorous quality testing to ensure purity, potency, and consistency.
Patient Safety: A commitment to providing safe, effective, and high-quality medications.
Frequently Asked Questions (FAQs)
1. What is Femara Tablet used for?
Femara Tablet is used for the treatment of hormone receptor-positive breast cancer in postmenopausal women, including early-stage adjuvant treatment, extended adjuvant treatment after tamoxifen, and advanced/metastatic breast cancer.
2. How does Femara Tablet work?
Femara contains letrozole, a nonsteroidal aromatase inhibitor that blocks the aromatase enzyme, preventing the conversion of androgens to estrogens. This significantly reduces estrogen levels in the body and inhibits the growth of hormone-sensitive breast cancer cells.
3. Can Femara be taken with food?
Yes, Femara tablets can be taken with or without food. It is recommended to take it at the same time each day for consistent treatment.
4. What should I do if I miss a dose?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your normal schedule. Do not double the dose.
5. Is Femara safe for premenopausal women?
No, Femara is contraindicated in premenopausal women. It is specifically indicated for postmenopausal women only.
6. How long should I take Femara Tablet?
For adjuvant treatment, the recommended duration is 5 years or until disease recurrence. For metastatic disease, treatment continues until tumor progression is evident. Always follow your doctor’s prescription.
7. What are the common side effects?
Common side effects include hot flashes, joint pain, bone pain, headache, nausea, fatigue, and hypercholesterolemia. These side effects are generally manageable but should be discussed with your doctor.
8. Do I need a prescription for Femara Tablet?
Yes, Femara Tablet is a prescription medication and is available only with a prescription from a qualified healthcare professional.
9. How should I store Femara?
Store at room temperature between 20°C to 25°C, in the original package to protect from moisture. Keep out of reach of children and pets.
10. What should I do if I experience side effects?
If you experience mild side effects, inform your doctor at your next appointment. If you experience severe allergic reactions, difficulty breathing, signs of bone fracture, or signs of liver dysfunction, seek immediate medical attention.
