What Is ALPESIB 150 MG?
ALPESIB 150 MG is a modern, targeted anticancer medication that contains Alpelisib—a first-in-class PI3Kα inhibitor used in the treatment of HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer. Manufactured by Everest Pharmaceuticals Ltd., ALPESIB 150 MG follows global quality standards and is supplied worldwide by Unit Pharmacy.
It is specifically designed for individuals whose cancer has progressed despite previous endocrine therapy. Unlike chemotherapy, ALPESIB targets molecular abnormalities, making it a highly selective precision medicine.
Key Highlights
- Active Ingredient: Alpelisib
- Drug Class: PI3K (phosphoinositide 3-kinase) inhibitors
- Target: PIK3CA mutations
- Form: Film-coated tablet
- Strength: 150 mg
- Use: Advanced/metastatic breast cancer
Because PIK3CA mutations drive tumor growth in nearly 40% of HR-positive breast cancer cases, ALPESIB directly blocks this malignant signaling pathway.
Mechanism of Action: How Alpelisib Works?
Alpelisib selectively inhibits the PI3Kα isoform, preventing activation of the PI3K/AKT signaling pathway.
The PI3K Pathway Regulates:
- Cell growth
- Cell survival
- Cell metabolism
- Tumor progression
- Hormone therapy resistance
When the PI3K pathway is abnormally overactive due to a PIK3CA mutation, cancer cells multiply unchecked and become resistant to endocrine treatments like aromatase inhibitors.
How ALPESIB Stops Cancer Growth
- Blocks PI3Kα activity
- Inhibits tumor cell proliferation
- Restores response to hormone therapy
- Slows down disease progression
This precision mechanism places ALPESIB among the most effective modern targeted therapies for metastatic breast cancer.
Medical Uses & Indications of Alpesib 150 mg
Approved Uses
ALPESIB 150 MG is approved for the treatment of:
- Hormone receptor-positive (HR+) breast cancer
- HER2-negative cancer
- Advanced or metastatic stage tumors
- Cases where the tumor has a confirmed PIK3CA mutation
- Patients whose cancer progressed after endocrine therapy
Eligible Patient Groups
- Postmenopausal women
- Men with advanced breast cancer
- Patients already treated with hormonal agents
- Patients with metastatic disease spread to bones, liver, or lungs
NOT recommended for:
- HER2-positive cancers
- Patients without PIK3CA mutation
- Early-stage breast cancer (not approved yet)
ALPESIB for PIK3CA-Mutated Breast Cancer
Approximately 30–40% of HR-positive/HER2-negative breast cancers have PIK3CA mutations, making this genetic change the most common driver mutation in breast cancer.
Why PIK3CA Mutation Testing Matters
Before prescribing ALPESIB, oncologists use:
- Tumor biopsies
- Liquid biopsies
- Molecular diagnostic tests
Patients testing positive for PIK3CA mutation respond significantly better to ALPESIB.
Benefits for Mutation-Positive Patients
- Better tumor shrinkage
- Improved response to Fulvestrant
- Delayed disease progression
- Enhanced overall therapy outcomes
ALPESIB is ONLY beneficial if a PIK3CA mutation is present.
ALPESIB + Fulvestrant Combination Therapy
ALPESIB is always prescribed in combination with Fulvestrant, an estrogen receptor antagonist.
Why This Combination Works
- Fulvestrant blocks estrogen signaling
- Alpelisib blocks PI3K mutation–driven growth
- Together, they attack cancer from two critical pathways
Clinical Benefits
- Increased progression-free survival
- Reduced tumor resistance
- Better outcomes compared to endocrine therapy alone
This combination is now considered one of the most powerful regimens for PIK3CA-mutated metastatic breast cancer.
Dosage and Administration of Alpesib 150 mg
Standard Recommended Dose
| Component | Dose |
|---|---|
| ALPESIB | 300 mg daily (usually 150 mg × 2 tablets) |
| Fulvestrant | 500 mg injection on specific schedule |
How to Take ALPESIB
- Once daily
- With food
- Swallow tablets whole
- Do NOT crush or chew
Missed Dose
- If less than 9 hours passed → take immediately
- If more than 9 hours → skip and continue next day
Dose Adjustments May Be Required For:
- Severe side effects
- High blood sugar
- Liver abnormalities
- Kidney impairment
Alpesib 150 mg Side Effects & Warnings
Like all anticancer therapies, ALPESIB may cause side effects. Early monitoring helps manage them effectively.
Common Side Effects
| Side Effect | Description |
|---|---|
| Hyperglycemia | Increased blood sugar (very common) |
| Nausea & vomiting | Digestive discomfort |
| Rash | Skin irritation |
| Fatigue | Low energy levels |
| Diarrhea | Gastrointestinal side effects |
| Weight loss | Reduced appetite |
Serious Side Effects
| Condition | Risk |
|---|---|
| Severe hyperglycemia | May need insulin or medication |
| Anaphylaxis | Rare allergic reaction |
| Severe skin reactions | Stevens-Johnson syndrome (very rare) |
| Lung inflammation | Pneumonitis-like symptoms |
| Kidney dysfunction | Requires monitoring |
Monitoring Required
- Liver function tests
- Kidney function
- Blood sugar levels
- Blood counts
- Skin condition
Drug Interactions of Alpesib 150 mg
ALPESIB interacts with various drugs that affect metabolic enzymes.
Avoid Combining With:
- Strong CYP3A4 inducers
- Certain antifungal medicines
- Some antibiotics
- Herbal supplements (e.g., St. John’s Wort)
Clinical Trial Evidence
The SOLAR-1 Trial demonstrated significant improvement in patients receiving Alpelisib + Fulvestrant compared to Fulvestrant alone.
Key Results:
| Outcome | Fulvestrant Alone | With ALPESIB |
|---|---|---|
| Progression-Free Survival | 5.7 months | 11.0 months |
| Response Rate | 12% | 35% |
| Tumor Shrinkage | Low | Significant |
This trial established ALPESIB as a breakthrough therapy.
Comparison: ALPESIB vs Other PI3K Inhibitors
| Drug | Isoform Target | Indication | Notes |
|---|---|---|---|
| Alpelisib (ALPESIB) | PI3K-α | HR+ HER2- metastatic breast cancer | Most specific & effective |
| Idelalisib | PI3K-δ | Lymphomas, CLL | Blood cancers only |
| Duvelisib | PI3K-δ/γ | CLL, SLL | Higher toxicity |
| Copanlisib | PI3K-α/δ | Lymphoma | Injectable |
Alpelisib is the ONLY PI3K inhibitor approved specifically for breast cancer.
Availability, Storage & Export Information
Storage
- Keep below 30°C
- Store in original packaging
- Protect from moisture and light
Global Export Availability
Exported widely to:
- UAE
- USA
- Philippines
- Vietnam
- African regions
- Latin America
Your website’s niche in oncology exports ensures fast availability for international patients.
ALPESIB Price, Packaging & Global Market Overview
Packaging
- A bottle/box typically contains 150 mg tablets
- Frequently available in:
- 30-tablet boxes
- 60-tablet therapy packs
Price Range
Since prices vary by region, demand, and manufacturer, the global pricing typically falls in:
| Region | Estimated Price (per 150 mg tablet) |
|---|---|
| Asia | Competitive pricing, brand & generic both available |
| Middle East | Moderate-to-high |
| Europe | Highest pricing |
| Africa | Variable, depending on access programs |
Why Prices Vary
- Patent status
- Local regulations
- Manufacturer
- Supply chain costs
Your pharmacy’s export model also helps lower costs for international buyers.
Why ALPESIB Is a Breakthrough in Precision Oncology
Alpesib 150 mg marks a dramatic leap in personalized cancer treatment for several reasons:
✔ Targets only mutation-positive tumors
✔ Avoids damage to healthy cells
✔ Works even when hormonal therapy fails
✔ Offers a tailored approach based on genetic testing
✔ Backed by strong clinical evidence
This makes ALPESIB 150 MG a cornerstone therapy for modern oncology.
Frequently Asked Questions of Alpesib 150 mg
1. What is ALPESIB 150 MG used for?
Ans: ALPESIB is used to treat HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, typically in combination with Fulvestrant.
2. Is Alpelisib a chemotherapy drug?
Ans: No. Alpelisib is a targeted therapy, not chemotherapy. It works by blocking the PI3K pathway responsible for cancer cell growth.
3. Do I need genetic testing before taking ALPESIB?
Ans: Yes. ALPESIB only works for tumors with PIK3CA mutations, so genetic confirmation is essential.
4. What are the most common side effects of ALPESIB?
Ans: The most common side effect is high blood sugar. Others include nausea, diarrhea, fatigue, and skin rash.
5. Can ALPESIB cure breast cancer?
Ans: ALPESIB is not a cure, but it significantly slows disease progression, shrinks tumors, and extends survival in many patients.
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