Alpesib 150 mg (Generic Alpelesib)

Product Name: Alpesib

Strength: 150 mg

Volume: 30 tablets

Indications: Advanced breast cancer

Manufacturer: Everest Pharmaceutical

Alpesib 150 mg is used in combination with Fulvestrant for the treatment of hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2 (HER2-negative), PIK3CA-mutated advanced or metastatic breast cancer in postmenopausal women and men who have been diagnosed with an FDA-approved test following progression on or after an endocrine-based regimen.

How does Alpesib 150 mg work?

Alpesib 150 mg blocks a protein in breast cancer called phosphatidylinositol-3-kinase inhibitor (PI3K) which leads cancer cells to grow. In some breast cancers PIK3CA is muted making PI3ka more active and cancer cells to grow. In breast cancer with PIK3CA mutation, Alpelisib works by blocking the cancer signaling path and stops producing new cancer cells in patients. In animal studies it was found that this medication can slow down tumor growth. As it alone can increase the activity of estrogen receptors, which may help cancer cells to grow, It is used in combination with Fulvestrant, an estrogen receptor agonist that works better than using the medication alone. Together, Fulvestrant, and Alpelisib can inhibit ER-positive and PIK3CA muted breast cancer.

What are the adverse effects of Alpesib Tablet?

  •       Glucose increased
  •       Creatinine increased
  •       Diarrhea
  •       Rash
  •       Lymphocyte count decreased
  •       Nausea
  •       Fatigue
  •       Hemoglobin decreased
  •       Decreased appetite
  •       Stomatitis
  •       Vomiting
  •       Dry skin
  •       Headache
  •       Abdominal pain
  •       Peripheral edema
  •       Dyspepsia
  •       Potassium and magnesium decreased

What are the cautions of the medications?

  •       Angioedema was reported in post-marketing
  •       Severe hypersensitivity reactions like anaphylaxis, anaphylactic shock.
  •       Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, was also reported. Symptoms are cough and dyspnea, and hypoxia.
  •       Based on the findings of the animal and its mechanism of action, it has a fetal risk for pregnant and breastfeeding women.
  •       Diarrhea or colitis was found while using this medication, including dehydration and acute kidney injury.
  •       Severe cutaneous adverse reaction.
  •       Severe hyperglycemia.
  •       Drug interactions with CYP3A4A and BCRP substrate and CYP2C9 inducers may occur. Avoid co-administration of this medication with these inducers, inhibitors.

Dosage and Administration Guidelines

The recommended dose of Alpesib is 300 mg daily, orally, with food. Continue the treatment until disease progression or unacceptable toxicity. Swallow the whole tablet with water; do not break, crush the tablet. Take the recommended dose at the same time every day; do not take it if it is broken, expired, or if it is out of the box. 

 If a dose of Alpesib is missed, it can be taken within 9 hours of the missed dose. Do not take it if it is more than 9 hours; take the scheduled dose the next day at the usual time. 

If it is suggested with fulvestrant, take 500 mg of fulvestrant in combination with Alpesib on Days 1, 15, and 29, and once monthly thereafter. If the patient vomits after taking the medication, advise them not to take any additional dose on that day; they may continue with the regular dose from the next day.

What are the common side effects?

Nausea, vomiting, tiredness, taste in food, loss of appetite, weight loss, or dry skin may occur. If any of these are seen and last for a long time, tell your doctor immediately. 

Diarrhea commonly occurs, but severe diarrhea can lead to dehydration and kidney problems. Drink enough liquid to prevent dehydration and ask your doctor or pharmacist for medicines to treat diarrhea.

Pain or sores may occur in your mouth. Brush your teeth gently and avoid using paste that contains alcohol. Rinse your mouth often with cool water mixed with salt and baking soda to prevent infection and unnecessary bleeding.

Temporary hair loss may occur, and normal hair growth should start after the treatment.

Inform your doctor right away if you have any serious side effects, such as lung problems, abdominal pain, or blood or mucus in stool.

This medication may increase the level of your blood sugar, increase thirst, and often urination. Tell your doctor if you have a history of high blood sugar; they may suggest other medicines to control diabetes and follow scheduled exercises to control blood sugar. 

There is less data on having an allergy using this medication; however, if you face an allergic problem after using this medication, inform your doctor. 

What are the precautions I should take before using this medication?

  • Tell your doctor if you are allergic to it. This medication may contain inactive ingredients that may cause allergic problems after getting inside of your body.
  • Tell your pharmacist or doctor if you have any medical conditions like diabetes, lung problems, kidney problems, liver disease, or a history of severe skin reactions.
  • Before having surgery, inform your doctor about all your prescription, non-prescription, and herbal medicines you are using.
  • Older adults may be more sensitive to medicines, especially those who have blood sugar issues. 
  • As the drug can be absorbed through the skin and lungs, pregnant women should not breathe the dust of the medicine as it may harm the unborn baby.
  • To avoid an unexpected pregnancy during the treatment, use reliable birth control and be aware of becoming pregnant. Your doctor should do a pregnancy test before starting this medication. Tell your doctor instantly if you become pregnant while using this medication. They will tell you the benefits and problems of the medication.

What are the medications that may interact with Alpesib 150 mg tablets?

Make a list of all of the drugs you are using, prescription, non-prescription, herbal, and homeopathic. Show the list to your doctor, they will tell you which among the list may interact with Alpesib 150 mg tablets. There are some medicines that interact with these drugs are listed below.

  • Apalutamide
  • Rifamycins
  • Carbamazepine
  • phenytoin

What should I do if I take an overdose of Alpesib 150 mg?

Call the emergency line immediately if you feel a breathing problem after taking an overdose of the medicine or call a poison centre right away. If you feel normal after taking an overdose, then call your pharmacist and get suggestions on it.

What should I do if I miss a dose?

In case of a missed dose, take the dose if it is less than 9 hours, do not take it if it is more than 9 hours, then go with the regular dose, informing your healthcare provider.

How to store Alpesib 150 mg and what is the disposal instruction?

Store the medicine at room temperature away from direct light and moisture. Do not store it in the bathroom; keep it away from children and pets. If the medication has expired or is no longer needed, call the local waste disposal team. Do not flush or throw it in the drain.

What is the price of Generic Alpelesib in Bangladesh?

The price of generic Alpelisib 150 mg tablets in Bangladesh, specifically the brand Alpesib manufactured by Everest Pharmaceuticals, is typically around:

  • Unit Price: ৳ 1,500.00 (Bangladeshi Taka) per tablet.

  • Box Price: ৳ 42,000.00 for a box of 28 tablets.

Please note that pricing can vary based on the specific distributor, pharmacy, location, and current market conditions.

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