Alpelisib
About Alpelisib
Alpelisib is a prescription tablet used to treat a specific type of advanced or metastatic breast cancer. It is designed for adults whose cancer is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, and has a mutated 'PIK3CA' gene. This medicine is used in combination with another hormone therapy to help slow down the growth and spread of cancer cells.
You will typically take this medicine once daily at the same time each day to maintain consistent levels in your body. It is highly important to take Alpelisib with food, as this helps your body absorb the medicine properly. Making healthy dietary choices, such as monitoring your carbohydrate intake, can also support your treatment, as this medicine can affect your blood sugar levels.
While taking Alpelisib, you may experience common side effects like diarrhoea, nausea, fatigue, or hair thinning. However, you must contact your doctor immediately if you develop serious side effects, such as a severe skin rash, breathing difficulties, or signs of extremely high blood sugar like constant thirst and frequent urination.
Before starting your treatment, tell your doctor if you have a history of diabetes, severe skin rashes, or lung problems. Do not take this if you have a history of severe allergic reactions to this medicine or any of its ingredients. Women who are pregnant or planning to become pregnant must not take this medication, as it can harm an unborn baby.
This medicine can interact with other prescription drugs, over-the-counter products, and herbal supplements, which may change how it works or increase your risk of side effects. It is also advised to avoid alcohol and smoking during treatment, as they can worsen side effects like fatigue, diarrhoea, or liver strain. Always consult your doctor if you are breastfeeding or if you are an older adult, as your doctor may need to monitor your health more closely.
Uses of Alpelisib
Medicinal Benefits
The primary benefit of Alpelisib is its ability to delay the progression of advanced breast cancer. By stopping the signals that allow cancer cells to grow, this medicine helps to keep the disease under control for a longer period.
- Slowing Tumour Growth: It helps shrink or stop the growth of tumours, which can relieve physical discomfort, pain, or pressure caused by the spread of cancer in the body.
- Extended Progression-Free Survival: Clinical evidence shows that combining this medicine with endocrine therapy significantly extends the time a patient lives without their cancer worsening, allowing for more stable, quality time with loved ones.
- Targeted Treatment: Because it specifically targets the mutated PIK3CA pathway, it offers a personalised approach to therapy, focusing directly on the genetic driver of the tumour.
Directions for Use
- Take Alpelisib with meals, as it helps with absorption and reducing stomach upset.
- Alpelisib is usually taken once daily at the same time. However, follow the recommended dose and timing as directed by your doctor for optimal results.
- Swallow the tablet as a whole with water.
- Do not crush, chew or break it.
Storage
Side Effects of Alpelisib
Common Side Effects (Usually mild):
- Increased blood sugar levels
- Diarrhoea or loose stools
- Nausea or vomiting
- Feeling unusually tired or weak
- Mild skin rash or dry skin
- Decreased appetite and weight loss
- Thinning of the hair
Serious Side Effects (Consult your doctor right away):
- Severe skin redness, blistering, peeling, or painful sores on the skin, lips, mouth, or eyes
- Excessive thirst, frequent urination, nausea, confusion, difficulty breathing, or fruity-smelling breath, which may be signs of severely high blood sugar
- Severe or persistent diarrhoea, especially with dizziness, reduced urination, or other signs of dehydration
- New or worsening cough, shortness of breath, or difficulty breathing
- Swelling of the face, lips, tongue, or throat, hives, or difficulty breathing
- Yellowing of the skin or eyes, dark urine, severe tiredness, or pain in the upper abdomen, whichmay be signs of liver problems
- Reduced urination, swelling of the legs or ankles, or unusual tiredness, which may be signs of kidney problems
Medicines Containing this Salt
View AllDrug Warnings
- Check Your Packaging: Always inspect your tablet blister or bottle before use. Do not take the medication if the seal is broken, or if the tablets appear chipped, discoloured, or powdery.
- Test Blood Sugar Regularly: Make sure you have a reliable home glucose monitor and test your blood sugar as directed by your healthcare team, especially during the first few weeks of starting treatment.
- Report Rashes Instantly: Even a minor rash can progress quickly. Contact your clinical team at the very first sign of skin redness, itching, or peeling.
- Use Reliable Contraception: Both male and female patients must use effective, non-hormonal birth control during treatment and for a specified time after the final dose, as this medicine can cause severe harm to a developing foetus.
- Keep a Side Effect Log: Write down when you experience symptoms like diarrhoea, nausea, or fatigue, along with their severity, to help your doctor make informed decisions about your dose.
Drug Interactions
- Acid-reducing medications (such as proton pump inhibitors): May decrease the absorption of Alpelisib, making it less effective. Talk to your doctor about safe alternatives.
- Strong CYP3A4 inducers (such as rifampin or phenytoin): Can speed up how your body processes this medicine, significantly lowering its levels in your blood and reducing its ability to fight cancer.
- BCRP inhibitors (such as certain heart or immune medicines): May increase the amount of Alpelisib in your body, raising your risk of developing severe side effects.
Drug-Drug Interactions Checker List:
Safety Advice
Alcohol
cautionAvoid alcohol consumption while on treatment with Alpelisib.
Pregnancy
unsafeAlpelisib should not be used during pregnancy. So, inform your doctor if you are pregnant or suspect pregnancy. You or your partner must use a reliable form of contraception to prevent pregnancy while taking these medications.
Breast Feeding
cautionLactating women should not breastfeed throughout Alpelisib treatment and for one week following the final dosage.
Driving
cautionAlpelisib does not influence the ability to drive or use machines. However, go only if you are alert, as the Alpelisib may cause weakness or tiredness in some people.
Liver
cautionLimited information is available. Inform your doctor before taking the Alpelisib if you have had a liver impairment/disorder history. Your doctor will prescribe only if the benefits outweigh the risks.
Kidney
cautionNo dose adjustment is recommended for patients with mild to moderate renal impairment (CLcr 30 to < 90 mL/min). The effect of severe renal impairment (CLcr < 30 mL/min) on alpelisib is unknown. So, inform your doctor before taking the Alpelisib if you have had a kidney impairment/disorder history. Your doctor will prescribe only if the benefits outweigh the risks.
Children
unsafeSafety and effectiveness in patients below the age of 18 years have not been established. Hence, use is not recommended.
Habit Forming
Diet & Lifestyle Advise
- Monitor Your Blood Sugar: Because this medicine frequently raises blood sugar, work with your doctor to monitor your glucose levels. Focus on a diet low in refined carbohydrates and simple sugars, choosing high-fibre whole grains, lean proteins, and non-starchy vegetables instead.
- Stay Well-Hydrated: Diarrhoea is a common side effect that can cause dehydration. Drink plenty of clear fluids, such as water, broth, or electrolyte solutions, throughout the day. Avoid caffeine, highly spiced foods, and dairy products if you experience loose stools.
- Protect Your Skin: To prevent or manage mild skin rashes, use gentle, fragrance-free soaps and moisturisers. Avoid hot showers, and always apply a broad-spectrum sunscreen (SPF 30 or higher) when going outdoors, as your skin may be more sensitive to sunlight.
- Eat Small, Frequent Meals: If you experience nausea or a loss of appetite, try eating five or six small, nutrient-dense meals throughout the day rather than three large ones.
Special Advise
- Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to Alpelisib.
- Pregnancy testing is recommended prior to starting treatment with Alpelisib.
- Do not donate Sperm throughout treatment and at least one week after treatment.
Patients Concern
Disease/Condition Glossary
Breast cancer: Breast cancer is a type of cancer that develops in breast cells stimulated by a female sex hormone called estrogen. Breast cancer may form in lobules (glands that produce milk), ducts of the breast (the pathway that brings milk from glands to the nipple), and the fatty tissue or the fibrous connective tissue within the breast. The tumour cells invade other healthy breast cells and travel to lymph nodes, a primary pathway for the cancer cells to move to other body parts. Symptoms of breast cancer include a lump in the breast or tissue thickening, which feels different than the normal surrounding tissues, breast pain, redness, swelling, and nipple discharge other than breast milk.
Metastatic breast cancer, also called stage IV breast cancer, has spread to another part of the body, most commonly the bones, lungs, brain, or liver. The process of cancer spreading is called metastasis. Metastasis happens when cancer cells break away from the original tumour in the breast and travel to other parts of the body. These cancer cells travel through the bloodstream or the lymphatic system.
FAQs
Alpelisib is used to treat Advanced or metastatic breast cancer.
Alpelisib contains Alpelisib. In breast cancers with a PIK3CA gene mutation, a protein called PI3K is involved in helping the cancer cells multiply and grow. By blocking the action of PI3K, Alpelisib helps stop the growth and spread of the cancer.
It is critical to understand that Alpelisib is not a traditional chemotherapy drug and functions in a different manner. It works by specifically targeting cancer cells and preventing their growth and spread.
While taking Alpelisib, make sure you visit your doctor at all the appointments to ensure that treatment works. Regular monitoring of blood and lipid tests and weight checks are required. An effective way of contraception should be used by both men and women while taking the Alpelisib.
Based on findings from animal studies, Alpelisib may impair fertility in males and females of reproductive potential. Discuss the risks of taking this medication with your doctor.
No, you should not take Alpelisib on an empty stomach. Taking this medicine with food is essential because it helps your body absorb the active ingredients properly. If taken without food, the medication may not work as effectively to fight the cancer cells. Talk to your doctor or pharmacist if you struggle with eating meals.
If you notice any skin rash, redness, itching, or peeling, you must contact your healthcare team immediately. Skin reactions can range from mild dryness to severe, life-threatening conditions. Do not attempt to treat a new rash with over-the-counter creams without guidance. Talk to your doctor for a proper evaluation.
Alpelisib can significantly increase blood sugar levels (hyperglycemia), and this can sometimes be severe. Your healthcare provider will check your blood sugar before and during treatment and may monitor it more frequently if you have diabetes or are at higher risk. Tell your healthcare provider promptly if you develop symptoms such as excessive thirst, dry mouth, frequent urination, or increased appetite with weight loss. Your doctor may prescribe or adjust diabetes medicines and may change or interrupt your Alpelisib dose if blood sugar becomes very high.
No, you must not become pregnant while taking Alpelisib, as it can cause serious harm or birth defects in an unborn baby. Both female and male patients should use highly effective, non-hormonal birth control during treatment and for a specified time after the last dose. Talk to your doctor about safe family planning options.
You should avoid grapefruit and grapefruit juice, as they can increase the levels of the medicine in your body and make side effects worse. Additionally, it is wise to limit foods high in simple sugars and refined carbohydrates to help keep your blood sugar in a healthy range. Talk to your doctor or a dietitian for personalised dietary advice.
You will typically take this medicine for as long as your cancer remains stable and you do not experience severe, unmanageable side effects. Your doctor will routinely perform scans and blood tests to monitor your progress and decide how long the treatment should continue. Talk to your doctor about your specific treatment timeline.
It is highly recommended to avoid or strictly limit alcohol while taking this medicine. Alcohol can worsen common side effects like nausea, diarrhoea, and fatigue, and it can place extra strain on your liver. Talk to your doctor about whether it is safe for you to have an occasional drink.
Diarrhoea is a common side effect of this medicine, but if it becomes severe or you have more than a few loose stools a day, you must contact your doctor right away. Severe diarrhoea can quickly lead to dangerous dehydration. Your doctor may recommend starting an over-the-counter anti-diarrhoeal medicine or temporary lifestyle changes. Talk to your doctor before taking any new medication.
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