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compositionComposition:ALPELISIB-250MG
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Pivikto 200 mg/50 mg Tablet is used to treat advanced or metastatic breast cancer. It 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. Common side effects of this medication are rash, decreased appetite, weight loss, nausea, mouth sores, hair loss, tiredness and weakness, vomiting, allergic reactions, skin reactions, high blood sugar levels, lung problems, and diarrhoea.

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Written By Bayyarapu Mahesh Kumar , M Pharmacy
Reviewed By Dr Aneela Siddabathuni , MPharma., PhD
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More about the Product

Composition :

ALPELISIB-250MG

Manufacturer/Marketer :

Medicines India

Consume Type :

Oral

Expires on or after :

Jan-27

Return Policy :

Not Returnable

About Pivikto 200 mg/50 mg Tablet

Pivikto 200 mg/50 mg Tablet 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 Pivikto 200 mg/50 mg Tablet 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 Pivikto 200 mg/50 mg Tablet , 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 Pivikto 200 mg/50 mg Tablet

Your doctor may prescribe Pivikto 200 mg/50 mg Tablet to help manage the following condition:

  • Advanced or Metastatic Breast Cancer: Pivikto 200 mg/50 mg Tablet is prescribed to treat breast cancer that has spread to other parts of the body (metastatic) or is locally advanced. It specifically targets cancer cells that are hormone receptor (HR)-positive, HER2-negative, and have an abnormal PIK3CA gene, working alongside hormone therapy to block signals that cause cancer cells to multiply.

Key Benefits

The primary benefit of Pivikto 200 mg/50 mg Tablet 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.
Side effects of Pivikto 200 mg/50 mg Tablet
Overcome Medication-Induced Nausea: A 9-Step Plan
  • Inform your doctor about the nausea and discuss possible alternatives to the medication or adjustments to the dosage.
  • Divide your daily food intake into smaller, more frequent meals to reduce nausea.
  • Opt for bland, easily digestible foods like crackers, toast, plain rice, bananas, and applesauce.
  • Avoid certain foods that can trigger nausea, such as fatty, greasy, spicy, and smelly foods.
  • Drink plenty of fluids, such as water, clear broth, or electrolyte-rich beverages like coconut water or sports drinks.
  • Use ginger (tea, ale, or candies) to help relieve nausea.
  • Get adequate rest and also avoid strenuous activities that can worsen nausea.
  • Talk to your doctor about taking anti-nausea medication if your nausea is severe.
  • Record when your nausea occurs, what triggers it, and what provides relief to help you identify patterns and manage your symptoms more effectively.
  • Rest well; get enough sleep.
  • Eat a balanced diet and drink enough water.
  • Manage stress with yoga and meditation.
  • Limit alcohol and caffeine.
  • Physical activities like walking or jogging might help boost energy and make you feel less tired.
Dealing with Medication-Induced Headache:
  • Hydrate your body: Drink enough water to prevent dehydration and headaches.
  • Calm Your Mind: Deep breathing and meditation can help you relax and relieve stress.
  • Rest and Recharge: Sleep for 7-8 hours to reduce headache triggers.
  • Take rest: lie down in a quiet, dark environment.
  • Cold or warm compresses can help reduce tension.
  • Stay Upright: Maintain good posture to keep symptoms from getting worse.
  • To treat headaches naturally, try acupuncture or massage therapy.
  • Over-the-counter pain relievers include acetaminophen and ibuprofen.
  • Prescription Assistance: Speak with your doctor about more substantial drug alternatives.
  • Severe Headaches: Seek emergency medical assistance for sudden, severe headaches.
  • Frequent Headaches: If you get reoccurring headaches, consult your doctor.
  • Headaches with Symptoms: Seek medical attention if your headaches include fever, disorientation, or weakness.
Here are the step-by-step strategies to manage the side effects of "indigestion" caused by medication usage:
  • Take medications with food (if recommended): It can help prevent stomach distress and indigestion.
  • Eat smaller, more frequent meals: Divide daily food intake into smaller, more frequent meals to ease digestion.
  • Avoid trigger foods: Identify and avoid foods that trigger indigestion, such as spicy, fatty, or acidic foods.
  • Stay upright after eating: Sit or stand upright for at least 1-2 hours after eating to prevent stomach acid from flowing into the oesophagus.
  • Avoid carbonated drinks: Avoid drinking carbonated beverages, such as soda or beer, which can worsen indigestion.
  • Manage stress: To alleviate indigestion, engage in stress-reducing activities like deep breathing exercises or meditation.
  • Consult a doctor if needed: If indigestion worsens or persists, consult a healthcare professional to adjust the medication regimen or explore alternative treatments.
  • Inflammation in the lungs needs immediate medical attention. To manage this effect, the doctor's instructions must be followed strictly.
  • Intake of cod liver oil can smoothen the functioning of the body process.
  • Rest and refrain from physical activity, and restart after a few days.
  • Avoid smoking as it can worsen the swelling.
  • Practice meditation and yoga to enhance lung efficiency gradually after consulting with your doctor.

Directions for Use

  • Take Pivikto 200 mg/50 mg Tablet with meals, as it helps with absorption and reducing stomach upset.
  • Pivikto 200 mg/50 mg Tablet 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.

How Pivikto 200 mg/50 mg Tablet Works

Pivikto 200 mg/50 mg Tablet contains alpelisib. It works as a targeted therapy known as a PI3K inhibitor. In some breast cancers, a gene called PIK3CA becomes mutated, causing an enzyme called PI3K-alpha to become overactive. This overactive enzyme acts like a stuck gas pedal, sending continuous signals that tell the cancer cells to grow, divide, and survive even when they should not. When you take Pivikto 200 mg/50 mg Tablet , the active molecules bind directly to this overactive enzyme and shut down its signalling pathway. By blocking this specific pathway, the medicine cuts off the growth signals to the cancer cells. When used in combination with hormone therapy, this dual approach effectively starves the tumour of the signals and hormones it needs to grow, helping to shrink the tumour or stop it from spreading further.
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Alcohol

Caution

Avoid alcohol consumption while on treatment with Pivikto 200 mg/50 mg Tablet .

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Pregnancy

Unsafe

Pivikto 200 mg/50 mg Tablet 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.

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Breast Feeding

Caution

Lactating women should not breastfeed throughout Pivikto 200 mg/50 mg Tablet treatment and for one week following the final dosage.

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Driving

Caution

Pivikto 200 mg/50 mg Tablet does not influence the ability to drive or use machines. However, go only if you are alert, as the Pivikto 200 mg/50 mg Tablet may cause weakness or tiredness in some people.

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Liver

Caution

Limited information is available. Inform your doctor before taking the Pivikto 200 mg/50 mg Tablet if you have had a liver impairment/disorder history. Your doctor will prescribe only if the benefits outweigh the risks.

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Kidney

Caution

No 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 Pivikto 200 mg/50 mg Tablet if you have had a kidney impairment/disorder history. Your doctor will prescribe only if the benefits outweigh the risks.

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Children

Unsafe

Safety and effectiveness in patients below the age of 18 years have not been established. Hence, use is not recommended.

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Heart

Caution

Take Pivikto 200 mg/50 mg Tablet with caution, especially if you have a history of heart diseases/conditions. The dose may be adjusted by your doctor as required.

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Geriatrics

Caution

Pivikto 200 mg/50 mg Tablet should be used with caution in elderly patients. Please consult your doctor before use.

What if I have taken an overdose of Pivikto 200 mg/50 mg Tablet

If you take more than your prescribed dose of Pivikto 200 mg/50 mg Tablet , seek emergency medical assistance. An overdose can lead to severe complications, including dangerously high blood sugar levels or severe gastrointestinal distress.

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.
health query

Have a query?

How Soon It Starts Working

The time required for Pivikto 200 mg/50 mg Tablet to start to work: Pivikto 200 mg/50 mg Tablet ideally shows its action within 2 to 4 hours after administration. The time for which the effects of Pivikto 200 mg/50 mg Tablet last: The duration of action for Pivikto 200 mg/50 mg Tablet is unknown.

What if you forget to take Pivikto 200 mg/50 mg Tablet

If you miss a dose of Pivikto 200 mg/50 mg Tablet , take it with food as soon as you remember, provided it is within 9 hours of your scheduled time. If more than 9 hours have passed since your usual dosing time, skip the missed dose entirely and take your next dose at your regularly scheduled time. Do not take two doses at once to make up for a missed one.

Storage

• Store Pivikto 200 mg/50 mg Tablet tablets in their original packaging at room temperature, between 20°C and 25°C (68°F to 77°F).

Drug 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-Drug Interactions

verifiedApollotooltip
  • Acid-reducing medications (such as proton pump inhibitors): May decrease the absorption of Pivikto 200 mg/50 mg Tablet , 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 Pivikto 200 mg/50 mg Tablet in your body, raising your risk of developing severe side effects.
No Drug - Drug interactions found in our data. We may lack specific data on this medicine and are actively working to update our database. Consult your doctor for personalized advice

Drug-Drug Interactions

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Drug-Food Interactions

verifiedApollotooltip
  • Taking without food: Consuming this medicine on an empty stomach significantly reduces how much of the drug is absorbed, which can make your treatment less effective. Always take it with a meal.
  • Grapefruit and grapefruit juice: May interfere with how your body breaks down the medicine, potentially leading to higher levels in your blood and increased side effects.
     
No Drug - Food interactions found in our database. Some may be unknown. Consult your doctor for what to avoid during medication.

Drug-Food Interactions

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Habit Forming

No

Therapeutic Class

[KINASE INHIBITORS]

FAQs

Pivikto 200 mg/50 mg Tablet is used to treat Advanced or metastatic breast cancer.
Pivikto 200 mg/50 mg Tablet 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 Pivikto 200 mg/50 mg Tablet , 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 Pivikto 200 mg/50 mg Tablet .
Based on findings from animal studies, Pivikto 200 mg/50 mg Tablet 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 Pivikto 200 mg/50 mg Tablet 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.
Pivikto 200 mg/50 mg Tablet 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 Pivikto 200 mg/50 mg Tablet dose if blood sugar becomes very high.
No, you must not become pregnant while taking Pivikto 200 mg/50 mg Tablet , 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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Country of origin

Switzerland
Other Info - PIV0020
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