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Alpelisib

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Why is this medication prescribed?

In order to treat a specific type of breast cancer that has spread to nearby tissues or other parts of the body in women who have already experienced menopause (“change of life,” the end of menstrual cycles) or in men whose cancer worsened during or after specific other treatments, alpelisib (Piqray) and fulvestrant (Faslodex) are typically combined. Adults and children 2 years of age and older who have specific forms of PIK3CA Related Overgrowth Spectrum are treated with alpelisib (Vijoice) (PROS; a genetic condition that causes overgrowth and abnormalities in certain body tissues). Alpelisib belongs to the group of drugs known as kinase inhibitors. Cancer is treated by inhibiting the signals that the disease uses to spread by preventing the growth of cancer cells. By suppressing the impulses that lead to anomalies and overgrowth in specific body tissues, it treats PROS by reducing the extent of the abnormalities and alleviating symptoms.

How should this medicine be used?

Alpelisib is available as an oral tablet. Once daily, it is often taken with food for the length of time that your doctor prescribes treatment. Take alpelisib every day at about the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Utilize alpelisib precisely as advised. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole. Never take a tablet that has been cracked, fractured, or otherwise harmed.

Alpelisib (Vijoice) can be dissolved with water if you are taking it for PROS and are unable to swallow the tablets whole. Insert the tablet(s) into a glass of water that is 2 to 4 ounces (60 to 120 mL) in volume. After waiting five minutes, smash the tablets and whisk the concoction with a spoon. Drink the concoction right away. To rinse out any remaining particles, add an additional 2 to 3 tablespoons of water to the glass and mix with the same spoon. To ensure that you receive the full dosage of the drug, sip the entire combination, and repeat as required.

Do not take another dose of alpelisib if you vomit after taking it. Continue taking your medication as usual.

Do not take another dose of alpelisib if you vomit after taking it. Continue taking your medication as usual.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking alpelisib,

  • If you have an allergy to alpelisib, any other drugs, herbal remedies, or any of the substances in alpelisib tablets, tell your doctor and pharmacist right away. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any prescription and over-the-counter drugs, vitamins, or dietary supplements you are currently taking or intend to take. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor if you have ever experienced a rash with red sores on your lips, mouth, or skin, or if your skin has shed or blistered. Also mention if you have diabetes or kidney illness.
  • If you or your partner are expecting a child, let your doctor know right away. Neither you nor your partner should become pregnant while using alpelisib. Before starting therapy, women who are capable of getting pregnant must take a pregnancy test. They should also use reliable birth control throughout the course of treatment and for a week following the last dose. Use a condom and reliable birth control while undergoing therapy, as well as for a week following the last dose, if you are a male with a female partner who is capable of becoming pregnant. Call your doctor if you or your partner become pregnant while taking alpelisib. The foetus may suffer from alpelisib.
  • Inform your doctor if you are nursing a baby. Breastfeeding is not advised during therapy and for one week following the last dose, according to your doctor.
  • You should be aware that this medicine may lower both male and female fertility. You should discuss the dangers of taking alpelisib with your doctor.
  • You should be aware that alpelisib may elevate blood sugar levels. If you have diabetes or high blood sugar, check it as frequently as your doctor recommends. Call your doctor if your blood sugar is higher than usual. If you experience any of the following side effects while taking alpelisib: severe thirst, frequent urination, intense hunger, blurred vision, confusion, or weakness, call your doctor right away. Calling your doctor as soon as you experience any of these symptoms is crucial because untreated high blood sugar can result in the deadly disease known as ketoacidosis. If ketoacidosis is not treated right away, it could become life-threatening. Dry mouth, nausea, vomiting, shortness of breath, fruity-smelling breath, and diminished consciousness are all signs of ketoacidosis. If you have frequent nausea, vomiting, or diarrhoea while taking alpelisib, contact your doctor right away. While using alpelisib, your doctor may recommend adjusting your diet or medicine to assist control your blood sugar.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. However, skip the missing dose and carry on with your regular dosing plan if more than 9 hours have passed since the missed dose. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Alpelisib might have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Vomiting
  • Extreme fatigue
  • Diminished appetite
  • Taste of food alteration
  • Weight loss
  • Continent pain
  • Heartburn
  • Hair fall
  • Headache
  • Itching
  • Arid skin
  • Mouth ache
  • Virility dryness
  • Fever
  • Increasing arm or leg swelling

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you experience any of these symptoms or any of the ones detailed in the SPECIAL PRECAUTIONS section:

  • A fast heartbeat, rash, flushing, fever, difficulty breathing or swallowing, swelling of the face, mouth, lips, tongue, or throat may also be present
  • Rash, skin that is blistered, peeling, or red, sores on the lips, eyes, or mouth, fever, and flu-like symptoms
  • Chest pain, a cough, shortness of breath, and breathing issues
  • Symptoms such as severe diarrhoea, dry mouth, cramps, weakness, decreased urination, and swelling in the legs or ankles
  • Stomach ache, diarrhoea that is red or watery
  • Frequent, uncomfortable, or necessary urinating

Other adverse effects of alpelisib are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose symptoms could include:

  • Nausea
  • Rash
  • Not enough energy
  • Increased appetite and thirst
  • Mouth ache
  • Urinating more frequently or more heavily

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to alpelisib, your doctor will order specific lab tests both before and during your therapy.

Before you start therapy, your doctor will run a lab test to determine whether alpelisib is a viable treatment option for your cancer (Piqray).

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Piqray®
  • Vijoice
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