Piqray

The usual adult dose of Piqray (Alpelisib) is 300 mg (2 x 150 mg tablets) taken by mouth, once daily. It should be taken immediately after eating and at approximately the same time each day. If you experience a lot of side effects, your doctor may switch you to a lower dose.

Swallow the tablets whole. Do not crush, break, or chew the tablets. Safely discard any tablets that are broken or cracked. Do not take tablets that are not intact.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Piqray (Alpelisib) exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible after some food if it is within 9 hours of the missed dose. Then continue with your regular schedule. If it is more than 9 hours since the missed dose, skip the missed dose and continue with your regular dosing schedule. If you vomit after taking a dose, do not take another dose, and take the next dose at the regular time. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Piqray (Alpelisib) in its original package at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause hair loss; it may cause diarrhea; it may cause high blood sugar levels, you may experience excessive thirst, high urine output, increased appetite, tiredness; it may cause nausea and vomiting; it may cause a skin reaction; it may cause pain in the mouth. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

50 mg
Each light pink, unscored, round and curved, bevelled-edged tablet, imprinted with "L7" on one side and "NVR" on the other side, contains 50 mg of Piqray (Alpelisib). Nonmedicinal ingredients: hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate; tablet coating: hypromellose, iron oxide black, iron oxide red, macrogol / polyethylene glycol (PEG), talc, and titanium dioxide.

150 mg
Each pale red, unscored, ovaloid and curved, bevelled-edged tablet, imprinted with "UL7" on one side and "NVR" on the other side, contains 150 mg of Piqray (Alpelisib). Nonmedicinal ingredients: hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate; tablet coating: hypromellose, iron oxide black, iron oxide red, macrogol / polyethylene glycol (PEG), talc, and titanium dioxide.

200 mg
Each light red, unscored, ovaloid and curved, bevelled-edged tablet, imprinted with "YL7" on one side and "NVR" on the other side, contains 200 mg of Piqray (Alpelisib). Nonmedicinal ingredients: hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate; tablet coating: hypromellose, iron oxide black, iron oxide red, macrogol / polyethylene glycol (PEG), talc, and titanium dioxide.

Do not take Piqray (Alpelisib) if you are allergic to Piqray (Alpelisib) or any ingredients of the medication.

There may be an interaction between Piqray (Alpelisib) and any of the following:

• Apalutamide
• Carbamazepine
• Celecoxib
• Clopidogrel
• Cobicistat
• Cyclosporine
• diabetes medications (e.g., Canagliflozin, chlorpropamide, Glyburide, insulin, Linagliptin, Liraglutide, Metformin, Repaglinide, Rosiglitazone)
• Eltrombopag
• Enzalutamide
• etravirine
• Fluvastatin
• Hepatitis C antivirals (e.g., elbasvir, glecaprevir, grazoprevir, pibrentasvir, velpatasvir, voxilaprevir)
• HIV protease inhibitors (e.g., atazanavir, lopinavir)
• Lapatinib
• Leflunomide
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• Mitotane
• Ondansetron
• Osimertinib
• Phenobarbital
• Phenytoin
• primidone
• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, moxifloxacin)
• Regorafenib
• siponimod
• rifampin
• Teriflunomide
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Piqray (Alpelisib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Piqray (Alpelisib).

Anemia: Piqray (Alpelisib) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Birth control: Women who may become pregnant should use effective birth control while taking Piqray (Alpelisib) and for at least 1 week after stopping Piqray (Alpelisib). Men taking Piqray (Alpelisib) who have partners who may become pregnant should also use effective birth control while taking Piqray (Alpelisib) and for at least 1 week after stopping Piqray (Alpelisib).

Bleeding: Piqray (Alpelisib) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Dehydration: Severe dehydration can occur with the use of Piqray (Alpelisib). This may be due to severe or persistent diarrhea, vomiting, or decreased fluid intake. Dehydration can lead to kidney failure, if it is severe enough. During treatment with Piqray (Alpelisib), you may be encouraged to drink extra water. Your doctor will do blood tests to check the function of your kidneys.

Diabetes: Piqray (Alpelisib) may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. Cases of severely increased blood sugar levels causing diabetic ketoacidosis have occurred.

If you develop symptoms of diabetic ketoacidosis such as difficulty breathing, feeling very thirsty, vomiting, abdominal pain, nausea, loss of appetite, confusion, and unusual tiredness, seek urgent medical attention.

People with diabetes may find it necessary to monitor their blood sugar more frequently while using Piqray (Alpelisib).

Deterioration of the jaw bone: People with cancer who are being treated with Piqray (Alpelisib) and Fulvestrant have reported developing osteonecrosis of the jaw (deterioration of the jaw bone). Report any pain, swelling, or infection of the jaw to your doctor, and avoid invasive dental procedures such as tooth extractions. Your doctor may recommend that you see a dentist before starting Piqray (Alpelisib). It is important to practice good oral hygiene while taking Piqray (Alpelisib).

Hypersensitivity syndrome: A Anaphylaxis (severe allergic reaction) called hypersensitivity syndrome has occurred for some people with the use of Piqray (Alpelisib). This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Infection: As well as killing cancer cells, Piqray (Alpelisib) can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections.

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking Piqray (Alpelisib). This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking Piqray (Alpelisib), contact your doctor immediately.

Race: People of Asian heritage who take Piqray (Alpelisib) are more likely to experience severe reactions to Piqray (Alpelisib), such allergic reactions, severe skin reactions, and pancreatitis.

Pregnancy: Piqray (Alpelisib) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Piqray (Alpelisib), contact your doctor immediately.

Breast-feeding: It is not known if Piqray (Alpelisib) passes into breast milk. If you are a breast-feeding mother and are taking Piqray (Alpelisib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Piqray (Alpelisib) have not been established for children.

Seniors: People over the age of 65 are more likely to experience side effects from Piqray (Alpelisib).

To fully benefit from the effect of this medication, and to limit any adverse reactions, make sure that the health care facility overseeing your treatment has provided you with all the information needed to properly administer this drug. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. This medication should be swallowed whole. It should not be split, crushed or chewed. If you remember missing a dose within 9 hours of the time it is usually taken, take the missed dose as soon as possible, then take the next dose at the regularly scheduled time. If the dose is missed by more than 9 hours, skip the missed dose. Do not double the next dose to catch up. This medication is more effective if taken with food. Always take it with a meal or a snack.