Piqray

Piqray is a prescription medication used to treat advanced or metastatic, HR positive, HER2 negative, PIK3CA mutated breast cancer.

Piqray belongs to a group of drugs called PI3K inhibitors that block the PI3K pathway. The PI3K pathway helps both healthy and cancer cells get the energy they need. When this pathway is overactivated because of a mutation in the PIK3CA gene, it can allow cancer cells to survive and grow. PI3K inhibitors kill cancer cells by blocking this pathway.

This medication comes as film-coated tablets and is available in three strengths that contain 50 mg, 150 mg and 200 mg of alpelisib. Take Piqray at approximately the same time each day. Swallow tablets whole (tablets should not be chewed, crushed or split prior to swallowing).

Common side effects include rash, nausea, tiredness/weakness, decreased appetite, mouth sores, vomiting, weight loss, hair loss, and changes in certain blood tests.

Piqray is a prescription medicine used in combination with the medicine fulvestrant to treat women who have gone through menopause and men:

• who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and
• whose disease has progressed on or after endocrine therapy.

Your healthcare provider will test your cancer for an abnormal “PIK3CA” gene to make sure that Piqray is right for you. 

It is not known if Piqray is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Piqray. See the "Picray Precautions" section.

The most common side effects of Piqray when used with fulvestrant include:

• rash
• nausea
• tiredness and weakness
• decreased appetite 
• mouth sores
• vomiting
• weight loss
• hair loss
• changes in certain blood tests

Piqray may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of Piqray.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

• Medicine called a strong CYP3A4 inducer because it decreases the effects of Piqray. This class of medicines includes Rifamate (rifampin), an antibiotic used to treat tuberculosis, and Carbatrol (carbamazepine), which is used to control certain types of seizures in people with epilepsy.
• A type of medicine called a BCRP inhibitor because it increases the effects of Piqray. This class of medicines includes Zegerid and Prilosec  (omeprazole) and the antibiotic novobiocin.
• St. John’s wort, an herb that is sometimes used to control depression and anxiety, because it can decrease the effects of Piqray.
• Medicines called CYP2C9 substrates. The blood thinner warfarin (brand names: Coumadin and Jantoven) is a CYP2C9 substrate. If you are on warfarin and are prescribed Piqray, your doctor will closely monitor levels of warfarin in your blood.

You should not eat grapefruit or drink grapefruit juice because they can increase the effects of Piqray.

This is not a complete list of Piqray drug interactions. Ask your doctor or pharmacist for more information.

Piqray may cause serious side effects, including:

Severe allergic reactions. Tell your healthcare provider or get medical help right away if you have trouble breathing, flushing, rash, fever, or fast heart rate during treatment with Piqray.

Severe skin reactions. Tell your healthcare provider or get medical help right away if you get severe rash or rash that keeps getting worse, reddened skin, flu-like symptoms, blistering of the lips, eyes or mouth, blisters on the skin or skin peeling, with or without fever.

High blood sugar levels (hyperglycemia). Hyperglycemia is common with Piqray and can be severe.Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Piqray. Your healthcare provider may monitor your blood sugar levels more often if you have a history of Type 2 diabetes. Tell your healthcare provider right away if you develop symptoms of hyperglycemia, including:

• excessive thirst o dry mouth
• more frequent urination than usual or a higher amount of urine than normal
• increased appetite with weight loss

Lung problems (pneumonitis). Tell your healthcare provider right away if you develop new or worsening symptoms of lung problems, including:

• shortness of breath or trouble breathing 
• cough
• chestpain

Diarrhea. Diarrhea is common with Piqray and can be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney problems. If you develop diarrhea during treatment with Piqray, tell your healthcare provider right away. Your healthcare provider may tell you to drink more fluids or take medicines to treat diarrhea.

Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Piqray if you get certain serious side effects.

Do not take Piqray if you have had a severe allergic reaction to Piqray or are allergic to any of the ingredients in Piqray.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Piqray, grapefruit and grapefruit juice may interact and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before you take Piqray, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of diabetes
• have a history of skin rash, redness of skin, blistering of the lips, eyes or mouth, or skin peeling
• are pregnant or plan to become pregnant.

Females who are able to become pregnant:

Your healthcare provider will check to see if you are pregnant before you start treatment with Piqray. 

You should use effective birth control during treatment with Piqray and for 1 week after the last dose.

Talk to your healthcare provider about birth control methods that may be right for you during this time.

If you become pregnant or think you are pregnant, tell your healthcare provider right away.

Males with female partners who are able to become pregnant should use condoms and effective birth control during treatment with Piqray and for 1 week after the last dose. If your female partner becomes pregnant, tell your healthcare provider right away. 

You should also read the Full Prescribing Information of fulvestrant for important pregnancy, contraception, and infertility information.

• are breastfeeding or plan to breastfeed. It is not known if Piqray passes into your breast milk. Do not breastfeed during treatment with Piqray and for 1 week after the last dose. You should also read the Full Prescribing Information of fulvestrant for important lactation information.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. Piqray and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

Tell your healthcare provider if you are pregnant or plan to become pregnant.

Piqray can cause harm to the unborn baby when administered to a pregnant woman. There are no available data in pregnant women to inform the drug- associated risk.

In animal studies, pregnant animals were given this medication and had some babies born with problems. 

Females who are able to become pregnant:

• Your healthcare provider will check to see if you are pregnant before you start treatment with Piqray. 
• You should use effective birth control during treatment with Piqray and for 1 week after the last dose.
• Talk to your healthcare provider about birth control methods that may be right for you during this time.
• If you become pregnant or think you are pregnant, tell your healthcare provider right away.
• Males with female partners who are able to become pregnant should use condoms and effective birth control during treatment with Piqray and for 1 week after the last dose. If your female partner becomes pregnant, tell your healthcare provider right away. 
• You should also read the Full Prescribing Information of fulvestrant for important pregnancy, contraception, and infertility information.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Piqray passes into your breast milk. Do not breastfeed during treatment with Piqray and for 1 week after the last dose.

• Take Piqray exactly as your healthcare provider tells you.
• Do not change your dose or stop taking Piqray unless your healthcare provider tells you.
• Take Piqray 1 time each day, at about the same time each day.
• TakePiqraywithfood.
• Swallow Piqray tablets whole. Do not chew, crush or split the tablets.
• Do not take any Piqray tablets that are broken, cracked, or that look damaged.
• If you miss a dose of Piqray, you may still take it with food up to 9 hours after the time you usually take it. If it has been more than 9 hours after you usually take your dose, skip the dose for that day. The next day, take the dose at your usual time. Do not take 2 doses to make up for a missed dose.
• If you vomit after taking a dose of Piqray, do not take another dose on that day. Take your next dose at your usual time.

Take Piqray exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Piqray is 300 mg (two 150 mg film-coated tablets) taken orally, once daily, with food.

If you take too much Piqray, call your healthcare provider or go to the nearest hospital emergency room right away.

Store Piqray at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Piqray and all medicines out of the reach of children.