50 mg, 150 mg, and 200 mg film-coated tablets
alpelisib
What Piqray is and what it is used for
What Piqray is
Piqray contains the active substance alpelisib, which belongs to a group of medicines called phosphatidylinositol ‑ 3‑ kinase inhibitors (PI3K inhibitors).
What Piqray is used for
Piqray is used to treat menopausal women and men with a type of breast cancer called advanced hormone receptor (HR) ‑positive, human epidermal growth factor receptor 2 ( HER2 ) ‑negative breast cancer. Piqray is used in combination with fulvestrant, hormone therapy for cancer, in patients who have not responded to other hormone therapies and who have certain changes ( mutations ) in a gene called PIK3CA.
Your doctor will take a blood sample and/or a sample of tumor tissue from you which will be tested for these PIK3CA mutations. If the result is positive (your cancer has mutation one), treatment with Piqray is likely to affect you.
How Piqray works
Piqray works by blocking the effects of enzymes called phosphatidylinositol ‑ 3‑ kinases (PI3K). These enzymes help cancer cells to grow and multiply. Piqray, through its blocking effect of the enzymes, can reduce the growth and spread of cancer and help destroy cancer cells.
Ask your doctor, pharmacist, or nurse if you have any questions about how Piqray works or why it has been prescribed for you.
What you need to know before taking Piqray
Follow all instructions from your doctor carefully. They may differ from the general information in this leaflet. Consult a doctor if you are unsure
Do not take Piqray
- if you are allergic to alpelisib or any of the other ingredients of this medicine (listed in section 6). Ask your doctor if you think you may be allergic.
Warnings and cautions
Talk to your doctor or pharmacist before taking Piqray.
Talk to your doctor or pharmacist before taking Piqray if any of the following apply to you:
- if you have or have ever had high blood sugar or diabetes (or signs of high blood sugar, such as severe thirst and dry mouth, need to urinate more often than usual or larger amounts of urine than usual, fatigue, nausea, or increased appetite at the same time as weight loss).
- if you have ever had Stevens-Johnson syndrome (SJS), erythema multiforme (EM), drug reaction with eosinophilia and systemic symptoms (DRESS) or toxic epidermal necrolysis (TEN; possible symptoms are red skin, blistering of the lips, eyes or mouth, skin peeling, with or without fever, rash).
- if you have a severe skeletal disease that affects the jaw ( osteonecrosis of the jaw, ONJ)
If you get any of the following treatments with Piqray, talk to your doctor or pharmacist immediately:
- Skin rash, itching, hives, shortness of breath, difficulty breathing, wheezing, coughing, fainting, dizziness, changes in the level of consciousness, low blood pressure, reddening of the skin, swelling of the face or throat, blue discoloration of the lips, tongue or skin (possible signs of severe allergic reactions).
- New or altered breathing problems such as difficulty breathing or pain when breathing, coughing, rapid breathing, blue discoloration of the lips, tongue, or skin, hiccups (possible signs of non-infectious pneumonitis or pneumonia ).
- Increased thirst and dry mouth, urination more often than usual, fatigue, increased appetite along with weight loss, confusion, nausea, vomiting, breath with a fruity odor, difficulty breathing, and dry or reddening skin, which may be signs of elevated blood sugar levels ( hyperglycemia ) and its complications.
- Skin rash, flushing, blistering of the lips, eyes, or mouth, dandruff, sometimes a fever (possible signs of one of the following skin reactions: Stevens-Johnson syndrome (SJS), erythema multiforme (EM), drug reaction with eosinophilia and systemic symptoms (DRESS) or toxic epidermal necrolysis (TEN))
- New symptoms or worsening of symptoms that affect the mouth (such as loose teeth, pain or swelling, wounds that do not heal, or fluids).
- Piqray can cause severe diarrhea.
Your doctor may need to treat these symptoms, pause the treatment or reduce the dose, or stop taking Piqray altogether.
Blood tests before and during treatment with Piqray
Your doctor will take blood samples before and regularly during treatment with Piqray to monitor your blood sugar. Based on the results, your doctor may give you the treatment you need, such as prescribing medicine that lowers your blood sugar. If necessary, your doctor may temporarily stop your treatment with Piqray or lower the dose of Piqray to lower your blood sugar. Your doctor may also decide to stop taking Piqray permanently.
Be sure to check your blood sugar regularly before starting treatment, during treatment, and after stopping treatment with Piqray.
- Your doctor will tell you exactly when and where to submit blood samples. Treatment with Piqray should only start if the tests show that you have the right levels of sugar in your blood. This is because Piqray may increase blood sugar (hyperglycemia), which may be serious and require treatment. Only regular fasting blood tests can tell your doctor if you develop hyperglycemia.
- Your doctor will tell you exactly when and where to check your blood sugar. During the first 4 weeks, especially the first 2 weeks, of Piqray treatment, this will need to be done more often. After that, you take blood tests at least once a month, depending on how your blood sugar levels change.
Children and young people
Piqray should not be used in children and adolescents under 18 years of age.
Other drugs and Piqray
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This applies in particular to the following:
- eltrombopag, a drug used to treat low platelet counts
- medicines used to treat breast cancer, such as lapatinib, everolimus or ribocyclib
- pantoprazole, a drug used to treat heartburn and reduce the amount of acid produced in the stomach
- midazolam, a medicine used as a sedative or for insomnia
- rifampicin, a drug used to treat tuberculosis and other serious infections
- encorafenib, a drug used to treat a specific type of skin cancer
- warfarin, a drug used to reduce the blood’s ability to coagulate
Ask your doctor or pharmacist if you are not sure if any of your medicines are included in the above groups.
Pregnancy, breastfeeding, and fertility
Piqray should not be used by women who are or may be pregnant or breastfeeding. Piqray can harm an unborn baby. If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Women should not breastfeed during treatment and for at least 1 week after the last dose of Piqray. Your doctor will talk to you about the possible risks of taking Piqray while you are pregnant or breastfeeding.
If you are a woman and could become pregnant, your doctor will rule out that you are pregnant before you can start treatment with Piqray. You may need to do a pregnancy test.
Women who may become pregnant must use effective contraception during treatment and for at least 1 week after stopping Piqray. Ask your doctor about suitable contraceptives. If you think you may be pregnant after starting treatment with Piqray, tell your doctor immediately.
During treatment and for at least 1 week after it has ended, male patients should use condoms during intercourse with female partners who may become pregnant. If the partner of a male patient suspects that she has become pregnant during this time, she should immediately tell a doctor.
Driving and using machines
Treatment with Piqray may cause fatigue. You should therefore be extra careful when driving a vehicle or using machines during treatment with Piqray.
Piqray contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
3. How to take Piqray
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
How much Piqray should you take?
The recommended starting dose of Piqray is 300 mg once daily. Your doctor will decide which dose is right for you.
Depending on the dose you have been prescribed, take the following number:
- 300 mg dose: two 150 mg tablets
- 250 mg dose: one 200 mg tablet and one 50 mg tablet
- 200 mg dose: a 200 mg tablet
If you vomit after taking the Piqray tablet or tablets, do not take more tablets until it is time for the next dose according to your schedule.
Your doctor will decide which dose of fulvestrant to take and when to take it.
Depending on how your body responds to the treatment, your doctor may want to adjust the dose of Piqray. You must follow your doctor’s instructions. If you experience side effects, your doctor may ask you to take a lower dose, to stop treatment with Piqray, or to stop it altogether.
When to take Piqray
The Piqray tablets are packaged with blister cards. Each blister card shows the tablet or tablets you should take each day of the week. Follow the instructions on the blister card.
Take Piqray once a day, immediately after eating. Take Piqray at the same time each day, then it will be easier to remember to take your medicine.
How to take Piqray
Piqray tablets should be swallowed whole and should not be chewed, crushed or divided before ingestion. Do not take a tablet that is broken, cracked, or damaged in any other way as you may not take the full dose.
How long should you take Piqray?
Take Piqray for as long as your doctor tells you to.
This is a long-term treatment that can last for several months or years. Your doctor will check your condition at regular intervals to see if the treatment has the desired effect.
If you have any further questions on the use of Piqray, ask your doctor or pharmacist.
If you take more Piqray than you should
People who have taken too many Piqray tablets have experienced effects that are known side effects of Piqray including high blood sugar levels, nausea, fatigue, and itching. If you have accidentally taken too many tablets, or if someone else has accidentally taken your medicine, contact a doctor or hospital immediately for advice. Medical care may be needed.
If you forget to take Piqray
If you forget to take a dose of Piqray, if less than 9 hours have passed since you took it, you can still take one dose immediately after a meal. If more than 9 hours have passed since you took it, you should skip dose one that day. The next day you take a dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Piqray
If you stop taking Piqray, your illness may worsen. Do not stop taking Piqray unless your doctor tells you to.
If you have any further questions on the use of Piqray, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious
If you get any serious side effects, stop taking the medicine and contact your doctor immediately.
Very common: may affect more than 1 in 10 people
- Strong thirst, need to urinate more often than usual or urinate larger amounts than usual, increased appetite at the same time as weight loss (possible symptoms of high blood sugar, also called hyperglycemia )
- Fever, cough, runny nose, enlarged lymph nodes, joint pain, skin rash, night sweats, weight loss (possible symptoms of low lymphocyte count, a type of white blood cell )
Common: may affect up to 1 in 10 people
- Skin rash, itching, hives, shortness of breath, difficulty breathing, wheezing, coughing, fainting, dizziness, changes in the level of consciousness, low blood pressure, redness of the skin, swelling of the face and/or throat, blue discoloration of the lips, tongue or skin (possible signs of severe allergic reactions)
- Breathing problems such as difficulty breathing or pain when breathing, coughing, rapid breathing, blue discoloration of the lips, tongue, or skin, hiccups (possible signs of pneumonitis )
- Urinates less often than usual or in smaller amounts than usual, swelling of bones, ankles, and around the eyes, fatigue, confusion, nausea, cramps, chest pain (possible symptoms of acute renal failure )
- Pain, swelling or numbness in the jaw, feeling of heaviness in the jaw, or a tooth that comes loose (possible symptoms of osteonecrosis in the jaw)
- Skin rash, redness of the skin, blistering of the lips, eyes, or mouth, peeling of the skin (possible symptoms of erythema multiforme)
Uncommon: may affect up to 1 in 100 people
- Difficulty breathing, headache, nausea, vomiting (possible symptoms of a condition called ketoacidosis which means high levels of acids in the blood)
- Severe pain in the upper abdomen (possible symptoms of pancreatitis )
- Skin rash, red skin, blisters on the lips, eyes, or mouth, skin rash, fever (possible symptoms of Stevens-Johnson syndrome)
No known frequency: can not be calculated from the available data
- Confusion, dry mouth, dry or reddening skin, nausea, vomiting, fatigue, need to urinate frequently, thirst (possible symptoms of the hyperglycaemic hyperosmolar non-ketotic syndrome (HHNKS))
- Skin rash, fever (possible symptoms of drug reaction with eosinophilia and systemic symptoms (DRESS))
Other possible side effects
Other side effects that may occur are listed below. If these side effects get serious, talk to your doctor, pharmacist, or nurse.
Very common:
- Painful and frequent urination (signs of urinary tract infection).
- Fatigue, pale skin (possible symptoms of anemia a condition that involves a lack of red blood cells )
- Bleeding or bruising for no apparent reason (signs of low platelet count )
- Reduced appetite
- Headache
- Strange taste in the mouth ( dysgeusia )
- Diarrhea
- Nausea
- Vomiting
- Sores in the mouth with inflamed mucous membranes ( stomatitis ).
- Abdominal pain
- Anxious stomach, indigestion, ( dyspepsia )
- Rash
- Hair loss or thinning hair ( alopecia )
- Itching ( pruritus )
- Dry skin
- Fatigue
- Pain, redness, and swelling of the respiratory tract or esophagus or genital mucosa (mucositis)
- Swollen hands, ankles, or feet ( edema )
- Fever ( pyrexia )
- Dry mucous membranes
- Weight loss
- Decreased calcium content in the blood, can sometimes lead to seizures (hypocalcemia)
- Decreased potassium levels in the blood, which are associated with muscle weakness, muscle cramps, and/or abnormal heart rhythm ( hypokalaemia )
Usual:
- Dehydration
- Difficulty falling asleep (insomnia)
- Dry eyes
- Dimsyn
- Headache, dizziness (possible symptoms of high blood pressure )
- Swelling of part or all of the arm (including the fingers) or the leg (including the toes), heaviness, restriction of movement, discomfort, thickening of the skin, and recurrent infections (possible symptoms of lymphedema)
- Toothache
- Bleeding, tender, or enlarged gums (signs of gingivitis)
- Cracked and chapped lips (keilit)
- Pain in the gums
- Erythema
- Skin inflammation with rash ( dermatitis )
- Redness and/or swelling and possible scaling of the palms and soles of the feet, which may be accompanied by a tingling sensation and burning pain (signs of hand-foot syndrome)
- Muscle cramps
- Muscle pain ( myalgia )
- General swelling ( edema )
During treatment with Piqray, the results of some blood tests may become abnormal, as follows:
Very common:
- High levels of the following enzymes in the blood: gamma-glutamyltransferase, alanine aminotransferase, lipase
- High blood sugar
- The high content of creatinine and/or calcium
- Low number / low levels of lymphocytes, platelets, sugar, hemoglobin, and/or albumin
- Prolonged activated partial thromboplastin time (a measure of the blood’s ability to coagulate)
Usual:
- High levels of glycosylated hemoglobin (a marker of blood sugar level during the last 8 to 12 weeks)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
5. How to store Piqray
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
The expiration date is the last day of the specified month.
No special storage instructions.
Do not take this medicine if you notice that the packaging is damaged or shows signs of being tampered with in any way.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the package and other information
Content declaration
- The active substance in Piqray is alpelisib.
- Each 50 mg film-coated tablet contains 50 mg of alpelisib.
- Each 150 mg film-coated tablet contains 150 mg of alpelisib.
- Each 200 mg film-coated tablet contains 200 mg of alpelisib.
- Other ingredients are:
- Tablet core: microcrystalline cellulose, mannitol, sodium starch glycolate, hypromellose, magnesium stearate.
- Coating: Hypromellose, red and black iron oxide (E172), titanium dioxide (E171), macrogol, talc.
What the medicine looks like and the contents of the pack
Piqray 50 mg film-coated tablets are light pink round tablets marked with “L7” on one side and “NVR” on the other side. Approximate diameter: 7.2 mm.
Piqray 150 mg film-coated tablets are pale red oval tablets marked with “UL7” on one side and “NVR” on the other side. Approximate size: 14.2 mm (length), 5.7 mm (width).
Piqray 200 mg film-coated tablets are light red oval tablets marked with “YL7” on one side and “NVR” on the other side. Approximate size: 16.2 mm (length), 6.5 mm (width).
Piqray is supplied as film-coated tablets in blisters. Piqray is available in the following pack sizes:
- Packs of 50 mg and 200 mg film-coated tablets (for patients on a daily dose of 250 mg ):
- Packs for 14 days treatment: 28 film-coated tablets (14 50 mg and 14 200 mg).
- Packs for 28 days treatment: 56 film-coated tablets (28 at 50 mg and 28 at 200 mg).
- Multipack containing 168 film-coated tablets (3 x 56, each containing 28 tablets of 50 mg and 28 tablets of 200 mg).
- Packs of 150 mg film-coated tablets (for patients on a daily dose of 300 mg ):
- Packs for 14 days of treatment: 28 film-coated tablets.
- Packs for 28 days of treatment: 56 film-coated tablets.
- Multipack containing 168 (3 x 56) film-coated tablets.
- Packs of 200 mg film-coated tablets (for patients on a daily dose of 200 mg ):
- Packs for 14 days of treatment: 14 film-coated tablets.
- Packs for 28 days of treatment: 28 film-coated tablets.
- Multipack containing 84 (3 x 28) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Lek Pharmaceuticals dd
Verovskova Ulica 57
1526 Ljubljana
Slovenia
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 88 04 52 555 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| .ΠροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | SwedenNovartis Sverige ABTel: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsTel: +371 67 887 070 | United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370 |