TRUQAP 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

TRUQAP 160mg film-coated tablets

TRUQAP 200mgfilm-coated tablets

capivasertib

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is TRUQAP and what is it used for
2. What you need to know before you take TRUQAP
3. How to take TRUQAP
4. Possible side effects
5. Storage of TRUQAP
6. Contents of the pack and other information

1. What is TRUQAP and what is it used for

What is TRUQAP

TRUQAP is a medicine used to treat cancer. It contains the active substance capivasertib. Capivasertib belongs to a group of medicines called AKT inhibitors.

What TRUQAP is used for

TRUQAP is used in combination with fulvestrant (another anti-cancer medicine) to treat adult patients who have hormone receptor-positive, HER2-negative advanced or metastatic breast cancer with one or more abnormal “PIK3CA”, “AKT1”, or “PTEN”genes and whose cancer is not responding to other medicines that block the action of hormones (hormonal therapy). Women who have not reached menopause will also be treated with a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist. In men, your doctor will decide whether you should receive treatment with an LHRH agonist.

Your doctor will check your cancer to see if you have at least one abnormal “PIK3CA”, “AKT1”, or “PTEN”gene to make sure that TRUQAP is suitable for you.

How TRUQAP works

TRUQAP works by blocking the effects of certain proteins called AKT kinases. These proteins help cancer cells grow and multiply. By blocking their action, TRUQAP can reduce the growth of cancer cells.

If you have any questions about how TRUQAP works or why you have been prescribed this medicine, ask your doctor.

What other medicine will be given with TRUQAP

When you take this medicine, you will also be given another medicine called fulvestrant.

2. What you need to know before you take TRUQAP

Do not takeTRUQAP if:

You are allergic to capivasertib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to yourhealthcare providerbefore startingTRUQAP if:

• You have or have had diabetes or high blood sugar levels (hyperglycemia) or signs of high blood sugar levels including being very thirsty, having a dry mouth, needing to urinate more often than usual, urinating more than usual, having an increased appetite with weight loss.
• You have any current infection.
• You have diarrhea or soft stools.
• You have a rash or other skin problems.
• You have kidney problems or high levels of creatinine or uric acid in the blood (observed in blood tests).
• You have liver problems.

Ask your doctor to provide you with the package leaflet of fulvestrant as it contains important information about the medicine.

During treatment with TRUQAP, talk to your doctor immediately if you experience the following side effects. Your doctor may need to treat these symptoms, temporarily stop your treatment, reduce your dose, or permanently stop your treatment with TRUQAP:

High blood sugar levels (hyperglycemia)

• Your doctor will check your blood sugar levels before you start treatment with TRUQAP, but also regularly during your treatment with TRUQAP and more frequently in the first eight weeks of treatment. You should have your blood sugar levels checked on days 3 or 4 of the week of administration, before taking TRUQAP. Depending on the results, your doctor will take the necessary actions, such as prescribing you a medicine to lower your blood sugar levels or consulting an endocrinologist. Your blood sugar levels and medication will need to be monitored more frequently if you have diabetes.
• Your doctor will tell you exactly when and where to have your blood tests. Treatment with TRUQAP can only be started if the tests show that you have the correct blood sugar levels. This is because TRUQAP can increase the sugar in your blood (hyperglycemia), which can be serious and cause life-threatening complications.
• Signs of high blood sugar levels include being very thirsty, having a dry mouth, needing to urinate more often than usual, urinating more than usual, having an increased appetite with weight loss. Additional symptoms such as nausea, vomiting, abdominal pain, difficulty breathing, fruity odor of the breath, confusion, unusual fatigue or sleepiness, may be signs of an acute complication of high blood sugar.

Any sign of diarrhea

• Your doctor or pharmacist will advise you to drink more fluids or take medicines to treat diarrhea.
• Signs of diarrhea are soft or watery stools.

Skin rash and other skin reactions to the medicine

• Signs of skin rash and other skin reactions to the medicine include rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, dry skin, skin inflammation, peeling and/or scaling of the skin surface.

Children and adolescents

TRUQAP is not recommended for use in children or adolescents under 18 years of age. The safety and efficacy of TRUQAP have not been studied in this age group.

Other medicines andTRUQAP

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines that do not require a prescription. Some medicines used to treat infections may increase the risk of side effects of TRUQAP, and your doctor may need to reduce the dose of TRUQAP. See examples below:

• Certain antibiotics (e.g., clarithromycin, telithromycin).
• Certain antifungals (e.g., ketoconazole, itraconazole, voriconazole, posaconazole).
• Certain antivirals (e.g., boceprevir, nelfinavir, ritonavir, telaprevir).

Some medicines may reduce the effectiveness of TRUQAP, such as carbamazepine, phenytoin, St. John's Wort (a herbal medicine), and rifampicin.

TRUQAP may also increase the risk of side effects or alter the effectiveness of certain medicines, such as bupropion, carbamazepine, cyclosporine, fentanyl, irinotecan, simvastatin. Your doctor may need to adjust the dose of these medicines.

The medicines listed here may not be the only ones that can interact with TRUQAP. Ask your doctor or pharmacist if you are not sure if your medicine is one of the medicines listed above.

Pregnancy and fertility

Do not take TRUQAP if you are pregnant or plan to become pregnant. TRUQAP may harm the fetus.

If you are a woman who could become pregnant, your doctor will ask you to provide a negative pregnancy test before starting treatment and will recommend that you have a pregnancy test during treatment.

Contraception in men and women

If you are a woman, you must avoid becoming pregnant while taking TRUQAP. Talk to your doctor about contraceptive methods if there is any chance you could become pregnant. If you can become pregnant, you must use an effective contraceptive method during treatment with TRUQAP and for 4 weeks after the last dose. If you become pregnant during treatment, tell your doctor immediately. Your doctor may advise you on appropriate contraceptive methods.

If you are a man, you must use a condom when having sexual intercourse with a female partner who is pregnant or could become pregnant while taking TRUQAP and for 16 weeks after the last dose. Your female partner must also use an appropriate contraceptive method. You must tell your doctor if your female partner becomes pregnant.

Breast-feeding

Tell your doctor if you are breast-feeding before taking TRUQAP. For the safety of your baby, you must not breast-feed during treatment with TRUQAP.

Driving and using machines

TRUQAP may affect your ability to drive or use machines. If you feel tired while taking TRUQAP, you must be careful when driving or using tools or machines.

TRUQAP contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially “sodium-free”.

3. How to take TRUQAP

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

• The usual starting dose is 400 mg (two 200 mg tablets) taken twice a day (a total of 4 tablets each day) for four consecutive days followed by three days without administration. See Table 1.
• Swallow the tablets whole with water and take them with a 12-hour interval (2 in the morning and 2 in the afternoon) approximately at the same time on the days of administration.
• Do not chew, crush, or divide the tablets before swallowing. Do not swallow any tablet that is broken, cracked, or damaged in any way, as you may not be taking the full dose.
• You can take the tablets with or without food.

Table1 TRUQAP dosing schedule

• Do not take the tablets on days 5, 6, and 7.

Write the day you take your first dose on the carton.

While taking TRUQAP, you will also receive another medicine called fulvestrant. Your doctor will determine the dose and schedule of fulvestrant.

If you vomit, do not take an additional dose. Take the next dose of TRUQAP at your usual time.

Avoid grapefruit and grapefruit juice while taking TRUQAP, as it may increase the risk of side effects of TRUQAP.

Depending on how your body responds to treatment with TRUQAP, your doctor may adjust your dose of TRUQAP. It is very important to follow your doctor's instructions. If you have certain side effects, your doctor may reduce the dose, temporarily stop treatment, or permanently stop treatment.

The number of tablets to take depends on the prescribed dose as follows:

• Dose of 400 mg: two 200 mg tablets twice a day
• Dose of 320 mg: two 160 mg tablets twice a day
• Dose of 200 mg: one 200 mg tablet twice a day

How long to take TRUQAP

Take TRUQAP for as long as your doctor tells you to.

This is a long-term treatment that may last for months or years. Your doctor will regularly check your condition to see if the treatment is working as expected. If you have any doubts about how long to take TRUQAP, talk to your doctor or pharmacist.

If you take more TRUQAP than you should

If you take too many tablets, or if someone else takes your medicine, contact a doctor or hospital for advice immediately. Show the TRUQAP packaging and this leaflet. Medical treatment may be necessary.

If you forget to take TRUQAP

If you forget a dose, you can still take it within 4 hours of the time you usually take it.

If more than 4 hours have passed since the time you usually take your dose, skip that dose. Take the next dose at your usual time. Check Table 1 for the dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking TRUQAP

Do not stop taking TRUQAP unless your doctor tells you to. If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Talk to your doctor immediately if you experience any of the following side effects during treatment with TRUQAP. Your doctor may need to treat these symptoms, temporarily stop your treatment, reduce your dose, or permanently stop your treatment with TRUQAP.

High blood sugar levels (hyperglycemia)

• Excessive thirst and dry mouth

• Need to urinate more often than usual
• Producing more urine than usual
• Increased appetite with weight loss

Your doctor or pharmacist will check your blood sugar levels before you start and during treatment with TRUQAP. They will check your blood sugar levels more frequently if you have diabetes.

Diarrhea

• Soft or watery stools

Your doctor or pharmacist will advise you to drink more fluids or take medicines to treat diarrhea.

Skin rash and other skin reactions to the medicine

• Rash
• Redness of the skin
• Blisters on the lips, eyes, or mouth
• Peeling of the skin
• Dry skin
• Skin inflammation
• Peeling and/or scaling of the skin surface

Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people)

• Infection of the urinary tract
• Low hemoglobin levels in the blood
• Loss of appetite
• Feeling sick (nausea)
• Vomiting
• Sores or ulcers in the mouth with inflammation of the gums (stomatitis)
• Itching (pruritus)
• Fatigue
• Headache

Common (may affect up to 1 in 10 people)

• Unusual taste in the mouth (dysgeusia)
• Stomach upset, indigestion (dyspepsia)
• Skin rash
• Pain, redness, and swelling of the mucous membranes in different parts of the body, e.g., genital mucosa (mucositis)
• High levels of creatinine in the blood observed in blood tests, which may be a sign of kidney problems
• High levels of hemoglobin A1c in the blood (a marker of blood sugar levels over the last 8 to 12 weeks)
• Low levels of potassium in the blood
• Dizziness
• Fainting (syncope)
• Stomach pain
• Fever
• Kidney problems, including a rapid loss of kidney function (acute kidney injury)
• Weight loss

Uncommon (may affect up to 1 in 100 people)

• Hypersensitivity
• Toxic skin rash (allergic rash)
• Diabetic ketoacidosis (a serious complication of high blood sugar)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of TRUQAP

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 expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of damage to the packaging or if the tablet is broken, cracked, or not intact 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. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition ofTRUQAP

The active ingredient of TRUQAP is capivasertib.

• Each 160 mg film-coated tablet contains 160 mg of capivasertib.
• Each 200 mg film-coated tablet contains 200 mg of capivasertib.

The other excipients are:

• Tablet core: microcrystalline cellulose (E460i), calcium hydrogen phosphate, sodium croscarmellose (E468), and magnesium stearate (E470b) (see section 2 “TRUQAP contains sodium”).
• Film coating: hypromellose, titanium dioxide (E171), macrogol 3350, polydextrose, copovidone, medium-chain triglycerides, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172).

Appearance and Packaging of the Product

TRUQAP 160 mg film-coated tablets

Film-coated tablets, round, biconvex, beige in color, engraved with “CAV” above “160” on one side and smooth on the other side. Approximate diameter: 10 mm.

TRUQAP 200 mg film-coated tablets

Film-coated tablets, capsule-shaped, biconvex, beige in color, engraved with “CAV 200” on one side and smooth on the other side. Approximate diameter: 14.5 mm (length) and 7.25 mm (width).

TRUQAP is supplied in aluminum blisters (with sun symbols for morning/moon for night) containing 16 film-coated tablets. Each pack contains 64 tablets (4 blisters).

Marketing Authorization Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu