Truqap 160 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Truqap is available in 160 mg and 200 mg tablets.

Truqap in combination with fulvestrant is used to treat adult patients who have hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer that is advanced or that has spread to other parts of the body with one or more abnormal “PIK3CA”, “AKT1”, or “PTEN” gene and whose cancer is not responding to other anti-hormonal based therapies.

Your healthcare provider will test your cancer to see if it has at least one abnormal “PIK3CA”, “AKT1”, or “PTEN” gene to make sure that Truqap is right for you.

Truqap works by blocking the effects of proteins called AKT Kinases. These proteins help cancer cells to grow and multiply. By blocking their action, Truqap can reduce growth and spread of the cancer and help to destroy cancer cells.

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

If you think you may be allergic, ask your doctor for advice.

Before you take Truqap, tell your healthcare provider if:

• You have or have ever had high blood sugar or diabetes (or signs of high blood sugar, such as being very thirsty and having dry mouth, needing to pass urine more often than usual, making greater amounts of urine than usual, increased appetite with weight loss).
• You have diarrhoea or loose stool.
• You have rash or other skin disorders.
• You have kidney problems or high levels of creatinine or uric acid in your blood.
• You have liver problems.
• You are taking or have recently taken any other medicine, including medicines obtained without a prescription.
• You are pregnant or plan to become pregnant. Truqap may harm your unborn baby. If you are able to become pregnant, you should use an effective method of birth control during your treatment and at least for 4 weeks after the last dose of Truqap.
• You are breastfeeding or plan to breastfeed. It is not known if Truqap passes into your breast milk. Do not breastfeed during treatment.
• You are a male with female partners who are or able to become pregnant. Male patients should use condoms and effective birth control during treatment with Truqap and for 16 weeks after the last dose. If your female partner becomes pregnant, tell your healthcare provider right away.
• You have poor dental health or history of osteonecrosis of the jaw.

You should read the Package Leaflet of fulvestrant for important information on warnings and precautions.

• High blood sugar levels (hyperglycaemia)
  • Your doctor or pharmacist or nurse will monitor your blood sugar levels before you start and during treatment with Truqap. They will monitor your blood sugar levels more frequently if you have diabetes.
  • For signs of high blood sugar – see Section 4 Possible side effects.
• Any signs of diarrhoea
  • Your doctor or pharmacist or nurse will advise you to drink more fluids or take medicines to treat diarrhoea.
  • For signs of diarrhoea – see Section 4 Possible side effects.
• Any skin reactions
  • For signs of skin reactions – see Section 4 Possible side effects.
• Problems with your mouth, teeth or jaw
  • New or worsening oral symptoms including dental health, pain or swelling and non-healing of mouth sores or discharge.

Your doctor may need to treat these symptoms, temporarily pause your treatment, reduce your dose, or permanently stop your treatment with Truqap.

Do not give this medicine to children or adolescents under 18 years of age.

Tell your doctor or pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Some medicines may increase the risk of side effects 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).
• Drugs to slow or reduce the risk of bone fracture (e.g., alendronate, denosumab)

Some medicines may reduce the effectiveness of Truqap, for example carbamazepine, phenytoin, St. John’s wort (an herbal medicine), and rifampicin.

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

Do not take Truqap if you are pregnant.

If you are a woman who could become pregnant, your doctor will ask you to provide a negative pregnancy test prior to starting treatment and advise you to perform a pregnancy test during your treatment.

If you are a woman, you should avoid becoming pregnant while taking Truqap. Discuss contraception with your doctor if there is any possibility that you may become pregnant. If you are a woman who could become pregnant, you should use an effective method of birth control during treatment with Truqap and for 4 weeks after the last dose. If you do become pregnant during treatment, tell your doctor immediately.

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

Before taking Truqap, tell your doctor if you are breast-feeding. For the safety of your baby, you should not breast-feed during the treatment with Truqap.

Truqap may affect your ability to drive or use machines. If you feel tired while taking Truqap, take special care when driving or using tools or machines.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

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

This is a long-term treatment, possibly lasting for months or years. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. If you have questions about how long to take Truqap, talk to your doctor or pharmacist or nurse.

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

If you miss a dose, you may still take it within 4 hours from the time you usually take it.

If it has been more than 4 hours after you usually take your dose, skip that dose. Take the next dose at your usual time. Refer to Table 1 for dosing schedule. Do not take two doses to make up for a missed dose.

Do not stop taking Truqap unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

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

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

• Urinary tract infection
• Low level of red blood cells (anaemia)
• Loss of appetite
• Nausea
• Vomiting
• Diarrhoea
• Mouth sores or ulcers with gum inflammation (stomatitis)
• Itching (pruritus)
• Tiredness

Common (may affect up to 1 in 10 people)

• Hypersensitivity
• Strange taste in the mouth (dysgeusia)
• Upset stomach, indigestion (dyspepsia)
• Dry skin
• Pain, redness and swelling of mucosa in different parts of the body, e.g. of genital mucosa (mucosal inflammation)
• High blood level of creatinine
• High blood level of glycosylated haemoglobin (a marker of blood sugar level over the last 8 to 12 weeks)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance of Truqap is capivasertib.

• Each 160 mg Truqap film-coated tablets contains 160 mg capivasertib.
• Each 200 mg Truqap film-coated tablets contains 200 mg capivasertib.

The other excipients are:

• Tablet core: Microcrystalline cellulose, Calcium hydrogen phosphate, Croscarmellose sodium, Magnesium stearate.
• Coating material: Hypromellose, Titanium dioxide (E171), Macrogols, Polydextrose, Copovidone, Medium chain Triglycerides, Black iron oxide (E172), Red iron oxide (E172), Yellow iron oxide (E172).

Truqap 160 mg film-coated tablets

Round, biconvex, beige film-coated tablets debossed with ‘CAV’ above ‘160’ on one side and plain on the reverse. Approximate diameter: 10 mm.

Truqap 200 mg film-coated tablets

Capsule shaped, biconvex, beige film-coated tablets debossed with ‘CAV 200’ on one side and plain on the reverse. Approximate size: 14.5 mm (length), 7.25 mm (width).

Truqap is supplied in a pack size of 64 tablets, comprising four Alu/Alu blisters of 16 tablets.