Truqap

Truqap (capivasertib) is a targeted oral therapy used to treat certain types of breast cancer or prostate cancer in adults, in combination with other medicines. It works by blocking the AKT protein, switching off a key signal that cancer cells use to grow and divide. Truqap belongs to a class of medicines called kinase inhibitors. It is also referred to as an AKT inhibitor.

Truqap is usually taken as two 200 mg tablets twice daily on a 4-day on, 3-day off schedule.

Truqap received FDA approval for breast cancer on November 17, 2023, following positive results from the CAPItello-291 Phase III trial. On June 12, 2026, it was approved for PTEN-deficient metastatic prostate cancer based on results from the CAPItello-281 Phase III trial.

Truqap is FDA-approved to treat breast cancer and prostate cancer in certain adults.

Breast cancer

Truqap is FDA-approved for HR-positive, HER2-negative locally advanced or metastatic breast cancer in adults whose tumors carry a PIK3CA, AKT1, or PTEN gene alteration confirmed by an FDA-approved test. Breast cancer must have progressed on at least one endocrine-based regimen in the metastatic setting, or cancer has reoccurred on or within 12 months of completing adjuvant therapy. Truqap is used in combination with Fulvestrant (Faslodex) for breast cancer.

Prostate cancer

Truqap is FDA-approved for PTEN-deficient metastatic prostate cancer that is androgen pathway modulation-naive or -sensitive (mAPMN/S), previously known as metastatic hormone-sensitive prostate cancer (mHSPC), confirmed by the VENTANA PTEN (SP218) companion diagnostic test. It is taken in combination with abiraterone and prednisone for prostate cancer.

Truqap (capivasertib) is a kinase inhibitor that works by blocking a protein called AKT. Cancer cells use the AKT pathway to grow and survive, and in certain cancers, genetic changes such as mutations in PIK3CA or AKT1, or loss of the PTEN gene, cause this pathway to stay continuously switched on.

By blocking AKT, Truqap cuts off that growth signal, slowing or stopping cancer progression.

This is why genetic testing is required before starting Truqap. The drug is specifically designed to target this molecular vulnerability, which is present in certain HR-positive, HER2-negative breast cancers and PTEN-deficient prostate cancers.

Take Truqap twice daily (approximately 12 hours apart), in the morning and evening, at the same times each day. Take Truqap for 4 days in a row, followed by 3 days off each week.

Truqap can be taken with or without food. Swallow tablets whole with water. Do not chew, crush, or split the tablets, and do not take any tablets that are broken, cracked, or damaged.

If you vomit after taking a dose, do not take an additional dose. Take your next dose at your usual time.

Always take Truqap exactly as your healthcare provider instructs. Do not change your dose or stop taking it without speaking to your doctor first.

What happens if I miss a dose?

If you miss a dose, you may still take it within 4 hours of your usual time. If more than 4 hours have passed, skip that dose and take your next dose at the usual time. Do not take 2 doses at the same time to make up for a missed dose.

High blood sugar (hyperglycemia)

Truqap can cause high blood sugar, including a serious complication called diabetic ketoacidosis, which can be fatal. Your doctor will check your blood sugar before starting treatment and periodically throughout. Contact your doctor if you experience excessive thirst, frequent urination, blurred vision, confusion, difficulty breathing, or increased hunger with unexplained weight loss. The safety of Truqap has not been established in patients with type 1 diabetes or those taking insulin. Depending on severity, your doctor may temporarily stop, reduce, or permanently discontinue your dose.

Diarrhea

Diarrhea occurs in most patients taking Truqap and can be severe enough to cause dehydration. Stay well hydrated, begin antidiarrheal treatment at the first signs, and contact your healthcare provider if symptoms develop or worsen. Your dose may need to be adjusted based on severity.

Skin reactions

Skin reactions are common with Truqap and can sometimes be severe. Tell your doctor promptly if you develop a new or worsening rash, redness, or peeling skin. Depending on severity, your dose may need to be adjusted or discontinued.

Risk to unborn baby (embryo-fetal toxicity)

Truqap can cause serious harm to an unborn baby. If you are of childbearing potential, use effective contraception during treatment and for 1 month after your last dose. Notify your healthcare provider immediately if you are or become pregnant during treatment.

Do not take Truqap if you have had a severe allergic reaction to capivasertib or any of the inactive ingredients.

Before starting Truqap, tell your healthcare provider if you have any of the following conditions:

• A history of high blood sugar or diabetes
• A history of rash or other skin disorders
• Liver problems
• Any current infection
• Are planning a pregnancy, are pregnant, or breastfeeding.

Pregnancy

Truqap can harm an unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant before starting treatment.

If you are able to become pregnant, your healthcare provider will carry out a pregnancy test before you start treatment. Use effective birth control during treatment and for 1 month after your last dose. Talk to your healthcare provider about suitable contraception options. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment.

If you are a male with a female partner who is able to become pregnant, use effective birth control during treatment and for 4 months after your last dose. Tell your healthcare provider right away if your partner becomes pregnant.

Breastfeeding

Do not breastfeed during treatment with Truqap. Talk to your healthcare provider about the best way to feed your baby during this time.

Common side effects

Common Truqap side effects occurring in 20% or more of patients include:

• Diarrhea
• Mouth sores
• Nausea
• Skin reactions
• Changes in certain blood tests
• Tiredness
• Vomiting

Serious Truqap side effects

High blood sugar (hyperglycemia)

Your healthcare provider will monitor your blood sugar before you start and throughout treatment. The safety of Truqap has not been established in people with type 1 diabetes or those who use insulin. If you have a history of diabetes, your blood sugar will be monitored more frequently. If you have a fever, chills, infection, serious injury, or a new illness, tell your healthcare provider before taking your next dose.

Tell your healthcare provider if you develop any of the following symptoms of high blood sugar:

• Excessive thirst
• Confusion
• Dry mouth
• Nausea
• More frequent or larger amounts of urination than usual
• Vomiting
• Fruity odor on breath
• Increased appetite with weight loss
• Dry or flushed skin

Diarrhea

Diarrhea is common with Truqap and can be severe. Severe diarrhea can lead to dehydration. Tell your healthcare provider if you develop loose or watery stools. Your provider may advise you to increase fluid intake or take medication to treat diarrhea.

Skin reactions

Tell your healthcare provider or get medical help right away if you develop a rash that is new or worsening, redness, fever, blistering of the lips, eyes, or mouth, blisters on the skin, skin peeling, or dry skin.

Your healthcare provider may reduce your dose, temporarily stop treatment, or permanently discontinue Truqap if you experience certain serious side effects.

These are not all the possible side effects of Truqap. Contact your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Do not drink grapefruit juice or eat grapefruit during treatment with Truqap. Grapefruit can increase the amount of Truqap in your blood, which may increase the risk of side effects.

Truqap dose for breast cancer (HR-positive, HER2-negative, locally advanced or metastatic)

The recommended dose of Truqap for breast cancer is 400 mg twice daily (approximately 12 hours apart), with or without food, for 4 days followed by 3 days off. Truqap is taken in combination with fulvestrant. Treatment continues until disease progression or unacceptable toxicity.

For premenopausal and perimenopausal women, a luteinizing hormone-releasing hormone (LHRH) agonist should also be given alongside Truqap in line with standard clinical practice. For men, your doctor may also recommend an LHRH agonist depending on your individual circumstances.

Truqap dose for prostate cancer (PTEN-deficient mAPMN/S)

The recommended dose of Truqap for prostate cancer is 400 mg twice daily (approximately 12 hours apart), with or without food, for 4 days followed by 3 days off. Truqap is taken in combination with abiraterone and prednisone. Treatment continues until disease progression or unacceptable toxicity.

Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently, or should have had bilateral orchiectomy.

Truqap is available as 160 mg and 200 mg tablets. See full prescribing information for dose modifications for adverse reactions.

How well does Truqap work for breast cancer?

In the CAPItello-291 Phase III trial, Truqap plus fulvestrant more than doubled the time patients with advanced HR-positive, HER2-negative breast cancer lived without their cancer growing or spreading, compared with fulvestrant alone.

Patients taking Truqap plus fulvestrant had a median progression-free survival of 7.3 months, compared with 3.1 months for those taking fulvestrant alone, a difference of 4.2 months. Individual results may vary.

How well does Truqap work for prostate cancer?

In the CAPItello-281 Phase III trial, Truqap in combination with abiraterone and androgen deprivation therapy (ADT) reduced the risk of disease progression or death by 19% compared with abiraterone and ADT alone in patients with PTEN-deficient metastatic prostate cancer.

Median progression-free survival was 33.2 months with Truqap compared with 25.7 months without it, an improvement of 7.5 months. Overall survival data are still maturing and will be reported as the trial continues.

Strong CYP3A inhibitors

Avoid taking strong CYP3A inhibitors with Truqap if possible. If you cannot avoid taking both medicines together, your doctor will reduce your Truqap dose. Common examples of strong CYP3A inhibitors include ketoconazole, itraconazole, clarithromycin, and ritonavir.

Moderate CYP3A inhibitors

If you take a moderate CYP3A inhibitor with Truqap, your doctor will reduce your Truqap dose. Common examples include fluconazole, erythromycin, and diltiazem.

Strong and moderate CYP3A inducers

Avoid taking strong or moderate CYP3A inducers with Truqap. Common examples of CYP3A inducers include rifampicin, carbamazepine, phenytoin, and St John's Wort.

This list is not complete. Other drugs may interact with Truqap, including prescription and over-the-counter medicines, vitamins, and herbal products. Always tell your doctor and pharmacist about all medicines you are taking before starting Truqap.

Store in original packaging at room temperature between 20°C to 25°C (68°F to 77°F). Throw away (discard) Truqap after 45 days if the tablets are not kept in the original packaging.

Active ingredient: capivasertib.

Inactive ingredients: copovidone, croscarmellose sodium, dibasic calcium phosphate, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, polydextrose, polyethylene glycol 3350, and titanium dioxide.

AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.

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