Truqap

Pronunciation: TRUE-cap
Generic name: capivasertib
Dosage form: tablets (160 mg, 200 mg)
Drug class: Multikinase inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Nov 21, 2023.

What is Truqap used for?

Truqap (capivasertib) is a cancer medicine used to treat breast cancer that is HR-positive or HER2-negative and has an abnormal PIK3CA, AKT1, or PTEN gene. Usually, the body can attack cancer cells, but when you have an abnormal PIK3CA, AKT1, or PTEN gene, these make the cancer cells able to grow and survive. Truqap is a kinase inhibitor that works by blocking pathways that help the cancer cells survive and grow, so reduces cancer growth.

Truqap is from a class of medicines called an AKT inhibitor.

Truqap received FDA approval on November 17, 2023, after positive results from the CAPItello-291 Phase III trial.

How well does Truqap work?

Truqap used with Faslodex (fulvestrant) had a 50% decrease in risk of cancer progression or death compared to patients using Faslodex alone. The median progression-free survival (PFS) for the Truqap with Faslodex groups was 7.3 months versus the Faslodex group, which was 3.1 months. These results are from the CAPItello-291 Phase III trial in patients with tumors with PI3K/AKT pathway changes.

What is Truqap used for?

Truqap is FDA-approved to be used in combination with fulvestrant for adult breast cancer patients that is:

hormone receptor (HR)-positive or human epidermal growth factor receptor 2 (HER2)-negative
locally advanced or metastatic breast cancer
with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test
have had cancer progress while on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Truqap side effects

Common Truqap side effects include diarrhea, mouth sores, nausea, skin reactions, changes in certain blood tests, tiredness, and vomiting; these occur in 20% of patients or more.

Serious Truqap side effects

High blood sugar levels (hyperglycemia) - Your healthcare provider will monitor your blood sugar levels before you start and during treatment with this medicine. It is not known if this medicine is safe for people with type 1 diabetes or people who use insulin to treat their diabetes. Your healthcare provider will monitor your blood sugar levels more often if you have a history of diabetes. Tell your healthcare provider if you develop symptoms of high blood sugar, including:

excessive thirst
confusion
dry mouth
nausea
more frequent urination than usual or a bigger amount of urine than normal
vomiting
a fruity odor on breath
increased appetite with weight loss
dry or flushed skin

Diarrhea – Diarrhea is common during treatment with Truqap and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration). Tell your healthcare provider if you develop any signs of diarrhea, including loose or watery stool. Your healthcare provider will tell you to drink more fluids or take medicines to treat diarrhea.

Skin reactions – Tell your healthcare provider or get medical help right away if you get a rash or if the rash keeps getting worse, reddening of the skin, fever, blistering of the lips, eyes, or mouth, blisters on the skin, skin peeling, or dry skin.

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

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

What to avoid

You should not drink grapefruit juice or eat grapefruit during treatment with this medicine.

Who should not take Truqap?

You should not take Truqap if you have had a severe allergic reaction to the active ingredient, capivasertib, or are allergic to any of the inactive ingredients.

Before taking this medicine

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

have a history of high levels of sugar in your blood or diabetes
have a history of rash or other skin disorders
have liver problems

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant, as it can harm your unborn baby.

Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before you start treatment with this medicine. You should use effective birth control during treatment with Truqap and for 1 month 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 effective birth control during their treatment with Truqap and for 4 months after the last dose. If your female partner becomes pregnant, tell your healthcare provider right away.

Breastfeeding

Tell your healthcare provider are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with Truqap. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.

How should I take Truqap?

Take Truqap 2 times each day (about 12 hours apart) in the morning and evening, at about the same times each day.

Take Truqap tablets for 4 days in a row, followed by 3 days of not taking Truqap each week.

Take with or without food. Swallow tablets whole with water. Do not chew, crush, or split the tablets. Do not take any tablets that are broken, cracked, or that look damaged.

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

Truqap tablets are taken in combination with Faslodex (fulvestrant).

For women who have not reached menopause or are just starting menopause, your healthcare provider will prescribe a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist to take with Truqap and fulvestrant

Take this medicine exactly as your healthcare provider tells you. Do not change your dose or stop taking this medicine unless your healthcare provider tells you.

Dosing information

The recommended dose of Truqap is 400 mg orally twice daily (approximately 12 hours apart), with or without food, for 4 days, followed by 3 days off. Continue taking this medicine until the disease progresses or has unacceptable toxicity.

Truqap is taken in combination with fulvestrant.

See full prescribing information for Truqap dosage modifications for adverse reactions and recommended fulvestrant dosing information.

Truqap is available as 160mg and 200mg tablets.

What happens if I miss a dose?

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. Do not take 2 doses at the same time to make up for a missed dose.

Interactions

Strong CYP3A Inhibitors: If possible, avoid taking strong CYP3A Inhibitors with this medicine; if you can not avoid using both medicines together, then reduce Truqap dose.

Moderate CYP3A Inhibitors: Reduce Truqap dose.

Strong and Moderate CYP3A Inducers: Avoid the use of strong and moderate CYP3A inducers with this medicine.

This list is not complete. Other drugs may interact with Truqap including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

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

Ingredients

Active ingredient: capivasertib.

Inactive ingredients: 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.