Capivasertib

Breast Neoplasms

Drug Status

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Government Approvals

US(FDA), UK(BNF)

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WHO Essential Medicine

NO

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Known Teratogen

No

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Pharmaceutical Class

NA

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Controlled Drug Substance

No

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Drug Ingredient

Capivasertib

Summary

  • Capivasertib is used for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in adults. It's used in combination with another drug, fulvestrant, for patients whose cancer has progressed after endocrine therapy and have specific genetic alterations in their tumors.

  • Capivasertib is a kinase inhibitor, which means it blocks the action of a protein called AKT involved in cell survival and growth. By blocking this protein, Capivasertib disrupts the signaling pathways that promote cancer cell growth, slowing or stopping the spread of cancer cells.

  • Capivasertib is typically prescribed for adults at a dose of 400 mg. It's taken orally twice daily, approximately 12 hours apart, for 4 days, followed by 3 days off.

  • Common side effects of Capivasertib include diarrhea, cutaneous adverse reactions (skin reactions), nausea, fatigue, and vomiting. Serious adverse effects can include severe hyperglycemia (high blood sugar), diarrhea, and cutaneous reactions.

  • Capivasertib can cause severe hyperglycemia, diarrhea, and cutaneous adverse reactions. It is not recommended during pregnancy, and both males and females of reproductive potential should use effective contraception during treatment. It's not advised for breastfeeding mothers. It's contraindicated in patients with severe hypersensitivity to Capivasertib or its components.

Indications and Purpose

How does Capivasertib work?

Capivasertib is a kinase inhibitor that targets and inhibits the activity of AKT, a protein involved in cell growth and survival. By blocking AKT, Capivasertib disrupts the signaling pathways that promote cancer cell proliferation, helping to slow or stop the spread of cancer cells.

Is Capivasertib effective?

Capivasertib has been shown to be effective in clinical trials, such as the CAPItello-291 study, where it was used in combination with fulvestrant to treat hormone receptor-positive, HER2-negative advanced breast cancer. The study demonstrated a statistically significant improvement in progression-free survival for patients receiving Capivasertib compared to those receiving a placebo.

What is Capivasertib?

Capivasertib is used in combination with fulvestrant to treat hormone receptor-positive, HER2-negative advanced breast cancer in adults. It works by inhibiting the activity of AKT, a protein that promotes cancer cell growth and survival. By blocking this protein, Capivasertib helps slow or stop the spread of cancer cells.

Directions for Use

For how long do I take Capivasertib?

Capivasertib is typically used until disease progression or unacceptable toxicity occurs. The exact duration varies depending on individual response and tolerance to the treatment.

How do I take Capivasertib?

Capivasertib should be taken orally twice daily, approximately 12 hours apart, for 4 days followed by 3 days off. It can be taken with or without food. Patients should avoid consuming grapefruit or grapefruit juice while taking this medication, as it may interact with the drug.

How should I store Capivasertib?

Capivasertib should be stored in its original packaging at room temperature, between 20°C to 25°C (68°F to 77°F). It should be kept out of reach of children and not stored in the bathroom to avoid exposure to moisture.

What is the usual dose of Capivasertib?

The usual dose for adults is 400 mg taken orally twice daily, approximately 12 hours apart, for 4 days followed by 3 days off. Capivasertib is not recommended for children as its safety and effectiveness have not been established in pediatric patients.

Warnings and Precautions

Can Capivasertib be taken safely while breastfeeding?

Women are advised not to breastfeed during treatment with Capivasertib due to the potential for serious adverse reactions in a breastfed child. There is no data on the presence of Capivasertib in human milk, but it has been detected in the plasma of suckling rat pups.

Can Capivasertib be taken safely while pregnant?

Capivasertib can cause fetal harm when administered to pregnant women. It is advised that females of reproductive potential use effective contraception during treatment and for 1 month after the last dose. Males with female partners of reproductive potential should use contraception during treatment and for 4 months after the last dose. There is no strong evidence from human studies, but animal studies have shown reproductive toxicity.

Can I take Capivasertib with other prescription drugs?

Capivasertib interacts with strong and moderate CYP3A inhibitors, which can increase its concentration and risk of toxicity. It is advised to avoid these inhibitors or adjust the Capivasertib dose if they must be used together. Additionally, Capivasertib may affect the plasma concentrations of drugs metabolized by CYP3A, CYP2B6, and UGT1A1.

Is Capivasertib safe for the elderly?

Elderly patients (65 years and older) may experience a higher incidence of severe side effects, dose reductions, and treatment discontinuations. It is important for elderly patients to be closely monitored by their healthcare provider while taking Capivasertib to manage any adverse reactions effectively.

Who should avoid taking Capivasertib?

Capivasertib is contraindicated in patients with severe hypersensitivity to the drug or its components. Important warnings include the risk of severe hyperglycemia, diarrhea, and cutaneous adverse reactions. Patients should be monitored for these conditions, and treatment may need to be adjusted or discontinued if severe side effects occur.