Capivasertib is used in combination with fulvestrant (Faslodex) to treat a certain type of hormone receptor–positive (depends on hormones such as estrogen to grow) advanced breast cancer that has spread to nearby tissues or other parts of the body in adults whose cancer got worse during or after certain other treatments. Capivasertib is also used in combination with another medication and fulvestrant (Faslodex) to treat a certain type of hormone receptor–positive advanced breast cancer that has spread to other parts of the body in women who have not experienced menopause (change of life; end of monthly menstrual periods) and in those who are close to or who have already experienced menopause. Capivasertib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Capivasertib comes as a tablet to take by mouth. It is usually given with or without food twice daily (about 12 hours apart) for the first 4 days of a 7-day cycle. The cycle may be repeated as recommended by your doctor. Take capivasertib at around the same times every day (usually in the morning and in the evening). Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take capivasertib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with water; do not split, chew, or crush them. Do not take tablets that are broken, cracked, or damaged in any way.

If you vomit after taking capivasertib, do not take another dose. Continue your regular dosing schedule the next day.

Your doctor may temporarily or permanently stop your treatment or adjust your dose of capivasertib depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take capivasertib even if you feel well. Do not stop taking capivasertib without talking to your doctor.

If you have not yet experienced menopause (change of life; end of monthly menstrual periods) or are just starting menopause, your doctor will probably prescribe another medication such as goserelin (Zoladex) or leuprolide (Eligard, Lupron) to take along with capivasertib and fulvestrant to treat your breast cancer.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking capivasertib,

• tell your doctor and pharmacist if you are allergic to capivasertib, any other medications, or any of the ingredients in capivasertib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription or herbal products may interact with capivasertib: St. John’s Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking capivasertib. Do not start any of this medication while taking capivasertib without discussing with your healthcare provider.
• tell your doctor if you have a rash or other skin problem, high triglycerides (a fatty substance in the blood), or kidney or liver problems.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are taking capivasertib. If you are female, you will need to have a pregnancy test before you start treatment, and you should use birth control to prevent pregnancy during your treatment and for 1 month after your final dose. If you are male, you and your partner should use birth control to prevent pregnancy during your treatment with capivasertib and for 4 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking capivasertib, call your doctor. Capivasertib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking capivasertib.
• you should know that capivasertib may cause an increase in blood glucose. If you have diabetes or high blood sugar, check your blood sugar as often as directed by your doctor. If your blood sugar is higher than usual, call your doctor. Tell your doctor immediately if you have any of the following symptoms while you are taking capivasertib: extreme thirst, frequent urination, extreme hunger, blurred vision, confusion, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, upset stomach and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness. Call your doctor if you are unable to eat or drink normally due to nausea, vomiting, or diarrhea while you are taking capivasertib. Your doctor may need to change your diet or medication to help control your blood sugar while you are taking capivasertib.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it. However, if it is more than 4 hours after the time you were supposed to take the dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Capivasertib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• mouth sores
• tiredness
• decreased appetite
• headache

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, stop taking and call your doctor immediately or get emergency medical treatment:

• rash; blistering, peeling, dry, or reddened skin; blistering of the lips, eyes, or mouth; fever; flu-like symptoms
• diarrhea (loose, watery, or more frequent stools); stomach cramps
• dry mouth, weakness, decreased urination, swelling of legs or ankles
• frequent, painful, or urgent urination

Capivasertib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body’s response to capivasertib.

Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with capivasertib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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