Pronunciation:

kap-eye-va-SER-tib

Brand Names:

• Truqap

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Capivasertib is used in combination with fulvestrant to treat HR-positive, HER-2 negative breast cancer that is advanced or metastatic (cancer that has spread) in patients with abnormal genes (eg, PIK3CA, AKT1, or PTEN) that has progressed on or after receiving endocrine treatment. Your doctor will test for the presence of the mutation.

Capivasertib belongs to the group of medicines, called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of capivasertib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of capivasertib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amprenavir
• Apalutamide
• Aprepitant
• Atazanavir
• Boceprevir
• Bosentan
• Carbamazepine
• Cenobamate
• Ceritinib
• Ciprofloxacin
• Clarithromycin
• Clofazimine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabrafenib
• Darunavir
• Diltiazem
• Dipyrone
• Dronedarone
• Duvelisib
• Efavirenz
• Elagolix
• Enzalutamide
• Erythromycin
• Etravirine
• Fluconazole
• Fluvoxamine
• Fosamprenavir
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ivosidenib
• Ketoconazole
• Letermovir
• Lonafarnib
• Lorlatinib
• Lumacaftor
• Mifepristone
• Mitotane
• Modafinil
• Nafcillin
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Paritaprevir
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritlecitinib
• Ritonavir
• Saquinavir
• Schisandra sphenanthera
• St John's Wort
• Telaprevir
• Telithromycin
• Telotristat Ethyl
• Thioridazine
• Troleandomycin
• Tucatinib
• Verapamil
• Voriconazole
• Voxelotor

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• High blood sugar, history of or
• Liver disease or
• Skin problems, history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take the medicine with or without food at about the same time each day.

Swallow the tablet whole. Do not chew, crush, or split it. Do not take this medicine if it is broken, cracked, or damaged.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

For women who have not reached menopause or are just starting menopause, your doctor may also give you luteinizing hormone-releasing hormone medicine together with this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For breast cancer:
    • Adults—400 milligrams (mg) 2 times a day (at least 12 hours apart) for 4 days in a row, followed by 3 days of not taking it each week. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose and it is within 4 hours of the usual time, take it as soon as you can. Then go back to your regular schedule. If you miss a dose and it is more than 4 hours of your usual time, skip the missed dose and go back to your regular dosing schedule.

If you vomit after you take this medicine, do not take another dose. Wait and take your next dose at the regularly scheduled time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to check for any problems that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 1 month after your last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

This medicine may cause diarrhea (colitis), and in some cases it can be severe. Your doctor may give you medicine to treat diarrhea. Drink plenty of fluids to prevent dehydration and kidney problems. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor. Call your doctor right away if you have stomach pain, or mucus or blood in your stool.

This medicine may cause serious skin reactions, including erythema multiforme, palmar-plantar erythrodysesthesia, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, redness, swelling, pain of the skin, scaling of the skin on the hands and feet, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, tingling of the hands and feet, trouble breathing, ulceration of the skin, unusual bleeding or bruising, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Agitation

black, tarry stools

blistering, peeling, or loosening of the skin

blurred vision

chest pain

chills

cloudy urine

coma

confusion

cough

decreased urine output

depression

diarrhea

dizziness

dry mouth

fever

flushed, dry skin

fruit-like breath odor

headache

hostility

increased hunger

increased thirst

increased urination

irritability

itching

joint or muscle pain

lethargy

muscle twitching

nausea

painful or difficult urination

rapid weight gain

red irritated eyes

redness, swelling, or pain of the skin

scaling of the skin on the hands and feet

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stomach pain

sweating

swelling of the face, ankles, or hands

swollen glands

tingling of the hands and feet

trouble breathing

ulceration of the skin

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decreased appetite

swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.