Akeega 50 mg-500 mg tablet

Generic name:
Niraparib/abiraterone - oral

Brand name(s)
Akeega

This combination medication is used to treat prostate cancer. It contains 2 medications: niraparib and abiraterone. Niraparib works by slowing the growth of cancer cells. Abiraterone works by decreasing the amount of testosterone the body makes, which helps slow down the growth and spread of prostate cancer.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth on an empty stomach as directed by your doctor, usually once daily. Swallow the tablets whole with water. Do not break, crush, or chew the tablets. Do not eat food for 2 hours before and 1 hour after taking this medication. Taking this medication with food increases the amount of this drug in your body and increases the risk of side effects.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Constipation, trouble sleeping, dizziness, nausea, or vomiting may occur. Rarely, nausea and vomiting can be severe. Taking this medication at bedtime may help reduce nausea. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication may raise your blood pressure and heart rate. Check your blood pressure and heart rate regularly and tell your doctor if the results are high. Your doctor may control your blood pressure and heart rate with medication.

Tell your doctor right away if you have any serious side effects, including:

• swelling of the hands/ankles/feet
• muscle cramps/weakness
• leg pain

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Rarely, this medication may also cause certain cancers of the bone marrow or blood cells. Tell your doctor right away if you develop any of the following symptoms:

• unusual tiredness/weakness
• pale skin
• signs of infection (such as sore throat that doesn't go away, fever, chills, painful urination, pink/bloody urine)
• easy bruising/bleeding
• weight loss

Rarely, this medication may cause a condition called PRES (posterior reversible encephalopathy syndrome). Get medical help right away if you develop a headache that doesn't go away, seizures, sudden vision changes, or mental/mood changes (such as confusion).

Get medical help right away if you have any very serious side effects, including:

• chest pain
• fast/irregular heartbeat
• severe dizziness
• fainting
• symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to niraparib or abiraterone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• previous heart attack
• high blood pressure
• liver disease
• diabetes

This product can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This product may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using this product, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this product safely.

Using corticosteroid medications for a long time along with this product can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication should not be used by women, especially during pregnancy or breastfeeding. It may harm an unborn or breastfeeding baby. Men using this medication should ask about reliable forms of birth control during treatment and for 4 months after the last dose. Consult your doctor for more details.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• radium Ra 223

Other medications can affect the removal of this product from your body, which may affect how it works. Examples include drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital, primidone), rifamycins (such as rifampin), St. John's wort, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, blood pressure, heart rate, potassium levels, liver function, PSA blood test) should be done before you start taking this product and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to take each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.