Niraparib and abiraterone (Oral)

Note: Women who can become pregnant should not use or handle niraparib and abiraterone tablets without protection (e.g., gloves).

Niraparib and abiraterone combination is used along with prednisone to treat metastatic castration-resistant prostate cancer (prostate cancer that does not respond to treatments that lower testosterone and has spread to other areas of the body) with a harmful or possibly harmful BRCA mutation gene. Your doctor will perform a test to check for this mutation before you start the medicine.

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

It is very important that your doctor checks your progress at regular visits. This will help your doctor see if the medicine is working correctly and decide if you should keep taking it. Blood and urine tests may be needed to check for side effects.

Pregnant women or women who may become pregnant should not handle or touch the tablets without protection (e.g., gloves). This medicine may cause birth defects if a man is using it when his partner becomes pregnant. Use a condom plus another form of birth control during treatment with this medicine and for at least 4 months after the last dose. Tell your doctor right away if a pregnancy occurs while you are using this medicine.

Tell your doctor if you have bone pain, blood in the urine or stools, fever or chills, cough, sore throat, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of a bone marrow problem called myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

This medicine can temporarily lower the number of white blood cells in your blood, which may increase the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this happens, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you or your child think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you or your child notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause hypokalemia. Check with your doctor right away if you have decreased urine, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have a decrease in the amount of urine, swelling of the fingers, hands, feet, or lower legs, trouble breathing, or weight gain. These may be symptoms of fluid retention.

This medicine may cause heart rhythm problems (e.g., QT prolongation and torsades de pointes). Check with your doctor right away if you have chest pain or discomfort, irregular or slow heart rate, fainting, or trouble breathing.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not interrupt or stop using this medicine together with prednisone without first asking your doctor. This medicine may cause an adrenal gland problem. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may cause hypoglycemia (low blood sugar), especially if you have diabetes and take certain medicines for diabetes. Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness.

Abiraterone and prednisone/prednisolone may increase your risk for bone fractures and death when used together with radium Ra 223 dichloride (radiation treatment). You should not receive treatment with radium Ra 223 dichloride for at least 5 days after your last dose of Akeega™ with prednisone. Tell your doctor if you are having any other treatment for your prostate cancer.

This medicine may increase your chance of having a brain condition called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you start having chest pain, sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are receiving this medicine.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

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.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it may provide. For this medicine, consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on how age affects the use of the niraparib and abiraterone combination in children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in older adults that would limit the use of the niraparib and abiraterone combination.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if there is a possibility of an interaction. If you are taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen for their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Daprodustat
• Dasabuvir
• Eliglustat
• Selexipag

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

• Abametapir
• Acarbose
• Albiglutide
• Alogliptin
• Amiodarone
• Amphetamine
• Apalutamide
• Aripiprazole
• Atomoxetine
• Benzphetamine
• Canagliflozin
• Carbamazepine
• Carvedilol
• Cerivastatin
• Chlorpropamide
• Cilostazol
• Clomipramine
• Clozapine
• Codeine
• Dabrafenib
• Dapagliflozin
• Desipramine
• Desloratadine
• Deutetrabenazine
• Dextroamphetamine
• Dihydrocodeine
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dulaglutide
• Duloxetine
• Empagliflozin
• Encainide
• Enclomiphene
• Enzalutamide
• Ertugliflozin
• Exenatide
• Fedratinib
• Fenfluramine
• Fexinidazole
• Flecainide
• Fluoxetine
• Fosphenytoin
• Glimepiride
• Glipizide
• Glyburide
• Haloperidol
• Hydroxyamphetamine
• Ifosfamide
• Iloperidone
• Imipramine
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Itraconazole
• Ivosidenib
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lixisenatide
• Lofexidine
• Loperamide
• Lumacaftor
• Lurasidone
• Mavacamten
• Metformin
• Methamphetamine
• Methoxyphenamine
• Metoprolol
• Mexiletine
• Miglitol
• Mitotane
• Montelukast
• Naloxegol
• Nateglinide
• Nebivolol
• Nicergoline
• Nortriptyline
• Omaveloxolone
• Ondansetron
• Ospemifene
• Oxycodone
• Ozanimod
• Paclitaxel
• Paroxetine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimozide
• Pioglitazone
• Piperaquine
• Pitolisant
• Pixantrone
• Prajmaline
• Pramlintide
• Primidone
• Propafenone
• Radium Ra 223 Dichloride
• Rifampin
• Rifapentine
• Risperidone
• Rosiglitazone
• Rosuvastatin
• Saxagliptin
• Semaglutide
• Simeprevir
• Sitagliptin
• St John's Wort
• Tamoxifen
• Tamsulosin
• Thioridazine
• Timolol
• Tolazamide
• Tolbutamide
• Tolperisone
• Tolterodine
• Tramadol
• Trimipramine
• Tropisetron
• Tucatinib
• Venlafaxine
• Vernakalant
• Voglibose
• Vortioxetine
• Yohimbine
• Zuclopenthixol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dextromethorphan
• Repaglinide

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Adrenal or pituitary problems, history of or
• Anemia or
• Bone marrow problems (e.g., acute myeloid leukemia, myelodysplastic syndrome) or
• Diabetes or
• Recent heart attack or
• Heart failure or
• History of heart or blood vessel disease or
• Heart rhythm problems (e.g., ventricular arrhythmia) or
• Hypertension (high blood pressure) or
• Hypokalemia (low potassium in the blood) or
• Neutropenia (low number of white blood cells) or
• Thrombocytopenia (low number of platelets)—Use with caution. May worsen these conditions.

• Severe kidney disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

• Moderate or severe liver disease—Should not be used in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

More common

• Bladder pain
• bleeding gums
• bloody or cloudy urine
• blurred vision
• body pain
• cough
• coughing up blood
• diarrhea
• difficult, burning, or painful urination
• dizziness
• falls
• fever or chills
• frequent urge to urinate
• headache
• increased menstrual flow or vaginal bleeding
• loss of taste or smell
• lower back or side pain
• muscle pain
• nausea
• nervousness
• nosebleeds
• pale skin
• paralysis
• pounding in the ears
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• slow or fast heartbeat
• sore throat
• stuffy or runny nose
• swelling
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• Agitation
• anxiety
• chest pain or tightness
• coma
• confusion
• decreased urine output
• depression
• heart stops
• hostility
• inability to speak
• irritability
• lethargy
• lightheadedness
• muscle twitching
• no breathing
• no pulse or blood pressure
• pain, redness, or swelling in the arm or leg
• pain or swelling in the arms or legs without any injury
• pinpoint red spots on the skin
• rapid weight gain
• seizures
• severe or sudden headache
• slurred speech
• sneezing
• stupor
• swelling of the face, ankles, or hands
• temporary blindness
• unconscious
• weakness in the arm and/or leg on one side of the body, sudden and severe

Incidence not known

• Bone pain
• chest discomfort
• dark urine
• darkening of the skin
• fainting
• increased hunger
• loss of appetite
• mental depression
• nervousness
• nightmares
• problems with vision, speech, or walking
• shakiness
• skin rash
• stomach pain, severe
• swelling of the fingers, hands, feet, or lower legs
• swollen glands
• unusual drowsiness
• yellow eyes or skin

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. Your health care professional may also 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

• Constipation
• decreased appetite
• trouble sleeping

Less common

• Lack or loss of strength

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.

In the U.S.

• Akeega

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Medicines used to treat cancer are very strong and can have many side effects. Before receiving 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. To do so may increase the chance of side effects.

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

You should also receive a gonadotropin-releasing hormone (GnRH) analog treatment or have had a surgery to lower testosterone in your body (surgical castration) during treatment with this medicine.

Take this medicine on an empty stomach. Do not eat food 2 hours before or 1 hour after taking this medicine.

Swallow the tablet whole. Do not break, crush, or chew it.

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 (tablet):For castration-resistant prostate cancer: Adults—2 tablets once a day taken together with 10 milligrams (mg) prednisone. Each tablet contains 100 mg niraparib and 500 mg abiraterone. 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 of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.