Pronunciation:

nye-RAP-a-rib, a-bir-A-ter-one AS-e-tate

Brand Names:

• Akeega

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Note: Women of childbearing potential should not use or handle niraparib and abiraterone tablets without protection (eg, gloves).

Niraparib and abiraterone combination is used in combination with prednisone to treat metastatic castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has spread to other parts of the body) with a deleterious or suspected deleterious BRCA mutation gene. Your doctor will use a test to check for this mutation before you receive the medicine.

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 niraparib and abiraterone combination 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 niraparib and abiraterone combination 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 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 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.

• Abametapir
• Acarbose
• Albiglutide
• Alogliptin
• Amiodarone
• Amphetamine
• Apalutamide
• Aripiprazole
• Atomoxetine
• Benzphetamine
• Canagliflozin
• Carbamazepine
• Carvedilol
• Cerivastatin
• Chlorpropamide
• Cilostazol
• Clarithromycin
• 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
• Spironolactone
• 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 cause an increased risk of certain side effects, but using both drugs 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

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Adrenal or pituitary problems, history of or
• Anemia or
• Bone marrow problems (eg, acute myeloid leukemia, myelodysplastic syndrome) or
• Diabetes or
• Heart attack, recent or
• Heart failure or
• Heart or blood vessel disease, history of or
• Heart rhythm problems (eg, 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 make these conditions worse.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, moderate or severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Pregnant women or women who may become pregnant should not handle or touch the tablets without protection (eg, 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 occurs, 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 decrease in 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 (eg, 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 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.

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

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. 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

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.