This combination product contains 2 medications: niraparib and abiraterone. Niraparib belongs to the class of medications called PARP inhibitors. Abiraterone belongs to the class of medications called androgen biosynthesis inhibitors.

Niraparib-abiraterone in combination are taken along with the medication prednisone to treat metastatic prostate cancer (cancer that has spread to other parts of the body) when chemotherapy is not an appropriate treatment option. It stops your body from making testosterone, a male hormone that is involved in the growth of prostate cancer, and prevents the repair of DNA in the cancer cells.

If you are taking another medication, such as a GnRH agonist, continue to take this medication until your doctor tells you otherwise.

Niraparib-abiraterone has been granted a notice of compliance with conditions (NOC/c) by Health Canada for the treatment of metastatic prostate cancer for people with the BRCA gene mutation. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The usual recommended dose of this medication is 200 mg of niraparib and 1000 mg of abiraterone acetate (2 100 mg/500 mg tablets), taken by mouth once daily. Niraparib-abiraterone is usually taken along with the medication prednisone or prednisolone.

Niraparib-abiraterone must be taken on an empty stomach. Try to take it at the same time very day for the most benefit. Do not eat any solid food or drink any liquids for 2 hours before taking niraparib-abiraterone or for at least 1 hour after taking abiraterone. Taking this medication with food causes the medication to be absorbed into the body quickly and may cause increased side effects. Swallow the medication whole with water. Do not break or crush the tablets.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

50 mg/500 mg
Each yellowish-orange-to-yellowish-brown, oval tablet, debossed with “N 50 A” on one side and plain on the other side, contains 50 mg of niraparib (as niraparib tosylate) and 500 mg of abiraterone acetate. Nonmedicinal ingredients: colloidal anhydrous silica, crospovidone, glycerol monocaprylocaprate, hypromellose, iron oxide (E172), iron oxide red (E172), iron oxide yellow (E172), lactose monohydrate, magnesium stearate, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, and titanium dioxide (E171).

100 mg/500 mg
Each orange, oval tablet, debossed with “N 100 A” on one side and plain on the other side, contains 100 mg of niraparib (as niraparib tosylate) and 500 mg of abiraterone acetate. Nonmedicinal ingredients: colloidal anhydrous silica, crospovidone, glycerol monocaprylocaprate, hypromellose, iron oxide (E172), iron oxide red (E172), iron oxide yellow (E172), lactose monohydrate, magnesium stearate, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, and titanium dioxide (E171).

Do not take this medication if you are allergic to niraparib-abiraterone or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• decreased appetite
• difficulty sleeping
• dizziness
• fatigue
• joint pain
• nausea
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal heart rhythms (such as fast or slow heart rate, palpitations)
• increased frequency of flu- or cold-like symptoms (e.g., runny nose, nasal congestion, sore throat, fatigue)
• increased blood pressure (e.g., shortness of breath, dizziness, fainting, chest pain or pressure, ankle or leg swelling, bluish colour to lips and skin, racing or pounding heartbeat)
• increased sensitivity to the sun (e.g., sunburn, blistering)
• shortness of breath
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of low potassium levels (e.g., muscle twitches, weakness, or a pounding heartbeat)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. 

If you have a history of clotting, you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Blood counts: This medication can decrease the number of neutrophils (a type of white blood cell that helps fight infection), red blood cells (which carry oxygen), and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. If you notice any signs of infection (e.g., fever, chills, or sore throat) or unusual bleeding or bruising, contact your doctor immediately.

Drowsiness/dizziness: Niraparib-abiraterone may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.

Fluid and electrolyte balance: Abiraterone can cause your body to retain fluid and the level of potassium in your blood to change while taking this medication. If you experience symptoms of fluid and low potassium levels such as muscle weakness, muscle twitches, or a pounding, racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of the electrolytes in your blood while you are taking this medication.

Galactose intolerance/glucose malabsorption:  Niraparib-abiraterone medications are prepared with lactose. If you have lactose or galactose intolerance, you should not take this medication.

Heart disease: The effects of this medication on people with heart disease have not been studied. Niraparib-abiraterone can cause increased blood pressure and fluid retention, which may affect how well your heart works. If you have a history of heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Niraparib-abiraterone may reduce liver function and can cause liver failure. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Low blood sugar: People with diabetes who are taking medications such as repaglinide or pioglitazone, may experience decreased levels of blood glucose as a result of taking this medication. If you have diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Muscle effects: In rare cases, serious muscle damage has been associated with the use of abiraterone. Your risk may be increased if you are taking other medications which can cause this effect (i.e., "statin" cholesterol-lowering medications). Report any unexplained muscle pain, tenderness, weakness or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Other cancers: Rarely, people who are using niraparib-abiraterone develop myelodysplastic syndrome/acute myeloid leukemia (AML) or other diseases where the bone marrow is not able to properly make blood cells. These illnesses can be life-threatening. Discuss any concerns you may have with your doctor.

Posterior Reversible Encephalopathy Syndrome (PRES): This is a rare disease of the brain that may occur when using medications like niraparib-abiraterone. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.

Sensitivity to sunlight: This medication may increase the sensitivity of the skin to sunlight, increasing the risk of sunburn. Avoid exposure to sunlight for long periods of time, particularly between the hours of 10 am and 2 pm, while you are taking this medication and for 7 days after completing treatment. Wear a broad-spectrum sunscreen and lip balm with an SPF of 15 or greater. If you notice any unusual skin rash or peeling, contact your doctor immediately.

Vaccines: Live vaccines such as yellow fever, BCG, cholera, typhoid, varicella, meningococcal, and diphtheria should not be given while you are receiving etoposide. They work by administering a small amount of live bacterium into the body to cause the body to develop defenses against them. When they are given at the same time as a medication that may reduce the strength of your immune system, it may cause a severe infection.

Other vaccines given when you are receiving this medication may not work well enough to protect you from infections. Talk to your doctor about which vaccinations you need before starting treatment.

Pregnancy: It is not known if niraparib-abiraterone is found in semen. If you are engaged in sexual activity with a pregnant person, a condom should be used. If you are engaged in sexual activity with a person who may become pregnant, a condom and a second effective method of birth control should be used. Condoms must be used during treatment with this medication and for 3 months after treatment has ended.

Due to the way that abiraterone works, it is possible that exposure to this medication during pregnancy may harm the developing baby. To prevent accidental exposure to abiraterone, people who could become pregnant should wear gloves when handling these tablets.

Breast-feeding: It is not known if abiraterone passes into breast milk. To prevent accidental exposure to abiraterone, people who could become pregnant should wear gloves when handling these tablets.

Children: The safety and effectiveness of using this medication have not been established for children.

There may be an interaction between abiraterone and any of the following:

• 5-ASA medications (e.g., mesalamine, olsalazine, sulfasalazine)
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• antipsychotics (e.g., aripiprazole, chlorpromazine, clozapine, haloperidol, pimozide, risperidone)
• apalutamide
• atomoxetine
• baricitinib
• beta-adrenergic blockers (e.g., carvedilol, metoprolol, propranolol)
• bosentan
• carbamazepine
• codeine
• dabrafenib
• danazol
• deferiprone
• denosumab
• deucravacitinib
• dextromethorphan
• doxepin
• doxorubicin
• efavirenz
• elagolix
• eliglustat
• enzalutamide
• eslicarbazepine
• etravirine
• flecainide
• fosphenytoin
• leflunomide
• lumacaftor and ivacaftor
• lorlatinib
• metoclopramide
• mitotane
• modafinil
• natalizumab
• ocrelizumab
• ofatumumab
• olaparib
• paroxetine
• phenobarbital
• phenytoin
• pimecrolimus
• pioglitazone
• pitolisant
• primidone
• propafenone
• repaglinide
• rifabutin
• rifampin
• rosiglitazone
• ruxolitinib
• St. John's wort
• sotorasib
• sphingosine 1-phosphate (S1P) receptor inhibitors (e.g., fingolimod, ponesimod, siponimod)
• spironolactone
• "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
• tacrolimus
• tamoxifen
• tamsulosin
• testosterone
• tetrabenazine
• tofacitinib
• tramadol
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• upadacitinib
• vaccines
• vortioxetine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.