Akeega is a prescription medicine used to treat types of prostate cancer, it is used together with prednisone. Akeega contains niraparib and abiraterone acetate and is the first dual-action tablet combining a PARP inhibitor with abiraterone acetate.

Akeega is used for metastatic castration-resistant prostate cancer (mCRPC), that has an abnormal BRCA gene (BRCA-positive). This is prostate cancer that has spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone. Your doctor will perform a test to make sure this medicine right for you.

Akeega received FDA approval on 11 August, 2023, approval was based on positive results from the randomized, double-blind, placebo-controlled multi-center Phase 3 MAGNITUDE study.

Take Akeega exactly as your healthcare provider tells you. 

• Take Akeega tablets once daily in combination with prednisone
• Take Akeega on an empty stomach. Do not eat food 2 hours before and 1 hour after taking Akeega as taking it with food may cause more of the medicine to be absorbed by the body than is needed which may cause side effects. 
• Swallow tablets whole with water. Do not break, crush, or chew tablets.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Akeega if you have certain side effects. 
• You should not change or stop taking your prescribed dose of Akeega or prednisone without talking with your healthcare provider first. 
• You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with Akeega unless you have had surgery to lower the amount of testosterone in your body (surgical castration).

If you miss a dose of  your tablets, take the dose as soon as possible on the same day. Return to your normal schedule on the following day. Do not take extra tablets to make up the missed dose. 

The recommended adult dosage of Akeega is 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 10 mg prednisone daily until disease progression or unacceptable toxicity. 

Akeega is available as: 

• 50 mg niraparib/500 mg abiraterone acetate tablet 
• 100 mg niraparib/500 mg abiraterone acetate tablet

Tell your healthcare provider about all of your medical conditions, including if you:

• have high blood pressure or heart problems
• have low blood potassium levels
• have liver or kidney problems
• have a history of adrenal problems
• have diabetes
• are receiving any other treatment for prostate cancer.

Pregnancy

Females: Tell your healthcare professional if you are pregnant, become pregnant or plan to become pregnant. Akeega can cause harm to your unborn baby and loss of pregnancy (miscarriage).

Females who are or may become pregnant should handle Akeega tablets with protection, such as gloves.

Males: with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 4 months after the last dose of this medicine.

Akeega may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. 

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Akeega passes into your breastmilk.

The most common Akeega side effects: 

• muscle and bone pain
• tiredness 
• changes in liver function blood tests 
• constipation
• high blood pressure
• nausea
• changes in kidney function blood tests
• increased potassium level in the blood 
• decreased potassium level in the blood
• swelling in your legs or feet 
• shortness of breath 
• decreased appetite 
• vomiting
• dizziness 
• Coronavirus disease 2019 (COVID-19)
• headache
• stomach area pain 
• bleeding 
• urinary tract infection 
• cough
• trouble sleeping
• decreased weight
• irregular heartbeat (arrhythmia)
• falls
• fever.

Akeega may cause serious side effects 

Bone marrow problems called myelodysplastic syndrome (MDS) or a type of cancer of the blood called acute myeloid leukemia (AML).  See 'Important Information below for more details.

Low blood potassium levels (hypokalemia), fluid retention (edema), high blood pressure (hypertension) and heart problems. Tell your healthcare provider if you have any of the following symptoms 

• dizziness
• fast or irregular heartbeats
• feel faint or lightheaded
• headache
• confusion
• muscle weakness
• pain in your legs
• swelling in your hands, ankles, legs or feet 

Liver problems. Severe liver problems, liver failure, and death has happened in people treated with abiraterone acetate, one of the active ingredients in Akeega. Tell your healthcare provider right away if you develop any symptoms of liver problems, including:

• yellowing of the skin or eyes
• darkening of the urine
• severe nausea or vomiting .

Adrenal problems. Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress. Tell your healthcare provider right away if you develop any symptoms of adrenal problems, including:

• feeling tired
• weakness
• feeling dizzy or lightheaded
• nausea or vomiting
• weight loss

Low blood sugar (hypoglycemia). Akeega may cause low blood sugar in people taking medicines for diabetes. Severe low blood sugar has happened in people who take certain medicines for diabetes and were treated with abiraterone acetate, one of the active ingredients in Akeega. You and your healthcare provider should check your blood sugar levels during treatment and after you stop treatment with Akeega. Your healthcare provider may need to change the dose of your diabetes medicine to reduce your risk of low blood sugar. Tell your healthcare provider right away if you have any of the following signs or symptoms of low blood sugar, including:

• headache 
• drowsiness 
• weakness 
• dizziness 
• confusion
• irritability
• hunger
• fast heartbeat
• sweating
• feeling jittery. 

Increased risk of bone fracture and death when abiraterone acetate, one of the active ingredient in this medicine, and prednisone or prednisolone is used in combination with a type of radiation called Radium 223 (Ra-223) dichloride. You should not receive treatment with Ra-223 dichloride for at least 5 days after your last dose of Akeega with prednisone. Tell your healthcare provider about any other treatments you are taking for prostate cancer.  

Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a condition that affects the brain and may happen during treatment with Akeega. If you have headache, vision changes, confusion, or seizure with or without high blood pressure, please contact your healthcare provider. 

Fertility problems in males this medicine may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. 

These are not all the possible side effects of Akeega. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Important Information

Akeega may cause serious side effects including:

Bone marrow problems called myelodysplastic syndrome (MDS) or a type of cancer of the blood called acute myeloid leukemia (AML). MDS or AML that may lead to death has happened in people treated with niraparib, one of the active ingredients in Akeega. If you develop MDS or AML, your healthcare provider will stop treatment with this medicine. Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with Akeega but can also be a sign of serious bone marrow problems, including MDS and AML. Tell your healthcare provider if you have any of the following symptoms during treatment:

• pale skin
• weakness
• shortness of breath
• feeling tired
• bruising or bleeding more easily
• fever o frequent infections
• blood in the urine or stool
• weight loss

Your healthcare provider will do blood tests to check your blood cell counts: 

• weekly during the first month of treatment,
• every 2 weeks for the next 2 months of treatment, 
• monthly for the remainder of the year, 
• then every other month and as needed during treatment.

What should I tell my doctor before taking Akeega?

Tell your healthcare provider about all of your medical conditions, including if you:

• have high blood pressure or heart problems
• have low blood potassium levels
• have liver or kidney problems
• have a history of adrenal problems
• have diabetes
• are receiving any other treatment for prostate cancer.

Pregnancy

Females: Tell your healthcare professional if you are pregnant, become pregnant or plan to become pregnant. Akeega can cause harm to your unborn baby and loss of pregnancy (miscarriage).

Females who are or may become pregnant should handle Akeega tablets with protection, such as gloves.

Males: with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 4 months after the last dose of this medicine.

Akeega may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. 

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Akeega passes into your breastmilk.

How should I take Akeega?

Take Akeega exactly as your healthcare provider tells you. 

• Take Akeega tablets once daily in combination with prednisone
• Take Akeega on an empty stomach. Do not eat food 2 hours before and 1 hour after taking Akeega as taking it with food may cause more of the medicine to be absorbed by the body than is needed which may cause side effects. 
• Swallow tablets whole with water. Do not break, crush, or chew tablets.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Akeega if you have certain side effects. 
• You should not change or stop taking your prescribed dose of Akeega or prednisone without talking with your healthcare provider first. 
• You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with Akeega unless you have had surgery to lower the amount of testosterone in your body (surgical castration).

If you miss a dose of  your tablets, take the dose as soon as possible on the same day. Return to your normal schedule on the following day. Do not take extra tablets to make up the missed dose. 

Akeega Dosing Information

The recommended adult dosage of Akeega is 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 10 mg prednisone daily until disease progression or unacceptable toxicity. 

Akeega is available as: 

• 50 mg niraparib/500 mg abiraterone acetate tablet 
• 100 mg niraparib/500 mg abiraterone acetate tablet