WARNINGS & PRECAUTIONS

• Females who are or may become pregnant should handle AKEEGA tablets with protection, such as gloves. AKEEGA can cause harm to an unborn baby and loss of pregnancy.¹

summary

Here is a passage from the AKEEGA PATIENT INFORMATION which may be helpful to address your question:

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 medicines in AKEEGA. If you develop MDS or AML, your healthcare provider will stop treatment with AKEEGA.¹
  • 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 with AKEEGA¹:
    • Pale skin
    • Weakness
    • Shortness of breath
    • Feeling tired
    • Bruising or bleeding more easily
    • Fever
    • Frequent infections
    • Blood in urine or stool
    • Weight loss
  • Your healthcare provider will do blood tests to check your blood cell counts¹:
    • 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 with AKEEGA.
• Low blood potassium levels (hypokalemia), fluid retention (edema), high blood pressure (hypertension) and heart problems. To decrease the chance of this happening, you must take prednisone with AKEEGA exactly as your healthcare provider tells you. Your healthcare provider will check your blood pressure, do blood tests to check your potassium levels, and check for any signs and symptoms of fluid retention at least weekly for the first 2 months of treatment, then 1 time a month during treatment with AKEEGA. Tell your healthcare provider if you have any of the following symptoms¹:
  • Dizziness
  • Confusion
  • Fast or irregular heartbeats
  • Muscle weakness
  • Feel faint or lightheaded
  • Pain in your legs
  • Headache
  • 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 medicines in AKEEGA. Your healthcare provider will do blood tests to check your liver function before starting treatment with AKEEGA, every 2 weeks for the first 3 months of treatment, and then monthly thereafter during treatment with AKEEGA. Tell your healthcare provider right away if you develop any symptoms of liver problems, including¹:
  • Yellowing of the skin or eyes
  • Severe nausea or vomiting
  • Darkening of the urine
• 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, including¹:
  • Feeling tired
  • Nausea or vomiting
  • Weakness
  • Weight loss
  • Feeling dizzy or lightheaded
• 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 medicines 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 decrease 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, including¹:
  • Headache
  • Irritability
  • Drowsiness
  • Hunger
  • Weakness
  • Fast heartbeat
  • Dizziness
  • Sweating
  • Confusion
  • Feeling jittery
• Increased risk of bone fracture and death when abiraterone acetate, one of the medicines in AKEEGA, 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.¹
• 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.¹

The most common side effects of AKEEGA include¹:

• Muscle and bone pain
• Swelling in your legs or feet
• Bleeding
• Tiredness
• Shortness of breath
• Urinary tract infection
• Changes in liver function blood tests
• Decreased appetite
• Cough
• Constipation
• Vomiting
• Trouble sleeping
• High blood pressure
• Dizziness
• Decreased weight
• Nausea
• Coronavirus disease 2019 (COVID-19)
• Irregular heartbeat (arrhythmia)
• Changes in kidney function blood tests
• Headache
• Falls
• Increased potassium level in the blood
• Stomach area pain
• Fever
• Decreased potassium level in the blood

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.¹

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-1088.¹

additional information

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest using it in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the PATIENT INFORMATION for AKEEGA.¹