Patient information: uses, side effects, how to take - Akeega

What is the most important information I should know about AKEEGA?

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 AKEEGA. If you develop MDS or AML, your healthcare provider will stop treatment with AKEEGA.
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 AKEEGA:

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 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 with AKEEGA.

See " What are the possible side effects of AKEEGA?" for more information about side effects.

What is AKEEGA?

AKEEGA is a prescription medicine used with prednisone to treat adults with prostate cancer:

who have a certain type of abnormal BRCA gene, and
whose prostate cancer has spread to other parts of the body (metastatic prostate cancer).

Your healthcare provider will perform a test to make sure AKEEGA is right for you.

It is not known if AKEEGA is safe and effective in females.

It is not known if AKEEGA is safe and effective in children.

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
are 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.
have a partner who is pregnant or may become pregnant.
- 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 AKEEGA.
are breastfeeding or plan to breastfeed. It is not known if AKEEGA passes into your breastmilk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. AKEEGA may affect the way other medicines work, and other medicines may affect how AKEEGA works.

How should I take AKEEGA?

Take AKEEGA and prednisone exactly as your healthcare provider tells you.
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with AKEEGA if you have certain side effects.
Do not change or stop taking your prescribed dose of AKEEGA or prednisone without talking with your healthcare provider first.
Take your prescribed dose of AKEEGA 1 time a day.
Take AKEEGA on an empty stomach at least 1 hour before or 2 hours after food. Taking AKEEGA with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.
Swallow AKEEGA tablets whole with water. Do not break, crush, or chew tablets.
If you miss a dose of AKEEGA, 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.
You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with AKEEGA unless you have had a surgery to lower the amount of testosterone in your body (surgical castration).
If you take too much AKEEGA, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of AKEEGA?

AKEEGA may cause serious side effects, including:

See " What is the most important information I should know about 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 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 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, 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 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, 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 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.
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.

The most common side effects of AKEEGA include:

decreased hemoglobin
decreased lymphocytes
muscle and bone pain
tiredness
decreased platelets
changes in liver function blood tests

constipation
high blood pressure
nausea
decreased neutrophils
changes in kidney function blood tests
increased potassium level in the blood

decreased potassium level in the blood
swelling in your legs or feet
increased bilirubin levels in the blood
respiratory tract infection
irregular heartbeat (arrhythmia)

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.

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.

How should I store AKEEGA?

Store AKEEGA at room temperature between 68°F to 77°F (20°C to 25°C).

Keep AKEEGA and all medicines out of the reach of children.

General information about the safe and effective use of AKEEGA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AKEEGA for a condition for which it was not prescribed. Do not give AKEEGA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about AKEEGA that is written for health professionals.

What are the ingredients in AKEEGA?

Active ingredients: niraparib tosylate and abiraterone acetate

Inactive ingredients:

Core tablet: colloidal anhydrous silica, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, sodium lauryl sulfate.

50 mg/500 mg film-coated tablets: The film-coating contains iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate, glycerol monocaprylocaprate, polyvinyl alcohol, talc, and titanium dioxide.

100 mg/500 mg film-coated tablets: The film-coating contains iron oxide red, iron oxide yellow, sodium lauryl sulphate, glycerol monocaprylocaprate, polyvinyl alcohol, talc, and titanium dioxide.

Manufactured for: Janssen Biotech, Inc., Horsham, PA 19044, USA

For patent information: www.janssenpatents.com

For more information, call Janssen Biotech, Inc. at 1-800-526-7736 (1-800-JANSSEN) or go to www.akeegahcp.com.

Akeega: Uses, Side Effects and Dosage