Abiraterone Acetate: Package Insert and Label Information (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Abiraterone Acetate Tablets, USP are available containing 250 mg or 500 mg of abiraterone acetate, USP.

500 mg film-coated tablets: The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with M on one side of the tablet and AB500 on the other side. They are available as follows:

NDC 0378-6921-91

bottles of 60 tablets

250 mg uncoated tablets: The 250 mg tablets are white to off-white, oval, unscored tablets debossed with M on one side of the tablet and AB250 on the other side. They are available as follows:

NDC 0378-6920-78bottles of 120 tablets

Storage and Handling: Store at 20° to 25°C (68° to 77°F); excursions permitted in the range from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Keep out of reach of children.

Based on its mechanism of action, abiraterone acetate tablets may harm a developing fetus. Women who are pregnant or women who may be pregnant should not handle abiraterone acetate 250 mg uncoated tablets or other abiraterone acetate tablets if broken, crushed, or damaged without protection, e.g., gloves [see Use in Specific Populations (8.1)].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions:

Inform patients that abiraterone acetate tablets are associated with hypertension, hypokalemia, and peripheral edema that may lead to QT prolongation and Torsades de Pointes in patients who develop hypokalemia while taking abiraterone acetate tablets. Advise patients that their blood pressure, serum potassium and signs and symptoms of fluid retention will be monitored clinically at least monthly. Advise patients to adhere to corticosteroids and to report symptoms of hypertension, hypokalemia, or edema to their healthcare provider [see Warnings and Precautions (5.1)].

Adrenocortical Insufficiency:

Inform patients that abiraterone acetate tablets with prednisone is associated with adrenal insufficiency. Advise patients to report symptoms of adrenocortical insufficiency to their healthcare provider [see Warnings and Precautions (5.2)].

Hepatotoxicity:

Inform patients that abiraterone acetate tablets are associated with severe hepatotoxicity. Inform patients that their liver function will be monitored using blood tests. Advise patients to immediately report symptoms of hepatotoxicity to their healthcare provider [see Warnings and Precautions (5.3)].

Hypoglycemia:

Inform patients that severe hypoglycemia has been reported when abiraterone acetate tablets were administered to patients with pre-existing diabetes who were receiving medications containing thiazolidinediones (including pioglitazone) or repaglinide, antidiabetic drugs. Advise patients with diabetes to monitor glucose levels during and after treatment with abiraterone acetate tablets [see Warnings and Precautions (5.6) and Drug Interactions (7.2)].

Use in Combination with Radium Ra 223 Dichloride:

Advise patients that radium Ra 223 dichloride showed an increase in mortality and an increased rate of fracture when used in combination with abiraterone acetate tablets plus prednisone/prednisolone. Inform patients to speak with their healthcare provider about any other medications or treatment they are currently taking for prostate cancer [see Warnings and Precautions (5.4)].

Dosing and Administration:

Inform patients that abiraterone is taken once daily with prednisone (once or twice daily according to their healthcare provider’s instructions) and to not interrupt or stop either of these medications without consulting their healthcare provider.
Inform patients receiving GnRH therapy that they need to maintain this treatment during the course of treatment with abiraterone acetate tablets.
Instruct patients to take abiraterone acetate tablets as a single dose once daily on an empty stomach. Instruct patients to not eat food 2 hours before and 1 hour after taking abiraterone acetate tablets. Abiraterone acetate tablets taken with food causes increased exposure and may result in adverse reactions. Instruct patients to swallow tablets whole with water and not to crush or chew the tablets [see Dosage and Administration (2.3)].
Inform patients that if they miss a dose of abiraterone acetate tablets or prednisone, they should take their normal dose the following day. If more than one daily dose is skipped, inform patients to contact their healthcare provider [see Dosage and Administration (2.3)].

Embryo-Fetal Toxicity:

Inform patients that abiraterone acetate tablets may harm a developing fetus and can cause loss of pregnancy.
Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the final dose of abiraterone acetate tablets [see Use in Specific Populations (8.1)].
Advise females who are pregnant or women who may be pregnant not to handle abiraterone acetate 250 mg uncoated tablets or other abiraterone acetate tablets if broken, crushed, or damaged without protection, e.g., gloves [see Use in Specific Populations (8.1) and How Supplied/Storage and Handling (16)].

Infertility:

Advise male patients that abiraterone acetate tablets may impair fertility [see Use in Specific Populations (8.3)].

Patient Information

Abiraterone Acetate Tablets, USP

(a” bir a’ ter one as’ e tate)

What are abiraterone acetate tablets?

Abiraterone acetate tablets are a prescription medicine that is used along with prednisone. Abiraterone acetate tablets are used to treat men with prostate cancer that has spread to other parts of the body.

It is not known if abiraterone acetate tablets are safe and effective in females or children.

Before taking abiraterone acetate tablets, tell your healthcare provider about all of your medical conditions, including if you:

have heart problems
have liver problems
have diabetes
have a history of adrenal problems
have a history of pituitary problems
are receiving any other treatment for prostate cancer
are pregnant or plan to become pregnant. Abiraterone acetate tablets can cause harm to your unborn baby and loss of pregnancy (miscarriage). Females who are or may become pregnant should not handle abiraterone acetate uncoated tablets or other abiraterone acetate tablets if broken, crushed, or damaged without protection, such as gloves.
have a partner who is pregnant or may become pregnant.
o
Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment with abiraterone acetate tablets and for 3 weeks after the last dose of abiraterone acetate tablets.
are breastfeeding or plan to breastfeed. It is not known if abiraterone acetate passes into your breastmilk.

Tell your healthcare provider about all the medicines you take or treatments you receive , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Abiraterone acetate tablets can interact with many other medicines.

You should not start or stop any medicine before you talk with the healthcare provider that prescribed abiraterone acetate tablets.

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take abiraterone acetate tablets?

Take abiraterone acetate tablets and prednisone exactly as your healthcare provider tells you.
Take your prescribed dose of abiraterone acetate tablets 1 time a day.
Your healthcare provider may change your dose if needed.
Do not change or stop taking your prescribed dose of abiraterone acetate tablets or prednisone without talking with your healthcare provider first.
Take abiraterone acetate tablets as a single dose one time a day on an empty stomach. Do not eat food 2 hours before and 1 hour after taking abiraterone acetate tablets.
Do not take abiraterone acetate tablets with food. Taking abiraterone acetate tablets with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.
Swallow abiraterone acetate tablets whole. Do not crush or chew tablets.
Take abiraterone acetate tablets with water.
If you miss a dose of abiraterone acetate tablets or prednisone, take your prescribed dose the following day. If you miss more than 1 dose, tell your healthcare provider right away.
Your healthcare provider will do blood tests to check for side effects.

What are the possible side effects of abiraterone acetate tablets?

Abiraterone acetate tablets may cause serious side effects including:

High blood pressure (hypertension), low blood potassium levels (hypokalemia), fluid retention (edema), and irregular heartbeats can happen during treatment with abiraterone acetate tablets. This can be life threatening. To decrease the chance of this happening, you must take prednisone with abiraterone acetate tablets 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 every month during treatment with abiraterone acetate tablets. Tell your healthcare provider if you get any of the following symptoms:
o
dizziness
o
fast or irregular heartbeats
o
feel faint or lightheaded
o
headache
o
confusion
o
muscle weakness
o
pain in your legs
o
swelling in your legs or feet
Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress.
Severe liver problems. You may develop changes in liver function blood tests. Your healthcare provider will do blood tests to check your liver before treatment with abiraterone acetate tablets and during treatment with abiraterone acetate tablets. Liver failure may occur, which can lead to death. Tell your healthcare provider right away if you notice any of the following changes:
o
yellowing of the skin or eyes
o
darkening of the urine
o
severe nausea or vomiting
Increased risk of bone fracture and death when abiraterone acetate tablets and prednisone or prednisolone, are used in combination with a type of radiation called radium Ra 223 dichloride. Tell your healthcare provider about any other treatments you are taking for prostate cancer.
Severe low blood sugar (hypoglycemia). Severe low blood sugar with abiraterone acetate tablets can happen in people who have diabetes and take certain antidiabetic medicines. You and your healthcare provider should check your blood sugar levels regularly during treatment with abiraterone acetate tablets and after you stop treatment. Your healthcare provider may also need to change the dose of your antidiabetic medicines. Signs and symptoms of low blood sugar may include:
headache
drowsiness
weakness
dizziness
confusion
irritability
hunger
fast heartbeat
sweating
feeling jittery

The most common side effects of abiraterone acetate tablets include:

feeling very tired
joint pain
high blood pressure
nausea
swelling in your legs or feet
low blood potassium levels
hot flushes
diarrhea
vomiting
infected nose, sinuses, or throat (cold)
cough
headache
low red blood cells (anemia)
high blood cholesterol and triglycerides
high blood sugar levels
certain other abnormal blood tests

Abiraterone acetate tablets 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 abiraterone acetate tablets. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store abiraterone acetate tablets?

Store abiraterone acetate tablets at room temperature between 20º to 25ºC (68º to 77ºF).

Keep abiraterone acetate tablets and all medicines out of the reach of children.

General information about the safe and effective use of abiraterone acetate tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use abiraterone acetate tablets for a condition for which they were not prescribed. Do not give abiraterone acetate tablets to other people, even if they have the same symptoms that you have. They may harm them.

You can ask your healthcare provider or pharmacist for information about abiraterone acetate tablets that is written for health professionals.

What are the ingredients of abiraterone acetate tablets?

Active ingredient: abiraterone acetate

Inactive ingredients: 500 mg film-coated tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.

250 mg film-coated tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.

250 mg uncoated tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.

Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Auro PR Inc.
RD 156 Caguas West Industrial Park, Lot 24
Caguas, PR 00725 U.S.A.

Revised: 3/2022
ABIRT:R14p/PL:ABIRT:R12p

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