Abiraterone Acetate (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Abiraterone acetate tablets, USP 250 mg are white to off-white, oval tablets debossed with “NA250” on one side and plain on other side. Abiraterone acetate tablets 250 mg are available in high-density polyethylene bottles of 120 tablets.

NDC 64980-418-12

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted in the range from 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature ].

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 tablets 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)

Hypertension, Hypokalemia, and Fluid Retention

  • Inform patients that abiraterone acetate is associated with hypertension, hypokalemia, and peripheral edema. Advise patients 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 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 is 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) ].

Dosing and Administration

  • Inform patients that abiraterone acetate are taken once daily with prednisone 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.
  • Instruct patients to take abiraterone acetate on an empty stomach, either one hour before or two hours after a meal. Abiraterone acetate 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 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) ].

Fetal Toxicity

  • Inform patients that abiraterone acetate may harm a developing fetus. 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 [see Use in Specific Populations (8.1) ].
  • Women who are pregnant or women who may be pregnant should not handle 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

Manufactured by:
Natco Pharma Limited
Kothur — 509228, India.
Distributed by:
Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663 Revised: 01/2019

SPL PATIENT PACKAGE INSERT SECTION

PATIENT INFORMATION
Abiraterone Acetate (A-bir-A-ter-one AS-e-tate) Tablets, USP
Read this Patient Information that comes with abiraterone acetate tablets before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What are abiraterone acetate tablets?
Abiraterone acetate tablets is 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.
Abiraterone acetate tablets is not for use in women.
It is not known if abiraterone acetate tablets are safe or effective in children.
Who should not take abiraterone acetate tablets?
Abiraterone acetate tablets are not for use in women.

Do not take abiraterone acetate if you are pregnant or may become pregnant. Abiraterone acetate tablets may harm your unborn baby.
Women who are pregnant or who may become pregnant should not touch abiraterone acetate tablets if broken, crushed, or damaged without protection, such as gloves.
What should I tell my healthcare provider before taking abiraterone acetate tablets?
Before you take abiraterone acetate tablets , tell your healthcare provider if you:
• have heart problems
• have liver problems
• have a history of adrenal problems
• have a history of pituitary problems
• have any other medical conditions
• plan to become pregnant. See “Who should not take abiraterone acetate tablets ?”
• are breastfeeding or plan to breastfeed. It is not known if abiraterone acetate tablets passes into your breast milk. You and your healthcare provider should decide if you will take abiraterone acetate tablets or breastfeed. You should not do both. See “Who should not take abiraterone acetate tablets?”

Tell your healthcare provider about all the medicines you take , 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 stop taking your prescribed dose of abiraterone acetate tablets or prednisone without talking with your healthcare provider first.
• Take abiraterone acetate tablets on an empty stomach, either one hour before or two hours after a meal. 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.
• Men who are sexually active with a pregnant woman must use a condom during and for 3 weeks after treatment with abiraterone acetate tablets. If their female partner may become pregnant, a condom and another form of birth control must be used during and for 3 weeks after treatment with abiraterone acetate tablets. Talk with your healthcare provider if you have questions about birth control.
• 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) and fluid retention (edema). Tell your healthcare provider if you get any of the following symptoms:

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

Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress.
Liver problems. You may develop changes in liver function blood test. 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 if you notice any of the following changes:
• yellowing of the skin or eyes
• darkening of the urine
• severe nausea or vomiting 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

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of abiraterone acetate tablets. For more information, ask your healthcare provider or pharmacist.
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 abiraterone acetate tablets?
• Store abiraterone acetate tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Keep abiraterone acetate tablets and all medicines out of the reach of children.
General information about 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 it was not prescribed. Do not give your abiraterone acetate tablets to other people, even if they have the same symptoms that you have. It may harm them.
This leaflet summarizes the most important information about abiraterone acetate tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about abiraterone acetate tablets that is written for healthcare professionals.
For more information contact Rising Pharmaceuticals, Inc. at 1-866-562-4597.
What are the ingredients of abiraterone acetate tablets?
Active ingredient: abiraterone acetate
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.

Manufactured by:
Natco Pharma Limited
Kothur — 509 228, India.

Distributed by:
Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663.


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

Revised: 01/2019

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