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ABIRATERONE ACETATE tablet


  1. What Are Abiraterone Acetate Tablets?
  2. How Should I Take Abiraterone Acetate Tablets?
  3. Abiraterone Acetate Tablets May Cause Serious Side Effects Including:
  4. Tell Your Healthcare Provider If You Get Any Of The Following Symptoms:
  5. The Most Common Side Effects Of Abiraterone Acetate Include:
  6. How Should I Store Abiraterone Acetate Tablets?
  7. Active Ingredient:
  8. Inactive Ingredients:
  9. Manufactured For:
  10. What Are Abiraterone Acetate Tablets?
  11. Before You Take Abiraterone Acetate Tablets, Tell Your Healthcare Provider If You:
  12. How Should I Store Abiraterone Acetate Tablets?
  13. Marketed/packaged By:
  14. Hypertension, Hypokalemia, And Fluid Retention:
  15. Adrenocortical Insufficiency:
  16. Hepatotoxicity:
  17. Dosing And Administration:
  18. Fetal Toxicity:
  19. Infertility:
  20. Patient Information
  21. Who Should Not Take Abiraterone Acetate Tablets?
  22. How Should I Take Abiraterone Acetate Tablets?
  23. Abiraterone Acetate Tablets May Cause Serious Side Effects Including:
  24. The Most Common Side Effects Of Abiraterone Acetate Tablets Include:
  25. What Are The Ingredients Of Abiraterone Acetate Tablets?
  26. Manufactured By:
  27. Distributed By:
  28. Revised: 1/2019document Id:

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.

Abiraterone acetate tablets are not for use in women.

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

Before you take Abiraterone Acetate Tablets, tell your healthcare providerabout all of your medical conditions, includingif you:

  • have heart problems
  • have liver problems
  • 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 tablets 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.
  • 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 breast milk.

Tell your healthcare provider about all the medicines you takeor treatments you receive, including prescription and over-the -counter medicines, vitamins, and herbal supplements. Abiraterone acetate 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 notchange orstop 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, at least one hour before or at least 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.
  • 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.

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: 

dizziness

confusion

fast or irregular heartbeats

muscle weakness

feel faint or lightheaded

pain in your legs

headacheswelling in your legs or feet
  • Adrenal problemsmay 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

Increased risk of bone fracture and deathwhen abiraterone acetate tablets and prednisone or prednisolone, is 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.

The Most Common Side Effects Of Abiraterone Acetate Include: 

feeling very tired

vomiting

joint pain

infected nose, sinuses, or throat (cold)

high blood pressure

cough

nauseaheadache
swelling in your legs or feetlow red blood cells (anemia)
low blood potassium levelshigh blood cholesterol and triglycerides
hot flusheshigh blood sugar levels
diarrheacertain 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.

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 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 abiraterone acetate tablets 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 abiraterone acetate tablets that is written for health professionals.

For more information contact Apotex Corp. at 1-800-706-5575.

Active Ingredient: 

abiraterone acetate

Inactive Ingredients: 

colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate.

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

APOTEX INC.

Abiraterone Acetate Tablets, USP

250 mg

Manufactured For: 

Apotex Inc.Apotex Corp.Toronto, OntarioWeston, FloridaCanada M9L 1T9USA 33326

RevisJuly 2019

Rev: 9

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.

Abiraterone acetate tablets are not for use in women.

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

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.
  • are breastfeeding or plan to breastfeed. It is not known if abiraterone acetate 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.

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 Store Abiraterone Acetate Tablets? 

  • Store abiraterone acetate tablets at room temperature between 20 to 25 C (68 to 77 F).

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 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.

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

Marketed/packaged By: 

GSMS, Inc

Camarillo, CA 93012 USA

Hypertension, Hypokalemia, And Fluid Retention: 

  • Inform patients that abiraterone acetate tablets are associated with hypertension, hypokalemia, and peripheral edema. Advise patients to report symptoms of hypertension, hypokalemia, or edema to their healthcare provider[seeWarnings 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[seeWarnings 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[seeWarnings and Precautions (5.3)].

Dosing And Administration: 

  • Inform patients that abiraterone is 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 tablets.
  • Instruct patients to take abiraterone acetate tablets on an empty stomach, either one hour before or two hours after a meal. 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[seeDosage 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[seeDosage and Administration (2.3)].

Fetal Toxicity: 

  • Inform patients that abiraterone acetate tablets 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 tablets[seeUse 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[seeUse in Specific Populations (8.1)andHow Supplied/Storage and Handling (16)].

Infertility: 

Patient Information 

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

Hypertension, Hypokalemia, and Fluid Retention

  • Inform patients that abiraterone acetate tablets are associated with hypertension, hypokalemia, and peripheral edema. Advise patients to report symptoms of hypertension, hypokalemia, or edema to their healthcare provider [

    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.

    Abiraterone acetate tablets are 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 tablets 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 250 mg uncoated tablets or other abiraterone acetate tablets if broken, crushed, or damaged without protection, such as gloves.

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.

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
confusion
fast heartbeats
muscle weakness
feel faint or lightheaded
pain in your legs
headache
swelling in your legs or feet
  • Adrenal problemsmay 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
vomiting
joint pain
infected nose, sinuses, or throat (cold)
high blood pressure
cough
nausea
headache
swelling in your legs or feet
low red blood cells (anemia)
low blood potassium levels
high blood cholesterol and triglycerides
hot flushes
high blood sugar levels
diarrhea
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.

What Are The Ingredients Of Abiraterone Acetate Tablets? 

Active ingredient: abiraterone acetate, USP

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.

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

Manufactured By: 

Aizant Drug Research Solutions Pvt Ltd

Survey No 172/173,

Apparel Park Road, Dulapally Village,

Qutbullaphur Mandal, Hyderabad,

Andhra Pradesh, India.

Distributed By: 

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Revised: 01/2019

DRUG: Abiraterone Acetate

GENERIC: Abiraterone Acetate

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-021-01

STRENGTH: 250 mg

COLOR: White (White to off-white)

SHAPE: Oval

SCORE: no score

SIZE: 16 mm

IMPRINT: A;250

QTY: 120 Tablets

Label
ABIRATERONE ACETATE
abiraterone acetate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64679-021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ABIRATERONE ACETATE(UNII: EM5OCB9YJ6) (ABIRATERONE - UNII:G819A456D0)ABIRATERONE ACETATE250 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
ColorWHITE (white to off-white)Scoreno score
ShapeOVALSize16mm
FlavorImprint CodeA;250
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64679-021-01120 in 1 BOTTLE; Type 0: Not a Combination Product02/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20838002/27/2019
Labeler -Wockhardt USA LLC. (170508365)
Registrant -Wockhardt Limited (650069115)
Establishment
NameAddressID/FEIBusiness Operations
Aizant Drug Research Solutions Pvt Ltd650372951ANALYSIS(64679-021) , LABEL(64679-021) , MANUFACTURE(64679-021) , PACK(64679-021)

Revised: 1/2019document Id: 

fc449cb5-473b-402b-b404-78dd879dc3e0Set id: 76f9bb2f-4946-4391-9e7d-e4f867cf84dbVersion: 1Effective Time: 20190126Wockhardt USA LLC.



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