INTRODUCTION

ABITATE U 250MG contains abiraterone which belongs to the group of medicines called antineoplastic agents. It is used to treat metastatic prostate cancer in adult men. It is generally used in combination with prednisone or prednisolone to lower the risk of high blood pressure, edema (fluid retention in your body) or decrease in blood potassium levels. It can also be used in combination with androgen deprivation therapy to lower testosterone levels in case of early-stage hormone sensitive prostate cancer.

Abiraterone inhibits androgen production in your body and reduces the growth of prostate cancer. This medicine must not be taken with food, because presence of meals can interfere with its effect. During this treatment, your doctor would periodically check your blood to look for any unwanted side effects on your liver.

The most common side effect of taking this medicine are fluid retention, irregular heartbeat, bone fractures or increased cholesterol levels. Talk to your doctor if any of these symptom bothers you. Avoid concomitant use of this medicine with Ra-223, because it may increase the risks of bone fracture or death. Before taking this medicine, inform your doctor if you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia). Your doctor might suggest an alternative treatment. Male patients who are having sex with a woman who can become pregnant, must use a condom and another effective birth control method. This medicine is strictly not recommended for use in male children and adolescents.

USES OF ABITATE U 250MG

• Treats metastatic prostate cancer in adult men

HOW ABITATE U 250MG WORKS

ABITATE U 250MG inhibits the production of androgens by selectively binding and inhibiting the activity of the enzyme CYP17A1, which in turn leads to decrease in serum levels of testosterone and slows down the growth of prostate cancer.

DIRECTIONS FOR USE

Take ABITATE U 250MG as directed by your physician. It should not be taken with meals. Take this medicine either 1 hour before or 2 hours after eating meals. Swallow the medicine completely with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose for you depending upon your condition. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF ABITATE U 250MG

HOW TO MANAGE SIDE EFFECTS

Diarrhea:

Drink lots of fluids, such as water or juice, to avoid dehydration. Do not take any medicines without speaking to a doctor.

Skin rash:

Avoid hot showers because hot water can irritate the skin. Do not rub or scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use moisturizers to soothe and hydrate the affected area. If it does not get better, speak to a doctor.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• Ra-223 (used to treat prostate cancer)
• ketoconazole (used to treat fungal infections)
• medicines used to treat heart problems (e.g. quinidine, procainamide, amiodarone and sotalol)
• medicines used to treat epilepsy (e.g. phenytoin)
• medicines for diabetes (e.g. insulin, metformin)
• herbal medicines (e.g., St John’s wort to treat depression) and others
• methadone (used to relieve pain or as part of drug addiction detoxification)
• moxifloxacin (used to treat bacterial infection)
• antipsychotics (used for serious mental illnesses) such as chlorpromazine

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT ABITATE U 250MG

Can ABITATE U 250MG cure prostate cancer?

Yes. It is indicated to treat metastatic prostate cancer in adult males.

Can ABITATE U 250MG be used with prednisolone?

Yes. It can be used in combination with prednisone or prednisolone to lower the risk of high blood pressure, edema (fluid retention in your body) or decrease in blood potassium levels.

Is ABITATE U 250MG habit forming?

No. It is not habit-forming in nature.

REFERENCES

1. Beverly Moy, Richard J. Lee and Mathew Smith. Natural products in cancer chemotherapy: Hormones and related drugs. Goodman & Gilman’s: The pharmacological basics of therapeutics. 12th Edition. New York MC Graw Hill Medical 2011. Page – 1767.

2. Gerald G. Briggs and Roger K. Freeman. A. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation, Tenth Edition. 2015. Page – 37.

3. Cougar Biotechnology, Inc. Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on April 2014] [Accessed 6th November 2020] https://clinicaltrials.gov/ct2/show/NCT00638690

4. Janssen Research & Development, LLC. A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients with Advanced Prostate Cancer. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on March 2019] [Accessed 6th November 2020] https://clinicaltrials.gov/ct2/show/NCT01685983

5. Aloysius James, Bini Vincent, Akhila Sivadas and K. Pavithran. A Study on the Clinical Outcome of Abiraterone Acetate in Castration Resistant Prostate Cancer Patients. NCBI; PMC US National Library of Medicine, National Institute of Health. January 2018 [Accessed 6th November 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6018245/

6. Janssen-Cilag SpA. Electronic Medicines Compendium (EMC); [Revised on June 2020] [Accessed 6th November 2020] https://www.medicines.org.uk/emc/files/pil.2381.pdf

7. Patheon Inc. U.S. Food & Drug Administration; [Revised on March 2015] [Accessed 6th November 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s016lbl.pdf

USEFUL DIAGNOSTIC TESTS

• Prostate Specific Antigen (Free) PSA
• Prostate Specific Antigen (Total) PSA