INTRODUCTION

AZEL 80 CAPSULE contains Enzalutamide, which belongs to the group of medicines called Androgen receptor inhibitors. It is used to manage adult men with prostate cancer who no longer respond to hormone therapy or surgical treatment or if the cancer, despite responding to treatment, has spread to other parts of the body.

Prostate cancer occurs in the prostate gland (a gland in males that produces the seminal fluid to transport sperm). Symptoms include problems while urinating (difficulty, decreased force, or blood in the urine), blood in the semen, bone pain, erectile dysfunction, and weight loss.

Enzalutamide acts by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, it stops the growth of prostate cancer cells and can further induce cancer cell death and tumour regression.

Before taking AZEL 80 CAPSULE, inform your doctor if you have kidney problems, liver problems, or heart conditions like arrhythmia (heart rhythm problem). AZEL 80 CAPSULE is not recommended for use by pregnant and breastfeeding women. AZEL 80 CAPSULE is not recommended for use in children and adolescents. Consult your doctor before taking it.

The most common side effects of taking AZEL 80 CAPSULE are tiredness, broken bones, hot flushes, high blood pressure, headaches, feeling anxious, dry skin, itching, difficulty remembering, and breast enlargement in men. Consult your doctor if any of the symptoms worsen.

USES OF AZEL 80 CAPSULE

• To manage prostate cancer

HOW AZEL 80 CAPSULE WORKS

AZEL 80 CAPSULE works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, it stops the growth of prostate cancer cells and can induce cancer cell death and tumour regression.

DIRECTIONS FOR USE

Take AZEL 80 CAPSULE as advised by your physician. Swallow it with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age, body weight, and disease condition.

SIDE EFFECTS OF AZEL 80 CAPSULE

HOW TO MANAGE SIDE EFFECTS

Headache

Drink enough water and avoid bright lights. A cold compress will also have a soothing effect.

WARNING & PRECAUTIONS

PREGNANCY

Contraindicated

AZEL 80 CAPSULE is not recommended for use by pregnant women. Consult your doctor before taking it. Women who are or may become pregnant should not handle broken or damaged medicine without wearing protection like gloves.

BREASTFEEDING

Contraindicated

AZEL 80 CAPSULE is not recommended for breastfeeding women. Consult your doctor before taking it.

DRIVING AND USING MACHINES

Use with Caution

AZEL 80 CAPSULE may have a moderate influence on the ability to drive and use machines, so avoid driving or handling machines while on AZEL 80 CAPSULE.

KIDNEY

Use with Caution

AZEL 80 CAPSULE should be taken with caution in patients with severe kidney disease. Consult your doctor before taking it.

LIVER

Use with Caution

AZEL 80 CAPSULE should be used with caution in patients with severe liver disease. Consult your doctor before taking it.

ALLERGY

Contraindicated

Do not take AZEL 80 CAPSULE if you are allergic to enzalutamide.

HEART DISEASE

Use with Caution

AZEL 80 CAPSULE should be taken with caution in patients with heart or blood vessel conditions, including heart rhythm problems (arrhythmia). Consult your doctor before taking it.

USE IN PEDIATRICS

Contraindicated

AZEL 80 CAPSULE is not recommended for use in children and adolescents. Consult your doctor before taking it.

USE IN GERIATRICS

Contraindicated

Your doctor will give you the right dose depending on your age, body weight, and disease condition. Consult your doctor before taking AZEL 80 CAPSULE.

INTERACTIONS

A. Drug-drug interactions:

Before taking AZEL 80 CAPSULE, inform your doctor if you are taking any of the following medicines:

• anticoagulants (Ex. warfarin, acenocoumarol, and clopidogrel)
• medicines used to manage asthma and other respiratory diseases (Ex. aminophylline, theophylline).
• medicines used to manage certain psychiatric disorders such as depression and schizophrenia (Ex. clozapine, olanzapine, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, risperidone, ziprasidone, bupropion, lithium, mirtazapine, diazepam, midazolam, and haloperidol)
• medicines used to manage cholesterol (Ex. gemfibrozil, atorvastatin, simvastatin)
• medicines used to manage pain (Ex. fentanyl, tramadol, pethidine, methadone)
• medicines used to manage cancer (Ex. cabazitaxel, docetaxel)
• medicines used to manage epilepsy (Ex. carbamazepine, clonazepam, phenytoin, primidone, and valproic acid)
• medicines used to manage sleep disorders (Ex. zolpidem)
• medicines used to manage heart conditions or lower blood pressure (Ex. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, and verapamil), to manage heart conditions or strokes (Ex. dabigatran etexilate), to manage heart rhythm problems (Ex. quinidine, procainamide, amiodarone, and sotalol)
• medicines used to manage serious diseases related to inflammation (Ex. dexamethasone, prednisolone)
• medicines used to manage HIV infection (Ex. indinavir, ritonavir)
• medicines used to manage bacterial infections (Ex. clarithromycin, doxycycline)
• medicines used to manage thyroid disorders (Ex. levothyroxine)
• medicines used to manage gout (Ex. colchicine)
• medicines used to manage stomach disorders (Ex. omeprazole)
• medicines used to manage organ rejection (Ex. tacrolimus)
• moxifloxacin (a medicine used to manage bacterial infections)

Overdosage:

If you or anyone else accidentally takes too much of AZEL 80 CAPSULE, consult your doctor immediately or visit the nearby hospital. The symptoms of an overdose are seizures.

SYNOPSIS

MORE INFORMATION

• Keep AZEL 80 CAPSULE out of reach of children
• Store below 30°C

FAQs ABOUT AZEL 80 CAPSULE

Q: Can AZEL 80 CAPSULE cause confusion?

A: Yes, AZEL 80 CAPSULE can develop a condition involving the brain called posterior reversible encephalopathy syndrome. If you have seizures, an increasing headache, confusion, blindness, or vision problems, please contact your doctor as soon as possible.

Q: What if I forget to take AZEL 80 CAPSULE?

A: If you forget to take AZEL 80 CAPSULE at the usual time, take it as soon as you remember. If you forget it for the whole day, take it the following day. If you forget to take the medicine for more than one day, talk to your doctor immediately. Do not take a double dose.

Q: Is AZEL 80 CAPSULE a chemotherapy drug?

A: No, AZEL 80 CAPSULE is not a chemotherapy drug, despite being used in the management of cancer. It is a type of hormone therapy that works to prevent prostate cancer cells from growing and spreading by blocking the action of a group of hormones called androgens.

Q: Can AZEL 80 CAPSULE be taken by a woman?

A: No. AZEL 80 CAPSULE is not recommended for women. It is used to manage prostate cancer in men.

REFERENCES

1. Jean Hoffman, Wm Kevin Kelly. Enzalutamide: a novel antiandrogen for patients with castrate-resistant prostate cancer. [Revised on March 2013] [Accessed on 9th May 2022] https://pubmed.ncbi.nlm.nih.gov/23300275/

2. Astellas Pharma Europe B.V. Electronic Medicines Compendium (EMC). [Revised in April 2022] [Accessed on 9th May 2022] https://www.medicines.org.uk/emc/files/pil.10318.pdf

3. Enzalutamide. Mayo Clinic. [Revised in June 2021] [Accessed on 9th May 2022] https://www.mayoclinic.org/diseases-conditions/prostate-cancer/diagnosis-treatment/drc-20353093

USEFUL DIAGNOSTIC TESTS

• Digital rectal exam (DRE)
• Prostate-specific antigen (PSA) test
• MRI scan
• Ultrasound

AUTHOR DETAILS

Written By Dr. N. Sai Swaroop, Pharm.D
Last updated on 31 Oct 2023 | 06:06 PM(IST)