Obnyx Capsule (Enzalutamide 40mg)

INTRODUCTION

OBNYX contain enzalutamide which belongs to a group of medicine called androgen receptor inhibitors. It is used to treat adult men with prostate cancer that no longer responds to a hormone therapy or surgical treatment to lower testosterone (or) has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone.

Prostate cancer is marked by an uncontrolled (malignant) growth of cells in the prostate gland. The prostate is the walnut-sized gland in men, located just below the bladder and in front of the rectum, surrounding the urethra which is the tube that carries urine out of the bladder. It is also called as prostatic carcinoma.

The most common side effects are tiredness, hot flushes, high blood pressure. OBNYX works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing. This medicine 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.

This medicine is strictly not recommended for use in children and adolescents. Before taking this medicine tell your doctor if you have ever had kidney disease, heart disease, liver problems.

USES OF OBNYX

Treat adult men with prostate cancer

HOW OBNYX WORKS

OBNYX works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing.

DIRECTIONS FOR USE

Always take OBNYX exactly as your doctor has told you. OBNYX can be taken with or without food. Try to take OBNYX at the same time each day. It should be swallowed whole with water. Do not crush or chew the medicine. The recommended dose of this medicine is one tablet once a day.

SIDE EFFECTS OF OBNYX

SERIOUS
Seizure or loss of consciousness
Posterior reversible encephalopathy syndrome (PRES) (quickly worsening symptoms such as headache, decreased alertness, confusion, reduced eyesight, blindness, blurred vision, or other visual problems)
Allergic reactions such as swelling of the face, tongue, lip or throat
Chest pain or discomfort or shortness of breath
COMMON
Tiredness or weakness
Broken bones
Hot flushes
High blood pressure
Headache
Falls and fractures
Feeling anxious
Dry skin, itching
Difficulty remembering
Blockage of the arteries in the heart (ischemic heart disease)
Breast enlargement in men (gynaecomastia)
Symptom of restless legs syndrome (an uncontrollable urge to move a part of the body, usually the leg)
Reduced concentration
Forgetfulness
Back pain
Constipation
Joint pain
Decreased appetite
Diarrhoea

HOW TO MANAGE SIDE EFFECTS

Headache:

Apply hot or cold-water bag on your head. Take rest in a quiet and dark room. Drink tea or coffee.

Constipation:

Take fibre rich foods such as fresh fruit, vegetables and cereals, and drink plenty of water. Exercise more regularly.

Diarrhoea:

Drink lot of fluid such as water or squash, to avoid dehydration. Do not take any other medicines without talking to a doctor.

WARNING & PRECAUTIONS

PREGNANCY
Enzalutamide can cause harm to your unborn baby and loss of pregnancy (miscarriage). OBNYX is not recommended for use in pregnant women unless necessary. Discuss the risks and benefits with your doctor.

BREASTFEEDING
It is not known if Enzalutamide passes into your breast milk. OBNYX is not recommended for use in breastfeeding women unless necessary. Discuss the risks and benefits with your doctor.

DRIVING AND USING MACHINES
OBNYX has moderate effect on your ability to drive or use any tools or machines as the side effects include psychiatric and neurological events including seizure. If you are at higher risk of seizures, talk to your doctor.

ALCOHOL
Consumption of alcohol is not recommended during treatment with OBNYX.

KIDNEY
OBNYX should be used with caution in patients suffering from active kidney diseases. Consult your doctor for advice.

LIVER
OBNYX should be used with caution in patients suffering from liver function impairment or active liver diseases. Consult your doctor for advice.

ALLERGY
Do not take OBNYX if you are allergic (hypersensitive) to enzalutamide or any other ingredients in this medicine.

HEART DISEASE
OBNYX should be used with caution in patients suffering from active heart diseases. Consult your doctor for advice.

OTHERS

Tell your doctor if you have or had a condition such as,

Have a history of seizures, brain injury, stroke, or brain tumor
Posterior reversible encephalopathy syndrome (PRES) (symptoms such as worsening headache, confusion, blindness, or other vision problems)
Have high blood pressure
Have abnormal amounts of fat or cholesterol in your blood (dyslipidemia)

INTERACTIONS

Talk to your doctor if you are taking,

Medicines such as aminophylline, theophylline (used to treat asthma and other respiratory diseases)
Medicines such as clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine, diazepam, midazolam, haloperidol (used to treat certain psychiatric disorders such as severe anxiety, depression, and schizophrenia)
Pethidine, fentanyl, tramadol (used to treat pain)
Gemfibrozil, atorvastatin, simvastatin (used for lower cholesterol)
Carbazitaxel, docetaxel (used to treat cancer)
Carbamazepine, clonazepam, phenytoin, primidone, valproic acid (used to treat epilepsy)
Zolpidem (used to treat sleep disorders)
Bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil (used to treat heart conditions or lower blood pressure)
Dexamethasone, prednisolone (used to treat serious disease related to inflammation)
Indinavir, ritonavir (used to treat HIV infection)
Clarithromycin, doxycycline, moxifloxacin (used to treat bacterial infections)
Levothyroxine (used to treat thyroid disorders)
Colchicine (used to treat gout)
Omeprazole (used to treat stomach disorders)
Dabigatran etexilate (used to prevent heart conditions or strokes)
Tacrolimus (used to prevent organ rejection)
Warfarin, acenocoumarol, clopidogrel (used to prevent blood clots)
Quinidine, procainamide, amiodarone and sotalol (used to treat heart rhythm problems)
Methadone (used for pain relief and part of drug addiction detoxification)