Bicalutamide Apotex
Bicalutamide Apotex Uses, Dosage, Side Effects, Food Interaction and all others data.
Bicalutamide Apotex is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.
When Bicalutamide Apotex is combined with luteinizing hormone releasing hormone (LHRH) analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with Bicalutamide Apotex as a single agent for prostate cancer, rises in serum testosterone and estradiol have been noted.
In a subset of patients who have been treated with Bicalutamide Apotex and an LHRH agonist, and who discontinue Bicalutamide Apotex therapy due to progressive advanced prostate cancer, a reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed.
Bicalutamide Apotex is an antineoplastic hormonal agent primarily used in the treatment of prostate cancer. Bicalutamide Apotex is a pure, nonsteroidal anti-androgen with affinity for androgen receptors (but not for progestogen, estrogen, or glucocorticoid receptors). Consequently, Bicalutamide Apotex blocks the action of androgens of adrenal and testicular origin which stimulate the growth of normal and malignant prostatic tissue. Prostate cancer is mostly androgen-dependent and can be treated with surgical or chemical castration. To date, antiandrogen monotherapy has not consistently been shown to be equivalent to castration.
| Trade Name | Bicalutamide Apotex |
| Availability | Prescription only |
| Generic | Bicalutamide |
| Bicalutamide Other Names | Bicalutamida, Bicalutamide, Bicalutamidum |
| Related Drugs | estradiol, Premarin, Xtandi, Casodex, Zytiga, Lynparza |
| Type | |
| Formula | C18H14F4N2O4S |
| Weight | Average: 430.373 Monoisotopic: 430.061040456 |
| Protein binding | 96% |
| Groups | Approved |
| Therapeutic Class | Hormonal Chemotherapy |
| Manufacturer | |
| Available Country | Netherlands |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Bicalutamide Apotex 50 mg daily is used for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
Bicalutamide Apotex 150 mg daily is not approved for use alone or with other treatments
Bicalutamide Apotex is also used to associated treatment for these conditions: Stage D2 Prostatic carcinoma
How Bicalutamide Apotex works
Bicalutamide Apotex competes with androgen for the binding of androgen receptors, consequently blocking the action of androgens of adrenal and testicular origin which stimulate the growth of normal and malignant prostatic tissue.
Dosage
Bicalutamide Apotex dosage
The recommended dose for Bicalutamide Apotex therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that Bicalutamide Apotex be taken at the same time each day. Treatment with Bicalutamide Apotex should be started at the same time as treatment with an LHRH analog.
Side Effects
Anaemia; angioedema, urticaria; decreased appetite, DM, wt gain, dehydration, gout; decreased libido, depression, anxiety, hypertonia, confusion, neuropathy, nervousness, dizziness, somnolence; hot flush; abdominal pain, constipation, nausea, dyspepsia, flatulence, anorexia, rectal haemorrhage, dry mouth, melaena; hepatotoxicity, jaundice, hypertransaminasaemia; alopecia, hirsutism, dry skin, pruritus/rash, photosensitivity; haematuria, dysuria, urinary retention, impaired urination, urinary frequency; gynaecomastia, breast tenderness, erectile dysfunction; asthenia, oedema, chest pain, neck pain, fever, sepsis, chills, neoplasm; cough, pharyngitis, bronchitis, pneumonia, rhinitis.
Precaution
Patient with decreased bone density, history of or risk factors for QT prolongation, diabetes, Moderate to severe hepatic and severe renal impairment (CrCl <30 mL/min).
Interaction
May induce torsade de pointes or QT prolongation if co-administered with class IA (e.g. quinidine) or class III (e.g. amiodarone) antiarrhythmic agents, methadone, antipsychotics, moxifloxacin. Enhanced anticoagulant effect of warfarin. Increased adverse effects when used with drugs that may inhibit oxidation (e.g. cimetidine, ketoconazole). May increase serum levels of ciclosporin and Ca channel blockers.
Food Interaction
- Take at the same time every day.
- Take with or without food. Food does not significantly affect absorption.
Bicalutamide Apotex Drug Interaction
Unknown: aspirin, aspirin, aspirin, aspirin, rosuvastatin, rosuvastatin, omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, tamsulosin, tamsulosin, leuprolide, leuprolide, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol
Bicalutamide Apotex Disease Interaction
Elimination Route
Bicalutamide Apotex is well-absorbed following oral administration, although the absolute bioavailability is unknown.
Half Life
5.9 days
Clearance
- Apparent oral cl=0.32 L/h [Normal Males]
Pregnancy & Breastfeeding use
Pregnancy category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Nursing Mothers: Bicalutamide Apotex is not indicated for use in women.
Contraindication
Females, children, Pregnancy and lactation. Concomitant use of terfenadine, astemizole or cisapride.
Special Warning
Renal Impairment: No dosage adjustment is necessary for patients with renal impairment.
Hepatic Impairment: No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide no dosage adjustment is necessary.
Pediatric Use: The safety and effectiveness of Bicalutamide Apotex in pediatric patients have not been established.
Geriatric Use: In two studies in patients given 50 or 150 mg daily, no significant relationship between age and steady-state levels of total bicalutamide or the active R-enantiomer has been shown.
Women: Bicalutamide Apotex has not been studied in women.
Acute Overdose
Long-term clinical trials have been conducted with dosages up to 200 mg of Bicalutamide Apotex daily and these dosages have been well tolerated. A single dose of Bicalutamide Apotex that results in symptoms of an overdose considered to be life threatening has not been established. There is no specific antidote; treatment of an overdose should be symptomatic.
In the management of an overdose with Bicalutamide Apotex, vomiting may be induced if the patient is alert. It should be remembered that, in this patient population, multiple drugs may have been taken. Dialysis is not likely to be helpful since Bicalutamide Apotex is highly protein bound and is extensively metabolized. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
Storage Condition
Store at controlled room temperature, 20° to 25° C.
Innovators Monograph
You find simplified version here Bicalutamide Apotex
Bicalutamide Apotex contains Bicalutamide see full prescribing information from innovator Bicalutamide Apotex Monograph, Bicalutamide Apotex MSDS, Bicalutamide Apotex FDA label
FAQ
What is Bicalutamide Apotex used for?
Bicalutamide Apotex is an antiandrogen medication that is primarily used to treat prostate cancer. It is typically used together with a gonadotropin-releasing hormone analogue or surgical removal of the testicles to treat advanced prostate cancer.
How safe is Bicalutamide Apotex?
Bicalutamide Apotex is a new antiandrogen that offers the convenience of once-daily administration, demonstrated activity in prostate cancer, and an excellent safety profile.
How does Bicalutamide Apotex work?
Bicalutamide Apotex works by blocking the effects of testosterone (a male hormone), which helps stop the growth and spread of cancer cells.
What are the common side effects of Bicalutamide Apotex?
Common side effects of Bicalutamide Apotex are include:
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine
- blurred vision
- body aches or pain
- chills
- congestion
- cough
- cough producing mucus
- difficult or labored breathing
- dizziness
- dryness or soreness of the throat
- fever
- headache
- hoarseness
- lower back or side pain
- nervousness
- painful or difficult urination
- pounding in the ears
- rapid weight gain
- runny nose
- slow or fast heartbeat
Is Bicalutamide Apotex safe during pregnancy?
This Bicalutamide Apotex must not be given to a pregnant woman or a woman who intends to become pregnant.
Is Bicalutamide Apotex safe during breastfeeding?
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Can I drink alcohol with Bicalutamide Apotex?
Drinking alcohol while taking Bicalutamide Apotex may produce excessive facial flushing. Avoid drinking alcohol if this becomes bothersome.
Can I drive after taking Bicalutamide Apotex?
Bicalutamide Apotex may have an effect on male fertility which could be reversible. Bicalutamide Apotex is unlikely to affect your ability to drive or to operate machinery. However, some people may occasionally feel drowsy when taking Bicalutamide Apotex.
When should be taken of Bicalutamide Apotex?
It is best to take this medicine at the same time each day, in the morning or in the evening. This medicine should be started at the same time as treatment with a luteinizing hormone-releasing hormone analog.
How many time can I take Bicalutamide Apotex daily?
The usual dose is one tablet daily.
How long does it take Bicalutamide Apotex to start working?
In some cases (e.g. spinal cord metastasis), Bicalutamide Apotex will be started approximately 5-7 days before you receive the LHRH agonist. This is done to block the "flare" or surge of testosterone that occurs after LHRH agonist is given.
How long does Bicalutamide Apotex stay in my system?
Bicalutamide Apotex takes approximately 30 days for most of the Bicalutamide Apotex to be removed from your body. If you have severe liver impairment it will take longer.
How long can I take Bicalutamide Apotex ?
You take it for a few days before starting the luteinising hormone blocker, and stay on it for about 4 to 6 weeks.
Can I just stop taking Bicalutamide Apotex?
Do not stop taking these medicines without checking with your doctor first.
Who should not take Bicalutamide Apotex?
You should not use this medicine if you are allergic to Bicalutamide Apotex. Tell your doctor if you have or have ever had liver disease. you should know that Bicalutamide Apotex is only for use in men. If taken by pregnant women, Bicalutamide Apotex can cause abnormalities in the fetus. Women who are or may become pregnant should not take Bicalutamide Apotex.
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time. Call your doctor for instructions if you miss an appointment for your LHRH injection.
What happen If I suddenly stop taking Bicalutamide Apotex?
When you stop taking Bicalutamide Apotex it takes approximately 30 days for most of the Bicalutamide Apotex to be removed from your body. If you have severe liver impairment it will take longer.
Can I overdose on bransd?
If you take too much Bicalutamide Apotex, call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.
Can Bicalutamide Apotex cause heart problems?
The Naranjo scale strongly suggests that Bicalutamide Apotex was the cause of heart failure.
Does Bicalutamide Apotex increase testosterone?
Bicalutamide Apotex increases both testosterone and estradiol levels, and the estradiol levels approximate the low-normal levels of a premenopausal woman.
Will Bicalutamide Apotex affect my fertility?
Bicalutamide Apotex may be affected by Bicalutamide Apotex.
Can Bicalutamide Apotex affect my kidneys?
Androgens and anabolic steroids, including testosterone, have trophic and anabolic effects in the kidneys. Androgen deprivation therapy, including with GnRH agonists and Bicalutamide Apotex monotherapy, may increase the risk of kidney failure in men.
Can Bicalutamide Apotex affects my liver?
Bicalutamide Apotex monotherapy has been found to cause unfavorable liver changes in around 3% of men, with such changes necessitating discontinuation in about 0.3 to 1% of men. Very rarely, Bicalutamide Apotex has been associated with liver damage, lung disease, and sensitivity to light.
