Mylan-Bicalutamide
Mylan-Bicalutamide Uses, Dosage, Side Effects, Food Interaction and all others data.
Mylan-Bicalutamide 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 Mylan-Bicalutamide 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 Mylan-Bicalutamide 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 Mylan-Bicalutamide and an LHRH agonist, and who discontinue Mylan-Bicalutamide therapy due to progressive advanced prostate cancer, a reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed.
Mylan-Bicalutamide is an antineoplastic hormonal agent primarily used in the treatment of prostate cancer. Mylan-Bicalutamide is a pure, nonsteroidal anti-androgen with affinity for androgen receptors (but not for progestogen, estrogen, or glucocorticoid receptors). Consequently, Mylan-Bicalutamide 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 | Mylan-Bicalutamide |
| 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 | Canada |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Mylan-Bicalutamide 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.
Mylan-Bicalutamide 150 mg daily is not approved for use alone or with other treatments
Mylan-Bicalutamide is also used to associated treatment for these conditions: Stage D2 Prostatic carcinoma
How Mylan-Bicalutamide works
Mylan-Bicalutamide 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
Mylan-Bicalutamide dosage
The recommended dose for Mylan-Bicalutamide 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 Mylan-Bicalutamide be taken at the same time each day. Treatment with Mylan-Bicalutamide 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.
Mylan-Bicalutamide 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
Mylan-Bicalutamide Disease Interaction
Elimination Route
Mylan-Bicalutamide 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: Mylan-Bicalutamide 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 Mylan-Bicalutamide 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: Mylan-Bicalutamide has not been studied in women.
Acute Overdose
Long-term clinical trials have been conducted with dosages up to 200 mg of Mylan-Bicalutamide daily and these dosages have been well tolerated. A single dose of Mylan-Bicalutamide 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 Mylan-Bicalutamide, 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 Mylan-Bicalutamide 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 Mylan-Bicalutamide
Mylan-Bicalutamide contains Bicalutamide see full prescribing information from innovator Mylan-Bicalutamide Monograph, Mylan-Bicalutamide MSDS, Mylan-Bicalutamide FDA label
FAQ
What is Mylan-Bicalutamide used for?
Mylan-Bicalutamide 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 Mylan-Bicalutamide?
Mylan-Bicalutamide is a new antiandrogen that offers the convenience of once-daily administration, demonstrated activity in prostate cancer, and an excellent safety profile.
How does Mylan-Bicalutamide work?
Mylan-Bicalutamide 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 Mylan-Bicalutamide?
Common side effects of Mylan-Bicalutamide 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 Mylan-Bicalutamide safe during pregnancy?
This Mylan-Bicalutamide must not be given to a pregnant woman or a woman who intends to become pregnant.
Is Mylan-Bicalutamide 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 Mylan-Bicalutamide?
Drinking alcohol while taking Mylan-Bicalutamide may produce excessive facial flushing. Avoid drinking alcohol if this becomes bothersome.
Can I drive after taking Mylan-Bicalutamide?
Mylan-Bicalutamide may have an effect on male fertility which could be reversible. Mylan-Bicalutamide is unlikely to affect your ability to drive or to operate machinery. However, some people may occasionally feel drowsy when taking Mylan-Bicalutamide.
When should be taken of Mylan-Bicalutamide?
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 Mylan-Bicalutamide daily?
The usual dose is one tablet daily.
How long does it take Mylan-Bicalutamide to start working?
In some cases (e.g. spinal cord metastasis), Mylan-Bicalutamide 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 Mylan-Bicalutamide stay in my system?
Mylan-Bicalutamide takes approximately 30 days for most of the Mylan-Bicalutamide to be removed from your body. If you have severe liver impairment it will take longer.
How long can I take Mylan-Bicalutamide ?
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 Mylan-Bicalutamide?
Do not stop taking these medicines without checking with your doctor first.
Who should not take Mylan-Bicalutamide?
You should not use this medicine if you are allergic to Mylan-Bicalutamide. Tell your doctor if you have or have ever had liver disease. you should know that Mylan-Bicalutamide is only for use in men. If taken by pregnant women, Mylan-Bicalutamide can cause abnormalities in the fetus. Women who are or may become pregnant should not take Mylan-Bicalutamide.
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 Mylan-Bicalutamide?
When you stop taking Mylan-Bicalutamide it takes approximately 30 days for most of the Mylan-Bicalutamide 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 Mylan-Bicalutamide, call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.
Can Mylan-Bicalutamide cause heart problems?
The Naranjo scale strongly suggests that Mylan-Bicalutamide was the cause of heart failure.
Does Mylan-Bicalutamide increase testosterone?
Mylan-Bicalutamide increases both testosterone and estradiol levels, and the estradiol levels approximate the low-normal levels of a premenopausal woman.
Will Mylan-Bicalutamide affect my fertility?
Mylan-Bicalutamide may be affected by Mylan-Bicalutamide.
Can Mylan-Bicalutamide 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 Mylan-Bicalutamide monotherapy, may increase the risk of kidney failure in men.
Can Mylan-Bicalutamide affects my liver?
Mylan-Bicalutamide 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, Mylan-Bicalutamide has been associated with liver damage, lung disease, and sensitivity to light.
