Bypro
Bypro Uses, Dosage, Side Effects, Food Interaction and all others data.
Bypro 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 Bypro 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 Bypro 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 Bypro and an LHRH agonist, and who discontinue Bypro therapy due to progressive advanced prostate cancer, a reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed.
Bypro is an antineoplastic hormonal agent primarily used in the treatment of prostate cancer. Bypro is a pure, nonsteroidal anti-androgen with affinity for androgen receptors (but not for progestogen, estrogen, or glucocorticoid receptors). Consequently, Bypro 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 | Bypro |
| Availability | Prescription only |
| Generic | Bicalutamide |
| Bicalutamide Other Names | Bicalutamida, Bicalutamide, Bicalutamidum |
| Related Drugs | estradiol, Premarin, Xtandi, Casodex, Zytiga, Lynparza |
| Type | Tablet |
| Formula | C18H14F4N2O4S |
| Weight | Average: 430.373 Monoisotopic: 430.061040456 |
| Protein binding | 96% |
| Groups | Approved |
| Therapeutic Class | Hormonal Chemotherapy |
| Manufacturer | Fresenius Kabi |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Bypro 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.
Bypro 150 mg daily is not approved for use alone or with other treatments
Bypro is also used to associated treatment for these conditions: Stage D2 Prostatic carcinoma
How Bypro works
Bypro 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
Bypro dosage
The recommended dose for Bypro 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 Bypro be taken at the same time each day. Treatment with Bypro 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.
Bypro 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
Bypro Disease Interaction
Elimination Route
Bypro 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: Bypro 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 Bypro 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: Bypro has not been studied in women.
Acute Overdose
Long-term clinical trials have been conducted with dosages up to 200 mg of Bypro daily and these dosages have been well tolerated. A single dose of Bypro 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 Bypro, 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 Bypro 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 Bypro
Bypro contains Bicalutamide see full prescribing information from innovator Bypro Monograph, Bypro MSDS, Bypro FDA label
FAQ
What is Bypro used for?
Bypro 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 Bypro?
Bypro is a new antiandrogen that offers the convenience of once-daily administration, demonstrated activity in prostate cancer, and an excellent safety profile.
How does Bypro work?
Bypro 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 Bypro?
Common side effects of Bypro 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 Bypro safe during pregnancy?
This Bypro must not be given to a pregnant woman or a woman who intends to become pregnant.
Is Bypro 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 Bypro?
Drinking alcohol while taking Bypro may produce excessive facial flushing. Avoid drinking alcohol if this becomes bothersome.
Can I drive after taking Bypro?
Bypro may have an effect on male fertility which could be reversible. Bypro is unlikely to affect your ability to drive or to operate machinery. However, some people may occasionally feel drowsy when taking Bypro.
When should be taken of Bypro?
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 Bypro daily?
The usual dose is one tablet daily.
How long does it take Bypro to start working?
In some cases (e.g. spinal cord metastasis), Bypro 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 Bypro stay in my system?
Bypro takes approximately 30 days for most of the Bypro to be removed from your body. If you have severe liver impairment it will take longer.
How long can I take Bypro ?
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 Bypro?
Do not stop taking these medicines without checking with your doctor first.
Who should not take Bypro?
You should not use this medicine if you are allergic to Bypro. Tell your doctor if you have or have ever had liver disease. you should know that Bypro is only for use in men. If taken by pregnant women, Bypro can cause abnormalities in the fetus. Women who are or may become pregnant should not take Bypro.
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 Bypro?
When you stop taking Bypro it takes approximately 30 days for most of the Bypro 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 Bypro, call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.
Can Bypro cause heart problems?
The Naranjo scale strongly suggests that Bypro was the cause of heart failure.
Does Bypro increase testosterone?
Bypro increases both testosterone and estradiol levels, and the estradiol levels approximate the low-normal levels of a premenopausal woman.
Will Bypro affect my fertility?
Bypro may be affected by Bypro.
Can Bypro 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 Bypro monotherapy, may increase the risk of kidney failure in men.
Can Bypro affects my liver?
Bypro 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, Bypro has been associated with liver damage, lung disease, and sensitivity to light.
