Generic Casodex ( Bicalutamide )

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Casodex is a non-steroidal antiandrogen used to treat metastatic prostate cancer. It is given together with a luteinizing hormone-releasing hormone (LHRH) analogue or after surgical castration. The medication works by blocking the effects of androgens, the male hormones that can fuel prostate cancer growth.
The recommended dose is one 50 mg tablet taken once daily, with or without food. Treatment should be started at the same time as an LHRH analogue or after surgical castration.
The administration form is a film-coated tablet containing 50 mg of bicalutamide.
Casodex does not work overnight. It is part of a long-term treatment plan for advanced prostate cancer, and its benefit builds over weeks and months of steady use.
Alcohol should be avoided during treatment. It can increase the risk of liver problems and add to side effects like drowsiness and dizziness.
The most common side effects are hot flushes, weakness, constipation, nausea, and peripheral edema. Breast tenderness and gynecomastia are also common.
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Common Use Casodex

Bicalutamide is a non-steroidal antiandrogen. It works by binding to androgen receptors in the prostate and other tissues, which blocks testosterone and dihydrotestosterone from stimulating cancer cell growth. Health Canada has approved Casodex 50 mg for use in combination with an LHRH analogue or with surgical castration in the treatment of metastatic prostate cancer (stage D2). It is not approved as monotherapy for localized prostate cancer. In fact, Health Canada has warned that Casodex 150 mg should not be used as immediate treatment for localized prostate cancer in patients who would otherwise be under watchful waiting, because a large clinical study showed an increased death rate with that dose. The 50 mg dose used in combination therapy for metastatic disease is not affected by this warning.

Basic Casodex Information

• INN (International Nonproprietary Name): Bicalutamide
• Brand names available in Canada: Casodex® (AstraZeneca Canada Inc., DIN 02184478); generics include Apo-Bicalutamide (Apotex Inc., DIN 02296063), Bicalutamide (Accord Healthcare Inc., DIN 02325985), Bicalutamide (Sanis Health Inc., DIN 02519178), Jamp-Bicalutamide (Jamp Pharma Corporation, DIN 02357216), pms-Bicalutamide (Pharmascience Inc., DIN 02275589), Pro-Bicalutamide-50 (Pro Doc Limitée, DIN 02311038), Teva-Bicalutamide (Teva Canada Limited, DIN 02270226), and others
• ATC Code: L02BB03
• Forms and dosages: Film-coated tablet – 50 mg
• Manufacturers in Canada: AstraZeneca Canada Inc. (Casodex, DIN 02184478, market status: marketed, date 2002-01-14), Apotex Inc. (Apo-Bicalutamide, DIN 02296063), Accord Healthcare Inc. (Bicalutamide, DIN 02325985), Sanis Health Inc. (Bicalutamide, DIN 02519178, marketed since 2022-04-28), Jamp Pharma Corporation (Jamp-Bicalutamide, DIN 02357216), Pharmascience Inc. (pms-Bicalutamide, DIN 02275589), Pro Doc Limitée (Pro-Bicalutamide-50, DIN 02311038, marketed since 2026-03-10), Teva Canada Limited (Teva-Bicalutamide, DIN 02270226), and Dominion Pharmacal (DOM-Bicalutamide, DIN 02281139, cancelled post-market)
• Registration status in Canada: Approved by Health Canada. Casodex 50 mg is listed under DIN 02184478, with a market status of "Marketed" since 2002-01-14. Multiple generic bicalutamide 50 mg tablets are also approved and marketed under various DINs, including 02296063 (Apo-Bicalutamide, Apotex), 02325985 (Bicalutamide, Accord), 02519178 (Bicalutamide, Sanis), 02357216 (Jamp-Bicalutamide), 02275589 (pms-Bicalutamide), 02311038 (Pro-Bicalutamide-50), and 02270226 (Teva-Bicalutamide). The original Casodex 50 mg product monograph is dated July 13, 2017, and was issued by AstraZeneca Canada Inc.. Health Canada has issued a discontinuation report for Casodex, with the market status listed as "Cancelled Post Market" in a 2025 report. However, the product is still listed as "Marketed" in the Health Canada Drug Product Database as of the most recent update.
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies. Casodex should only be prescribed by a qualified healthcare professional experienced in the treatment of prostate cancer and the use of antiandrogens.

Dosage & Direction

Take Casodex exactly as your doctor prescribes. The recommended dose for metastatic prostate cancer is one 50 mg tablet once daily, with or without food. Treatment with Casodex should be started at the same time as an LHRH analogue or after surgical castration. No dose adjustment is required for patients with mild liver impairment or any degree of kidney impairment. However, the drug may accumulate in patients with moderate to severe liver impairment, and your doctor should monitor you closely in that case. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once. Do not stop taking Casodex without talking to your doctor. Stopping treatment suddenly may allow the cancer to progress.

Precautions

Casodex can cause drowsiness. If you feel sleepy, be careful when driving or operating machinery. Casodex is extensively metabolized by the liver. Rare cases of liver failure, including fatal cases, have been reported. Your doctor should check your liver function before you start treatment and periodically during treatment. Tell your doctor right away if you develop yellowing of the skin or eyes, dark urine, or severe stomach pain. Antiandrogen withdrawal syndrome is a phenomenon where antiandrogens, including Casodex, can paradoxically stimulate prostate cancer growth in some patients. If your PSA level rises or your symptoms get worse, your doctor may stop the antiandrogen and monitor you for 6 to 8 weeks to see if you respond to the withdrawal. Casodex can cause changes in bone density. Since it is used in combination with LHRH analogues or surgical castration, which also affect bone health, your doctor may monitor your bone mineral density. Casodex has been associated with interstitial pneumonitis, a lung condition that can be serious. This has been reported more often at doses above 50 mg. Tell your doctor if you develop new or worsening shortness of breath, cough, or fever. Casodex can affect blood sugar control. A decrease in glucose tolerance and/or HbA1c has been observed in patients taking Casodex. If you have diabetes, monitor your blood sugar more closely. Casodex can prolong the QT interval on an electrocardiogram. This risk is higher when it is used with other drugs that also prolong the QT interval, such as certain antiarrhythmics, antipsychotics, antidepressants, opioids, and antibiotics. Your doctor should evaluate this risk before starting treatment. Casodex is not for use in women or children. Its safety and effectiveness have not been established in these groups. Men taking Casodex should use adequate contraception during treatment and for at least 130 days after the last dose, because the drug can affect fertility and may harm a fetus.

Contraindications

Do not take Casodex if you have had an allergic reaction to bicalutamide or any of the inactive ingredients in the tablet. The product contains lactose monohydrate. Casodex is contraindicated in patients with localized prostate cancer who would otherwise be under watchful waiting or active surveillance. It is also contraindicated in women and children, as safety and efficacy have not been studied in these populations.

Possible Side Effects

In a large clinical trial comparing Casodex 50 mg once daily to flutamide 250 mg three times daily, both in combination with an LHRH analogue, the most common side effects in the Casodex group were hot flushes (53%), asthenia (22%), constipation (22%), nausea (14%), peripheral edema (13%), anemia (13%), hematuria (12%), abdominal pain (11%), and dizziness (10%). Other side effects reported in at least 5% of patients include gynecomastia (9%), rash (9%), chest pain (8%), erectile dysfunction (7%), flatulence (7%), dyspepsia (7%), loss of appetite (6%), breast tenderness (6%), and weight gain (5%). Less common side effects include heart failure (4%), depression (4%), dry skin (4%), alopecia (4%), itching (3%), drowsiness (3%), myocardial infarction (3%), decreased libido (2%), hirsutism (2%), and hypersensitivity reactions (1%), including angioedema and urticaria. Liver enzyme abnormalities were reported in 7% of patients. These changes were often transient and rarely serious, but they sometimes required discontinuation of treatment. Serious side effects that require immediate medical attention include severe liver injury (jaundice, dark urine, abdominal pain), interstitial pneumonitis (shortness of breath, cough, fever), and severe allergic reactions (rash, swelling of the face or throat, difficulty breathing). If you develop any of these, stop the medication and seek medical help right away.

Drug Interaction

Casodex is a moderate inhibitor of CYP3A4 and a weaker inhibitor of CYP2C9, 2C19, and 2D6. While in vitro studies suggest it could inhibit CYP3A4, clinical studies indicate that this inhibition is unlikely to be clinically significant for most drugs metabolized by CYP450. However, the increase in drug exposure could matter for medications with a narrow therapeutic index, such as cyclosporine. Bicalutamide is highly protein-bound and can displace coumarin anticoagulants such as warfarin from binding sites. This can increase the anticoagulant effect and raise the INR, increasing the risk of bleeding. If you take warfarin, your doctor should monitor your PT/INR closely and adjust the warfarin dose as needed. Combined androgen blockade, which includes Casodex plus an LHRH analogue, can prolong the QT interval. Caution is advised when Casodex is used with other drugs known to prolong the QT interval or cause torsades de pointes. These include class IA and III antiarrhythmics (e.g., quinidine, amiodarone), some antipsychotics (e.g., chlorpromazine), some antidepressants (e.g., amitriptyline), methadone, macrolide antibiotics (e.g., erythromycin), quinolone antibiotics (e.g., moxifloxacin), and others. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements.

Missed Dose

If you miss a dose of Casodex, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Missing doses can affect the effectiveness of your treatment, so try to take the medication at the same time each day.

Overdose

The single dose of Casodex that causes life-threatening overdose symptoms has not been established. In animal studies, Casodex showed a low potential for acute toxicity, with an LD50 greater than 2000 mg/kg in rats and mice. Long-term clinical trials have been conducted with doses up to 200 mg per day, and these doses were well tolerated. There is no specific antidote. Treatment of an overdose should be symptomatic and supportive. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Casodex tablets at room temperature between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit). Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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