Consumer medicine information

Cosudex

Bicalutamide

BRAND INFORMATION

Brand name

Cosudex 50 mg

Active ingredient

Bicalutamide

Schedule

SUMMARY CMI

COSUDEX^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using COSUDEX?

COSUDEX contains the active ingredient bicalutamide. COSUDEX is used in combination with other medicines to treat advanced prostate cancer.

For more information, see Section 1. Why am I using COSUDEX? in the full CMI.

2. What should I know before I use COSUDEX?

Do not use if you have ever had an allergic reaction to COSUDEX or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use COSUDEX? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with COSUDEX and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take COSUDEX?

The usual adult dose is one 50 mg tablet taken each day.
Swallow your COSUDEX tablet whole with a full glass of water.

More instructions can be found in Section 4. How do I take COSUDEX? in the full CMI.

5. What should I know while using COSUDEX?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using COSUDEX. Be sure to keep all your appointments with your doctor so your progress can be checked. Use adequate contraception while you are taking COSUDEX and for at least 130 days after you have stopped taking COSUDEX.
Things you should not do	Do not give COSUDEX to anyone else, even if they have the same condition as you. Do not take COSUDEX to treat any other complaints unless your doctor tells you to. Do not stop taking COSUDEX, or lower the dosage, without checking with your doctor.
Driving or using machines	Be careful driving or operating machinery until you know how COSUDEX affects you.
Looking after your medicine	Keep your COSUDEX tablets in the blister foil until it is time to take them. Keep it in a cool, dry place where the temperature stays below 30°C.

For more information, see Section 5. What should I know while using COSUDEX? in the full CMI.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, some can be minor and temporary. However, some side effects may be serious. Tell your doctor immediately if you have chest pain, yellowing of the skin or eyes and dark coloured urine, rash, hives or severe itching of the skin, swelling of the face, lips, tongue and/or throat, swelling of other parts of the body including hands, feet or ankles, serious breathlessness, or sudden worsening of breathlessness, possibly with a cough or fever, shortness of breath, wheezing or trouble breathing.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

COSUDEX^®

Active ingredient: bicalutamide

Consumer Medicine Information (CMI)

This leaflet provides important information about using COSUDEX. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using COSUDEX.

Where to find information in this leaflet:

1. Why am I using COSUDEX?
2. What should I know before I use COSUDEX?
3. What if I am taking other medicines?
4. How do I take COSUDEX?
5. What should I know while using COSUDEX?
6. Are there any side effects?
7. Product details

1. Why am I using COSUDEX?

COSUDEX contains the active ingredient bicalutamide. COSUDEX is an anti-androgen medicine. Androgens such as testosterone are natural male sex hormones. In some types of prostate cancer, androgens may help the cancer cells grow. COSUDEX interferes with some of the actions of these hormones.

COSUDEX is used in combination with other medicines to treat advanced prostate cancer.

COSUDEX should only be taken by men.

2. What should I know before I use COSUDEX?

Warnings

Do not use COSUDEX if:

you are allergic to bicalutamide, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you are allergic to other anti-androgen medicines.
you are taking cisapride or the antihistamines, terfenadine and astemizole.
you are a woman.

Check with your doctor if you:

have any other medical conditions
have liver problems

It may not be safe for you to take COSUDEX if you have problems with your liver.

have heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions

The risk of you having further heart rhythm problems may increase if you are taking COSUDEX.

take any medicines for any other condition
have allergies to medicines or substances such as foods, preservatives or dyes.

If you have an allergic reaction, you may get a skin rash, hay fever, or have difficulty breathing or feel faint.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not take COSUDEX if you are a woman.

COSUDEX may also cause a period of low fertility or infertility whilst you are taking it and for a period afterwards. NOTE however that you may not be infertile. As COSUDEX may affect your sperm, effective contraception must be used by you and/or your partner while you are taking COSUDEX and for at least 130 days after you have stopped taking COSUDEX.

Children

Do not give COSUDEX to children.
There is no experience of its use in children.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with COSUDEX and affect how it works.

Tell your doctor if you are taking:

cisapride (see Warnings)
the antihistamines terfenadine and astemizole (see Warnings)
medicines used to prevent blood clots, especially warfarin as COSUDEX may reduce their effectiveness which may lead to bleeding and you therefore may need more monitoring
midazolam
ciclosporin
medicines used to treat high cholesterol
calcium channel blockers
carbamazepine
quinidine
antiviral medicines for HIV infection

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect COSUDEX.

4. How do I take COSUDEX?

How much to take

The usual adult dose is one 50 mg tablet taken each day.
Swallow your COSUDEX tablet whole with a full glass of water.
Follow the directions given to you by your doctor or pharmacist carefully, they may differ from the information contained in the leaflet.

When to take COSUDEX

Take COSUDEX at about the same time each day.
COSUDEX 50 mg should be started at the same time as the other medicines you have been given for the treatment of prostate cancer.
It does not matter if you take COSUDEX before, with or after food.

How long to take COSUDEX

Continue taking COSUDEX for as long as your doctor or pharmacist tells you.

If you forget to take COSUDEX

COSUDEX should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, as long as it is 12 hours before the next dose is due.

If it is less than 12 hours for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you use too much COSUDEX

If you think that you have used too much COSUDEX, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using COSUDEX?

Things you should do

Be sure to keep all your appointments with your doctor so your progress can be checked.
Tell any other doctors, dentists and pharmacists who are treating you that you are taking COSUDEX.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking COSUDEX.
COSUDEX may affect your sperm (semen) while you are taking it and for some time after you stop taking it. As a precaution, you and/or your partner must use adequate contraception while you are taking COSUDEX and for at least 130 days after you have stopped taking COSUDEX.
If you go into hospital, please let the medical staff know you are taking COSUDEX.

Remind any doctor, dentist or pharmacist you visit that you are using COSUDEX.

Things you should not do

Do not give COSUDEX to anyone else, even if they have the same condition as you.
Do not take COSUDEX to treat any other complaints unless your doctor tells you to.
Do not stop taking COSUDEX, or lower the dosage, without checking with your doctor.
Do not take COSUDEX if the packaging is torn or shows signs of tampering.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how COSUDEX affects you.

Some patients may feel dizzy or weak.

Looking after your medicine

Keep your COSUDEX tablets in the blister foil until it is time to take them,
If you take COSUDEX out of the blister foil, it will not keep well.
Keep it where the temperature stays below 30°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

You may experience the following side effects:

Very common (may affect more than 1 in 10 people)	What to do
hot flushes or sweating breast tenderness or changes in breast size stomach pain or indigestion nausea or vomiting diarrhoea or constipation unusual tiredness or weakness dizziness or light-headedness headache chill	Speak to your doctor if you have any of these very common side effects and they worry you.

Common (may affect up to 1 in 10 people)	What to do
itching or dry skin, rashes increased hairiness or hair loss flatulence (wind) dry mouth loss of appetite or weight changes depression difficulty sleeping pelvic pain decrease in your sexual drive inability to get or maintain an erection	Speak to your doctor if you have any of these common side effects and they worry you.

Serious side effects

Serious side effects

What to do

chest pain
yellowing of the skin or eyes and dark coloured urine
rash, hives or severe itching of the skin
swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing
swelling of other parts of the body including hands, feet or ankles
serious breathlessness, or sudden worsening of breathlessness, possibly with a cough or fever
shortness of breath, wheezing or trouble breathing
frequent urination
dizziness when exercising and looking pale (anaemia)
excessive thirst with weight loss, and passing large amounts of urine

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What COSUDEX contains

Active ingredient (main ingredient)	bicalutamide
Other ingredients (inactive ingredients)	lactose monohydrate sodium starch glycolate povidone magnesium stearate (E572) hypromellose macrogol 300 titanium dioxide (E171)
Potential allergens	lactose

Do not take this medicine if you are allergic to any of these ingredients.

What COSUDEX looks like

COSUDEX 50 mg tablets are white, round film-coated tablets. One side of the tablet is marked CDX 50 and the other side has an arrow shape.

COSUDEX tablets are packed in blister foils of 28 tablets (Aust R 54639).

Who distributes COSUDEX

AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342

This leaflet was prepared in August 2024.

COSUDEX^® is a trademark of the AstraZeneca group of companies.

[VV-RIM-01369759 v10]

Published by MIMS October 2024

BRAND INFORMATION

Brand name

Cosudex 50 mg

Active ingredient

Bicalutamide

Schedule

1 Name of Medicine

Bicalutamide.

2 Qualitative and Quantitative Composition

Each Cosudex tablet contains 50 mg bicalutamide.
Bicalutamide is a fine white to off white powder. At 37°C it is practically insoluble in water (4.6 mg/litre), acid (4.6 mg/litre at pH 1) and alkali (3.7 mg/litre at pH 8). In organic solvents it is slightly soluble in ethanol, sparingly soluble in methanol and freely soluble in acetone and tetrahydrofuran.

Excipients with known effect:

lactose monohydrate. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Round, biconvex, white film-coated tablet impressed with Cdx50 on one side and an arrow shaped logo on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of advanced prostate cancer in combination with LHRH agonist therapy.
Prevention of disease flare associated with the use of LHRH agonists.

4.2 Dose and Method of Administration

Adult males including the elderly.

One tablet (50 mg) once a day.
Treatment with Cosudex 50 mg should be started at the same time as treatment with a LHRH agonist.

Renal impairment.

No dosage adjustment is necessary for patients with renal impairment.

Hepatic impairment.

No dosage adjustment is necessary for patients with mild hepatic impairment.
Increased accumulation may occur in patients with moderate to severe hepatic impairment (see Section 4.4 Special Warnings and Precautions for Use). In such cases, a lower or less frequent dose may be considered.

4.3 Contraindications

Cosudex is contraindicated in females and children.
Known hypersensitivity to bicalutamide or any other constituents of the formulation.
Co-administration of terfenadine, astemizole or cisapride with Cosudex is contraindicated (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

Hyperglycaemia.

A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes. Consideration should therefore be given to monitoring blood glucose in patients receiving Cosudex in combination with LHRH agonists.

Potentiation of coumarin anticoagulant effects.

Potentiation of coumarin anticoagulant effects have been reported in patients receiving concomitant Cosudex therapy, which may result in increased Prothrombin Time (PT) and International Normalised Ratio (INR). Some cases have been associated with risk of bleeding. Close monitoring of PT/INR is advised and anticoagulant dose adjustment should be considered (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.8 Adverse Effects (Undesirable Effects)).

Use in patients with metastatic prostate cancer.

In patients with metastatic prostate cancer, treatment with bicalutamide monotherapy has been associated with reduced survival compared to castration. Bicalutamide should therefore not be used without concomitant GnRH agonist therapy in these patients.

Use in hepatic impairment.

Bicalutamide is extensively metabolised in the liver. Data suggests that its elimination may be slower in subjects with severe hepatic impairment and this could lead to increased accumulation of bicalutamide. Therefore, bicalutamide should be used with caution in patients with moderate to severe hepatic impairment.
Periodic liver function testing should be considered due to the possibility of hepatic changes. The majority of these changes occur within the first 6 months of bicalutamide therapy.
Rare cases of death or hospitalisation due to severe liver injury have been observed with bicalutamide (see Section 4.8 Adverse Effects (Undesirable Effects)). Bicalutamide therapy should be discontinued if at any time a patient develops jaundice or if serum ALT rises above two times the upper limit of normal.

QT/ QTc interval prolongation.

Androgen deprivation therapy may prolong QT/ QTc interval. Prescribers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte imbalances should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Bicalutamide is extensively metabolised (via oxidation and glucuronidation) in the liver. Bicalutamide has shown no evidence of causing enzyme induction in humans during dosing at 50 mg daily in man. In vitro studies have shown that R-bicalutamide is an inhibitor of CYP3A4, with lesser inhibitory effects on CYP2C9, 2C19 and 2D6 activity.
The clinically or potentially significant drug interactions between bicalutamide and the following agents/ drug classes, which are theoretical or have been observed, are described below. The drug/drug interactions described include both interactions mediated through effects on P450 metabolism and interactions mediated through other mechanisms.

Effects of bicalutamide on other medicines.

LHRH agonists.

Although there is no evidence of any pharmacodynamic or pharmacokinetic interactions between bicalutamide and LHRH agonists at steady state, bicalutamide may prevent the harmful clinical consequences of flare associated with the start of LHRH agonist therapy.

Cytochrome P450.

Bicalutamide is an inhibitor of CYP 3A4 and has been shown to increase plasma levels of midazolam by up to 80%. Therefore, concomitant use of terfenadine, astemizole and cisapride is contraindicated. Caution should be exercised with other drugs metabolised by CYP 3A4, such as cyclosporin, calcium channel blockers, HIV antivirals, HMGCoA reductase inhibitors, carbamazepine, quinidine, etc.

Demonstrated interactions.

Warfarin.

In vitro studies have shown that bicalutamide can displace the coumarin anticoagulant warfarin from its protein binding sites. There have been reports of increased effect of warfarin and other coumarin anticoagulants when co-administered with Cosudex. It is therefore recommended that if Cosudex is administered in patients who are already receiving coumarin anticoagulants, PT/INR should be closely monitored and adjustments of anticoagulant dose considered (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).

Theoretical interactions.

Caution should be exercised when prescribing Cosudex with other drugs which may inhibit drug oxidation, e.g. cimetidine and ketoconazole. In theory, this could result in increased plasma concentrations of bicalutamide and an increase in adverse reactions.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Administration of bicalutamide may lead to inhibition of spermatogenesis. The long-term effects of bicalutamide on male fertility have not been studied. Atrophy of seminiferous tubules of the testes, atrophy of the epididymis, and atrophy of the male reproductive glands are predicted class effects of antiandrogens and have been observed in rats at exposures less than the therapeutic concentrations at the recommended clinical dose of 50 or 150 mg. Reversal of seminiferous tubule and seminal vesicle atrophy occurred in most animals by 4 months after the completion of dosing in a 6-month rat study. In this study, prostate atrophy was not fully reversible by 4 months after the completion of dosing. No recovery of seminiferous tubule atrophy was observed at 24 weeks after the completion of dosing in a 12-month rat study. Following 12 months of repeated dosing in dogs, the incidence of testicular atrophy was the same in dosed and control dogs after a 6 month recovery period. In male rats dosed at 250 mg/kg/day (less than human therapeutic concentrations after the recommended clinical dose of 50 mg or 150 mg), the precoital interval and time to successful mating were increased in the first pairing but no effects on fertility following successful mating were seen. These effects were reversed by 7 weeks after the end of an 11 week period of dosing. A period of subfertility or infertility should be assumed in man.
Antiandrogen therapy may cause morphological changes in spermatozoa. Although the effect of bicalutamide on sperm morphology has not been evaluated and no such changes have been reported for patients who received Cosudex, patients and/or their partners should follow adequate contraception during Cosudex therapy and for 130 days after Cosudex therapy.
(Category D)
Cosudex is contraindicated in females and must not be given to pregnant women.
Cosudex is contraindicated in females and must not be given to breast-feeding mothers.

4.7 Effects on Ability to Drive and Use Machines

During treatment with Cosudex, somnolence has been reported. Those patients who experience this symptom should observe caution when driving or using machines.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.
Cosudex 50 mg in general, has been well tolerated with few withdrawals due to adverse events.

Clinical trial data.

Combination therapy (with medical castration) in advanced prostate cancer.

The following adverse experiences were reported in clinical trials (as possible adverse drug reactions in the opinion of investigating clinicians, with a frequency of ≥ 1%) during treatment with Cosudex 50 mg plus an LHRH agonist. No causal relationship of these experiences to drug treatment has been made and some of the experiences reported are those that commonly occur in elderly patients. (See Table 1.)

Increased PT/INR. Accounts of coumarin anticoagulants interacting with Cosudex have been reported in post marketing surveillance (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.4 Special Warnings and Precautions for Use).

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
There is no human experience of overdosage. There is no specific antidote; treatment should be symptomatic. Dialysis may not be helpful, since bicalutamide is highly protein bound and is not recovered unchanged in the urine. General supportive care, including frequent monitoring of vital signs, is indicated.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Bicalutamide is a non-steroidal anti-androgen devoid of other endocrine activity. It binds to androgen receptors without activating gene expression and thus inhibits the androgen stimulus. This inhibition impairs the growth and encourages apoptosis in androgen dependent tumour cells and regression of prostatic tumours. In a subset of patients who experience disease progression while receiving bicalutamide, discontinuation of the drug may result in an 'anti-androgen withdrawal syndrome', which manifests as a fall in prostate specific antigen (PSA) level. It is unknown whether this phenomenon translates to a prolongation of tumour response or survival.
Bicalutamide is a racemate with its anti-androgenic activity being almost exclusively in the (R)-enantiomer.

Clinical trials.

Combination therapy (with medical castration) in advanced prostate cancer.

In a large multicentre, controlled clinical trial, 813 patients with previously untreated advanced prostate cancer were randomized to receive Cosudex 50 mg once daily (404 patients) or flutamide 250 mg (409 patients) three times a day, each in combination with a Luteinising Hormone Releasing (LHRH) (either goserelin acetate implant or leuprorelin acetate depot). At the time of analysis, the median time of follow-up was 49 weeks. Cosudex/ LHRH agonist therapy was associated with a statistically significant (p = 0.005) improvement in time to treatment failure.
Subjective responses (including scores for pain, analgesic use and Eastern Oncology Cooperative Group (ECOG) performance status) assessed in patients with symptoms at entry were seen in 95 (52%) patients treated with Cosudex and in 88 (54%) patients treated with flutamide, each in combination therapy with LHRH agonists. This small difference was not statistically significant between Cosudex 50 mg combination therapy and flutamide combination therapy.

Meta-analysis.

There is considerable debate regarding the relative merits of combination versus monotherapy in advanced prostate cancer, summarised by Dalesio et al 1995¹ in their meta-analysis of trials of maximal androgen blockade (MAB). This analysis showed no statistically significant reduction in the annual odds of death in favour of MAB. The meta-analysis included the effect of MAB only on mortality, and did not measure other end-points such as time to disease progression.
¹ Prostate Cancer Trialists' Collaborative Group. Maximum androgen blockade in advanced prostate cancer: an overview of 22 randomised trials with 3283 deaths in 5710 patients. Lancet 1995; 346: 265-269.

5.2 Pharmacokinetic Properties

Absorption.

Cosudex is well absorbed following oral administration. There is no evidence of any clinically relevant effect of food on bioavailability.

Distribution.

Bicalutamide is highly protein bound (racemate 96%, R-enantiomer 99.6%).
Steady-state plasma concentrations of the (R)-enantiomer of approximately 9 microgram per mL are observed during daily administration of Cosudex 50 mg. At steady state the predominantly active (R)-enantiomer accounts for 99% of the total circulating enantiomers.

Metabolism.

Bicalutamide undergoes stereospecific metabolism. Bicalutamide is extensively metabolised (via oxidation and glucuronidation).

Excretion.

Its metabolites are eliminated via the kidneys and bile in approximately equal proportions.
The (S)-enantiomer is rapidly cleared relative to the (R)-enantiomer, the latter having a plasma elimination half-life of about 1 week. On daily administration of Cosudex, the (R)-enantiomer accumulates about 10-fold in plasma as a consequence of its long half-life.

Special populations.

The pharmacokinetics of the (R)-enantiomer are unaffected by age, renal impairment or mild to moderate hepatic impairment. There is evidence that for subjects with severe hepatic impairment, the (R)-enantiomer is more slowly eliminated from plasma.

5.3 Preclinical Safety Data

Genotoxicity.

Bicalutamide was inactive in in vitro tests for gene mutation and in in vitro and in vivo tests for clastogenicity.

Carcinogenicity.

Two year oral carcinogenicity studies were conducted in male and female rats and mice at doses of 5, 15 or 75 mg/kg/day of bicalutamide. A variety of tumour target organ effects were identified and were attributed to the anti-androgenicity of bicalutamide, namely, testicular benign interstitial (Leydig) cell tumours in male rats at all dose levels and uterine adenocarcinoma in female rats at 75 mg/kg/day (at these dose levels plasma (R)-bicalutamide concentrations were less than human therapeutic concentrations after the maximum recommended clinical dose of 150 mg). There is no evidence of Leydig cell hyperplasia in patients; uterine tumours are not relevant to the indicated patient population.
A small increase in the incidence of hepatocellular carcinoma in male mice given 75 mg/kg/day of bicalutamide (approximately 2 times human therapeutic concentrations after the maximum recommended clinical dose of 150 mg) and an increased incidence of benign thyroid follicular cell adenomas in rats given 5 mg/kg/day (less than the human therapeutic concentrations after the maximum recommended clinical dose of 150 mg) and above were recorded. These neoplastic changes were progressions of non-neoplastic changes related to hepatic enzyme induction observed in animal toxicity studies. Enzyme induction has not been observed following bicalutamide administration in man.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each Cosudex tablet contains the following excipients: lactose monohydrate, sodium starch glycollate, povidone, magnesium stearate, hypromellose, macrogol 300 and titanium dioxide.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Cosudex 50 mg tablets are packed in PVC/aluminium blisters in packs of 28 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

90357-06-5.
(RS)-4'-cyano-α',α',α',- trifluoro-3- (4-fluorophenylsulphonyl)-2- hydroxy-2- methylpropiono-m-toluidide.
Molecular formula: C₁₈H₁₄F₄N₂O₄S.
Molecular weight: 430.38.

7 Medicine Schedule (Poisons Standard)

S4.

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Consumer medicine information

Cosudex

Bicalutamide

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BRAND INFORMATION

Cosudex 50 mg Tablets