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DUODART (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): WARNINGS

Duodart (Dutasteride and Tamsulosin Hydrochloride) should be prescribed after careful benefit risk assessment and after consideration of alternative treatment options including monotherapies.

Dutasteride is absorbed through the skin, therefore women and children must avoid contact with leaking capsules. If contact is made with leaking capsules the contact area should be washed immediately with soap and water.

Dutasteride with Tamsulosin HCl (Duodart) capsules must be taken approximately 30 minutes after the same meal each day. Taking Duodart (Dutasteride and Tamsulosin HCl) capsules on an empty stomach may increase the potential for cardiovascular related adverse events such as orthostatic hypotension.

Effects on prostate specific antigen (PSA) and prostate cancer detection

Digital rectal examination, as well as other evaluations for prostate cancer, should be performed on patients with BPH prior to initiating therapy with Dutasteride with Tamsulosin Hydrochloride (Duodart) and periodically thereafter.

PSA concentration is an important component of the screening process to detect prostate cancer. Generally, a serum PSA concentration greater than 4 ng/mL (Hybritech) requires further evaluation and consideration of prostate biopsy. Physicians should be aware that a baseline PSA less than 4 ng/mL in patients taking Duodart (Dutasteride with Tamsulosin) does not exclude a diagnosis of prostate cancer.

Dutasteride causes a decrease in serum PSA levels by approximately 50% after 6 months in patients with BPH, even in the presence of prostate cancer. Although there may be individual variation, the reduction in PSA by approximately 50% is predictable as it was observed over the entire range of baseline PSA values (1.5 to 10 ng/mL). Therefore to interpret an isolated PSA value in a man treated with Dutasteride and Tamsulosin (Duodart) for 6 months or longer, PSA values should be doubled for comparison with normal ranges in untreated men. This adjustment preserves the sensitivity and specificity of the PSA assay and maintains its ability to detect prostate cancer.

Any sustained increases in PSA levels while on Duodart (Dutasteride with Tamsulosin HCl) should be carefully evaluated, including consideration of non-compliance to therapy with this medication.

Total serum PSA levels return to baseline within 6 months of discontinuing treatment.

The ratio of free to total PSA remains constant even under the influence of dutasteride. If clinicians elect to use percent-free PSA as an aid in the detection of prostate cancer in men undergoing Dutasteride and Tamsulosin HCl (Duodart) therapy, no adjustment to its value is necessary.

Orthostatic Hypotension

As with other alpha-1 adrenergic blockers, orthostatic hypotension can occur in patients treated with tamsulosin, which in rare cases can result in syncope.

There have been no studies to investigate the effect of Duodart (Dutasteride with Tamsulosin Hydrochloride) on the ability to perform tasks that require judgement, motor or cognitive skills. However, patients should be informed about the possible occurrence of symptoms related to orthostatic hypotension such as dizziness when taking this drug.

Patients beginning treatment with Dutasteride and Tamsulosin HCl (Duodart) capsules should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness and vertigo) until the symptoms have resolved and to report such symptoms without delay to their doctor. They should also be cautioned to avoid situations where injury could result should these symptoms occur.

Patients switching from the current Australian tamsulosin product should be advised of the differences between this product and Duodart (Dutasteride with Tamsulosin HCl) capsules and the potential for orthostatic hypotension (particularly if Duodart is taken on an empty stomach).

Patients should be advised to take Dutasteride and Tamsulosin Hydrochloride (Duodart) approximately 30 minutes after the same meal each day and never on an empty stomach, as well as the need to maintain vigilance for signs of dizziness and vertigo.

Carcinogenicity

Dutasteride

In a carcinogenicity study in rats, dutasteride produced an increase in benign interstitial cell tumours in the testis at the high dose (158-fold clinical exposure). However, the endocrine mechanisms believed to be involved in the production of interstitial cell hyperplasia and adenomas in the rat are not relevant to humans. There were no clinically relevant effects on tumour profile in a carcinogenicity study in mice.

Tamsulosin

Oral (dietary) administration of tamsulosin for up to 2 years in rats and mice was associated with an increased incidence of pituitary adenoma, mammary gland hyperplasia, mammary gland fibroadenoma and (in mice only) mammary gland adenocarcinoma.

These effects occurred at plasma tamsulosin concentrations (AUC) up to 10 times lower than those expected in men undergoing treatment with tamsulosin, but they were observed only in female animals and are probably due to the hyperprolactinaemic effect of tamsulosin. It is not known if tamsulosin elevates prolactin during prolonged administration in humans. The relevance for human risk of the findings of prolactinmediated endocrine tumours in female rodents is unknown.

Genotoxicity

Dutasteride and tamsulosin hydrochloride showed no evidence of genotoxicity in a wide range of in vitro and in vivo tests.


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