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DUODART (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): ADVERSE REACTIONS, SIDE EFFECTS

There have been no clinical trials conducted with Duodart (Dutasteride with Tamsulosin); however, co-administration information for Years 1 and 2 is available from the CombAT (Combination of Avodart and Tamsulosin) study, a comparison of dutasteride 0.5 mg and tamsulosin 0.4 mg once daily for four years as co-administration or as monotherapy.

Information on the adverse event profiles of the individual components (dutasteride and tamsulosin) is also provided.

Dutasteride and Tamsulosin (Duodart) Co-administration

Clinical Trial Data

Year 2 data from the CombAT study have shown that the incidence of any investigatorjudged drug-related adverse event during the first and second years of treatment respectively was 22% and 5% for dutasteride + tamsulosin co-administration therapy, 14% and 5% for dutasteride monotherapy and 13% and 4% for tamsulosin monotherapy. The higher incidence of adverse events in the co-administration therapy group in the first year of treatment was due to a higher incidence of reproductive disorders, specifically ejaculation disorders, observed in this group.

The following investigator-judged drug-related adverse events (with an incidence of greater than or equal to 1%) have been reported during Years 1 and 2 of the CombAT study: altered (decreased) libido, impotence, ejaculation disorders, breast disorders, dizziness.

Dutasteride Monotherapy

Clinical Trial Data

In three phase III placebo controlled studies of dutasteride treatment (n=2167) compared to placebo (n=2158), investigator-judged drug-related adverse events after one and two years of therapy were similar in type and frequency to those observed in the dutasteride monotherapy arm of the CombAT study (see table above).

No change in the adverse event profile was apparent over a further 2 years in an open-label extension phase of these studies.

Post Marketing Data

Adverse drug reactions are listed below by system organ class and frequency. Frequencies are defined as: very common ( >= 1/10), common ( >= 1/100 and < 1/10), uncommon ( >= 1/1000 and < 1/100), rare ( >= 1/10,000 and < 1/1000) and very rare ( < 1/10,000) including isolated reports. Frequency categories determined from post-marketing data refer to reporting rate rather than true frequency.

Immune system disorders

Very rare: including rash, allergic reactions, pruritus, localised oedema, urticaria, angioedema.

Skin and subcutaneous tissue disorders

Rare: alopecia (primarily body hair loss), hypertrichosis.

Tamsulosin Monotherapy

Clinical Trial Data and Post marketing Data

Priapism

Rarely, tamsulosin, like other alpha1-antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction.

Abnormal ejaculation

Patients should also be advised on the potential for abnormal ejaculation, such as retrograde ejaculation, to occur upon commencement of tamsulosin treatment.

GlaxoSmithKline does not hold the safety database for any single ingredient tamsulosin product; therefore the adverse reactions and frequency categories below are based on information available in the public domain. In the table below, common and uncommon reactions are consistent with those identified in a clinical trial setting and the frequency categories generally reflect incidence over placebo. Rare and very rare reactions are consistent with those identified from post marketing reports and the frequency categories reflect reporting rates.

Cardiac disorders: uncommon: palpitations

Gastrointestinal disorders: uncommon: diarrhoea, vomiting, constipation

General disorders and administration site disorders: uncommon: asthenia

Nervous system disorders: common: dizziness; rare: syncope

Reproductive system and breast disorders: uncommon: abnormal ejaculation; uncommon: priapism

Respiratory, thoracic and mediastinal disorders: uncommon: rhinitis

Immune system disorders: uncommon: pruritis, rash, urticaria; rare: angioedema

Vascular disorders: uncommon: postural hypotension

During post marketing surveillance, reports of Intraoperative Floppy Iris Syndrome (IFIS), a variant of small pupil syndrome, during cataract surgery have been associated with alpha-1 adrenergic blocker therapy; including tamsulosin. Infrequent reports of skin desquamation have also been received.


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