Duodart Adverse Reactions

There have been no clinical trials conducted with DUODART; however, co-administration information is available from the CombAT (Combination of Avodart and Tamsulosin) study, a comparison of dutasteride 0.5mg and tamsulosin 0.4mg 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 co-administration: Clinical trial data: The following investigator-judged drug-related adverse events (with a cumulative incidence of greater than or equal to 1%) have been reported during the CombAT study. (See Table 1.)

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Dutasteride monotherapy: Clinical trial data: In three phase III placebo controlled studies of dutasteride (n=2167) treatment 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 1 as previously mentioned).
No change in the adverse event profile was apparent over a further 2 years in an open-label extension phase of these studies.
Postmarketing data: In addition to the adverse events reported from clinical trial data, postmarketing adverse drug reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <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: Allergic reactions, including rash, pruritus, urticaria, localised oedema, and angioedema.
Psychiatric disorders: Very rare: Depressed mood.
Skin and subcutaneous tissue disorders: Rare: Alopecia (primarily body hair loss), Hypertrichosis.
Reproductive system and breast disorders: Very rare: Testicular pain and testicular swelling.
Tamsulosin monotherapy: Clinical trial data and postmarketing data: GSK does not hold the safety database for any single ingredient tamsulosin product; therefore the adverse reactions and frequency categories as follows are based on information available in the public domain. In the table as follows, 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. (See Table 2.)

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During postmarketing 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 (see Precautions).
Postmarketing experience: In addition atrial fibrillation, arrhythmia, tachycardia, dyspnoea, epistaxis, vision blurred, visual impairment, erythema multiforme, dermatitis exfoliative and dry mouth have been reported in association with tamsulosin use.