ADVERSE REACTIONS
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trials in Hypogonadal Men
Table 2 shows the treatment emergent adverse reactions that were reported by either >4% of 155 patients in a 120 day, Phase 3 study or by >4% of 71 patients who continued to use AXIRON for up to 180 days. These data reflect the experience primarily with a testosterone dose of 60 mg, which was taken by all patients at the start of the study, and was the maintenance dose for 97 patients. However, the doses used varied from 30 mg to 120 mg.
Table 2: Adverse Reactions Seen With the Use of AXIRON in either the 120 Day Clinical Trial or in the Extension to 180 Days (>4%)
| Event
|
120 Days
(155 Patients)
|
180 Days
(71 Patients)
|
| Application Site Irritation
|
11 (7%)
|
6 (8%)
|
| Application Site Erythema
|
8 (5%)
|
5 (7%)
|
| Headache
|
8 (5%)
|
4 (6%)
|
| Hematocrit Increased
|
6 (4%)
|
5 (7%)
|
| Diarrhea
|
4 (3%)
|
3 (4%)
|
| Vomiting
|
4 (3%)
|
3 (4%)
|
| PSA Increased
|
2 (1%)
|
3 (4%)
|
Other less common adverse reactions reported by at least 2 patients in the 120 day trial included: application site edema, application site warmth, increased hemoglobin, hypertension, erythema (general), increased blood glucose, acne, nasopharyngitis, anger and anxiety. Other less common adverse reactions reported in fewer than 1% of patients in the 120 day trial included: asthenia, affect lability, folliculitis, increased lacrimation, breast tenderness, increased blood pressure, increased blood testosterone, neoplasm prostate and elevated red blood cell count.
During the 120 day trial one patient discontinued treatment because of affect lability/anger which was considered possibly related to AXIRON administration.
During the 120 day clinical trial there was an increase in mean PSA values of 0.13 ± 0.68 ng/mL from baseline. At the end of the 180 day extension clinical trial, there was an overall increase in mean PSA values of 0.1 ± 0.54 ng/mL.
Following the 120 day study, seventy-one (71) patients entered a two-month extension study with AXIRON. Two patients (3%) had adverse reactions that led to discontinuation of treatment during the period from Day 120 to Day 180. These reactions were: one patient with application site irritation (considered possibly related to AXIRON application) and one patient with dry skin and erythema, but not at the application site (considered not related to AXIRON administration) and application site erythema (considered possibly related to AXIRON administration).
No serious adverse reactions to AXIRON were reported during either the 120 day trial, or the extension to 180 days.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of AXIRON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Vascular Disorders: Venous thromboembolism [see Warnings and Precautions].
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