Serious POME reactions, involving cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular testosterone undecanoate 1000 mg (4 mL). The majority of these events lasted a few minutes and resolved with supportive measures; however, some lasted up to several hours and some required emergency care and/or hospitalization. To minimize the risk of intravascular injection of AVEED ® , care should be taken to inject the preparation deeply into the gluteal muscle, being sure to follow the recommended procedure for intramuscular administration.
g) Using a value of x 104 L/mol for the association constant of albumin for T, the calculated albumin-bound T varied from nmol/L (40 g/L albumin) to nmol/L (50 g/L albumin). In view of the relatively unimportant changes in FT, when the albumin concentration varies by as much as 25%, it was concluded that for routine purposes FT could be calculated assuming an albumin concentration of 43 g/L ( x 10-4 mol/L) if one is not dealing with sera from patients with marked abnormalities in plasma protein composition, such as in nephrotic syndrome or cirrhosis of the liver, or with sera obtained during pregnancy, in which cases the actual albumin concentration should be taken into account.
Analysis of serum testosterone concentrations from 117 hypogonadal men in the 84-week clinical study of Aveed indicated that serum testosterone concentrations achieved were inversely correlated with the patient's body weight. In 60 patients with pretreatment body weight of ≥ 100 kg, the mean (±SD) serum testosterone average concentration was 426 ± 104 ng/dL. A higher serum testosterone average concentration (568 ± 139 ng/dL) was observed in 57 patients weighing 65 to 100 kg. A similar trend was also observed for maximum serum testosterone concentrations.