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Neotect

Clinical Pharmacology
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CLINICAL PHARMACOLOGY

Technetium Tc 99m Depreotide Injection is a diagnostic radiopharmaceutical based upon a synthetic peptide with high affinity binding to somatostatin receptors (SSTR) in normal and abnormal tissues. (See Pharmacodynamics section for details).

Pharmacokinetics

Technetium Tc 99m radioactivity pharmacokinetic parameters were evaluated after a single intravenous administration of Depreotide containing 15-20 mCi of Technetium Tc 99m and 50 µg of Depreotide in normal subjects and in patients with selected disorders. The pharmacokinetic values were estimated from data corrected for radioactivity decay. The total radioactivity in the blood exhibited three-exponential phases with the pharmacokinetic parameters shown in Table 4.

Table 4. Pharmacokinetics Parameters of Technetium Tc 99m Depreotide Radioactivity (a)

Subjects

Effective Half-Life

Vss

CL total

CL renal

ta (min)

tb (min)

tg (hour)

(L/kg)

(mL/min/kg)

(mL/min/kg)

Normal

(n=9)

4.3 ± 2.5

43.6 ± 11.5

22.4 ± 11.90

1.56 ± 0.85

2.12 ± 1.3

0.37 ± 0.22

Hepatic dysfunction (n=3)

4.0 ± 0.4

48.3 ± 7.5

18.0 ± 3.3

1.7 ± 0.4

2.45 ± 0.3

0.24 (n=1)

Renal dysfunction (n=3)

2.9 ± 0.7

52.0 ± 9.9

17.2 ± 8.2

1.49 ± 0.95

1.49 ± 0.72

Not evaluated

Lung cancer (n=2)(b)

4.5,9.1

62,72

12.6,16.9

0.44,1.43

1.64,1.64

Not evaluated

(a) Only radioactivity was measured. Data expressed as mean value ± SD (n) where "n"is the number of subjects or patients.

(b) Only two lung cancer patients were studied;the calculated values for both patients are presented.

Brand Name: Neotect
Generic Name: NeoTect
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