DETECTNET Solution for injection Ref.[10056] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

11.1 Chemical Characteristics

Detectnet contains copper Cu 64 dotatate, which is a radioactive diagnostic drug for use with PET imaging. Chemically, copper Cu 64 dotatate is described as copper (Cu 64)N[(4,7,10-Tricarboxymethyl-1,4,7,10- tetraazacyclododec-1-yl) acetyl]-Dphenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L- threoninyl-L-cysteinyl-L-threonine-cyclic (2-7) disulfide. The molecular weight is 1497.2 Daltons and the following is the structural formula:

Detectnet is a sterile, clear, colorless to yellow solution for intravenous use. Each 10 mL single-dose vial contains 148 MBq (4 mCi) of copper Cu 64 dotatate at calibration date and time in 4 mL solution volume. Additionally, each mL of the solution contains 40 mg ascorbic acid, 0.05 ml of dehydrated alcohol, USP (ethanol) in sterile water for injection, USP. The pH is adjusted with sodium hydroxide, hydrochloric acid and is between 5.5 to 7.5.

11.2 Physical Characteristics

Table 2 and Table 3 display the principal radiation emission data and physical decay of copper Cu 64.

Copper Cu 64 decays with a half-life t1/2=12.7 hours:

  • 17.6% by positron emission to Ni 64 followed by emission of two 511 keV annihilation photons,
  • 38.5% by beta decay to Zn 64,
  • 43.8% by electron capture to Ni 64, and
  • 0.475% by gamma radiation/internal conversion.

Table 2. Principal radiation emission data (>1%) of copper Cu 64:

Radiation/Emission % Disintegration Mean Energy (keV)
Positron (β+) 17.6 278
Beta (β-) 38.5 190.7
Gamma (γ) 35.7
0.48 		511
1346

Table 3. Physical decay chart of copper Cu 64:

Hours Fraction Remaining Hours Fraction Remaining
0 1.00 18 0.374
1 0.947 24 (1 day) 0.270
3 0.849 36 (1.5 days) 0.140
6 0.721 48 (2 days) 0.073
9 0.612 72 (3 days) 0.020
12 0.520 96 (4 days) 0.005

11.3 External Radiation

Gamma constant: 3.6 X 10-5 mSv/hr per MBq at 1 meter (0.133 mrem/hr per mCi at 1 meter).

Table 4 displays the radiation attenuation by lead shielding of copper Cu 64.

Table 4. Radiation attenuation of copper Cu 64 by lead shielding:

Shield Thickness cm of
Lead (Pb) 		Coefficient of
Attenuation
0.51 0.5
1.60 0.1
3.45 0.01
6.83 0.001
Dosage Forms and Strengths

Injection; sterile, clear, colorless to yellow solution in a single-dose vial containing 148 MBq (4 mCi) (37 MBq (1 mCi) per 1 mL) of copper Cu 64 dotatate at calibration date and time.
How Supplied

Detectnet (NDC 69945-064-01) is supplied as a sterile, clear, colorless to yellow solution in a 10 mL single-dose vial containing 148 MBq (4 mCi) (37 MBq (1 mCi) per mL) of copper Cu 64 dotatate at calibration date and time.

The sealed vial is contained in a shielded (lead) container for radiation protection. The product is shipped in a Type A package.

Discard unused portion from the single-patient use vial.

Drugs

Drug Countries
DETECTNET United States
 
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