NETSPOT

NETSPOT- 68ga-dotatate
Advanced Accelerator Applications USA, Inc

1 INDICATIONS AND USAGE

NETSPOT, after radiolabeling with Ga 68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.

2 DOSAGE AND ADMINISTRATION

2.1 Radiation Safety

Drug Handling
After reconstitution and radiolabeling, handle the Ga 68 dotatate injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.1)]. Use waterproof gloves, effective radiation shielding and appropriate safety measures when preparing and handling Ga 68 dotatate injection.

Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

Patient Preparation
Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Ga 68 dotatate. Drink and void frequently during the first hours following administration to reduce radiation exposure.

2.2 Recommended Dosage and Administration Instructions

In adults and pediatric patients, the recommended amount of radioactivity to be administered for PET imaging is 2 MBq/kg (0.054 mCi/kg) of body weight up to 200 MBq (5.4 mCi).

NETSPOT may be radiolabeled with Ga 68 chloride eluate from the following generators:

  • Eckert & Ziegler GalliaPharm Germanium 68/Gallium 68 (Ge 68/Ga 68) generator
  • IRE ELiT Galli Eo Germanium 68/Gallium 68 (Ge 68/Ga 68) generator

After reconstitution with Ga 68 chloride eluate and buffer [see Dosage and Administration (2.3)], administer Ga 68 dotatate by intravenous injection (bolus).

Verify the injected radioactivity by measuring the radioactivity of the vial containing the Ga 68 dotatate injection with a dose calibrator before administration to the patient [see Dosage and Administration (2.4)]. Ensure that the injected radioactivity is within ± 10% of the recommended dose.

2.3 Drug Preparation

The NETSPOT kit is supplied as 2 vials [see Dosage Forms and Strengths (3)] which allows for direct preparation of Ga 68 dotatate injection with the eluate from one of the following generators (see below for specific instructions for use with each generator):

  • Eckert & Ziegler GalliaPharm Germanium 68/Gallium 68 (Ge 68/Ga 68) generator
  • IRE ELiT Galli Eo Germanium 68/Gallium 68 (Ge 68/Ga 68) generator

The Ge 68/Ga 68 generators are not supplied with the NETSPOT kit.

Components of the kit:

  • Vial 1 (reaction vial with lyophilized powder) contains: 40 mcg dotatate, 5 mcg 1,10-phenanthroline; 6 mcg gentisic acid; 20 mg mannitol.
  • Vial 2 (buffer vial) contains: 60 mg formic acid; 56.5 mg sodium hydroxide and water for injection.

Ancillary supplies (not included in the kit):

  • Ancillary supplies needed (not supplied in kit): 1 mL sterile plastic syringe, 5 mL sterile plastic syringe, non-metallic or silicone coated sterile needles, 0.2 micron sterile vented filter

Prepare Ga 68 dotatate for intravenous injection according to the following aseptic procedure:

a. Use suitable shielding to reduce radiation exposure.

b. Wear waterproof gloves.

c. Test periodically (weekly) the Ga 68 chloride eluate for Ge 68 breakthrough by suitable method. Ge 68 breakthrough and other gamma emitting radionuclides should be ≤ 0.001%.

d. Set the temperature of the shielded dry bath to 95°C (203°F), and wait for the temperature to reach the set point and stabilize.

e. Prepare syringes for elution and reconstitution steps per Table 1 below.

f. Use non-metallic or silicone coated needles to minimize trace metal impurity levels. Radiolabeling of carrier molecules with gallium (Ga 68) chloride is very sensitive to the presence of trace metal impurities.

g. Use 1 mL low dead space plastic syringe to precisely measure the adequate volume of reaction buffer to be added during preparation. Do Not use glass syringe.

h. Prior to piercing vial septums, flip-off cap and swab the top of the vial closure with alcohol to disinfect the surface, and allow the stopper to dry.

Table 1. Solutions for Generator Elution and Radiolabeling Reaction
Solutions for use with Eckert & Ziegler GalliaPharm generator
Syringe Solution Purpose

5 mL sterile plastic syringe

5 mL of 0.1 N sterile HCl supplied by the generator manufacturer

For elution of the generator

1 mL sterile plastic syringe

Vial 2 buffer

Calculate the volume (in mL) by multiplying the volume of HCl used for the elution of the generator in mL by its molarity:

Reaction buffer volume in mL = HCl volume in mL x HCl molarity (5 mL x 0.1 N = 0.5 mL of reaction buffer).

For radiolabeling reaction

Solutions for use with IRE Galli Eo generator
5 mL sterile plastic syringe

3.9 mL sterile water for injection

For preliminary dilution of Vial 1

1 mL sterile plastic syringe

Vial 2 buffer

Calculate the volume (in mL) by multiplying the volume of HCl used for the elution of the generator in mL by its molarity:

Reaction buffer volume in mL = HCl volume in mL x HCl molarity (1.1 mL x 0.1 N = 0.11 mL of reaction buffer).

For radiolabeling reaction

i. Pierce the Vial 1 septum with a sterile needle connected to a 0.2 micron sterile vented filter (not supplied) to maintain atmospheric pressure within the vial during the reconstitution process.

j. Follow the generator specific reconstitution procedures below. Then continue with the incubation step k.

Reconstitution with Eckert & Ziegler GalliaPharm generator

  • Connect the male luer of the outlet line of the GalliaPharm generator to a sterile needle.
  • Connect Vial 1 directly to the outlet line of the GalliaPharm generator by pushing the needle through the rubber septum and place the vial in a lead shield container.
  • Elute the generator directly into the Vial 1 according to the instructions for use of the GalliaPharm generator that are supplied by Eckert & Ziegler, in order to reconstitute the lyophilized powder with 5 mL of eluate. Perform the elution manually or by means of a pump.
  • At the end of the elution, disconnect the generator from Vial 1 by removing the needle from the rubber septum, and immediately (do not delay buffer addition more than 10 min) add the kit reaction buffer in the 1 mL sterile syringe (the amount of reaction buffer was determined in Table 1).
  • Withdraw the syringe and the 0.2 micron sterile air venting filter.

Reconstitution with IRE Galli Eo generator

  • Set the generator for the elution according to manufacturer instructions. Connect a sterile needle to the outlet tube of the generator, turn the button by 90° to loading position then wait 10 seconds before turning the button back to the initial position.
  • Reconstitute Vial 1 with 3.9 mL of sterile water for injection as prepared in Table 1.
  • Add the 0.1 mL reaction buffer to Vial 1 as prepared in Table 1.
  • Connect Vial 1 to the outlet line of the generator by pushing the needle through the rubber septum.
  • Connect one end of the two male luer ends of a sterile extension line to the 0.2 micron sterile vent filter inserted into Vial 1.
  • Assemble a sterile needle on the second male luer end of the sterile extension line and connect it to a sterile evacuated vial (17 mL minimum volume) by pushing the needle through the rubber septum. The generator elution will start.
  • Wait for the elution to be completed (minimum 3 minutes, according to the generator manufacturer instructions for use).
  • At the end of the elution, first withdraw the needle from the evacuated vial in order to establish atmospheric pressure into Vial 1 , then disconnect Vial 1 from the generator by removing the needle from the rubber septum and remove the 0.2 micron sterile vent filter from Vial 1.

Incubation

k. Using a tong, move Vial 1 to the heating hole of the dry bath, and leave the vial at 95°C (203°F), not to exceed 98°C (208°F), for at least 7 minutes (do not exceed 10 minutes heating) without agitation or stirring.

l. After 7 minutes, remove the vial from the dry bath, place it in an appropriate lead shield and let it cool down to room temperature for approximately 10 minutes.

m. Assay the whole vial containing the Ga 68 dotatate injection for total radioactivity concentration using a dose calibrator and record the result.

n. Perform the quality controls according to the recommended methods in order to check the compliance with the specifications [see Dosage and Administration (2.5)].

o. Prior to use, visually inspect the solution behind a shielded screen for radioprotection purposes. Only use solutions that are clear without visible particles.

p. Keep the vial containing the Ga 68 dotatate injection upright in a radio-protective shield container at a temperature below 25°C (77°F) until use.

q. After addition of Ga 68 chloride to the reaction vial, use Ga 68 dotatate injection within 4 hours.

Figure 1. Reconstitution Procedure for Eckert & Ziegler GalliaPharm Generator​

Figure 1. Reconstitution Procedure for Eckert & Ziegler GalliaPharm Generator
(click image for full-size original)

Figure 2. Reconstitution Procedure for IRE Galli Eo Generator​

Figure 2. Reconstitution Procedure for IRE Galli Eo Generator
(click image for full-size original)

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