Neotect
INDICATIONS
NeoTect® is a scintigraphic imaging agent that identifies somatostatin receptor-bearing pulmonary masses in patients presenting with pulmonary lesions on computed tomography and/or chest x-ray who have known malignancy or who are highly suspect for malignancy.
DOSAGE AND ADMINISTRATION
For imaging, NeoTect® is administered as a peripheral intravenous injection at a single dose of 15 to 20 mCi containing approximately 50 &mirco;g of Technetium Tc 99m radiolabeled Depreotide peptide.
Patients should drink at least an 8 oz.glass of water before drug administration.
| TABLE 8.ADVERSE EVENTS REPORTED IN ≥ 0.5% OF PATIENTS FOLLOWING NeoTect® INJECTION IN CLINICAL TRIALS | |
| Number of Patients Exposed | 647 |
| Number of Patients with At Least One Adverse Event | 29 (4.5%) |
| Nervous System | 13 (2%) |
| 7 (1.0%) | |
| 5 (0.8%) | |
| Gastrointestinal System | 7 (1.0%) |
| 4 (0.6%) | |
| Vascular (extracardiac) Disorder | 3 (0.5%) |
| Flushing | 3 (0.5%) |
The contents of Kit for the Preparation of Technetium Tc 99m Depreotide Injection are intended only for use in the preparationof Technetium Tc 99m Depreotide Injection and are not to be administered directly to the patient. Only one patient dose should be drawn from each reconstituted vial. (See Instructions for the Preparation Section).
The potential need for dose adjustment has not been studied in patients with renal insufficiency, or in pediatric or geriatric patients, or in patients on therapeutic somatostatin analogues.
IMAGING
Planar and SPECT images of the chest should be obtained between 2-4 hours after NeoTect® administration. SPECT images of the chest are required for optimal image interpretation.
RADIATION DOSIMETRY
Based on human data, the absorbed radiation dose to an average human adult (70 kg) from an intravenous injection of the agent are listed in Table 9. The values are listed in descending order as rad/mCi and mGy/MBq and assume urinary bladder emptying at 4.8 hours.
| Table 9. Estimated Absorbed Radiation Dose | ||
| Target Organ | rad/mCi | mGy/MBq |
| Kidneys | 0.33 | 0.090 |
| 0.16 | 0.042 | |
| 0.11 | 0.031 | |
| 0.088 | 0.024 | |
| Red Marrow | 0.078 | 0.021 |
| 0.078 | 0.021 | |
| Heart wall | 0.054 | 0.014 |
| Bone surface | 0.054 | 0.015 |
| 0.053 | 0.014 | |
| Adrenal glands | 0.044 | 0.012 |
| 0.037 | 0.010 | |
| Urinary bladder | 0.033 | 0.0089 |
| 0.031 | 0.0084 | |
| 0.019 | 0.0050 | |
| Upper Large Intestine | 0.019 | 0.0050 |
| Ovaries | 0.016 | 0.0042 |
| Lower Large Intestine | 0.014 | 0.0038 |
Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No.1 rev., Soc.Nucl.Med., 1976). Effective dose equivalent was calculated in accordance with ICRP 53 (Ann.ICRP 18, 1-4, 1988) and gave a value of 0.023 mSv/MBq (0.084 rem/mCi).
INSTRUCTIONS FOR THE PREPARATION OF TECHNETIUM Tc 99m DEPREOTIDE INJECTION
Use aseptic technique throughout. The user should wear waterproof gloves and use shielding at all times when handling the reconstituted vial or syringes containing the radioactive agent.
The patient doses should be measured using a suitably calibrated radioactivity dose meter immediately prior to administration to the patient.
1. Prepare a lead shielded rolling-boil water bath or equivalent heating block.
2. Allow the kit vial to warm to room temperature (20 to 25°C) and place it in a suitable shielding container and sanitize the rubber septum with a sanitizing alcohol swab.
3. Using a shielded syringe, inject the required activity of up to 50 mCi (1.8 GBq) of Sodium Pertechnetate Tc 99m Injection (diluted as appropriate with 0.9% Sodium Chloride Injection, U.S.P., to a total volume of one milliliter) into the shielded vial. (See Cautionary Notes 1 and 2). Before removing the syringe from the vial, withdraw a volume of gas from above the solution equal to the volume of pertechnetate added in order to normalize the pressure inside the vial. Mix for 10 seconds in order to ensure complete dissolution of the powder.
4. Immediately transfer the reaction vial to the lead shielded boiling water bath or heating block, maintaining the vial in the upright condition.Incubate for 10 minutes in this condition. Allow the vial to cool to body temperature (about 15 minutes) before proceeding.
5. Assay the total radioactivity, complete the user radiation label, and attach it to the vial.
6. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit: visually inspect the reconstituted solution at a safe distance through leaded glass. Do not use if the solution is not clear or if it contains foreign particulate matter.
7. Store the reconstituted injection at room temperature (20 - 25°C) and use within five hours of preparation.
Cautionary Notes
1. Add 15 to 50 mCi of Sodium Pertechnetate Tc 99m Injection in a total volume of 1 mL to obtain a single patient dose of 15 to 20 mCi from the entire reconstituted vial.
2. Safety and effectiveness of Technetium Tc 99m Depreotide Injection were established using investigational material shown to have a radiochemical purity of at least 90% prior to administration to patients in clinical studies.
3. The contents of the Kit for the Preparation of Technetium Tc 99m Depreotide Injection vial are not radioactive;however,after the addition of Sodium Pertechnetate Tc 99m Injection,adequate shielding of the final preparation must be maintained.
4. The labeling reaction involved in the preparation of Technetium Tc 99m Depreotide Injection depends upon maintaining tin in the divalent (reduced) state. Any oxidant present in the Sodium Pertechnetate Tc 99m Injection might adversely affect the quality of the preparation. Sodium Pertechnetate Tc 99m Injection containing oxidants ought not to be used for the preparation of the labeled product.
5. Sodium Chloride Injection, U.S.P., must be used as the diluent. Do not use bacteriostatic sodium chloride as a diluent for pertechnetate because it might adversely affect the radiochemical purity and, hence, the biological distribution of the tracer.
6. The contents of Kit for the Preparation of Technetium Tc 99m Depreotide Injection are sterile and non-pyrogenic.
7. Do not inject NeoTect® into Total Parenteral Nutrition (TPN) admixtures or inject into TPN intravenous administration lines.
In these solutions,NeoTect® may form a complex glycosyldepreotide conjugate. QUALITY CONTROL
An assay of the radiochemical purity of the prepared injection can be performed using the following chromatographic procedures.
Equipment and Materials
1. Two Gelman ITLC-SG strips (2 cm x 10 cm)
2. Two glass developing jars and covers
3. Saturated sodium chloride solution (SAS) See #7a
4. 1:1 (v/v) Methanol:1M Ammonium Acetate (MAM) See #7b
5. One 1-mL syringe and 21-gauge (or smaller gauge) needle
6. Suitable counting equipment
7. Preparation of reagents a. Saturated sodium chloride solution (SAS): may be prepared by adding about five grams of sodium chloride to the bottom of one chromatography chamber;add approximately 10 milliliters of distilled water to the solid sodium chloride and shake periodically during 10 to 15 minutes. Solid sodium chloride should remain at the bottom of the jar;if there is no residue, add more solid sodium chloride and shake again for 10 to 15 minutes. Continue until a solid residue remains.(The Saturated Sodium Chloride Solution can be reused. Add more distilled water or sodium chloride as needed for subsequent use, always maintaining some undissolved sodium chloride at the bottom of the chamber.) b. 1:1 Methanol: 1M Ammonium Acetate (MAM): 1M Ammonium Acetate: Add 3.9± 0.1 grams of solid ammonium acetate to a 50 mL volumetric flask. Add approximately 15 mL of distilled water to the flask, stopper, and swirl to dissolve the solid. Add distilled water up to the 50 mL mark, mix thoroughly.
The ammonium acetate solution can be used for up to one month.Label the solution with a one month expiration date.1:1 Methanol:1M Ammonium Acetate (MAM):Carefully mix one part methanol with one part 1M Ammonium Acetate. The MAM should be prepared fresh daily.
Method
1. Pour the MAM and SAS into separate glass developing jars to a depth of approximately 0.5 cm. Cover the jars and allow to equilibrate with the solvent vapors.
2. Mark two Gelman ITLC-SG strips with a light pencil at 1 cm from the bottoms of each.
3. Spot one drop (approximately 5 to 10 microliters) of Technetium Tc 99m Depreotide Injection at the origin of each strip using the hypodermic needle.Do not allow the spots to dry. CAUTION: Do not allow the needle to touch the strip.
4. Place the developing jars behind a lead shield.
6. Allow the solvent front to move to the top of the strip.
7. Remove the strip from the jar and allow the strip to dry behind a lead shield.
8. Cut the strips as described below: ITLC-SG MAM: cut the strip at Rf 0.4 (40% of the distance from the origin to the solvent front) ITLC-SG SAS: cut the strip at Rf 0.75 (75% of the distance from the origin to the solvent front)
9. Count each strip section in a dose calibrator and interpret the results as follows (refer to figure below): Percent Technetium Tc 99m non-mobile material = A A = 100 x {Activity in bottom piece of ITLC-SG MAM strip (Rf 0 to 0.40)} {Total Activity in both pieces of ITLC-SG MAM strip}
Percent Technetium Tc 99m pertechnetate, Technetium Tc 99m glucoheptonate and Technetium Tc 99m edetate = B
B = 100 x {Activity in top piece of ITLC-SG SAS strip (Rf 0.75 to 1)}
{Total Activity in both pieces of ITLC-SG SAS strip} Percent Technetium Tc 99m Depreotide Injection:100 - (A + B)
10.A value of at least 90% should be obtained in a satisfactory preparation. If radiochemical purity is not ≥90% please do not use it in patients.
HOW SUPPLIED
Each kit is comprised of one vial containing a sterile, non-pyrogenic, freeze-dried mixture of Depreotide, stannous chloride dihydrate, sodium glucoheptonate dihydrate and edetate disodium dihydrate. Kits are available as individual vials or as packs of five.
NDC 64570-511-10 — single vial
NDC 64570-511-05 — five vial pack
STORAGE
Store the kit at ≤ -10° C ( ≤14° F). Store the reconstituted injection solution at 20 - 25° C ( 68-77° F) using appropriate radiation shielding. Use within 5 hours of reconstitution.
The kit should be protected from light.
This reagent kit is approved for distribution to persons licensed by the U.S.Nuclear Regulatory Commission to use byproduct material identified in §35.200, or under an equivalent license of an Agreement State.
Manufactured by:
Rentschler Biotechnologie GmbH & Co.KG Laupheim, Germany for Berlex Laboratories Wayne, New Jersey 07470 ,Rev.June 2001
Generic Name: NeoTect
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