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Brand Name :
N/A
Synonyms :
Arcitumomab technetium-99m, Technetium (99mTc) arcitumomab, technetium Tc 99m arcitumomab, Technetium-99m arcitumomab
Class :
Diagnostic, Radioactive agent, Anti-CEA antibody
Dosage Forms & StrengthsÂ
Injectable soltuionÂ
1g with 20-30 mCiÂ
Colorectal Infection After SurgeryÂ
Diagnostic imaging for Colorectal disease
CEA-Scan® undergoes reconstitution with a solution of sodium pertechnetate Tc 99m before utilization
The usual adult recommended dose comprises a 1 mg single dose of Arcitumomab labeled with 20 to 30 mCi of Technetium Tc 99m
The dosage is given as a 2 ml intravenous injection after being diluted with 1 ml of Sodium Chloride Injection, USP
Alternatively, the contents of the vial may be diluted with Sodium Chloride isotonic Injection, USP, to a total volume of 30 ml, and the infusion can be given intravenously over a period of 5 to 20 minutes
For best imaging quality, the injection should take place four hours after reconstitution and within five minutes of that time
Before infusion, the sterile, non-pyrogenic, reconstituted mixture can be kept at room temperature without the need for bacteriostatic preservatives
The individual's dose is calculated in a dose calibrator prior to administration
Using immediate thin-layer chromatography, the radiochemical purity is required to be greater than 90% (ITLC)
It is essential to visually inspect for particles or discoloration; if found, dispose of the item right away and notify the manufacturer
It is advised to do immunoscintigraphy utilizing planar and SPECT (Single-Photon Emission Computed Tomography) techniques between two and five hours after injection
Additional views may be obtained up to twenty-four hours later, depending on the results of previous imaging tests
Dose Adjustments
Limited data is available
Safety and efficacy are not seen in pediatricsÂ
Refer to the adult dosingÂ
the extent of adverse effects can be raised when abciximab is used in combination
the extent of adverse effects can be raised when aducanumab is used in combination
the risk or extent of adverse effects can be raised when bevacizumab is combined with technetium tc-99m arcitumomab
the risk or extent of adverse effects can be raised when technetium tc-99m arcitumomab is combined with blinatumomab
the extent of adverse effects can be raised when alemtuzumab is combination
the extent of adverse effects can be raised when alirocumab is used in combination
the risk or extent of adverse effects can be raised when technetium tc-99m arcitumomab is combined with bezlotoxumab
Actions and Spectrum:Â
Actions:Â
Carcinoembryonic antigen (CEA), which is overexpressed in 95% of colorectal tumors, is recognized by arcitumomab. As a result, the radioisotope, which releases photons, and the antibody build up in these cancers. High-resolution pictures displaying the tumor’s location, state of remission or progression, and metastases can be acquired using SPECT (single photon emission computed tomography).Â
Spectrum:Â Â
This is a medication utilized in the diagnosis for colorectal cancers. Comprising the fragment (Fab) of the arcitumomab (monoclonal antibody) (CEA-Scan) and the technetium-99m (radionuclide) (immunoconjugate). Monoclonal antibody (arcitumomab), derived from the IgG1 murine monoclonal antibody NP-4, undergoes enzymatic cleavage by pepsin to produce the fragment of F(ab)2. The fragment is then prepared through reduction (mild).
Prior to administration, reconstitution of arcitumomab (monoclonal antibody) with a (99mTc) sodium pertechnetate (radioactive agent)solution obtained from a generator (technetium). FDA-approved in 1999, it serves as a aid in diagnosis, along with diagnostic (standard) assessments, to detect the location, presence, and risk of metastatic and/or recurrent colorectal carcinoma involving the extrahepatic abdomen, pelvis, and liver in colorectal carcinoma patients with a confirmed histological diagnosis.Â
Frequency not definedÂ
ItchingÂ
FeverÂ
EosinophiliaÂ
Radiation poisoningÂ
Â
Black Box Warning:Â
Patients may experience anaphylactic responses and other allergic reactions after receiving mouse protein. Drugs for the treatment of reactions to hypersensitivity, such as adrenaline, antihistamines, and corticosteroids, should be on hand for quick use in the event of an allergic reaction during CEA-Scan® administration, even though severe reactions of this kind have not been seen in clinical trials following this agent’s administration.Â
Contraindication/Caution:Â
ContraindicationsÂ
CautionsÂ
Pregnancy consideration:Â Â
Pregnancy category: CÂ
Breastfeeding warnings:Â Â
No data is available regarding the excretion of drug in breast milk.Â
Pregnancy category: CÂ
Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester.Â
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   Â
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.   Â
Category N: No data is available for the drug under this category.Â
Pharmacology:Â
Selective binding occurs with the CEA (carcinoembryonic antigen) expressed on the cell surface of colorectal tumors.Â
Pharmacodynamics:Â
Binds to CEA (carcinoembryonic antigen), a cell surface protein frequently elevated in malignancies beyond colorectal cancer. The covalently attached radioactive Tc99 to the antibody enables the radiodiagnostic detection of CEA-expressing cells and tumors. Pharmacokinetics:Â
AbsorptionÂ
The time to achieve peak effect is 30 minutesÂ
DistributionÂ
Protein-bound is 70-80%Â
The volume of distribution is 20 LÂ
MetabolismÂ
Most likely eliminated via the reticuloendothelial system’s opsonization or by the generation of human antimurine antibodies.Â
Elimination and ExcretionÂ
The half-life is 1 hourÂ
The drug is excreted 60% in feces and 25-30% in urine.Â
Administration:Â
Technetium Tc-99m arcitumomab is administered intravenously for radiodiagnosis. This monoclonal antibody selectively binds to the carcinoembryonic antigen (CEA) expressed on colorectal tumor cells. The antibody is covalently linked to the radioactive isotope Tc-99m, enabling the visualization of CEA-expressing cells and tumors through gamma imaging.
This diagnostic tool assists in the identification and localization of malignancies beyond the colon where CEA is overexpressed. The administration is a targeted approach, aiding in the detection and assessment of specific cancerous cells, contributing to improved diagnostic accuracy in oncology. Regular follow-ups and adjustments to the management plan are common to ensure optimal health outcomes.Â
Patient information leafletÂ
Generic Name: technetium Tc-99m arcitumomabÂ
Pronounced: tek-NEE-shee-um tee-see-NIN-ahyn ark-i-TOO-mo-mabÂ
Why do we use technetium Tc-99m arcitumomab?Â
Immunomedics is the manufacturer of technetium (99mTc) arcitumomab, a medication used for colorectal cancer diagnostic imaging. Technetium-99m, a radionuclide, and the Fab’ fragment of a monoclonal antibody (arcitumomab, brand name CEA-Scan) make up this combination.Â