PET Radiopharmaceuticals for cancers

Drug Information

  • Classification of drug: professional Ethical drug
  • Shape and form: Injection with colorless clear liquid contained in colorless transparent vial.
  • Effective component: 2-Deoxy-2-Fluoro-D-glucose(18F) liquid
  • Item Standard Code: 200503741


①	For measurement of abnormal glucose metabolism to help evaluation of the malignancy of a malignant tumor of a patient suspected or diagnosed by another examination method
②	For examination of the remaining glucose metabolism in a patient with a coronary artery disease and a problem in the left ventricle and myocardium of the left ventricle which has a reversible loss of function during systole in addition to myocardial perfusion scintigraphy
③	For confirmation of the part with abnormal glucose metabolism related to the part of epileptic seizure
Detailed information

Usage & Dose

①	 Inject 185-370 MBq(5-10 mCi) to an adult (70 kg) who has a malignant tumor, heart disease or epilepsy.
②	 In general, [18F]Fludeoxyglucose (hereinafter FDG) injection is to be administered for a patient after about 4-6 minutes of fast. If a patient has a heart disease, FDG can be injected to the patient who has fasted or taken glucose.
③	 The optimal administration speed and the limit of safe dosage of FDG injection have not been established. When injected consecutively, the interval of administration of FDG shall be long enough to accommodate the real (physical and biological) decay of the previous injection.
④	The dosage for the last patient (who is administered the drug long after its production time) shall be calculated based on the end of synthesis (EOS) using decay constant, and it should be measured with appropriate radioactivity verification system before administration of the drug.


Inject 185-370 MBq(5-10 mCi) of the drug intravenously for one adult patient.

Administration method

This drug shall be intravenously injected once.
The dosage for the last patient (who is administered the drug long after its production time) shall be calculated based on the end of synthesis (EOS) using decay constant, and it should be measured with appropriate radioactivity verification system before administration of the drug.
			<Half-life of fluorine(18F): 110 minutes>
<Half-life of fluorine(18F): 110 minutes>
Minutes Ratio of remaining minutes
0 1.00
15 0.909
30 0.826
60 0.683
110 0.500
220 0.250
440 0.060


1. Adverse Reactions 
                ①There were 374 pieces of data on the stability of this medicine in epilepsy. Among them, 245 pieces were about women and 105 pieces were about men. The rest 24 pieces did not specify gender. The average age was 47.8 (ranging from below 2 years of age to over 65). Among them, 18 people were between 0 and 2 years of age, 42 people were between 2 and 21, 213 people were between 21 and 98 people were over 65 and 3 men did not state their ages. It was not possible to know the racial background. There was no report in the data on the side effects of drugs that required legal arbitration. Among the 374 patients, 4 patients showed temporarily hypertension, 6 patients showed high and low blood sugar level, and 3 patients showed temporary ALP in the group of 42 people.
                ②	 There was no report about the side effects on malignant tumor or heart disease.

			2. General Caution
            ①Administer the drug only when it is thought that the benefit of diagnosis is more than the disadvantage of exposure to radiation and use minimum dosage.
②	Exposure to ionizing radiation may cause a cancer or genetic defect. The quantity of radioactivity used for the diagnosis of nuclear medicine is mostly less than 20mSv and there are few cases of side effects. However, the use of the quantity of radioactivity for medical treatment may cause a cancer and mutation. Therefore, this drug shall be used only when the harm of exposure to radioactivity is less than the harm of the disease.
③In order to minimize the amount of absorption of radiation in the bladder, tell the patient to drink much water for several hours before and after the intravenous injection of this drug to be able to empty the bladder frequently. In order to protect the patient and the people around the patient, have the patient use the same toilet for 12 hours after administration of the drug and flush the toilet several times after each time of secretion and wash hands slowly and thoroughly to prevent contamination by radioactivity.
④As transportation of FDG into the cell can be affected by the fast or change of the blood sugar level related to diabetes, the blood sugar level should be stabilized before administration of this drug. There is no proper research conducted on the permission of administration of the drug for a patient with diabetes or hyperglycemia.
⑤It is necessary to put the patient on 4~6 hours of fast before injection if the patient does not have diabetes and stabilize the blood sugar of the patient on the day from the day before the injection for a diabetes patient.
⑥If this drug is injected to a patient who has fasted, it will be difficult to locate the part of ischemia in myocardial perfusion scintigraphy as the neighboring myocardium is not seen well due to the limitation of accumulation of this drug to ischemic myocardium.
On the contrary, it becomes easy to locate the part of ischemia in a patient who was given glucose (50~75g of glucose one or two hours before injection of this drug) as the neighboring non-ischemic area is visible.
⑦ Radiopharmaceuticals may be used by only those who have the license to use and handle radionuclides. Radiopharmaceuticals shall be received, stored, used, moved and discarded according to related laws and regulations.

			3. Drug Interaction
			There is no report on the interaction between this drug and other drugs.

			4. Administration for pregnant women and breast-feeding women
            ①No research has been conducted on fertility using animals.
②The safety of this drug for a pregnant woman has not been established. Therefore, this drug shall be administered for a pregnant woman and a woman who has the possibility of being pregnant only if it is thought that the benefit is more than the risk to the pregnant woman and the fetus.
③ Though it is not known whether this drug is secreted through the mother’s milk, many drugs are secreted through the milk. Therefore, it is necessary to be very careful when injecting this drug to a breast-feeding mother.

			5. Administration for children 
            ①The stability and efficacy of this drug for child epilepsy patients have been established through the researches on child and adult patients. The recommended dosage is 96.2 MBq (2.6 mCi). No optimal dosage has been decided based the physique or weight.
②The stability and efficacy of this drug for examination of a malignant tumor or the myocardium of the left ventricle of the child patients under 16 years of age who have reversible loss of function during systole have not been established.

			6. Administration for the elderly 
			In general, the elderly has a low level of physiological function and thus it is necessary to administer the drug for the elderly carefully according to the condition of the patient.

			7. Other 
			No research has been conducted for evaluation of this drug’s carcinogenicity, mutagenicity and damage to fertility.