FDGCADPET 1194 MBq/ml INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FDGCADPET 1194 MBq/ml solution for injection

Fludeoxyglucose (18F)

In this leaflet:

1. What FDGCADPET 1194 MBq/ml solution for injection is and what it is used for
2. Before you use FDGCADPET 1194 MBq/ml solution for injection
3. How to use FDGCADPET 1194 MBq/ml solution for injection
4. Possible side effects
5. Storage of FDGCADPET 1194 MBq/ml solution for injection
6. Further information

1. What FDGCADPET 1194 MBq/ml solution for injection is and what it is used for

This medicinal product is for diagnostic use only.

It belongs to a group of medicinal products called diagnostic radiopharmaceuticals.

FDGCADPET 1194 MBq/ml solution for injection is indicated for use in obtaining images by positron emission tomography (PET) in the following oncological, cardiological, and neurological indications:

Oncology

The diagnostic objective is to visualize the increased uptake of glucose (sugar) in specific organs or tissues in the following indications:

Diagnosis:

• Characterization of solitary pulmonary nodule
• Detection of tumor of unknown origin, as evidenced by, for example, cervical adenopathy, hepatic or osseous metastases
• Characterization of a pancreatic mass

Staging:

• Tumors of the head and neck, including guided biopsy
• Primary lung cancer
• Locally advanced breast cancer
• Esophageal cancer
• Pancreatic carcinoma
• Colorectal cancer, especially in recurrences
• Malignant lymphoma
• Malignant melanoma, with Breslow > 1.5 mm or metastasis in lymph nodes at initial diagnosis

Monitoring of response to treatment:

• Malignant lymphoma
• Tumors of the head and neck

Detection in case of reasonable suspicion of recurrence:

• High-grade gliomas (III or IV)
• Tumors of the head and neck
• Thyroid cancer (non-medullary): patients with increased serum thyroglobulin levels and negative whole-body scan with radioactive iodine
• Primary lung cancer
• Breast cancer
• Pancreatic carcinoma
• Colorectal cancer
• Ovarian cancer
• Malignant lymphoma
• Malignant melanoma

Cardiology

The diagnostic objective is to visualize viable myocardial tissue to assess myocardial viability in patients with severe left ventricular dysfunction who are candidates for revascularization, only when conventional imaging techniques of blood flow are not conclusive.

Neurology

The diagnostic objective is to visualize the decrease in glucose metabolism (sugar) in the interictal phase to localize epileptogenic foci in the pre-surgical evaluation of partial temporal epilepsy.

2. Before using FDGCADPET 1194 MBq/ml solution for injection

Do not use FDGCADPET 1194 MBq/ml solution for injection

• if you are allergic (hypersensitive) to fludeoxyglucose (18F) or any of the other components of FDGCADPET.

Be careful with FDGCADPET 1194 MBq/ml solution for injection

• if you have decreased renal function, as your exposure to radiation may increase
• when you are administered FDGCADPET, due to the risk to others (from external radiation or contamination with urine droplets, vomit, etc.). Your doctor will indicate the appropriate radiological protection measures, in accordance with national legislation, advising you not to have direct contact with children during the 12 hours following injection.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

All medicines that affect blood glucose (sugar) levels may affect the outcome of the examination (e.g., corticosteroids, valproate, carbamazepine, phenytoin, phenobarbital, and catecholamines).

The administration of glucose and insulin affects the uptake of this medicinal product in cells (see "Patient preparation" in section 6).

Medicines that accelerate the regrowth of blood cells (colony-stimulating factors or CSFs) may interfere with the outcome of the examination.

No interaction studies have been conducted between fludeoxyglucose (18F) and any computed tomography (CT) contrast medium.

Use of FDGCADPET 1194 MBq/ml solution for injection with food and drinks

Please ensure you drink plenty of sugar-free liquids and empty your bladder before and after the examination to minimize the radiation you receive in your bladder.

You should fast for at least 4 hours before the examination to improve the performance of the test.

If you consume sugar or foods containing sugar, the test result may be altered.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are of childbearing age, you should rule out the possibility of pregnancy before administering this medicine. If you experience a delay in your menstrual period, you should consider yourself pregnant until proven otherwise. In case of doubt, it is very important that the radiation exposure is the minimum necessary to obtain the desired clinical information.Alternative techniques that do not involve the use of ionizing radiation should be considered.

If you are pregnant, you should know that only strictly necessary procedures should be performed during pregnancy, or when the benefit to the mother outweighs the risk to the fetus, taking into account that there is no clinical experience with the use of fludeoxyglucose (18F) in pregnancy. Procedures with radiopharmaceuticals performed in pregnant women also involve radiation doses to the fetus.

If you are breastfeeding, your doctor should consider the possibility of delaying the examination until the end of the breastfeeding period, taking into account the secretion of fludeoxyglucose (18F) in breast milk. If administration is unavoidable, you should stop breastfeeding for at least 12 hours after administration of this medicinal product and discard the expressed milk during this period. You should consider expressing milk before administration of this product and storing it for later use. Additionally, it is recommended to avoid direct contact between the mother and child during the first 12 hours after injection for radiological protection reasons.

Driving and using machines

No studies have been conducted on the ability to drive and use machines.

3. How to use FDGCADPET 1194 MBq/ml solution for injection

• FDGCADPET is a medicinal product used for a diagnostic test, which must be performed by qualified personnel or preferably under the supervision of a doctor who will indicate the instructions to follow at all times.
• FDGCADPET is administered by intravenous injection.
• The recommended dose in adults is 100 to 400 MBq (depending on the patient's body weight and the type of camera used)
• In the population under 18 years of age, clinical data on diagnostic efficacy and safety are scarce. Therefore, its use in pediatric oncology patients should be carefully evaluated. The dose should be a fraction of the recommended dose for adults, depending on their body mass (see "Posology" in section 6).
• Before performing the test, your blood glucose level will be determined, as hyperglycemia (high blood glucose level) may alter the sensitivity of the test.
• To obtain better results from the test, you should avoid any intense physical activity before the test, and it is recommended that you rest (lying comfortably without reading or talking) during the period between injection and examination and during image acquisition.
• In neurological examinations, you should relax beforehand in a dark room with low noise levels.
• In cardiological examinations, it is recommended that you ingest a dose of 50 g of glucose, approximately 1 hour before administration of this medicinal product. In case you have diabetes mellitus, your blood glucose level may be adjusted with a combined infusion of insulin and glucose.

If you use more FDGCADPET 1194 MBq/ml solution for injection than you should

Since FDGCADPET is administered by authorized personnel under strict control conditions, any overdose is very unlikely. However, in case you are administered an excessive dose, the radiation dose you receive may be reduced, causing an increase in the elimination of the radiopharmaceutical from the body, for which you will be advised to drink plenty of liquids to force and increase the frequency of urine elimination.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 5620420.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, FDGCADPET can have side effects, although not everybody gets them. However, no side effects have been observed after administration of fludeoxyglucose (18F) to date.

For all patients, exposure to ionizing radiation should be justified based on the expected diagnosis, receiving the minimum possible dose of radiation. Since the amount of substance administered is very low, the greatest risk is due to radiation. Exposure to ionizing radiation is associated with the induction of cancer and the possibility of developing hereditary defects. Most nuclear medicine examinations provide radiation levels (effective dose) below 20 mSv. The probability of these reactions is low. After administration of the maximum recommended activity of this medicinal product, the effective dose is approximately 7.6 mSv.

In patients with decreased renal function, it is possible that exposure to radiation may increase.

If you notice any side effects not mentioned in this leaflet or if you experience one of the side effects described in a severe form, inform your doctor or pharmacist.

5. Storage of FDGCADPET 1194 MBq/ml solution for injection

Keep out of the reach and sight of children.

Storage should be carried out in accordance with national regulations on radioactive materials.

Do not store above 25°C.

Store in the original package

Do not use this medicinal product after the expiry date stated on the label of the package: 10 hours from the date and time of calibration.

Radioactive waste should be disposed of in accordance with national and international regulations in force. The disposal of unused products or packaging will be established according to local requirements.

6. Additional Information

What does FDGCADPET 1194 MBq/ml injectable solution contain?

• The active ingredient is fludeoxyglucose (18F).
• The other components are sodium dihydrogen phosphate dihydrate, sodium chloride, and water for injection.

Appearance of the product and packaging content

FDGCADPET is a clear, colorless or slightly yellowish injectable solution. It is presented in 10 ml multidose vials with a fixed radioactive concentration of 1194 MBq/ml at the time and date of calibration, and an activity range of 1194 MBq to 10746 MBq per vial at the time and date of calibration.

Marketing authorization holder and manufacturer

Centro Andaluz de Diagnóstico PET, S.A.

Ronda de Capuchinos 11

41009 Sevilla

Email: administració[email protected]

Information of interest to healthcare professionals

Fluorine-18 decays to stable oxygen-18 with a half-life of 109.77 minutes through positron emission with a maximum energy of 634 KeV, followed by annihilation radiation of 511 KeV.

Dosage

Adults:

The recommended activity is detailed in section 3. "How to use FDGCADPET 1194 MBq/ml injectable solution".

Pediatric population (< 18 years of age):

The recommended activity is detailed in section 3 "How to use FDGCADPET 1194 MBq/ml injectable solution".

The activity to be administered in children and adolescents can be calculated from the recommended activity for adults based on body weight, using the following coefficients:

Administration of FDGCADPET and PET scan

• This medication should be administered exclusively by authorized personnel (see "General warnings" section below).
• The solution should be visually inspected before use. Only clear and particle-free solutions should be used.
• The activity of fludeoxyglucose (18F) should be measured with a calibrator immediately before injection.
• This medication may be diluted with a 9 mg/ml (0.9%) sodium chloride injectable solution.
• This medication should not be mixed with other medications, except with 0.9% sodium chloride.
• The vial should not be opened. After disinfecting the stopper, the solution should be extracted through the stopper using a single-use syringe with adequate protective shielding and sterile single-use needles.
• Extractions should be performed under aseptic conditions.
• The injection should be intravenous to avoid local extravasation and artifacts in the image.
• Emission images are typically obtained 45 to 60 minutes after injection of fludeoxyglucose (18F). If there is sufficient activity to obtain an adequate count rate, PET with fludeoxyglucose (18F) can also be performed up to two or three hours after administration, reducing background activity.
• If necessary, scans can be repeated at short intervals.
• If it is necessary to administer contrast for CT when performing a PET scan using a hybrid PET-CT scanner, this administration should be done in accordance with the authorized technical specifications.
• The administration of radiopharmaceuticals poses a risk to others due to external radiation or contamination from spills, vomit, etc. Therefore, radiological protection measures should be taken in accordance with national legislation.

Indication for the scan

For all patients: exposure to radiation should be justified based on the expected diagnosis, obtained with the minimum possible dose of radiation received by the patient.

In patients with decreased renal function: indication should be carefully considered, as they may be at increased risk of radiation exposure.

In pediatric population (< 18 years of age): it should be taken into account that the effective dose per MBq is higher than in adults (see "Dosimetry" section below).

Patient preparation

FDGCADPET should be administered to patients who are sufficiently hydrated and have fasted for at least 4 hours to obtain maximum activity, as glucose uptake by cells is limited ("saturable kinetics"). Fluid intake should not be limited (only glucose-containing beverages should be avoided).

To obtain high-quality images and reduce bladder exposure to radiation, patients should be asked to drink sufficient amounts of fluid and empty their bladder before and after the PET scan.

• Oncology and neurology

To avoid hyperfixation of the tracer in muscles, patients should avoid intense physical activity before the scan and remain at rest during the period between injection and scan, and during image acquisition (patients should be comfortably lying down, without reading or speaking).

Cerebral glucose metabolism depends on brain activity. Therefore, neurological scans should be performed after a period of relaxation in a dark, quiet room.

Serum glucose levels should be determined before administration, as hyperglycemia can decrease the sensitivity of FDGCADPET, especially when glucose levels are above 8 mmol/l. For the same reason, a PET scan with fludeoxyglucose (18F) should be avoided in patients with uncontrolled diabetes.

• Cardiology

Since glucose uptake in the myocardium is insulin-dependent, it is recommended to administer 50 g of glucose approximately one hour before administering FDGCADPET. Alternatively, especially in patients with diabetes mellitus, serum glucose levels can be adjusted using a combined infusion of insulin and glucose (Insulin-Glucose-Clamp) if necessary.

Interpretation of PET images with fludeoxyglucose (18F)

• Infectious and/or inflammatory diseases, as well as post-surgical regenerative processes, can cause significant uptake of fludeoxyglucose (18F) and, therefore, can lead to false-positive results.
• False-positive or false-negative results of PET with fludeoxyglucose (18F) cannot be excluded in the first 2-4 months after radiotherapy. If clinical indication requires an earlier diagnosis using PET with fludeoxyglucose (18F), the reason for performing the PET scan with fludeoxyglucose (18F) earlier should be documented.
• It is optimal to wait at least 4-6 weeks after the last cycle of chemotherapy, especially to avoid false-negative results. If clinical indication requires an earlier diagnosis using PET with fludeoxyglucose (18F), the reason for performing the PET scan with fludeoxyglucose (18F) earlier should be documented. If the chemotherapy regimen consists of cycles shorter than 4 weeks, the PET scan with fludeoxyglucose (18F) should be performed before starting a new cycle.
• In low-grade lymphomas and suspected recurrent ovarian cancer, only the positive predictive value should be considered, as the sensitivity of PET with fludeoxyglucose (18F) is limited.
• Fludeoxyglucose (18F) is not effective in detecting brain metastases.
• It is recommended that PET images with fludeoxyglucose (18F) be interpreted in relation to other anatomical imaging modalities, such as CT, ultrasound, or MRI. The combination of functional PET images with fludeoxyglucose (18F) and morphological images, for example PET-CT, can increase specificity and sensitivity, and is recommended for tumors of the pancreas, head and neck, lymphoma, melanoma, lung cancer, and recurrent colorectal cancer.
• When using a hybrid PET-CT scanner, various artifacts can occur in the PET image. It is recommended that PET and CT images be examined together and separately. These artifacts include:
• • In structures with significantly higher radiodensity than the normal range of tissues (e.g., implants, metal prostheses, etc.), excessive attenuation correction from CT data can occur, resulting in hypercaptant areas in the final PET images.
  • Intravenous iodinated contrast agents administered for CT scans are eliminated through the urinary system, accumulating in the kidneys, ureters, and bladder, and can cause artifacts in the venous vessels and a slight alteration in the degree of uptake of fludeoxyglucose (18F).
  • Oral contrast agents for CT scans are excreted through the intestinal tract, and if administered several hours before the PET-CT scan, can cause false-positive results in the coregistration with areas of high concentration of CT contrast, both in these areas and in other areas within the same slice.
  • Lack of alignment between PET and CT images (caused by patient movement, difference in scan time, and different spatial resolution) can cause areas of increased or decreased uptake of fludeoxyglucose (18F).
  • Movement of internal organs and the diaphragm during breathing can cause small errors in the localization and determination of the size of hepatic and/or splenic lesions in PET images.
• When using a coincidence gamma camera, sensitivity decreases compared to a dedicated PET camera, especially for lesions smaller than 1 cm.

General warnings

• It is recommended to avoid direct contact between the patient and small children during the 12 hours following injection.
• Radiopharmaceuticals should be received, used, and administered exclusively by qualified personnel, authorized for the use and handling of radionuclides, in authorized healthcare facilities. Their receipt, storage, use, transport, and disposal are subject to the relevant regulations and/or licenses of the competent official agencies.
• Radiopharmaceuticals intended for administration to patients should be prepared by the user in a way that meets both radiological safety requirements and pharmaceutical quality standards. Appropriate aseptic precautions should be taken in accordance with the Guidelines for Correct Manufacturing and Use of Radiopharmaceuticals.
• FDGCADPET should be stored and handled in adequate shielding to protect patients and workers as much as possible. It is specifically recommended to protect oneself from the effects of beta+ radiation and annihilation photons, using adequate shielding when extracting from the vial and injecting.

Dosimetry

The following table shows the calculated internal radiation dosimetry according to the ICRP publication No. 80, "Radiation Dose to Patients from Radiopharmaceuticals".

The resulting effective dose from the administration of 400 MBq of FDGCADPET is approximately 7.6 mSv (for a 70 kg person). For this activity of 400 MBq, the absorbed radiation dose by critical organs (these are bladder, heart, and brain) is respectively 64 mGy, 25 mGy, and 11 mGy.

This prospectus was approved in April 2006.