Piflufolastat: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 29, 2026🚩 Report this page

Piflufolastat

Active ingredient

Sold as Pylclari

GB MHRAEU EMA

Drug class: -
Availability: See label
Markets covered: 2
Products on record: 3

Overview

Piflufolastat is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	May 29, 2026
EU European Union	EMA	1	March 2, 2026

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised May 29, 2026[1]

This medicinal product is for diagnostic use only. Pylclari is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings: • Primary staging of patients with high-risk PCa prior to initial curative therapy, • To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised March 2, 2026[2]

This medicinal product is for diagnostic use only. Pylclari is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings: • Primary staging of patients with high-risk PCa prior to initial curative therapy, • To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent.
3

How to take

Sources & citations

[1]MHRA (UK) · PLGB443010003 · revised May 29, 2026
[2]European Medicines Agency · EMEA/H/C/005520 · revised March 2, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

GBOfficial regulatory label· revised May 29, 2026[1]

This medicinal product is for use in designated nuclear medicine facilities only and should only be handled by authorised personnel. Posology The mean recommended activity of (18F) piflufolastat is 4 MBq/kg of body weight and can vary from 3 to 5 MBq/kg of body weight depending on the PET equipment and acquisition mode used.
The minimum activity should not fall below 190 MBq and the maximum activity should not exceed 360 MBq. Renal impairment / Hepatic impairment Piflufolastat (18F) has only been studied in patients with mild renal impairment. Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in patients with severe impaired renal function.
Piflufolastat (18F) has not been studied in patients with hepatic impairment. Paediatric population There is no relevant use of piflufolastat (18F) in the paediatric population. Method of administration It is administered by a single intravenous injection.
Pylclari is presented in multidose vial. 5 ml of solution per vial. 2 ml to 10 ml. 6. For instructions on dilution of the medicinal product before administration, see section 12. Image acquisition It is recommended to position the patient supine with arms above the head.
A non contrast-enhanced low-dose CT scan is performed from the vertex of the skull through mid-thigh for attenuation correction and anatomic correlation. The PET acquisition is performed from mid-thigh through the vertex of the skull, starting 90 to 120 minutes after tracer injection.
It must include lower extremities if there is known or suspected disease. Image acquisition duration is 12 to 40 minutes depending on the type of PET cameras, number of bed positions (typically 6 to 8) and acquisition time per bed position (typically 2 minutes to 5 minutes).
If the acquisition leads to indeterminate findings, and provided a sufficient activity remains for adequate counting statistics, late acquisitions can also be performed, thus reducing background activity. 4.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 29, 2026[1]

Summary of safety profile The overall safety profile is based on data from its administration to 797 patients from three clinical studies and spontaneous reporting. In the clinical studies, each patient received a single administration with a median administered activity of 330 MBq.
Adverse reactions have been reported during clinical development and are listed below by MedDRA body system organ class. Tabulated list of adverse reactions The frequencies of adverse reactions are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), Uncommon (³1/1 000 to <1/100), Rare (³1/10 000 to <1/1 000), Very rare (<1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
Adverse reactions observed with piflufolastat (18F) MedDRA body system organ class Adverse reactions Frequency Immune system disorders Hypersensitivity Uncommon Metabolism and nutrition disorders Dehydration Uncommon Psychiatric disorders Disorientation Uncommon Syncope Not known* Dysgeusia Headache Common Dizziness Hyperaesthesia Nervous system disorders Migraine Uncommon Eye disorders Visual field defect Uncommon Ear and labyrinth disorders Vertigo Uncommon NauseaGastrointestinal disorders Vomiting Not known* Dry skinSkin and subcutaneous tissue disorders Rash Uncommon Arthralgia Muscular weakness Musculoskeletal and connective tissue disorders Pain in extremity Uncommon Renal and urinary disorders Dysuria Uncommon Fatigue Uncommon Chest discomfort Application site rash Feeling abnormal General disorders and administration site conditions Injection site pain Uncommon *Adverse reactions derived from spontaneous reporting with a not known frequency.
5%) being the most frequent. Three serious drug-related adverse events (hypersensitivity, headache, and paresthesia) were reported, all experienced by one patient and only hypersensitivity was assessed as drug- related in this patient who had a significant history of allergic reactions.
All three serious drug-related adverse events were resolved. Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 4 mSv when the maximal recommended activity of 360 MBq is administered in a 70 kg-weighted patient, these adverse reactions are expected to occur with a low probability.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 29, 2026[1]

Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available. Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit.
The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information. Renal impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
2. Patient preparation The patient should be well hydrated before the start of the examination and urged to void before the examination in order to reduce bladder activity and as often as possible during the first hours after the examination in order to reduce radiation exposure.
A diuretic expected to act within the uptake time period may be administered to improve interpretation of piflufolastat (18F) PET/CT as it results in less activity depositions in ureters and the bladder. After the procedure Close contact with infants and pregnant women should be restricted during the initial 12 hours following the injection.
Interpretation of piflufolastat (18F) images The recommended method for PET images interpretation with piflufolastat (18F) PET/CT is the visual interpretation. Lesions should be considered suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake is expected.
Piflufolastat (18F) accumulates in normal tissue where the density of PSMA is high including the lacrimal glands, salivary glands, liver, spleen, and kidneys. Normal organs demonstrate significant variability in the uptake of piflufolastat (18F); however, the impact of tumor burden on normal uptake is minimal and unlikely to be clinically significant.
g. g hemangioma, ganglia, since they can mimic lymph nodes, benign bone disease (Paget’s disease), pulmonary sarcoidosis/granulomatosis). Images should be interpreted only by readers trained in the interpretation of PET images with piflufolastat (18F).

This is not medical advice. Consult a qualified healthcare professional.

EUOfficial regulatory label· revised March 2, 2026[2]

This medicinal product is for use in designated nuclear medicine facilities only and should only be handled by authorised personnel. Posology The mean recommended activity of (18F) piflufolastat is 4 MBq/kg of body weight and can vary from 3 to 5 MBq/kg of body weight depending on the PET equipment and acquisition mode used.
The minimum activity should not fall below 190 MBq and the maximum activity should not exceed 360 MBq. Renal impairment / Hepatic impairment Piflufolastat (18F) has only been studied in patients with mild renal impairment. Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in patients with severe impaired renal function.
Piflufolastat (18F) has not been studied in patients with hepatic impairment. Paediatric population There is no relevant use of piflufolastat (18F) in the paediatric population. Method of administration It is administered by a single intravenous injection.
Pylclari is presented in multidose vial. 5 mL of solution per vial. 2 mL to 10 mL. 6. For instructions on dilution of the medicinal product before administration, see section 12. Image acquisition It is recommended to position the patient supine with arms above the head.
A non contrast-enhanced low-dose CT scan is performed from the vertex of the skull through mid-thigh for attenuation correction and anatomic correlation. The PET acquisition is performed from mid-thigh through the vertex of the skull, starting 90 to 120 minutes after tracer injection.
It must include lower extremities if there is known or suspected disease. Image acquisition duration is 12 to 40 minutes depending on the type of PET cameras, number of bed positions (typically 6 to 8) and acquisition time per bed position (typically 2 minutes to 5 minutes).
If the acquisition leads to indeterminate findings, and provided a sufficient activity remains for adequate counting statistics, late acquisitions can also be performed, thus reducing background activity. 4.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised March 2, 2026[2]

Summary of safety profile The overall safety profile is based on data from its administration to 797 patients from three clinical studies and spontaneous reporting. In the clinical studies, each patient received a single administration with a median administered activity of 330 MBq.
Adverse reactions have been reported during clinical development and are listed below by MedDRA body system organ class. Tabulated list of adverse reactions The frequencies of adverse reactions are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Rare (≥1/10 000 to <1/1 000), Very rare (<1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
Adverse reactions observed with piflufolastat (18F) MedDRA body system organ class Adverse reactions Frequency Immune system disorders Hypersensitivity Uncommon Metabolism and nutrition disorders Dehydration Uncommon Psychiatric disorders Disorientation Uncommon Nervous system disorders Syncope Not known* Dysgeusia Common Headache Dizziness Uncommon Hyperaesthesia Migraine Eye disorders Visual field defect Uncommon Ear and labyrinth disorders Vertigo Uncommon Gastrointestinal disorders Nausea Not known* Vomiting Skin and subcutaneous tissue disorders Dry skin Uncommon Rash Musculoskeletal and connective tissue disorders Arthralgia Uncommon Muscular weakness Pain in extremity Renal and urinary disorders Dysuria Uncommon General disorders and administration site conditions Fatigue Uncommon Chest discomfort Uncommon Application site rash Feeling abnormal Injection site pain *Adverse reactions derived from spontaneous reporting with a not known frequency.
5 %) being the most frequent. Three serious drug- related adverse events (hypersensitivity, headache, and paresthesia) were reported, all experienced by one patient and only hypersensitivity was assessed as drug-related in this patient who had a significant history of allergic reactions.
All three serious drug-related adverse events were resolved. Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 4 mSv when the maximal recommended activity of 360 MBq is administered in a 70 kg-weighted patient, these adverse reactions are expected to occur with a low probability.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised March 2, 2026[2]

Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available. Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit.
The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information. Renal impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
2. Patient preparation The patient should be well hydrated before the start of the examination and urged to void before the examination in order to reduce bladder activity and as often as possible during the first hours after the examination in order to reduce radiation exposure.
A diuretic expected to act within the uptake time period may be administered to improve interpretation of piflufolastat (18F) PET/CT as it results in less activity depositions in ureters and the bladder. After the procedure Close contact with infants and pregnant women should be restricted during the initial 12 hours following the injection.
Interpretation of piflufolastat (18F) images The recommended method for PET images interpretation with piflufolastat (18F) PET/CT is the visual interpretation. Lesions should be considered suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake is expected.
Piflufolastat (18F) accumulates in normal tissue where the density of PSMA is high including the lacrimal glands, salivary glands, liver, spleen, and kidneys. Normal organs demonstrate significant variability in the uptake of piflufolastat (18F); however, the impact of tumor burden on normal uptake is minimal and unlikely to be clinically significant.
g. g hemangioma, ganglia, since they can mimic lymph nodes, benign bone disease as Paget’s disease, or pulmonary sarcoidosis/granulomatosis). 5 Images should be interpreted only by readers trained in the interpretation of PET images with piflufolastat (18F).

This is not medical advice. Consult a qualified healthcare professional.