Axumin - nowy radioznacznik PET (wznowa biochem. CaP)

Axumin - nowy radioznacznik PET (wznowa biochem. CaP)

Nieprzeczytany postautor: zosia bluszcz » 07 cze 2018, 14:56

W nawiązaniu do postu Rakara dot. rozpoczecia produkcji radioznacznika Axumin w Polsce.




EPAR summary for the public

Axumin
fluciclovine (18F)



This is a summary of the European public assessment report (EPAR) for Axumin. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Axumin.

For practical information about using Axumin, patients should read the package leaflet or contact their doctor or pharmacist.

What is Axumin and what is it used for?


Axumin is a diagnostic medicine used with a body scan to check whether or not prostate cancer has returned.

It is used specifically with the body scan known as positron-emission tomography (PET) in men whose blood test for prostate-specific antigen (PSA) indicate that the cancer may have returned.

Axumin is a ‘radiopharmaceutical’: it contains the active substance fluciclovine (18F), which emits a small amount of radiation.

How is Axumin used?

Axumin is available as a solution for injection, which is given as a single injection into a vein around 3 to 5 minutes before the patient is to undergo a PET scan.

Axumin can only be obtained with a prescription. The PET images must be read by nuclear medicine physicians trained in interpreting PET scan images with Axumin. Patients should discuss the results of their PET scan with their doctor. For further information, see the package leaflet.


How does Axumin work?


The active substance in Axumin, fluciclovine (18F), works by entering prostate cancer cells via structures (LAT-1 and ASCT2) that are present in high numbers on the surface of these cells. Once inside the cancer cells, it emits radiation which is detected on the PET scan, enabling doctors to see where the cancer is located.

What benefits of Axumin have been shown in studies?

In a main study involving medical records from 115 men, PET scans with Axumin correctly detected cancers in 99% of all patients whose cancer had in fact returned (as confirmed by tissue sampling).
When the scans from this study were looked at by another team of researchers, the scans were again shown to be able to detect cancer in most patients who had it. (87% of patients with cancer had positive scans.)

However, because some scans with Axumin were falsely positive (showing that cancer had returned when tissue sampling was negative), a positive result on its own is not enough to make a diagnosis.
Depending on the person reading the scans, only 17 to 54% of patients whose tissue samples did not show cancer had a negative scan result.


All men enrolled in this study had already shown some signs that the cancer might have returned, such as increases in blood levels of PSA, a protein produced in the prostate glands. The accuracy of the scans varied depending on the PSA levels.


http://www.ema.europa.eu/docs/en_GB/doc ... 230833.pdf



EPAR summary for the public- Axumin.pdf
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Re: Axumin - nowy radioznacznik PET spec. dla CaP

Nieprzeczytany postautor: zosia bluszcz » 07 cze 2018, 15:06

Ze strony producenta:



Axumin® (fluciclovine F 18) injection | Safety & Side Effects


INDICATION
Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

-> Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.

-> Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.

-> Axumin use contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.


https://www.axumin.com/about/safety-side-effects
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