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What is Axumin, and how does it work?
What are the side effects of Axumin?
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- The clinical trial database for Axumin includes data from 877 subjects including 797 males diagnosed with prostate cancer.
- Most patients received a single administration of Axumin, a small number of subjects (n = 50) received up to five administrations of the drug.
- The mean administered activity was 370 MBq (range, 163 to 485 MBq).
- Adverse reactions were reported in =1% of subjects during clinical studies with Axumin.
- The most common adverse reactions were
- injection site pain,
- injection site erythema and
What is the dosage for Axumin?
Radiation Safety - Drug Handling
Axumin is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration. Use waterproof gloves and effective shielding, including syringe shields, when handling and administering Axumin.
Recommended Dose And Administration Instructions
The recommended dose is 370 MBq (10 mCi) administered as an intravenous bolus injection.
- Inspect Axumin visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored.
- Use aseptic technique and radiation shielding when withdrawing and administering Axumin.
- Calculate the necessary volume to administer based on calibration time and date, using a suitably calibrated instrument. The recommended maximum volume of injection of undiluted Axumin is 5mL.
- Axumin may be diluted with Sodium Chloride Injection, 0.9%.
- After the Axumin injection, administer an intravenous flush of sterile Sodium Chloride Injection, 0.9% to ensure full delivery of the dose.
- Dispose of any unused drug in a safe manner in compliance with applicable regulations.
Patient Preparation Prior To PET Imaging
- Advise the patient to avoid any significant exercise for at least one day prior to PET imaging.
- Advise patients not to eat or drink for at least 4 hours (other than small amounts of water for taking medications) prior to administration of Axumin.
Image Acquisition Guidelines
- Position the patient supine with arms above the head. Begin PET scanning 3 to 5 minutes after completion of the Axumin injection.
- It is recommended that image acquisition should start from midthigh and proceed to the base of the skull. Typical total scan time is between 20 to 30 minutes.
Image Display And Interpretation
- Localization of prostate cancer recurrence in sites typical for prostate cancer recurrence is based on fluciclovine F 18 uptake in comparison with tissue background.
- For small lesions (less than 1cm in diameter) focal uptake greater than blood pool should be considered suspicious for prostate cancer recurrence.
- For larger lesions, uptake equal to or greater than bone marrow is considered suspicious for prostate cancer recurrence.
- The radiation absorbed doses estimated for adult patients following intravenous injection of Axumin are shown in Table 1.
- Values were calculated from human biodistribution data using OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling) software.
- The (radiation absorbed) effective dose resulting from the administration of the recommended activity of 370 MBq of Axumin is 8 mSv.
- For an administered activity of 370 MBq (10 mCi), the highestmagnitude radiation doses are delivered to the pancreas, cardiac wall, and uterine wall: 38 mGy, 19 mGy, and 17 mGy, respectively.
- If a CT scan is simultaneously performed as part of the PET procedure, exposure to ionizing radiation will increase in an amount dependent on the settings used in the CT acquisition.
Table 1: Estimated Radiation Absorbed Doses in Various Organs /Tissues in Adults
who Received Axumin
|Organ/Tissue||Mean Absorbed Dose per Unit Administered
|Lower large intestine wall||12|
|Small intestine wall||13|
|Upper large intestine wall||13|
|Red bone marrow||25|
|Urinary bladder wall||25|
|Effective dose||22 (microSv/MBq)|
Is Axumin safe to use while pregnant or breastfeeding?
- Axumin is not indicated for use in females and there is no information on the risk of adverse development outcomes in pregnant women or animals with the use of fluciclovine F 18.
- Axumin is not indicated for use in females and there is no information of the presence of fluciclovine F 18 in human milk.
Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. The most common side effects of Axumin include injection site pain, injection site erythema, and dysgeusia.
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Prostate Cancer Symptoms, PSA Test, Treatments
Prostate cancer is the most common cancer in men. Learn the signs and symptoms of prostate cancer, along with causes and...
Is prostate cancer the most common cancer in men? Take this quiz to find out and learn the causes, symptoms and treatments of...
Related Disease Conditions
Prostate Cancer Staging and Prognosis
The prognosis for prostate cancer, as with any cancer, depends on how advanced the cancer has become, according to established stage designations. The patient's PSA score at diagnosis, as well as their Gleason score (the grading system used to determine the aggressiveness of prostate cancer) determines the prognosis and final stage designation. Prostate cancer has a high survival rate in general, but your chances depend on the stage of the cancer.
What Are the 5 Warning Signs of Prostate Cancer?
Prostate cancer rarely produces symptoms in the early stage; however, few signs can help in detecting prostate cancer.
Early Prostate Cancer
Second Source article from Government
Prostate Cancer: Erectile Dysfunction
Second Source article from The Cleveland Clinic
Prostate Cancer (Prostatic Cancer) Symptoms and Causes
Difficulty with urination – frequency, weak stream, trouble getting started, etc. – is usually the first sign of prostate cancer. But these and other early symptoms of prostatic cancer can also come from benign prostate conditions, so diagnostic testing is important, including PSA tests and digital rectal exam.
Prostate cancer is the most common cancer in men after skin cancer. Risk factors include age, family history, ethnicity, and diet. Prostate cancer is diagnosed by digital rectal exam, prostate specific antigen (PSA) test, and prostate biopsy. Symptoms may include frequent need to urinate, incontinence, pain, blood in the urine, fatigue, and more. Prognosis and treatment depend on cancer staging. Watchful waiting, surgery, radiation, cryotherapy, and other management strategies are available. Research and clinical trials strive to find new and better treatments for prostate cancer.
Prostate Cancer Facts
Prostate cancer is a leading cause of cancer and cancer death in males; in some men, identifying it early may prevent or delay metastasis and death from prostate cancer. The prostate is a walnut-shaped gland that is a part of the male reproductive system that wraps around the male urethra at it exits the bladder. Prostate cancer is common in men over 50 years of age, with the risk of developing prostate cancer increases with aging.
Can Prostate Cancer Be Completely Cured?
Prostate cancer is the second most common cancer in men. Due to routine screening of prostate-specific antigen (PSA) levels in the United States, nearly 90% of prostate cancers get detected in early stages. When found early, there are several treatment options available and prostate cancer has a high chance of getting cured.
Early-Stage Prostate Cancer Treatment
If prostate cancer is detected early and appears to be slow-growing, invasive procedures, chemotherapy, radiation and other approaches can sometimes do more harm than good. Many prostate cancer treatments come with side effects, like incontinence or impotence, so it’s in the patient’s interest to put off invasive treatments as long as is medically safe. Active surveillance is where doctors "watch and wait" for changes that could prompt medical intervention.
How Is Prostate Cancer Diagnosed?
Prostate cancer is largely a disease of men over 40, so it’s around this age doctors recommend the first prostate screening. The first exam is a blood test to determine if there are abnormal prostate specific antigen (PSA) levels in your blood – PSA is produced by the prostate. If the PSA is high, your doctor will perform a digital rectal exam, during which the doctor feels your prostate from inside your rectum with a gloved finger. Other diagnostic tests include an endoscopic biopsy of tumor tissue for analysis in a lab.
Prostate Cancer Treatment: Radical Prostatectomy Surgery
Radical prostatectomy, or surgical removal of the entire prostate gland, isn’t typically the first choice in prostate cancer treatment. Sometimes a radical approach is necessary to keep the cancer from metastasizing, however. Some cases are too severe or diagnosed too late for drugs or radiation to have much effect. In these cases, treatment teams may opt for a radical prostatectomy, despite potential side effects like impotence and incontinence.
Prostate Cancer Treatment: Hormonal Therapy
Prostate cancer is highly sensitive to, and dependent on, the level of the male hormone testosterone, which drives the growth of prostate cancer cells. Testosterone belongs to a family of hormones called androgens, and today front-line hormonal therapy for advanced and metastatic prostate cancer is called androgen deprivation therapy (ADT).
Prostate Cancer Treatment: Radiation, Brachytherapy and Radiopharmaceuticals
Radiation treatment for prostate cancer is a powerful tool at doctors’ disposal. Using radiation vs. surgery or other invasive treatments to kill cancer cells may still cause side effects, but ideally they are less severe. Radiation therapy can be performed via external beam therapy (EBRT) or the placement of radioactive seeds into the prostate (prostate brachytherapy) or using radioactive drugs (radiopharmaceuticals).
Prostate Cancer Treatment: Chemotherapy, Bone-Targeted and Immune Therapy
Doctors may introduce chemotherapy and immune therapy if other measures fail to cure a case of prostate cancer. However, unlike with other forms of cancer, chemotherapy isn’t the first choice for early prostate cancer. Immune therapy uses the body's own immune system to attack the prostate tumor, while bone-targeted therapy aims to preserve bone and prevent metastasis.
The early signs of prostate cancer
Prostate cancer in its early stages usually causes no signs and symptoms. Screening can help detect the cancer early.
Prostate Cancer Treatment: Focal Therapy and Other Experimental Treatments
Several new and experimental treatments for prostate cancer are under study, including treatments that use ultrasound, lasers, tissue-freezing gas, and new ways of administering radiation. These new methods are types of focal therapy, that is, treatment focused on the cancer cells in the prostate, rather than systemic therapy that administers medications or other treatments to the whole body with the aim of treating the prostate.
How Is Prostate Cancer Screening Done?
There are no standard or routine screening tests for prostate cancer. Studies are being done to find ways to make prostate-specific antigen (PSA) testing more accurate for early cancer detection.
When Should You Screen for Prostate Cancer?
Screening for prostate cancer helps detecta tumor early, enabling timely treatment and prevention of any complications. According to the American Cancer Society (ACS), the decision to get screened should be made by men in consultation with their doctor. The doctor needs to counsel the men about the uncertainties involved in the screening process, the risks and potential benefits of getting screened for prostate cancer.
Treatment & Diagnosis
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.