"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
- Clinician Information:
ProstaScint Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
ProstaScint Kit (capromab pendetide) is a monoclonal antibody used as a diagnostic imaging agent in newly-diagnosed patients with biopsy-proven prostate cancer, thought to be clinically-localized after standard diagnostic evaluation (e.g. chest x-ray, bone scan, CT scan, or MRI), who are at high-risk for pelvic lymph node metastases. Common side effects include increases in bilirubin, high or low blood pressure, elevated liver enzymes, and injection site reactions.
The recommended dose of ProstaScint is 0.5 mg radiolabeled with 5 mCi of Indium In 111 chloride. ProstaScint may interact with other drugs. Tell your doctor all medications and supplements you use. ProstaScint is not indicated for use in women, therefore it is unlikely to be used during pregnancy or while breastfeeding.
Our ProstaScint Kit (capromab pendetide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
ProstaScint FDA Prescribing Information: Side Effects
ProstaScint® (capromab pendetide) was generally well tolerated in the clinical trials. After administration of 529 single doses of Indium In 111 ProstaScint®, adverse reactions were observed in 4% of patients. The most commonly reported adverse reactions were increases in bilirubin, hypotension, and hypertension, which occurred in 1% of patients. Elevated liver enzymes and injection site reactions occurred in slightly less than 1% of patients. Other adverse reactions, listed in order of decreasing frequency, were: pruritus, fever, rash, headache, myalgia, asthenia, burning sensation in thigh, shortness of breath, and alteration of taste. Most adverse reactions were mild and readily reversible. Data from repeat administration in 61 patients revealed a similar incidence of adverse reactions (5%). No deaths were attributable to Indium In 111 ProstaScint® administration.
Read the entire FDA prescribing information for ProstaScint (Capromab Pendetide) »
Additional ProstaScint Kit Information
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.
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