Ordering Information for LUTATHERA®
(lutetium Lu 177 dotatate)
The following information is for educational purposes only. Contact AAA Customer Service as described below for detailed information regarding ordering.
Ordering LUTATHERA may be done through AAA Customer Service and your institution. Please follow the instructions listed below. Please note that LUTATHERA may only be ordered through AAA Customer Service.
E-Mail: orders-US@adacap.com or Fax: 973‑272‑1112
An online ordering system is currently not available but is planned for the future.
Ordering of Confirmation
Cancellation & Returns
Unused doses may be returned to AAA in accordance with the Product Returns Policy set forth in the Purchase Agreement. Unused dose claims will be charged an unused dose fee of $2,000. Unused dose fees will be waived in cases where the patient is no longer eligible for treatment due to pretreatment testing.
IMPORTANT SAFETY INFORMATION1
WARNINGS AND PRECAUTIONS
The most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in LUTATHERA arm) observed in NETTER-1 were lymphopenia (44%), increased GGT (20%), vomiting (7%), nausea (5%), elevated AST (5%), increased ALT (4%), hyperglycemia (4%), and hypokalemia (4%).
In ERASMUS, the following serious adverse reactions have been observed with a median follow-up time of more than 4 years after treatment with LUTATHERA: myelodysplastic syndrome (2%), acute leukemia (1%), renal failure (2%), hypotension (1%), cardiac failure (2%), myocardial infarction (1%), and neuroendocrine hormonal crisis (1%). Patients should be counseled and monitored in accordance with the LUTATHERA Prescribing Information.
Somatostatin and its analogs competitively bind to somatostatin receptors and may interfere with the efficacy of LUTATHERA. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA dose. Administer short- and long-acting octreotide during LUTATHERA treatment as recommended.
To report SUSPECTED ADVERSE REACTIONS, contact Advanced Accelerator Applications USA, Inc. at 1-844-863-19301-844-863-1930, or email@example.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
Distributed by: Advanced Accelerator Applications USA, Inc., NJ 07041
References: 1. LUTATHERA® [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; July 2018.