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.

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Ordering

All orders must be made using the approved order form. Orders may be faxed or e-mailed to the address or number below. To ensure availability, orders should be placed by the Tuesday 2 weeks prior to the Product Calibration Time. Calibration days are Monday to Friday (Tuesday to Friday for Hawaii). AAA does not guarantee a requested product calibration time until customer receives email confirmation from AAA.

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.

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Ordering of Confirmation

An order confirmation will be sent to your preferred contact information within 24 hours of placing an order. Please ensure that @adacap.com email addresses are not blocked by your email service.
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Cancellation & Returns

Orders may be canceled up to 10 days before the product calibration time at no charge. Late cancellations are accepted prior to start of production (normally 2 days before the product calibration time) for a fee of $500.

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.

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Customer Service

For ordering support or general questions, please contact AAA Customer Service at 844-DOSE-AAA. AAA Customer Service is available from 9:00 AM EST to 8:00 PM EST, Monday to Friday.
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Pharmacovigilance

Any issues pertaining to product quality or safety should be immediately reported to AAA atUS-pharmacovigilance@adacap.com

IMPORTANT SAFETY INFORMATION1

WARNINGS AND PRECAUTIONS

  • Radiation Exposure: Treatment with LUTATHERA contributes to a patient’s overall long-term cumulative radiation exposure and is associated with an increased risk for cancer. Radiation can be detected in the urine for up to 30 days following LUTATHERA administration. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with LUTATHERA consistent with institutional good radiation safety practices and patient management procedures.
  • Myelosuppression: In NETTER-1 clinical trial, myelosuppression occurred more frequently in patients receiving LUTATHERA with long acting octreotide at the following rates (all grades/grade 3 or 4): anemia (81%/0), thrombocytopenia (53%/1%), and neutropenia (26%/3%). Blood cell counts must be monitored prior to, during, and after treatment. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.
  • Secondary Myelodysplastic Syndrome and Leukemia: In NETTER-1, with a median follow-up time of 24 months, myelodysplastic syndrome (MDS) was reported in 2.7% of patients receiving LUTATHERA with long-acting octreotide. In ERASMUS, a Phase I/II clinical study, 15 patients (1.8%) developed MDS and 4 (0.5%) developed acute leukemia. The median time to the development of MDS was 28 months (9 to 41 months) and 55 months (32 to 155 months) for acute leukemia.
  • Renal Toxicity: Treatment with LUTATHERA will expose kidneys to radiation, which may impair renal function. In ERASMUS <1% of patients developed renal failure 3 to 36 months following LUTATHERA. Monitor serum creatinine and creatinine clearance to assess changes in renal function. Advise patients to urinate frequently during and after administration of LUTATHERA. A concomitant intravenous infusion of amino acids before, during and after LUTATHERA administration is mandatory for renal protection. Patients with baseline renal impairment may be at greater risk of toxicity. Perform more frequent assessments of renal function in patients with mild or moderate impairment. Withhold, reduce dose, or permanently discontinue based on severity of reaction. Do not decrease the dose of amino acid solution if the dose of LUTATHERA is reduced. LUTATHERA has not been studied in patients with severe renal impairment (CrCL < 30 mL/min).
  • Hepatotoxicity: In ERASMUS, <1% of patients were reported to have hepatic tumor hemorrhage, edema, or necrosis, with one patient experiencing intrahepatic congestion and cholestasis. Patients with hepatic metastasis may be at increased risk of hepatotoxicity due to radiation exposure. Monitor transaminases, bilirubin, and serum albumin during treatment. Withhold, reduce dose, or permanently discontinue based on severity of reaction.
  • Neuroendocrine hormonal crisis: Manifesting with flushing, diarrhea, bronchospasm and hypotension, neuroendocrine hormonal crisis occurred in 1% of patients in ERASMUS and typically occurred during or within 24 hours following the initial LUTATHERA dose. Monitor patients for flushing, diarrhea, hypotension, bronchoconstriction or other signs and symptoms of tumor-related hormonal release. Administer intravenous somatostatin analogs, fluids, corticosteroids, and electrolytes as indicated.
  • Embryo-Fetal Toxicity: LUTATHERA can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the final dose. Verify pregnancy status of females of reproductive potential prior to initiating LUTATHERA.
  • Risk of Infertility: LUTATHERA may cause infertility in males and females. Radiation absorbed by testis and ovaries from the recommended cumulative LUTATHERA dose falls within the range in which temporary or permanent infertility can be expected following external beam radiotherapy.

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

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.

SPECIFIC POPULATIONS

  • Lactation: Because of the potential risk for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with LUTATHERA and for 2.5 months after the final dose.

To report SUSPECTED ADVERSE REACTIONS, contact Advanced Accelerator Applications USA, Inc. at 1-844-863-19301-844-863-1930, or us-pharmacovigilance@adacap.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.

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