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12/15 ONC-1130276
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 * About GEP-NETs
 * Disease Progression
 * Efficacy
 * Safety
 * Dosing and Administration
 * Mechanism of Action
 * Access
 * Resources


IMPORTANT SAFETY INFORMATION AND INDICATION


QUICK LINKS

 * Full Prescribing Information
 * Visit Patient Site
 * Find a Treatment Site
 * Contact Us

IMPORTANT SAFETY INFORMATION

 

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, patient management procedures, Nuclear Regulatory Commission
   patient release guidance, and instructions to the patient for follow-up
   radiation protection at home.

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INDICATION



LUTATHERA® (lutetium Lu 177 dotatate) is indicated for the treatment of
somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors
(GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in
adults.




ABOUT GEP-NETS

 * Frequency
 * Classification
 * Delay in Diagnosis
 * Mortality


DISEASE PROGRESSION

 * Monitor for Progression
 * Identify Appropriate Patients for LUTATHERA Early
 * Patient Profiles


EFFICACY

 * NETTER-1 Study Design
 * Progression-Free Survival
 * Overall Response Rate
 * Overall Survival
 * Patient-Reported Symptom Diaries
 * Post Hoc Progression-Free Survival


SAFETY

 * Adverse Reactions
 * Laboratory Abnormalities
 * NETTER-1 Final Analysis
 * ERASMUS: Long-Term Safety
 * Warnings and Precautions
 * Radiation Safety
 * Radiation Exposure
 * Radiation Spill


DOSING AND ADMINISTRATION

 * Premedication and Concomitant Medications
 * Treatment Regimen
 * Infusion Schedule and Procedures
 * Patient Management
 * Dose Modifications


MECHANISM OF ACTION

 * Overview
 * Somatostatin Receptor Expression
 * Mechanism of Action for LUTATHERA


ACCESS

 * Access and Reimbursement
 * Ordering LUTATHERA


RESOURCES

 * Health Care Professional Resources
 * Patient Resources
 * LUTATHERA Treatment Sites

INDICATION

LUTATHERA® (lutetium Lu 177 dotatate) is indicated for the treatment of
somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors
(GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in
adults.

IMPORTANT SAFETY INFORMATION

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, patient management procedures, Nuclear Regulatory Commission
   patient release guidance, and instructions to the patient for follow-up
   radiation protection at home.
 * Myelosuppression: In the NETTER-1 clinical trial, myelosuppression occurred
   more frequently in patients receiving LUTATHERA with long-acting octreotide
   compared with patients receiving high-dose long-acting octreotide (all
   grades/grade 3/4): anemia (81%/0 vs 54%/1%), thrombocytopenia (53%/1% vs
   17%/0), and neutropenia (26%/3% vs 11%/0). In NETTER-1, platelet nadir
   occurred at a median of 5.1 months following the first dose. Of the 59
   patients who developed thrombocytopenia, 68% had platelet recovery to
   baseline or normal levels. The median time to platelet recovery was 2 months.
   Fifteen of the 19 patients in whom platelet recovery was not documented had
   post-nadir platelet counts. Among these 15 patients, 5 improved to grade 1, 9
   to grade 2, and 1 to grade 3. Monitor blood cell counts. Withhold dose,
   reduce dose, or permanently discontinue LUTATHERA based on the severity of
   myelosuppression.
 * Secondary Myelodysplastic Syndrome and Leukemia: In NETTER-1, with a median
   follow-up time of 76 months in the main study, myelodysplastic syndrome (MDS)
   was reported in 2.3% of patients receiving LUTATHERA with long-acting
   octreotide compared with no patients receiving high-dose long-acting
   octreotide. In ERASMUS, a phase 2 clinical study, 16 patients (2.0%)
   developed MDS and 4 (0.5%) developed acute leukemia. The median time to onset
   was 29 months (range, 9-45 months) for MDS and 55 months (range, 32-125
   months) for acute leukemia.
 * Renal Toxicity: In ERASMUS, 8 patients (<1%) developed renal failure 3 to 36
   months following LUTATHERA. Two of these patients had underlying renal
   impairment or risk factors for renal failure (eg, diabetes or hypertension)
   and required dialysis. Administer the recommended amino acid solution before,
   during, and after LUTATHERA to decrease the reabsorption of lutetium Lu 177
   dotatate through the proximal tubules and decrease the radiation dose to the
   kidneys. Advise patients to hydrate and to urinate frequently before, on the
   day of, and on the day after administration of LUTATHERA. Monitor serum
   creatinine and calculated creatinine clearance. Withhold dose, reduce dose,
   or permanently discontinue LUTATHERA based on the severity of renal toxicity.
   Patients with baseline renal impairment may be at increased risk of toxicity
   due to increased radiation exposure; perform more frequent assessments of
   renal function in patients with baseline mild or moderate impairment.
   LUTATHERA has not been studied in patients with baseline severe renal
   impairment (creatinine clearance <30 mL/min) or those with end-stage renal
   disease.
 * Hepatotoxicity: In ERASMUS, 2 patients (<1%) were reported to have hepatic
   tumor hemorrhage, edema, or necrosis, with 1 patient experiencing
   intrahepatic congestion and cholestasis. Patients with hepatic metastasis may
   be at increased risk of hepatotoxicity due to radiation exposure. Monitor
   transaminases, bilirubin, serum albumin, and the international normalized
   ratio during treatment. Withhold dose, reduce dose, or permanently
   discontinue LUTATHERA based on the severity of hepatotoxicity.
 * Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema,
   occurred in patients treated with LUTATHERA. Monitor patients closely for
   signs and symptoms of hypersensitivity reactions, including anaphylaxis,
   during and following LUTATHERA administration for a minimum of 2 hours in a
   setting in which cardiopulmonary resuscitation medication and equipment are
   available. Discontinue the infusion upon the first observation of any signs
   or symptoms consistent with a severe hypersensitivity reaction and initiate
   appropriate therapy. Premedicate patients with a history of grade 1/2
   hypersensitivity reactions to LUTATHERA before subsequent doses. Permanently
   discontinue LUTATHERA in patients who experience grade 3/4 hypersensitivity
   reactions.
 * Neuroendocrine Hormonal Crisis: Neuroendocrine hormonal crises, manifesting
   with flushing, diarrhea, bronchospasm, and hypotension, occurred in <1% of
   patients in ERASMUS and typically occurred during or within 24 hours
   following the initial LUTATHERA dose. Two (<1%) patients were reported to
   have hypercalcemia. 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 when administered to a
   pregnant woman. Verify the pregnancy status of females of reproductive
   potential prior to initiating LUTATHERA. Advise pregnant women of the
   potential risk to a fetus. Advise females of reproductive potential to use
   effective contraception during treatment with LUTATHERA and for 7 months
   after the last dose. Advise males with female partners of reproductive
   potential to use effective contraception during treatment with LUTATHERA and
   for 4 months after the last dose.
 * Risk of Infertility: LUTATHERA may cause infertility in males and females.
   Radiation absorbed by testes 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 the
LUTATHERA arm) observed in NETTER-1 were lymphopenia (44%), increased
gamma-glutamyl transferase (20%), vomiting (7%), nausea (5%), increased
aspartate aminotransferase (5%), increased alanine aminotransferase (4%),
hyperglycemia (4%), and hypokalemia (4%).

In ERASMUS, the following serious adverse reactions have been observed with a
median follow-up time of >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.

Glucocorticoids can induce downregulation of subtype 2 somatostatin receptors.
Avoid repeated administration of high doses of glucocorticoids during treatment
with LUTATHERA.

SPECIFIC POPULATIONS

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

Please see full Prescribing Information.


BACK TO TOP


GEP-NETs, gastroenteropancreatic neuroendocrine tumors.

References: 1. Lutathera. Prescribing information. Advanced Accelerator
Applications. 2. Strosberg J, El-Haddad G, Wolin E, et al; for the NETTER-1
trial investigators. Phase 3 trial of 177Lu-dotatate for midgut neuroendocrine
tumors. N Engl J Med. 2017;376(2):125-135.

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5/23 277529


 


NEW DATA ARE AVAILABLE –– RESULTS FROM NETTER-2

Novartis is happy to announce that the latest results from the NETTER-2 clinical
trial for LUTATHERA are now available. These results, in combination with the
results from the NETTER-1 study, could be significant for your patients.

To learn more, review the data across both trials for LUTATHERA.

Review the evidence across trials

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