RISK FROM RADIATION EXPOSURE |
- LUTATHERA contributes to a patient’s overall long-term radiation exposure. Long-term, cumulative radiation exposure is associated with an increased risk for cancer. Radiation can be detected in the urine for up to 30 days following administration of LUTATHERA1
- 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 home1
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MYELOSUPPRESSION |
- In NETTER-1, 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 or 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 weeks following the first dose1
- Of the 59 patients who developed thrombocytopenia, 68% had platelet recovery to baseline or normal levels1
- – 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, reduce dose, or permanently discontinue based on severity of myelosuppression1
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SECONDARY MDS AND LEUKEMIA |
- In NETTER-1, with a median follow-up time of 76 months in main study, MDS was reported in 2.3% of patients receiving LUTATHERA with long-acting octreotide compared with no patients receiving high-dose, long-acting octreotide1
- In ERASMUS, 16 patients (2.0%) developed MDS and 4 (0.5%) developed acute leukemia. The median time to the onset was 29 months (range, 9-45 months) for MDS and 55 months (range, 32-125 months) for acute leukemia1
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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 dialysis1
- Administer the recommended amino acid solution before, during, and after LUTATHERA to decrease reabsorption of LUTATHERA through the proximal tubules and decrease the radiation dose to the kidneys. Do not decrease the dose of the amino acid solution if the dose of LUTATHERA is reduced. Advise patients to urinate frequently during and after administration of LUTATHERA1
- Monitor serum creatinine and calculated creatinine clearance. Withhold, reduce dose, or permanently discontinue LUTATHERA based on severity of renal toxicity1
- 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. LUTATHERA has not been studied in patients with severe renal impairment (CrCL <30 mL/min)1
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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 exposure1
- Monitor transaminases, bilirubin, and serum albumin during treatment. Withhold, reduce dose, or permanently discontinue LUTATHERA based on severity of hepatoxicity1
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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 administration of LUTATHERA 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
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HORMONAL CRISIS |
- Neuroendocrine hormonal crisis, 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 dose of LUTATHERA. Two (<1%) patients were reported to have hypercalcemia1
- Monitor patients for flushing, diarrhea, hypotension, bronchoconstriction, or other signs and symptoms of tumor-related hormonal release. Administer intravenous SSAs, fluids, corticosteroids, and electrolytes as indicated1
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EMBRYO-FETAL TOXICITY |
- Based on its mechanism of action, LUTATHERA can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LUTATHERA in pregnant women. No animal studies using LUTATHERA have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, all radiopharmaceuticals, including LUTATHERA, have the potential to cause fetal harm1
- Verify pregnancy status of females of reproductive potential prior to initiating LUTATHERA1
- 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 final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with LUTATHERA and for 4 months after the final dose1
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RISK OF INFERTILITY |
- LUTATHERA may cause infertility in males and females. The recommended cumulative dose of 29.6 GBq of LUTATHERA results in a radiation-absorbed dose to the testes and ovaries within the range in which temporary or permanent infertility can be expected following external beam radiotherapy1
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