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 3/4): 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 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 months1
- – 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 31
- Monitor blood cell counts. Withhold dose, reduce dose, or permanently discontinue LUTATHERA based on the 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 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 LUTATHERA1
- Monitor serum creatinine and calculated creatinine clearance. Withhold dose, reduce dose, or permanently discontinue LUTATHERA based on the severity of renal toxicity1
- 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 disease1
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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, serum albumin, and the INR during treatment. Withhold dose, reduce dose, or permanently discontinue LUTATHERA based on the severity of hepatotoxicity1
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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 therapy1
- 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 reactions1
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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 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 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 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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