Pancreatic, thyroid, and other endocrine cancers:
Indications for: LUTATHERA
Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
Administer antiemetics before amino acid solution. Give IV amino acid solution (L-lysine and L-arginine) 30mins prior to, during and for ≥3hrs after Lutathera infusion; do not reduce solution dose even if Lutathera dose is reduced. Discontinue long-acting somatostatin analogues (eg, long-acting octreotide) for ≥4wks before starting Lutathera; give short-acting octreotide as needed; discontinue ≥24hrs prior to starting Lutathera. Premedicate those with prior Grade 1 or 2 hypersensitivity reactions to Lutathera; do not rechallenge if Grade 3 or 4 reactions occur. Administer Lutathera 7.4 GBq (200mCi) as an IV infusion every 8 weeks for a total of 4 doses. Give concomitant long-acting octreotide 30mg IM between 4–24hrs after each dose. Do not give long-acting octreotide within 4 weeks of each subsequent dose. Continue long-acting octreotide 30mg IM every 4 weeks after completing Lutathera until disease progression or for up to 18 months following treatment initiation. Dose modifications for adverse reactions: see full labeling.
Should be used by physicians trained and experienced in radiopharmaceuticals. Handle with appropriate safety measures to minimize radiation exposure during and after Lutathera. Increased risk for cancer with long-term cumulative radiation exposure. Monitor closely for hypersensitivity reactions during and after infusion for a minimum of 2hrs in a setting where cardiopulmonary resuscitation medication/equipment are available. Discontinue infusion at 1st signs/symptoms of a severe hypersensitivity reaction; permanently discontinue if Grade 3 or 4 reactions occur. Monitor CBCs, serum creatinine, CrCl, transaminases, bilirubin, serum albumin, and INR during therapy; withhold, reduce dose, or permanently discontinue based on severity of reaction. Advise patients to hydrate and urinate frequently before, on the day of, and the day after administration. Monitor for signs/symptoms of tumor-related hormonal disease (eg, flushing, diarrhea, hypotension, bronchoconstriction, others); give IV somatostatin analogues, fluids, corticosteroids, and electrolytes as indicated. Mild or moderate renal impairment: assess renal function more frequently. Severe hepatic or renal impairment (CrCl <30mL/min) or ESRD: not studied. Risk of infertility. Embryo-fetal toxicity. Advise to use effective contraception during and for 7 months (females of reproductive potential) or 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2.5 months after the last dose).
Efficacy may be affected by somatostatin and its analogues (see Adult dosing). Avoid concomitant repeated high-doses of glucocorticoids.
Lymphopenia, increased GGT, vomiting, nausea, increased AST/ALT, hyperglycemia, hypokalemia; myelosuppression, secondary myelodysplastic syndrome, leukemia, renal toxicity, hepatotoxicity, hypersensitivity reactions, neuroendocrine hormonal crisis.
Primarily renal with cumulative excretion of 44% within 5 hours, 58% within 24 hours, and 65% within 48 hours following administration.
Half-life: 71 ± 28 hours.
Mean clearance: 4.5 L/h (CV 31%).
Generic Drug Availability: