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.
Adult Dosage:
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.
Children Dosage:
Not established.
LUTATHERA Warnings/Precautions:
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).
LUTATHERA Classification:
Somatostatin analogue.
LUTATHERA Interactions:
Efficacy may be affected by somatostatin and its analogues (see Adult dosing). Avoid concomitant repeated high-doses of glucocorticoids.
Adverse Reactions:
Lymphopenia, increased GGT, vomiting, nausea, increased AST/ALT, hyperglycemia, hypokalemia; myelosuppression, secondary myelodysplastic syndrome, leukemia, renal toxicity, hepatotoxicity, hypersensitivity reactions, neuroendocrine hormonal crisis.
Drug Elimination:
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:
NO
How Supplied:
Single-dose vial—1
