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:

Administer antiemetics 30mins 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. 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:

Not established.

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 CBCs, serum creatinine, CrCl, transaminases, bilirubin, and serum albumin during therapy; withhold, reduce dose, or permanently discontinue based on severity of reaction. Advise patients to urinate frequently during and after therapy. 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. Pregnancy: exclude status prior to initiation. Use effective contraception during therapy and for 7 months (females), and 4 months (males w. female partners) after final dose. Nursing mothers: not recommended (during therapy and for 2.5 months after final dose).

Pharmacologic Class:

Somatostatin analogue.

Interactions:

Efficacy may be affected by somatostatin and its analogues (see Adults).

Adverse Reactions:

Lymphopenia, increased GGT, vomiting, nausea, increased AST/ALT, hyperglycemia, hypokalemia; myelosuppression, secondary myelodysplastic syndrome, leukemia, renal toxicity, hepatotoxicity, neuroendocrine hormonal crisis.

Generic Availability:

NO

How Supplied:

Single-dose vial—1