• Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

Contraindicated in:

• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Renal impairment
• Severe hepatic impairment
• Hepatic metastases (↑ risk of hepatotoxicity)
• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CNS: anxiety, dizziness, headache, dysgeusia.

CV: hypertension, peripheral edema, atrial fibrillation.

Derm: alopecia, flushing.

Endo: hyperglycemia, hyperuricemia, hypoglycemia, neuroendocrine hormonal crisis.

F and E: hyperkalemia, hypernatremia, hypocalcemia, hypokalemia.

GI: HEPATOTOXICITY, abdominal pain, constipation, diarrhea, nausea, vomiting.

GU: renal failure, ↓ fertility.

Hemat: neutropenia, LEUKEMIA, MYELODYSPLASTIC SYNDROME, anemia, leukopenia, lymphopenia, thrombocytopenia.

Metab: ↓appetite.

MS: pain.

Resp: cough.

Misc: fatigue, fever.

Drug-Drug:

• Effectiveness may be ↓ by somatostatin analogs, including octreotide; discontinue long-acting somatostatin analogs 4 wk and short-acting somatostatin analogs 24 hr before each dose.
• Effectiveness may be ↓ by corticosteroids; avoid repeated administration of high-dose corticosteroids during treatment.

• Solution for injection: 10 mCi/mL;

• IV (Adults): 7.4 GBq (200 mCi) every 8 wk for a total of 4 doses.

Lutathera

• Acts as a beta-emitting radionuclide which binds to somatostatin receptors, particularly subtype 2 receptors. Once bound to these receptors, the compound is internalized and then emits beta radiation which leads to cellular damage in somatostatin receptor-positive cells and in surrounding cells.

• Improvement in progression-free survival.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: radiopharmaceuticals

Absorption: IV administration results in complete bioavailability.

Distribution: Extensively distributed to extravascular tissues.

Metabolism/Excretion: Does not undergo hepatic metabolism. Primarily excreted in urine.

Half-life: 71 hr.

(blood concentrations)

• Inform patient that Lutathera contributes to overall long-term radiation exposure. Long-term cumulative radiation exposure is associated with increased risk for cancer. Radiation can be detected in urine for up to 30 days after Lutathera administration. Provide instructions to patient for follow-up radiation protection at home to minimize radiation exposure household contacts.
• Advise patient to urinate frequently during and after administration of Lutathera to decrease radiation dose to kidneys.
• Advise patient to notify health care professional if signs and symptoms of infection (fever, chills, dizziness, shortness of breath, increased bleeding or bruising) and neuroendocrine hormonal crisis occur.
• Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to avoid falls. Patient should also be cautioned not to drink alcoholic beverages or to take products containing aspirin or NSAIDs; may precipitate GI hemorrhage.
• Inform patient of risk for secondary cancers, including myelodysplastic syndrome and acute leukemia.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during for 7 mo after last dose and to avoid breastfeeding during and for 2.5 mo after last dose. Advise males with female partners of reproductive potential to use effective contraception during and for 4 mo after last dose. May impair male and female fertility.
• Emphasize importance of regular lab tests to monitor for side effects.

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NDC Code^*

• 69488- Advanced Accelerator Applications USA, Inc
  • 69488-003- Lutathera
    • 69488-003-01- 1 VIAL in 1 PACKAGE (69488-003-01) > 20.5 mL in 1 VIAL