Lutathera Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Lutathera Indications
Indications
Lutathera Dosage and Administration
Adult
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
Lutathera Contraindications
Not Applicable
Lutathera Boxed Warnings
Not Applicable
Lutathera Warnings/Precautions
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 Pharmacokinetics
Absorption
Mean blood exposure (AUC): 41 ng.h/mL (coefficient of variation [CV] 36%).
Mean maximum blood concentration (Cmax): 10 ng/mL (CV 50%).
Distribution
Mean volume of distribution: 460 L (CV 54%).
Non-radioactive lutetium Lu 175 dotate is 43% bound to human plasma proteins.
Coadministration of amino acids reduced the median radiation dose to the kidneys by 47% (34–59%) and increased the mean beta-phase blood clearance of lutetium Lu 177 dotatate by 36%.
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%).
Lutathera Interactions
Interactions
Efficacy may be affected by somatostatin and its analogues (see Adult dosing). Avoid concomitant repeated high-doses of glucocorticoids.
Lutathera Adverse Reactions
Adverse Reactions
Lutathera Clinical Trials
See Literature
Lutathera Note
Not Applicable
Lutathera Patient Counseling
See Literature