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Lutathera
lutetium Lu 177 dotatate
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-888-669-6682 or www.lutathera.com for more info]
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for XRT safety procedures, uses, premeds, concomitant meds, and dosing including toxicity-related dose adjustments
gastroenteropancreatic neuroendocrine tumor
- [7.4 GBq IV q8wk x4 doses]
- Info: for somatostatin receptor-positive disease; d/c long-acting somatostatin analogs at least 4wk before each dose; d/c short-acting somatostatin analogs at least 24h before each dose; give with long-acting octreotide 4-24h after each dose, continue long-acting octreotide after tx for up to 18mo total; give with amino acid solution 30min before, during, and for at least 3h after each dose
prostate CA, metastatic castration-resistant (off-label)
- [7.4 GBq IV q6wk for up to 6 doses]
- Info: for patients with progressive prostate-specific membrane antigen (PSMA)-positive disease
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined
Peds Dosing .
- Dosage forms: INJ
Restricted Distribution in US
- [1-888-669-6682 or www.lutathera.com for more info]
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for XRT safety procedures, uses, premeds, concomitant meds, and dosing including toxicity-related dose adjustments
gastroenteropancreatic neuroendocrine tumor
- [12 yo and older]
- Dose: 7.4 GBq IV q8wk x4 doses; Info: for somatostatin receptor-positive disease; give with amino acid solution 30min before, during, and for at least 3h after each dose
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: not defined
hepatic dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- avoid: breastfeeding during tx and x2.5mo after D/C
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: cumulative XRT exposure, long-term
- caution: renal impairment
- caution: renal impairment risk
- caution: hepatic metastases
Drug Interactions .
Overview
lutetium Lu 177 dotatate
radioligand therapeutic agent
- myelosuppressive oncologic agent
- hyperglycemic effects
Avoid/Use Alternative
- budesonide
- chloramphenicol
- cladribine oral
- cortisone
- deferiprone
- deflazacort
- dexamethasone
- dexrazoxane
- fexinidazole
- ganciclovir
- hydrocortisone
- methylprednisolone
- palifermin
- penicillamine
- prednisolone
- prednisone
- primaquine
- radium Ra 223 dichloride
- ropeginterferon alfa-2b
- triamcinolone
- valganciclovir
Monitor/Modify Tx
- acarbose
- albendazole
- alemtuzumab
- allopurinol
- alogliptin
- anti-thymocyte globulin
- atidarsagene autotemcel
- auranofin
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- bexagliflozin
- canagliflozin
- ceritinib
- chlorpromazine
- cidofovir
- clozapine
- colchicine
- colesevelam
- copper histidinate
- corticotropin
- cyclophosphamide
- dapagliflozin
- dapsone
- deferasirox
- deuruxolitinib
- dobutamine
- dopamine
- dulaglutide
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- empagliflozin
- ertugliflozin
- ethacrynic acid
- etuvetidigene autotemcel
- everolimus
- exagamglogene autotemcel
- exenatide
- filgrastim (G-CSF)
- flucytosine
- fluphenazine
- fosamprenavir
- foscarnet
- fosfomycin injection
- fostamatinib
- givinostat
- glimepiride
- glipizide
- glyburide
- hydroxychloroquine
- hydroxyurea
- insulin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- isoproterenol
- lanreotide
- leflunomide
- linagliptin
- linezolid
- liraglutide
- lixisenatide
- lonafarnib
- lovotibeglogene autotemcel
- lymphocyte immune globulin, anti-thymocyte globulin
- mercaptopurine
- mesalamine
- mesalamine rectal
- metformin
- methotrexate
- metolazone
- miglitol
- mycophenolate mofetil
- mycophenolic acid
- nateglinide
- niacin (vitamin B3)
- nicotine
- norepinephrine
- octreotide
- olsalazine
- pasireotide
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- perphenazine
- pioglitazone
- pramlintide
- proguanil
- pyrimethamine
- repaglinide
- ribavirin
- rifabutin
- rituximab
- rosiglitazone
- ruxolitinib topical
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- saxagliptin
- semaglutide
- sirolimus
- sitagliptin
- stiripentol
- succimer
- sulfasalazine
- teplizumab
- teriflunomide
- thalidomide
- tirzepatide
- tocilizumab
- tofacitinib
- torsemide
- trifluoperazine
- trimethoprim
- upadacitinib
- valproic acid
- vancomycin
- zidovudine
Adverse Reactions .
Serious Reactions
- myelosuppression
- lymphopenia
- secondary myelodysplastic syndrome
- secondary leukemia
- renal failure
- hepatotoxicity
- hypersensitivity reaction
- angioedema
- neuroendocrine hormonal crisis
- cardiac failure
- MI
- hypotension
- infertility
Common Reactions
- lymphopenia
- Cr incr.
- hyperglycemia
- anemia
- GGT incr.
- nausea
- alk phos incr.
- vomiting
- thrombocytopenia
- ALT or AST incr.
- fatigue
- hyperuricemia
- hypocalcemia
- bilirubin incr.
- neutropenia
- diarrhea
- abdominal pain
- hypokalemia
- appetite decr.
- headache
- dizziness
- peripheral edema
- flushing
- renal failure
- back pain
- HTN
- anxiety
- alopecia
- extremity pain
- cough
- constipation
- urinary disorder
- fever
- dysgeusia
- neck pain
- myalgia
- atrial fibrillation
- myelodysplastic syndrome
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; CBC with diff; Cr; LFTs; serum albumin; INR; hypersensitivity reaction signs/symptoms during and for at least 2h after infusion
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human or animal data available; possible risk of fetal harm based on drug's mechanism of action; lutetium Lu 177 dotatate tx includes radioactive components
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x7mo after D/C in patients of childbearing potential and during tx and x4mo after D/C in male patients
Lactation
Clinical Summary
avoid breastfeeding during tx and x2.5mo after D/C; no human data available, though possible risk of radiation exposure to infant based on drug's mechanism of action; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for lutetium Lu 177: unknown; CYP450: none
Excretion: for lutetium Lu 177: urine primarily; Half-life: 71h
Subclass: Radiopharmaceuticals, Oncologic
Mechanism of Action
for lutetium Lu 177: binds to somatostatin receptor-positive cells, inducing cellular damage by emitting beta radiation
Formulary .
No Formulary Selected
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