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Imdelltra (tarlatamab-dlle)
tarlatamab
Black Box Warnings .
Cytokine Release Syndrome
including life-threatening or fatal reactions, occurred in 57% of patients; initiate tx using step-up dosing schedule for cycle 1; administer concomitant meds before and after infusion on day 1 and day 8 of cycle 1 to reduce CRS incidence and severity; administer at appropriate healthcare facility, monitor patients x22-24h post-infusion at facility on days 1 and 8 of cycle 1, recommend patients remain within 1h of facility with caregiver x48h after days 1 and 8 of cycle 1 infusions, then monitor signs/symptoms during tx and counsel patients to seek immediate medical attention if signs/symptoms of CRS occur; withhold tx until CRS resolves or permanently D/C tx based on severity
Neurological Toxicities
life-threatening or fatal reactions, including immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 65% of patients; may occur concurrently with CRS, after CRS resolution, or in the absence of CRS; monitor patients for signs/symptoms during tx and treat promptly; withhold tx until ICANS resolves or permanently D/C tx based on severity
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = tarlatamab-dlle
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, concomitant meds, and dosing including toxicity-related dose adjustments
small cell lung CA, extensive-stage
- [10 mg IV x1 on days 1, 15 of 28-day cycle, starting cycle 2]
- Start: 1 mg IV x1 on day 1, then 10 mg IV x1 on day 8, then 10 mg IV x1 on day 15 of 28-day cycle for cycle 1; Info: for patients with disease progression on or after platinum-based chemo
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate-severe impairment: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- dehydration
- avoid: breastfeeding during tx and x2mo after D/C
- caution: patients of childbearing potential
- caution: infection, active
Drug Interactions .
Overview
tarlatamab
bispecific T cell engager
- immunomodulatory effects
- myelosuppressive oncologic agent
- caution advised with narrow therapeutic index drugs, especially during and up to 14 days after CRS; tarlatamab may incr. cytokine release leading to suppression of metabolic enzymes, may cause incr. levels of CYP450 substrates, risk of adverse effects
Contraindicated
- adenovirus vaccine, live
- BCG live intravesical
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- talimogene laherparepvec
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- abrocitinib
- anifrolumab
- chloramphenicol
- cladribine oral
- deferiprone
- dexrazoxane
- etrasimod
- fexinidazole
- ganciclovir
- palifermin
- penicillamine
- pimecrolimus topical
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- ritlecitinib
- ropeginterferon alfa-2b
- ruxolitinib topical
- valganciclovir
Monitor/Modify Tx
- albendazole
- alemtuzumab
- allopurinol
- anthrax vaccine
- anti-thymocyte globulin
- atidarsagene autotemcel
- auranofin
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- chikungunya vaccine
- cidofovir
- clozapine
- colchicine
- copper histidinate
- COVID-19 vaccine
- cyclophosphamide
- dapsone
- deferasirox
- deuruxolitinib
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- etuvetidigene autotemcel
- everolimus
- exagamglogene autotemcel
- filgrastim (G-CSF)
- flucytosine
- fluphenazine
- foscarnet
- fosfomycin injection
- fostamatinib
- givinostat
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- Japanese encephalitis vaccine
- leflunomide
- linezolid
- lonafarnib
- lovotibeglogene autotemcel
- lymphocyte immune globulin, anti-thymocyte globulin
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- mycophenolate mofetil
- mycophenolic acid
- olsalazine
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- pneumococcal vaccine
- poliovirus vaccine
- proguanil
- pyrimethamine
- respiratory syncytial virus vaccine
- ribavirin
- rifabutin
- rituximab
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- sipuleucel-T
- sirolimus
- smallpox/mpox vaccine, live
- stiripentol
- succimer
- sulfasalazine
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tocilizumab
- tofacitinib
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- vancomycin
- zidovudine
Caution Advised
- abatacept
- adalimumab
- anakinra
- avacopan
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- betamethasone
- bimekizumab
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- canakinumab
- certolizumab pegol
- ciclesonide
- clobetasol ophthalmic
- coccidioides immitis skin test antigen
- corticotropin
- cortisone
- crovalimab
- cyclosporine
- cytarabine
- danicopan
- daunorubicin
- deflazacort
- delgocitinib topical
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- dupilumab
- eculizumab
- efgartigimod alfa
- emapalumab
- etanercept
- etoposide
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- icotrokinra
- inebilizumab
- infliximab
- iptacopan
- ixekizumab
- lebrikizumab
- lomustine
- loteprednol ophthalmic
- methylprednisolone
- mirikizumab
- mitoxantrone
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- nadofaragene firadenovec intravesical
- narsoplimab
- natalizumab
- nipocalimab
- obinutuzumab
- ocrelizumab
- ofatumumab
- ozanimod
- pegcetacoplan
- pentostatin
- pirtobrutinib
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- ravulizumab
- relacorilant
- rilonacept
- rilzabrutinib
- risankizumab
- rozanolixizumab
- secukinumab
- selinexor
- sibeprenlimab
- siltuximab
- siponimod
- spesolimab
- sutimlimab
- tacrolimus
- temsirolimus
- tezepelumab
- thioguanine
- tildrakizumab
- trabectedin
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- vilobelimab
- voclosporin
- zilucoplan
Adverse Reactions .
Serious Reactions
- cytokine release syndrome
- fever
- hypotension
- tachycardia
- hypoxia
- neurotoxicity, severe
- immune effector cell-associated neurotoxicity syndrome
- peripheral neuropathy
- delirium
- syncope
- neutropenia
- thrombocytopenia
- anemia
- febrile neutropenia
- infection, serious
- opportunistic infection
- pneumonia
- hepatotoxicity
- hypersensitivity reaction
- pulmonary embolism
- respiratory failure
- tumor lysis syndrome
Common Reactions
- neurotoxicity
- cytokine release syndrome
- Hgb decr.
- fatigue
- ALT or AST elevated
- infection
- appetite decr.
- fever
- dysgeusia
- platelets decr.
- constipation
- musculoskeletal pain
- nausea
- cough
- bilirubin elevated
- neutrophils decr.
- immune effector cell-associated neurotoxicity syndrome
- headache
- dyspnea
- lymphocytes decr.
- sodium decr.
- potassium decr.
- sodium incr.
- magnesium decr.
- Cr incr.
- alk phos incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; CBC with diff, LFTs at baseline, before each dose up through day 15 of cycle 5, then before dose on day 1 of each cycle starting cycle 6, and as clinically indicated; signs/symptoms of cytokine release syndrome, neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS) x22-24h post-infusion at appropriate healthcare facility on days 1, 8 of cycle 1, then x6-8h post-infusion on day 15 of cycle 1 and days 1, 15 of cycle 2, then x3-4h post-infusion on days 1, 15 of cycles 3 and 4, then x2h post-infusion on days 1, 15 of cycle 5 and thereafter
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available, though likely to cross placenta based on animal data with surrogate molecule; possible risk of fetal harm based on drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x2mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x2mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for tarlatamab: catabolism; CYP450: unknown
Excretion: for tarlatamab: unknown; Half-life: 11.2 days
Subclass: Immunotherapy, Bispecific CD3 T-Cell Engagers ; Immunotherapy, DLL3 Inhibitors
Mechanism of Action
for tarlatamab: binds to delta-like ligand 3 (DLL3) receptors on cells, and CD3 receptors on T-cells, leading to T-cell activation and subsequent lysis of DLL3-expressing cells (bispecific T-cell engager)
Formulary .
No Formulary Selected
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