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Monjuvi (tafasitamab-cxix)
tafasitamab
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = tafasitamab-cxix
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, and dosing incl. toxicity-related dose adjustments
diffuse large B-cell lymphoma, relapsed or refractory
- [12 mg/kg/dose IV x1 on days 1, 4, 8, 15, 22 of 28-day cycle for cycle 1, then 12 mg/kg/dose IV x1 on days 1, 8, 15, 22 of 28-day cycle for cycles 2-3, then 12 mg/kg/dose IV x1 on days 1, 15 of 28-day cycle starting cycle 4 until dz progression]
- Info: for pts ineligible for autologous HSCT; use w/ lenalidomide for up to first 12 cycles
follicular lymphoma, relapsed or refractory
- [12 mg/kg/dose IV x1 on days 1, 8, 15, 22 of 28-day cycle for cycles 1-3, then 12 mg/kg/dose IV x1 on days 1, 15 of 28-day cycle for cycles 4-12]
- Info: use w/ lenalidomide and rituximab
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x3mo after D/C
- caution: pts of childbearing potential
Drug Interactions .
Overview
tafasitamab
CD19 antigen inhibitor
- hypokalemia
- immunosuppressive oncologic agent
- myelosuppressive oncologic agent
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
- arsenic trioxide
- chloramphenicol
- cladribine oral
- deferiprone
- deuruxolitinib
- 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
- abiraterone acetate
- acetazolamide
- albendazole
- albuterol
- albuterol inhaled
- alemtuzumab
- allopurinol
- aloe
- amphotericin
- anthrax vaccine
- anti-thymocyte globulin
- arformoterol inhaled
- asenapine
- asparaginase
- atidarsagene autotemcel
- auranofin
- axicabtagene ciloleucel
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- betamethasone
- betibeglogene autotemcel
- brexucabtagene autoleucel
- budesonide
- bumetanide
- carboplatin
- carfilzomib
- cetuximab
- chikungunya vaccine
- chlorothiazide
- chlorthalidone
- cidofovir
- cisplatin
- clozapine
- colchicine
- corticotropin
- cortisone
- COVID-19 vaccine
- crizotinib
- cyclophosphamide
- dapsone
- decitabine
- deferasirox
- deflazacort
- dexamethasone
- dichlorphenamide
- dinutuximab
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- emapalumab
- epinephrine
- ethacrynic acid
- everolimus
- exagamglogene autotemcel
- filgrastim (G-CSF)
- flucytosine
- fludrocortisone
- fluphenazine
- formoterol inhaled
- foscarnet
- fostamatinib
- furosemide
- givinostat
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydrochlorothiazide
- hydrocortisone
- hydroxychloroquine
- hydroxyurea
- iloperidone
- indapamide
- influenza H5N1 vaccine
- influenza vaccine
- insulin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- isoproterenol
- Japanese encephalitis vaccine
- leflunomide
- lenalidomide
- levalbuterol inhaled
- licorice
- linezolid
- lonafarnib
- lovotibeglogene autotemcel
- lumateperone
- lymphocyte immune globulin, anti-thymocyte globulin
- magnesium citrate
- mannitol
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methazolamide
- methotrexate
- methylprednisolone
- metolazone
- mifepristone
- motixafortide
- mycophenolate mofetil
- mycophenolic acid
- necitumumab
- nilotinib
- olodaterol inhaled
- olsalazine
- osilodrostat
- pamidronate
- panitumumab
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- pneumococcal vaccine
- poliovirus vaccine
- polyethylene glycol
- polyethylene glycol/electrolytes
- posaconazole
- prednisolone
- prednisone
- proguanil
- pyrimethamine
- respiratory syncytial virus vaccine
- ribavirin
- rifabutin
- rituximab
- sacituzumab govitecan
- salmeterol inhaled
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- selinexor
- sipuleucel-T
- sirolimus
- sirolimus albumin-bound
- smallpox/mpox vaccine, live
- sodium benzoate
- sodium phenylacetate
- sodium phenylbutyrate
- sodium polystyrene sulfonate
- sodium thiosulfate
- stiripentol
- succimer
- sulfasalazine
- sulfate bowel prep
- tagraxofusp
- teplizumab
- terbutaline
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topiramate
- torsemide
- trastuzumab
- triamcinolone
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- vamorolone
- vancomycin
- vilanterol inhaled
- zidovudine
- zonisamide
- zoster vaccine, recombinant
Caution Advised
- abatacept
- adalimumab
- anakinra
- avacopan
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- bimekizumab
- brodalumab
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- canakinumab
- certolizumab pegol
- clobetasol ophthalmic
- crovalimab
- cyclosporine
- danicopan
- deucravacitinib
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- dupilumab
- eculizumab
- efgartigimod alfa
- etanercept
- fingolimod
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- golimumab
- guselkumab
- hydrocortisone ophthalmic
- inebilizumab
- infliximab
- iptacopan
- ixekizumab
- lebrikizumab
- loteprednol ophthalmic
- mirikizumab
- mitoxantrone
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- natalizumab
- nipocalimab
- ocrelizumab
- ofatumumab
- ozanimod
- pegcetacoplan
- ponesimod
- pozelimab
- prednisolone ophthalmic
- ravulizumab
- rilonacept
- risankizumab
- rozanolixizumab
- secukinumab
- siltuximab
- siponimod
- spesolimab
- sutimlimab
- tacrolimus
- tezepelumab
- tildrakizumab
- tralokinumab
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vedolizumab
- vilobelimab
- voclosporin
- zilucoplan
Adverse Reactions .
Serious Reactions
- infusion rxn
- neutropenia
- febrile neutropenia
- thrombocytopenia
- anemia
- lymphopenia
- infection, serious
- pneumonia
- sepsis
- PML
Common Reactions
- neutropenia
- fatigue
- anemia
- diarrhea
- thrombocytopenia
- cough
- fever
- peripheral edema
- appetite decr.
- hypokalemia
- back pain
- constipation
- UTI
- bronchitis
- abdominal pain
- nausea
- vomiting
- muscle spasms
- rash
- febrile neutropenia
- dyspnea
- pruritus
- pneumonia
- arthralgia
- extremity pain
- headache
- paresthesia
- lymphopenia
- infusion rxn
- dysgeusia
- sepsis
- weight loss
- nasal congestion
- erythema
- musculoskeletal pain
- alopecia
- hyperhidrosis
- glucose incr.
- calcium decr.
- aPTT incr.
- GGT incr.
- albumin decr.
- magnesium decr.
- Cr incr.
- AST incr.
- uric acid incr.
- phosphate decr.
Safety/Monitoring .
Monitoring Parameters
CBC w/ diff at baseline, prior to each cycle, and periodically; s/sx infusion rxn during infusion; s/sx infection
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available, though likely to cross placenta based on human data w/ other monoclonal antibodies; possible risk of fetal and neonatal harm, incl. B-cell depletion, based on drug's mechanism of action; for infants exposed to tafasitamab in utero, avoid live vaccines until hematology eval. completed
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and x3mo after D/C in pts of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x3mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: other; CYP450: unknown
Excretion: other; Half-life: 17 days
Subclass: Immunotherapy, CD19 Inhibitors
Mechanism of Action
binds to cell surface antigen CD19, inducing tumor cell death via apoptosis and immune effector mechanisms, incl. antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) (monoclonal antibody)
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: MorphoSys US Inc. and Incyte Corp.
DEA/FDA: Rx
Approximate Retail Price
from http://www.goodrx.com/monjuvi
intravenous powder for injection:
- 200 mg (1 vial): $1,252.00
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