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Darzalex Faspro (daratumumab/ hyaluronidase-fihj)
daratumumab/ hyaluronidase
Adult Dosing .
Dosage forms: INJ: 120 mg/2000 units per mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = daratumumab/hyaluronidase-fihj
- [equivalency or interchangeability info]
- Info: not interchangeable with IV daratumumab; do not substitute on a mg to mg basis
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, postmeds, prophylactic meds, and dosing including toxicity-related dose adjustments
multiple myeloma, newly diagnosed
- [autologous HSCT ineligible, combo with bortezomib, melphalan, and prednisone]
- Dose: 1800 mg/30,000 units SC qwk x6 doses, then starting wk 7, give 1800 mg/30,000 units SC q3wk x16 doses, then starting wk 55, give 1800 mg/30,000 units SC q4wk; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C
- [autologous HSCT ineligible, combo with bortezomib, lenalidomide, and dexamethasone]
- Dose: 1800 mg/30,000 units SC qwk x6 doses, then starting wk 7, give 1800 mg/30,000 units SC q3wk x6 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C
- [autologous HSCT ineligible, combo with lenalidomide and dexamethasone]
- Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C
- [autologous HSCT eligible, combo with bortezomib, thalidomide, and dexamethasone]
- Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x4 doses for total 16wk induction tx, then upon recovery from autologous HSCT, give 1800 mg/30,000 units SC q2wk x4 doses for total 8wk consolidation tx; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C
- [autologous HSCT eligible, combo with bortezomib, lenalidomide, and dexamethasone]
- Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x4 doses for total 16wk induction tx, then upon recovery from autologous HSCT, give 1800 mg/30,000 units SC q2wk x4 doses for total 8wk consolidation tx; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C
multiple myeloma, relapsed or refractory
- [combo with bortezomib and dexamethasone]
- Dose: 1800 mg/30,000 units SC qwk x9 doses, then starting wk 10, give 1800 mg/30,000 units SC q3wk x5 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: for patients who have received at least 1 prior tx; give VZV prophylaxis within 1wk of tx start and x3mo after D/C
- [combo with lenalidomide and dexamethasone]
- Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: for patients who have received at least 1 prior tx; give VZV prophylaxis within 1wk of tx start and x3mo after D/C
- [combo with pomalidomide and dexamethasone]
- Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: for patients who have received at least 1 prior line of tx, including lenalidomide and a proteasome inhibitor; give VZV prophylaxis within 1wk of tx start and x3mo after D/C
- [combo with carfilzomib and dexamethasone]
- Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: for patients who have received 1-3 prior lines of tx; give VZV prophylaxis within 1wk of tx start and x3mo after D/C
- [monotherapy]
- Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: for patients who have received at least 3 prior lines of tx, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double-refractory to a PI and an IMiD; give VZV prophylaxis within 1wk of tx start and x3mo after D/C
smoldering multiple myeloma, high-risk
- [monotherapy]
- Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk for up to 3y; Max: 3y; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C
light chain amyloidosis, newly diagnosed
- [combo with bortezomib, cyclophosphamide, and dexamethasone]
- Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk for up to 2y; Max: 2y; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: 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
- caution: patients of childbearing potential
- caution: elderly patients
- caution: patients with IgG kappa myeloma protein
- caution: indirect Coombs test within 6mo after tx
- caution: light chain amyloidosis with cardiac involvement
- caution: HBV infection
- caution: HBV infection history
- caution: herpes zoster history
- caution: COPD
Drug Interactions .
Overview
daratumumab
CD38 antigen inhibitor
- immunomodulatory effects
- myelosuppressive oncologic agent
hyaluronidase
dispersion agent
-
None
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
- 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
- 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
- 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
- zoster vaccine, recombinant
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
- clobetasol ophthalmic
- coccidioides immitis skin test antigen
- corticotropin
- cortisone
- crovalimab
- cyclosporine
- danicopan
- deflazacort
- delgocitinib topical
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- dupilumab
- eculizumab
- efgartigimod alfa
- emapalumab
- etanercept
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- 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
- rilonacept
- rilzabrutinib
- risankizumab
- rozanolixizumab
- secukinumab
- selinexor
- sibeprenlimab
- siltuximab
- siponimod
- spesolimab
- sutimlimab
- tacrolimus
- tezepelumab
- thioguanine
- tildrakizumab
- trabectedin
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- vilobelimab
- voclosporin
- zilucoplan
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- glaucoma, acute angle-closure
- choroidal effusion
- myopia, acute
- myelosuppression
- infection, severe
- pneumonia
- sepsis
- CMV infection
- Listeriosis
- herpes zoster (shingles) reactivation
- HBV reactivation
- HTN
- arrhythmia
- cardiac failure (light chain amyloidosis use)
- cardiac arrest (light chain amyloidosis use)
- pancreatitis
- syncope
- fracture
Common Reactions
- URI
- diarrhea
- rash
- fatigue
- infusion reaction
- fever
- back pain
- injection site reaction
- edema
- arthralgia
- musculoskeletal pain
- muscle spasms
- constipation
- vomiting
- abdominal pain
- appetite decr.
- hyperglycemia
- hypocalcemia
- dehydration
- insomnia
- HTN
- hypotension
- dizziness
- peripheral neuropathy
- paresthesia
- bronchitis
- influenza
- UTI
- herpes zoster (shingles) reactivation
- sepsis
- HBV reactivation
- pruritus
- atrial fibrillation
- cough
- pneumonia
- nausea
- rigors
- dyspnea
- blurred vision
- headache
- leukocytes decr.
- lymphocytes decr.
- neutrophils decr.
- Plt decr.
- Hgb decr.
- albumin decr.
- ALT or AST incr.
- sodium decr.
- Cr incr.
Safety/Monitoring .
Monitoring Parameters
serological type and screen test before tx start; CBC with diff; signs/symptoms of hypersensitivity reaction, especially after 1st 2 injections; ophthalmic exam if ocular signs/symptoms
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available, though likely to cross placenta based on human data with other monoclonal antibodies; possible risk of fetal and neonatal harm, including myeloid or lymphoid cell depletion and decr. bone density, based on drug's mechanism of action; for infants exposed to daratumumab in utero, avoid live vaccines until hematology evaluation completed
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and x3mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for daratumumab: other; CYP450: unknown; for hyaluronidase: local; CYP450: unknown
Excretion: for daratumumab: other; Half-life: 20 days (multiple myeloma patients), 28 days (light chain amyloidosis patients); for hyaluronidase: unknown; Half-life: unknown; Info: permeability of tissue restored within 24-48h
Subclass: Immunotherapy, CD38 Inhibitors
Mechanism of Action
for daratumumab: binds to cell surface antigen CD38, inducing tumor cell death via apoptosis and immune effector mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC); for hyaluronidase: incr. subcutaneous tissue permeability by temporarily depolymerizing hyaluronan, leading to incr. absorption of daratumumab
Formulary .
No Formulary Selected
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