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Ivra
melphalan
Black Box Warnings .
Myelosuppression
severe myelosuppression leading to infection or bleeding may occur; incr. myelosuppression w/ IV formulation compared to oral formulation; monitor CBC w/ diff
Hypersensitivity Rxn
have occurred in 2% of pts receiving IV formulation, incl. anaphylaxis; D/C for serious hypersensitivity rxn
Secondary Malignancy
produces chromosomal aberrations in vitro and in vivo, thus consider potentially leukomogenic in humans
Adult Dosing .
Dosage forms: INJ
Special Note
- [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
multiple myeloma, palliative tx
- [16 mg/m^2/dose IV x1 on day 1 of 28-day cycle, starting cycle 5]
- Start: 16 mg/m^2/dose IV x1 on day 1 of 14-day cycle x4 cycles
renal dosing
- [see below]
- CrCl 10-50: decr. usual dose by 25%; CrCl <10: decr. usual dose by 50%
- HD: decr. usual dose by 50%, on dialysis days admin. after dialysis; no supplement; PD: decr. usual dose by 50%; no supplement
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy 1st trimester
- avoid: breastfeeding during tx and x1wk after D/C
- caution: pregnancy 2nd trimester
- caution: pregnancy 3rd trimester
- caution: pts of childbearing potential
- caution: male pts of reproductive potential
- caution: myelosuppression
- caution: CrCl <50
Drug Interactions .
Overview
melphalan
alkylating agent
- 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
- chloramphenicol
- cladribine oral
- deferiprone
- dexrazoxane
- etrasimod
- fexinidazole
- ganciclovir
- palifermin
- penicillamine
- pimecrolimus topical
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- ropeginterferon alfa-2b
- sipuleucel-T
- valganciclovir
Monitor/Modify Tx
- albendazole
- alemtuzumab
- allopurinol
- anthrax vaccine
- anti-thymocyte globulin
- asenapine
- atidarsagene autotemcel
- auranofin
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- chikungunya vaccine
- cidofovir
- clozapine
- colchicine
- COVID-19 vaccine
- cyclophosphamide
- dapsone
- deferasirox
- deuruxolitinib
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- everolimus
- exagamglogene autotemcel
- filgrastim (G-CSF)
- flucytosine
- fluphenazine
- foscarnet
- fostamatinib
- givinostat
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- iloperidone
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- Japanese encephalitis vaccine
- leflunomide
- linezolid
- lonafarnib
- lovotibeglogene autotemcel
- lumateperone
- 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
- ruxolitinib topical
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- sirolimus
- smallpox/mpox vaccine, live
- stiripentol
- succimer
- sulfasalazine
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tocilizumab
- tofacitinib
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- zidovudine
Caution Advised
- abatacept
- abrocitinib
- adalimumab
- anakinra
- anifrolumab
- avacopan
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- betamethasone
- bimekizumab
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- canakinumab
- carmustine
- certolizumab pegol
- clobetasol ophthalmic
- corticotropin
- cortisone
- crovalimab
- cyclosporine
- danicopan
- deflazacort
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- 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
- loteprednol ophthalmic
- methylprednisolone
- mirikizumab
- mitoxantrone
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- natalizumab
- nipocalimab
- ocrelizumab
- ofatumumab
- ozanimod
- pegcetacoplan
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- ravulizumab
- rilonacept
- risankizumab
- ritlecitinib
- rozanolixizumab
- secukinumab
- siltuximab
- siponimod
- spesolimab
- sutimlimab
- tacrolimus
- tezepelumab
- tildrakizumab
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- vilobelimab
- voclosporin
- zilucoplan
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
- secondary malignancy
- myelosuppression, severe
- bone marrow failure
- febrile neutropenia
- hepatitis
- hepatic veno-occlusive dz
- interstitial pneumonitis
- pulmonary fibrosis
- tissue damage, extravasation-related
- infertility
- diarrhea, severe
- mucositis, severe
- renal failure
- hypokalemia (HSCT use)
- hypophosphatemia (HSCT use)
Common Reactions
- myelosuppression
- nausea
- vomiting
- diarrhea
- mucositis
- stomatitis
- vasculitis
- injection site rxn
- pruritus
- rash
- urticaria
- edema, peripheral
- maculopapular rash
- alopecia
- sterility
- amenorrhea
- ALT or AST elevated
- pulmonary infiltrates
- fatigue
- hypokalemia
- hypophosphatemia
- appetite decr.
- fever
- constipation
- febrile neutropenia
- dizziness
- dysgeusia
- dyspepsia
Safety/Monitoring .
Monitoring Parameters
BUN/Cr at baseline; CBC w/ diff prior to each course, then periodically; LFTs
Look/Sound-Alike Drug Names
melphalan confused with: Mellaril; Myleran
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use in 1st trimester, weigh risk/benefit in 2nd and 3rd trimesters; no human data available; risk of teratogenicity in 1st trimester based on animal data and on human data w/ other alkylating agents
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x6mo after D/C in pts of childbearing potential and during tx and x3mo after D/C in male pts
Lactation
Clinical Summary
avoid breastfeeding during tx and x1wk after D/C; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: hydrolysis; CYP450: unknown
Excretion: urine (5.8-21.3% unchanged); Half-life: 75min
Subclass: Alkylating Agents, Nitrogen Mustards
Mechanism of Action
alkylates and cross-links DNA, inhibiting nucleic acid and protein synthesis
Formulary .
No Formulary Selected
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