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Hepzato
melphalan
Black Box Warnings .
Appropriate Use
avail. only through restricted distribution program (KEPZATO KIT REMS) due to severe peri-procedural complications risk; prescribers and healthcare facilities must enroll at 1-833-632-0457 or www.HEPZATOKITREMS.com
Peri-procedural Complications
severe complications incl. hemorrhage, hepatocellular injury, thromboembolic events may occur via hepatic intra-arterial admin; assess pts during and for at least 72h after admin.
Myelosuppression
may result in severe infection, bleeding, symptomatic anemia; monitor hematologic lab parameters; delay additional cycles until blood counts improve
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-833-632-0457 or www.HEPZATOKITREMS.com for more info]
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
hepatic metastases, uveal melanoma-associated
- [>35 kg]
- Dose: 3 mg/kg/dose intra-arterially q6-8wk for up to 6 doses; Max: 220 mg/dose; Info: for pts w/ unresectable dz affecting <50% of liver, and w/o extrahepatic dz or w/ extrahepatic dz limited to bone, lymph nodes, SC tissues, lung amenable to resection/XRT; D/C PO anticoagulants before procedure and resume when hemostasis restored; D/C antiplatelets 1wk before procedure; D/C ACE inhibitors, calcium channel blockers, or alpha-1 adrenergic blockers for at least 5 half-lives before procedure; use IBW
renal dosing
- [see below]
- CrCl >50: no adjustment; CrCl <50: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- ALT <157, AST <90, or bilirubin <1.5: no adjustment; ALT >157, AST >90, or bilirubin >1.5: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to latex
- hypersensitivity to iodinated contrast
- hypersensitivity to heparin
- HIT
- intracranial metastases, active
- brain lesion, active
- cardiac dz, active
- hepatic failure
- portal HTN
- varices
- coagulopathy, uncorrectable
- ANC <2000
- Plt <100,000
- Hgb <10
- hepatic surgery w/in prior 4wk
- antiplatelet use w/in prior wk
- PO anticoagulant use prior to procedure
- pts w/ contraindication to general anesthesia
- pregnancy 1st trimester
- avoid: breastfeeding during tx and x1wk after D/C
- caution: pregnancy 2nd trimester
- caution: pregnancy 3rd trimester
- caution: female pts of reproductive potential
- caution: male pts of reproductive potential
- caution: hypotension risk
- caution: hepatic vascular anatomy, abnormal
- caution: biliary anatomy, abnormal
- caution: gastric acid hypersecretion syndrome
- caution: bile duct surgery hx
- caution: chemotherapy use hx
- caution: bone XRT hx
- caution: bone marrow depression
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
- 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
- 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
- peri-procedural complications
- hemorrhage
- hepatocellular injury
- thromboembolism
- hypotension, severe
- myelosuppression, severe
- febrile neutropenia
- secondary malignancy
- hypersensitivity rxn
- anaphylaxis
- infertility
- cardiac arrest
- pleural effusion
- pulmonary edema
- hypoxia
Common Reactions
- fatigue
- platelets decr.
- Hgb decr.
- nausea
- musculoskeletal pain
- leukocytes decr.
- abdominal pain
- vomiting
- neutrophils decr.
- ALT or AST incr.
- INR incr.
- prolonged aPTT
- alk phos incr.
- dyspnea
- headache
- diarrhea
- contusion
- fever
- appetite decr.
- cough
- hemorrhage
- hypotension
- calcium decr.
- troponin-I incr.
- lethargy
- inguinal pain
- dizziness
- bilirubin incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; CBC w/ diff; coagulation panel; BP; peri-procedural complications during and for at least 72h after procedure
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 female pts 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 primarily; CYP450: unknown
Excretion: urine; Half-life: 1.07h
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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