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Xromi
hydroxyurea
Black Box Warnings .
Myelosuppression
may cause severe myelosuppression; do not give if bone marrow function markedly depressed; monitor blood counts, hold tx or decr. dose as necessary
Carcinogenic Risk
hydroxyurea is carcinogenic; advise sun protection and monitor pts for malignancies
Adult Dosing .
Dosage forms: SOL: 100 mg per mL
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, prophylactic meds, and dosing incl. toxicity-related dose adjustments
sickle cell dz (off-label)
- [15-35 mg/kg/dose PO qd]
- Start: 15 mg/kg/dose PO qd; Max: 35 mg/kg/day; Info: for pts w/ sickle cell anemia w/ recurrent moderate to severe painful crises; titrate dose by 5 mg/kg/day q8-12wk to max tolerated dose while maint. ANC 1000-3000 and Plt >80,000; round dose to nearest 10 mg
renal dosing
- [adjust dose amount]
- CrCl <60: 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 .
- Dosage forms: SOL: 100 mg per mL
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, prophylactic meds, and dosing incl. toxicity-related dose adjustments
sickle cell dz
- [6 mo and older]
- Dose: 15-35 mg/kg/dose PO qd; Start: 15 mg/kg/dose PO qd; Max: 35 mg/kg/day; Info: for pts w/ sickle cell anemia w/ recurrent moderate to severe painful crises; titrate dose by 5 mg/kg/day q8-12wk to max tolerated dose while maint. ANC 1000-3000 and Plt >80,000; round dose to nearest 10 mg
renal dosing
- [adjust dose amount]
- CrCl <60: 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]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy 1st trimester
- myelosuppression
- anemia, severe
- leg ulcer
- avoid: sun exposure
- avoid: breastfeeding during tx and for at least 5h after D/C
- caution: pregnancy 2nd trimester
- caution: pregnancy 3rd trimester
- caution: pts of childbearing potential
- caution: male pts of reproductive potential
- caution: interferon use hx
- caution: interferon use, concurrent
- caution: chemotherapy use hx
- caution: XRT hx
- caution: long-term use
- caution: CrCl <60
- caution: myeloproliferative disorder
Drug Interactions .
Overview
hydroxyurea
antimetabolite
- immunosuppressive effects
- immunosuppressive oncologic agent
- interferes w/ gene therapy
- methemoglobinemia
- myelosuppressive effects
- myelosuppressive oncologic agent
Contraindicated
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- smallpox vaccine, live
- varicella vaccine, live
Avoid/Use Alternative
- chloramphenicol
- deferiprone
- fexinidazole
- lovotibeglogene autotemcel
- palifermin
- primaquine
- radium Ra 223 dichloride
- valganciclovir
Monitor/Modify Tx
- acalabrutinib
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- albendazole
- alemtuzumab
- allopurinol
- anthrax vaccine
- anti-thymocyte globulin
- asciminib
- asenapine
- atidarsagene autotemcel
- auranofin
- azacitidine
- azathioprine
- balsalazide
- baricitinib
- belantamab mafodotin
- belinostat
- bendamustine
- benznidazole
- bevacizumab
- bexarotene
- blinatumomab
- bosutinib
- brentuximab vedotin
- brexucabtagene autoleucel
- busulfan
- cabazitaxel
- capecitabine
- carfilzomib
- carmustine
- chikungunya vaccine
- chlorambucil
- cidofovir
- ciltacabtagene autoleucel
- cladribine injection
- clofarabine
- clozapine
- colchicine
- COVID-19 vaccine
- crizotinib
- cytarabine
- dacarbazine
- dactinomycin
- dapsone
- dasatinib
- daunorubicin
- decitabine
- deferasirox
- dinutuximab
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- docetaxel
- doxorubicin
- duvelisib
- ebola vaccine, live
- efbemalenograstim alfa
- eflornithine
- elivaldogene autotemcel
- elranatamab
- enfortumab vedotin
- entrectinib
- epcoritamab
- eribulin
- etoposide
- everolimus
- exagamglogene autotemcel
- fam-trastuzumab deruxtecan
- fedratinib
- filgrastim (G-CSF)
- floxuridine
- fludarabine
- fluorouracil
- fluphenazine
- foscarnet
- fostamatinib
- gemcitabine
- givinostat
- glasdegib
- glofitamab
- Haemophilus b vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- ibritumomab tiuxetan
- ibrutinib
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- iloperidone
- imatinib
- influenza H5N1 vaccine
- influenza vaccine
- inotuzumab ozogamicin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- irinotecan
- isatuximab
- ixabepilone
- Japanese encephalitis vaccine
- leflunomide
- lenalidomide
- lifileucel
- linezolid
- lomustine
- lonafarnib
- loncastuximab tesirine
- lumateperone
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- lymphocyte immune globulin, anti-thymocyte globulin
- melphalan
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- midostaurin
- mitomycin
- mitotane
- mitoxantrone
- mogamulizumab
- momelotinib
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- nelarabine
- nilotinib
- obecabtagene autoleucel
- obinutuzumab
- ofatumumab
- olaparib
- oxaliplatin
- paclitaxel
- pacritinib
- palbociclib
- panobinostat
- pegfilgrastim (G-CSF)
- peginterferon beta 1a
- pemetrexed
- pentamidine
- pentostatin
- pirtobrutinib
- pneumococcal vaccine
- poliovirus vaccine
- pomalidomide
- pralatrexate
- procarbazine
- proguanil
- pyrimethamine
- quizartinib
- respiratory syncytial virus vaccine
- ribociclib
- rituximab
- romidepsin
- rucaparib
- ruxolitinib
- sacituzumab govitecan
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- selinexor
- sipuleucel-T
- sirolimus
- sirolimus albumin-bound
- smallpox/mpox vaccine, live
- stiripentol
- streptozocin
- succimer
- sulfasalazine
- tafasitamab
- tagraxofusp
- talazoparib
- talquetamab
- tarlatamab
- tazemetostat
- thalidomide
- thioguanine
- thiotepa
- tick-borne encephalitis vaccine
- tisagenlecleucel
- tofacitinib
- treosulfan
- trifluridine
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- venetoclax
- vincristine
- vinorelbine
- zanubrutinib
- zidovudine
Caution Advised
- abatacept
- abrocitinib
- adalimumab
- anakinra
- anifrolumab
- articaine
- avacopan
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- benzocaine topical
- betamethasone
- bimekizumab
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- bupivacaine
- bupivacaine liposomal
- butamben
- canakinumab
- certolizumab pegol
- chloroprocaine
- clobetasol ophthalmic
- corticotropin
- cortisone
- crovalimab
- cyclosporine
- danicopan
- deflazacort
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- dupilumab
- eculizumab
- efgartigimod alfa
- elotuzumab
- emapalumab
- etanercept
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- inebilizumab
- infliximab
- iptacopan
- ixekizumab
- lebrikizumab
- lidocaine
- loteprednol ophthalmic
- mepivacaine
- methylprednisolone
- mirikizumab
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- ocrelizumab
- ozanimod
- pegcetacoplan
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- procaine
- ravulizumab
- regorafenib
- risankizumab
- ritlecitinib
- ropivacaine
- rozanolixizumab
- secukinumab
- siltuximab
- siponimod
- spesolimab
- sutimlimab
- tacrolimus
- tetracaine
- tezepelumab
- tildrakizumab
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- vilobelimab
- voclosporin
- zilucoplan
Adverse Reactions .
Serious Reactions
- myelosuppression
- leukopenia
- anemia
- thrombocytopenia
- hemolytic anemia
- macrocytosis
- secondary leukemia (long-term use)
- skin CA (long-term use)
- infection
- vasculitic ulcer
- gangrene
- dermatomyositis
- lupus erythematosus
- radiation recall rxn
- mucositis, severe
- pancreatitis (combo w/ antiretrovirals)
- hepatotoxicity (combo w/ antiretrovirals)
- peripheral neuropathy (combo w/ antiretrovirals)
- fever
- hallucinations
- seizures
- interstitial lung dz
- pulmonary fibrosis
- pneumonitis
- alveolitis
- renal impairment
- tumor lysis syndrome
- male infertility
Common Reactions
- myelosuppression
- stomatitis
- infection
- anorexia
- nausea
- vomiting
- diarrhea
- constipation
- rash
- skin ulcer
- peripheral erythema
- facial erythema
- nail hyperpigmentation (long-term use)
- skin hyperpigmentation (long-term use)
- nail atrophy (long-term use)
- skin atrophy (long-term use)
- scaling
- alopecia
- renal impairment
- ALT or AST elevated
- headache
- drowsiness
- fever
- rigors
- dizziness
- asthenia
- edema
- dyspnea
- erythrocyte abnormalities
- arthralgia
- cough
- abdominal pain
- weight gain
- fatigue
- back pain
- extremity pain
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; Cr at baseline, then periodically; CBC w/ diff at baseline, then q2wk thereafter, or more frequently if renal or hepatic impairment
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use in 1st trimester, weigh risk/benefit in 2nd and 3rd trimesters; risk of teratogenicity in 1st trimester based on animal data at 0.3x and 0.8x MRHD; risk of fetal harm low in 2nd and 3rd trimesters based on limited human data
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and for at least 6mo after D/C in pts of childbearing potential and for at least 12mo after D/C in male pts
Lactation
Clinical Summary
avoid breastfeeding during tx and for at least 5h after D/C; no human data available, though possible risk of infant harm based on drug excretion into milk; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver 60%, intestines; CYP450: unknown
Excretion: urine primarily (40% unchanged); Half-life: 2-4h
Subclass: Antimetabolites, Urea Derivatives ; Sickle Cell Disease
Mechanism of Action
exact mechanism of action unknown; inhibits ribonucleotide reductase, immediately inhibiting DNA synthesis; increases fetal hemoglobin levels, RBC water content, and sickled cell deformability; alters RBC adhesion to endothelium
Formulary .
No Formulary Selected
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