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Mavenclad
cladribine
Black Box Warnings .
Malignancies
may incr. malignancy risk; contraindicated in patients w/ current malignancy; weigh tx benefit vs. risk in patients w/ prior malignancy or incr. malignancy risk; follow standard cancer screening guidelines in patients receiving tx
Teratogenicity Risk
contraindicated in pregnancy and in all patients of reproductive potential w/o effective contraception due to fetal harm potential; malformations and embryolethality occurred in animals; exclude pregnancy prior to tx in patients of childbearing potential; advise all patients of reproductive potential to use effective contraception during tx and x6mo after last dose in each tx course; D/C tx if patient becomes pregnant
Adult Dosing .
Dosage forms: TAB: 10 mg
Special Note
- [dosing clarification]
- Info: for patients w/ relapsing forms of multiple sclerosis, incl. relapsing-remitting disease and active secondary progressive disease; not recommended for patients w/ clinically isolated syndrome; total dose divided into 2 tx courses; each tx course divided into 2 cycles; if lymphocytes <200 hold tx and give anti-herpes prophylaxis; after 2 tx courses completed do not give additional tx w/in 2y
multiple sclerosis, relapsing forms
- [40-49.9 kg]
- Dose: 40 mg/cycle PO divided qd x4 consecutive days, then 23-27 days later, give 40 mg/cycle PO divided qd x4 consecutive days; Max: 20 mg/day; Info: repeat for 2nd tx course, starting >43wk after 1st tx course completed
- [50-59.9 kg]
- Dose: 50 mg/cycle PO divided qd x4-5 consecutive days, then 23-27 days later, give 50 mg/cycle PO divided qd x4-5 consecutive days; Max: 20 mg/day; Info: repeat for 2nd tx course, starting >43wk after 1st tx course completed
- [60-69.9 kg]
- Dose: 60 mg/cycle PO divided qd x4-5 consecutive days, then 23-27 days later, give 60 mg/cycle PO divided qd x4-5 consecutive days; Max: 20 mg/day; Info: repeat for 2nd tx course, starting >43wk after 1st tx course completed
- [70-79.9 kg]
- Dose: 70 mg/cycle PO divided qd x4-5 consecutive days, then 23-27 days later, give 70 mg/cycle PO divided qd x4-5 consecutive days; Max: 20 mg/day; Info: repeat for 2nd tx course, starting >43wk after 1st tx course completed
- [80-89.9 kg]
- Dose: 80 mg/cycle PO divided qd x4-5 consecutive days, then 23-27 days later, give 70 mg/cycle PO divided qd x4-5 consecutive days; Max: 20 mg/day; Info: repeat for 2nd tx course, starting >43wk after 1st tx course completed
- [90-99.9 kg]
- Dose: 90 mg/cycle PO divided qd x5 consecutive days, then 23-27 days later, give 80 mg/cycle PO divided qd x4-5 consecutive days; Max: 20 mg/day; Info: repeat for 2nd tx course, starting >43wk after 1st tx course completed
- [100-109.9 kg]
- Dose: 100 mg/cycle PO divided qd x5 consecutive days, then 23-27 days later, give 90 mg/cycle PO divided qd x5 consecutive days; Max: 20 mg/day; Info: repeat for 2nd tx course, starting >43wk after 1st tx course completed
- [>110 kg]
- Dose: 100 mg/cycle PO divided qd x5 consecutive days, then 23-27 days later, give 100 mg/cycle PO divided qd x5 consecutive days; Max: 20 mg/day; Info: repeat for 2nd tx course, starting >43wk after 1st tx course completed
renal dosing
- [see below]
- CrCl <60: avoid use
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B or C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- breastfeeding during tx and x10 days after D/C
- CrCl <60
- hepatic impairment, Child-Pugh Class B-C
- malignancy
- infection, active
- HIV
- hepatitis
- TB infection
- lymphocyte abnormality prior to 1st tx course
- lymphocytes <800 prior to 2nd tx course
- caution: hepatic disease
- caution: hepatotoxic agent use, concurrent
- caution: malignancy history
- caution: malignancy risk
- caution: blood transfusion
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
Drug Interactions .
Overview
cladribine oral
purine analog
- prodrug activated by intracellular phosphorylation
- BCRP substrate
- CNT3 substrate
- ENT1 substrate
- P-gp substrate
- hydroxypropyl betadex-containing agent
- immunomodulatory effects
- myelosuppressive effects
- separate cladribine admin. from all other oral drugs by at least 3h; combo may incr. bioavailability of other drugs (esp. agents w/ low solubility) due to complex w/ hydroxypropyl betadex, risk of adverse effects
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
- abacavir
- abatacept
- abemaciclib
- abrocitinib
- acalabrutinib
- adalimumab
- adefovir dipivoxil
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- albendazole
- aldesleukin
- alemtuzumab
- allopurinol
- anakinra
- anifrolumab
- anti-thymocyte globulin
- arsenic trioxide
- asciminib
- atidarsagene autotemcel
- auranofin
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- balsalazide
- baricitinib
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belantamab mafodotin
- belatacept
- belimumab
- belinostat
- belumosudil
- bendamustine
- benznidazole
- betamethasone
- betibeglogene autotemcel
- bevacizumab
- bexarotene
- bimekizumab
- blinatumomab
- bortezomib
- bosutinib
- brentuximab vedotin
- brexucabtagene autoleucel
- brigatinib
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- busulfan
- cabazitaxel
- canakinumab
- capecitabine
- capmatinib
- carboplatin
- carfilzomib
- carmustine
- certolizumab pegol
- chlorambucil
- chloramphenicol
- cidofovir
- cilostazol
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clobetasol ophthalmic
- clofarabine
- clozapine
- cobicistat
- colchicine
- copanlisib
- corticotropin
- cortisone
- crizotinib
- crovalimab
- cyclophosphamide
- cyclosporine
- cytarabine
- dacarbazine
- dactinomycin
- danicopan
- dapsone
- daratumumab
- darolutamide
- dasatinib
- daunorubicin
- decitabine
- deferasirox
- deferiprone
- deflazacort
- delgocitinib topical
- deucravacitinib
- deuruxolitinib
- dexamethasone
- dexamethasone ophthalmic
- dexrazoxane
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- dipyridamole
- diroximel fumarate
- docetaxel
- dostarlimab
- doxorubicin
- dupilumab
- duvelisib
- eculizumab
- efgartigimod alfa
- eflornithine
- elacestrant
- elbasvir
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- eltrombopag
- eluxadoline
- emapalumab
- emtricitabine
- enasidenib
- encorafenib
- enfortumab vedotin
- entrectinib
- epcoritamab
- epirubicin
- eribulin
- etanercept
- etoposide
- etrasimod
- everolimus
- exagamglogene autotemcel
- fam-trastuzumab deruxtecan
- febuxostat
- fedratinib
- fexinidazole
- fingolimod
- floxuridine
- flucytosine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluorouracil
- fluphenazine
- fluticasone furoate
- fluticasone propionate
- foscarnet
- fostamatinib
- fostemsavir
- fruquintinib
- futibatinib
- ganciclovir
- gemcitabine
- gemtuzumab ozogamicin
- gilteritinib
- givinostat
- glasdegib
- glecaprevir
- glofitamab
- golimumab
- grazoprevir
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxychloroquine
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- imatinib
- imetelstat
- imlunestrant
- inebilizumab
- infliximab
- inotuzumab ozogamicin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- iptacopan
- irinotecan
- isatuximab
- itraconazole
- ivosidenib
- ixabepilone
- ixekizumab
- lamivudine
- lazertinib
- lebrikizumab
- leflunomide
- lenacapavir
- lenalidomide
- leniolisib
- lifileucel
- linezolid
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- lonafarnib
- loncastuximab tesirine
- lopinavir/ritonavir
- loteprednol ophthalmic
- lovotibeglogene autotemcel
- lurbinectedin
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- lymphocyte immune globulin, anti-thymocyte globulin
- maribavir
- melphalan
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- methylprednisolone
- midostaurin
- mirikizumab
- mitomycin
- mitotane
- mitoxantrone
- mogamulizumab
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- natalizumab
- nelarabine
- nifedipine
- nilotinib
- nimodipine
- nipocalimab
- niraparib
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- olaparib
- olsalazine
- osimertinib
- oteseconazole
- oxaliplatin
- ozanimod
- paclitaxel
- pacritinib
- palbociclib
- panobinostat
- pegcetacoplan
- peginterferon alfa 2a
- peginterferon beta 1a
- pemetrexed
- penicillamine
- pentamidine
- pentostatin
- pibrentasvir
- pimecrolimus topical
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- pozelimab
- pralatrexate
- prednisolone
- prednisolone ophthalmic
- prednisone
- primaquine
- procarbazine
- proguanil
- pyrimethamine
- quizartinib
- rabies vaccine
- radium Ra 223 dichloride
- ravulizumab
- regorafenib
- resmetirom
- ribavirin
- ribociclib
- rifabutin
- rilonacept
- rilzabrutinib
- risankizumab
- ritlecitinib
- ritonavir
- rituximab
- rolapitant
- romidepsin
- ropeginterferon alfa-2b
- rozanolixizumab
- rucaparib
- ruxolitinib
- ruxolitinib topical
- sacituzumab govitecan
- sarilumab
- satralizumab
- secukinumab
- selinexor
- selpercatinib
- siltuximab
- siponimod
- sirolimus
- sirolimus albumin-bound
- sotorasib
- sparsentan
- spesolimab
- stiripentol
- streptozocin
- succimer
- sulfasalazine
- sulindac
- sunvozertinib
- sutimlimab
- tacrolimus
- tafamidis
- tafasitamab
- tagraxofusp
- talazoparib
- talquetamab
- tarlatamab
- tazemetostat
- teclistamab
- tedizolid phosphate
- telmisartan
- temozolomide
- temsirolimus
- tenofovir alafenamide
- tenofovir disoproxil
- teplizumab
- teriflunomide
- thalidomide
- thioguanine
- thiotepa
- ticagrelor
- tildrakizumab
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- trabectedin
- tralokinumab
- trastuzumab
- treosulfan
- triamcinolone
- trifluridine
- trimethoprim
- turmeric
- ublituximab
- upadacitinib
- ustekinumab
- vadadustat
- valganciclovir
- valproic acid
- vamorolone
- vancomycin
- vanzacaftor/tezacaftor/deutivacaftor
- vedolizumab
- velpatasvir
- venetoclax
- vilobelimab
- vimseltinib
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- voxilaprevir
- zanubrutinib
- zidovudine
- zilucoplan
- ziv-aflibercept
- zongertinib
Monitor/Modify Tx
- anthrax vaccine
- chikungunya vaccine
- COVID-19 vaccine
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- furosemide
- gabapentin
- gabapentin enacarbil
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- ibuprofen
- influenza H5N1 vaccine
- influenza vaccine
- Japanese encephalitis vaccine
- ledipasvir
- meningococcal vaccine
- momelotinib
- pneumococcal vaccine
- poliovirus vaccine
- pretomanid
- respiratory syncytial virus vaccine
- sipuleucel-T
- smallpox/mpox vaccine, live
- tick-borne encephalitis vaccine
- typhoid vaccine
Caution Advised
- apalutamide
- carbamazepine
- coccidioides immitis skin test antigen
- danshen
- dicloxacillin
- efavirenz
- fosphenytoin
- lorlatinib
- lumacaftor/ivacaftor
- meropenem
- nadofaragene firadenovec intravesical
- omaveloxolone
- oxcarbazepine
- phenobarbital
- phenytoin
- ponesimod
- primidone
- rifampin
- rifapentine
- St. John's wort
- tipranavir
- tuberculin purified protein derivative
- vaborbactam
Adverse Reactions .
Serious Reactions
- malignancy
- infection, serious
- opportunistic infection
- lymphopenia
- neutropenia
- pancytopenia
- thrombocytopenia
- liver injury
- hypersensitivity reaction
- cardiac failure
- seizures
Common Reactions
- lymphopenia
- infection
- URI
- neutropenia
- Hgb decr.
- headache
- thrombocytopenia
- hypersensitivity reaction
- nausea
- back pain
- arthralgia
- insomnia
- bronchitis
- HTN
- pyrexia
- depression
- alopecia
Safety/Monitoring .
Monitoring Parameters
CBC w/ diff before each tx course, then at 2mo and 6mo after tx start in each tx course, or if lymphocytes <200 at 2mo continue qmo x4mo, then continue periodically as clinically indicated; LFTs before each tx cycle and course; pregnancy test, and screening for cancer, HIV, HBV, HCV, TB, signs/symptoms of acute infection before each tx course; MRI at baseline if none w/in 3mo before 1st tx course; VZV antibody testing at baseline if no varicella or vaccination history
Pregnancy/Lactation .
Pregnancy
Clinical Summary
contraindicated during pregnancy; inadequate human data available; risk of fetal harm, incl. teratogenicity and embryo-fetal death based on animal data w/ cladribine IV
Pregnancy Reporting
report pregnancy during tx or w/in 6mo of last dose in patients and partners of male patients to EMD Serono Adverse Event Line at 1-800-283-8088 ext. 5563 or fax 1-781-681-2961
Individuals of Reproductive Potential
obtain negative pregnancy test before each tx course; avoid pregnancy by using effective contraception during tx and for at least 6mo after last dose in each tx course in patients of childbearing potential and male patients
Lactation
Clinical Summary
breastfeeding contraindicated during tx and x10 days after last dose; 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: phosphorylation; CYP450: none; Info: prodrug converted to active metabolite
Excretion: urine (28.5% unchanged); Half-life: 1 day
Subclass: Multiple Sclerosis
Mechanism of Action
exact mechanism of action unknown; impairs DNA synthesis w/ cytotoxic effects on B- and T-lymphocytes, resulting in lymphocyte depletion
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: EMD Serono, Inc.
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
oral tablet:
- 10 mg (1 box, 5 tablets): $43,037.00
oral tablet:
- 10 mg (1 box, 8 tablets): $70,385.00
oral tablet:
- 10 mg (1 box, 9 tablets): $79,182.00
oral tablet:
- 10 mg (1 box, 10 tablets): $87,979.00
oral tablet:
- 10 mg (1 box, 6 tablets): $52,791.00
oral tablet:
- 10 mg (1 box, 7 tablets): $61,588.00
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