Dosing & Uses
Dosage Forms & Strengths
capsule
- 200mg (Droxia)
- 300mg (Droxia)
- 400mg (Droxia)
- 500mg (Hydrea, generic)
tablet
- 100mg (Siklos)
- 1000mg (tripled-scored) (Siklos)
Solid Tumors
Intermittent Therapy: 80 mg/kg PO q3day, OR
Continuous Therapy: 20-30 mg/kg PO qDay
Head & Neck Tumors
Concomitant therapy with irradiation
Chronic Myelocytic Leukemia, Resistant
Continuous Therapy: 20-30 mg/kg PO qDay
Sickle Cell Disease
Hydrea or generic (off-label)
- Start: 15 mg/kg/day as single dose; monitor patient’s blood cell count q2Weeks
- Titrate by 5 mg/kg/day q12wk
- Dose is not increased if blood counts are between acceptable range and toxic
- Not to exceed 35 mg/kg/day
- Discontinue therapy until hematologic recovery if blood counts are considered toxic; may resume treatment after reducing dose by 2.5 mg/kg/day from dose associated with hematological toxicity
Siklos
- Indicated to reduce frequency of painful crises and the need for blood transfusions in adults with sickle cell anemia who have recurrent moderate-to-severe painful crises
- Initial dose: 15 mg/kg PO qDay
- Calculate rounded doses to the nearest 50-mg or 100-mg strength based on clinical judgment
- Monitor blood cell counts q2weeks
-
Dose adjustment based on blood counts
- Increase dose 5 mg/kg/day q8Weeks or if a painful crisis occurs
- Give until mild myelosuppression (absolute neutrophil count [ANC] 2,000-4,000/mcL) achieved, not to exceed 35 mg/kg/day
- Increase dosing only if blood counts are in an acceptable range or if a painful crisis occurs
- Do not increase if myelosuppression occurs
Thrombocythemia, Essential (Off-label)
Titrate to control platelets & maintain WBC count
HIV, Adjunct Treatment (Off-label)
500 mg PO BID
Use with antiretrovirals
Psoriasis (Off-label)
1000-1500 mg/day PO qDay-BID
Dosage Modifications
Hepatic impairment: Closely monitor hematologic parameters
Renal Impairment
- CrCl ≥60 mL/min: No dosage adjustment necessary
- CrCl <60 mL/min or end-stage renal disease (ESRD): Reduce dose to 7.5 mg/kg/day and closely monitor the hematologic parameters
- ESRD patients on dialysis: On dialysis days, administer dose following hemodialysis
Hematologic toxicities
-
Blood counts acceptable range
- Neutrophils ≥2,000 cells/mm3
- Platelets ≥80,000/mm3
- Hemoglobin >5.3 g/dL
- Reticulocytes ≥80,000/mm3 if hemoglobin <9 g/dL
-
Blood counts toxic range
- Neutrophils <2,000 cells/mm3
- Platelets <80,000/mm3 if hemoglobin <4.5 g/dL
- Reticulocytes <80,000/mm3 if hemoglobin <9 g/dL
- Discontinue treatment until hematologic recovery
-
Dosing after hematologic recovery
- Reduce dose by 5 mg/kg/day from the dose associated with hematologic toxicity
- May titrate up or down q8Weeks in 5 mg/kg/day increments
- Patient should be at a stable dose with no hematologic toxicity for 24 weeks
- Permanently discontinue treatment if hematologic toxicity develops twice
Dosing Considerations
Use fetal hemoglobin (HbF) levels to evaluate the efficacy in clinical use
Obtain HbF levels every three to four months; monitor for an increase in HbF of at least two-fold over the baseline value
Verify the pregnancy status of females of reproductive potential before initiating
Dosage Forms & Strengths
tablet
- 100mg (Siklos)
- 1000mg (tripled-scored) (Siklos)
Sickle Cell Disease
Indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in children aged ≥2 years with sickle cell anemia with recurrent moderate-to-severe painful crises
<2 years: Safety and efficacy not established
2-18 years
-
Initial dose
- 20 mg/kg PO qDay
- Monitor blood counts q2weeks
-
Dose adjustment based on blood counts
- Increase dose 5 mg/kg/day q8Weeks or if a painful crisis occurs Give until mild myelosuppression (absolute neutrophil count [ANC] 2,000/mcL to 4,000/mcL) is achieved, not to exceed 35 mg/kg/day
- Increase dosing only if blood counts are in an acceptable range (see Dosage Modifications) or if a painful crisis occurs
- Do not increase if myelosuppression occurs
Dosage Modifications
Hepatic impairment: Closely monitor hematologic parameters
Renal Impairment
- CrCl ≥60 mL/min: No dosage adjustment necessary
- CrCl <60 mL/min or end-stage renal disease (ESRD): Reduce dose to 10 mg/kg/day and closely monitor the hematologic parameters
- ESRD patients on dialysis: On dialysis days, administer dose following hemodialysis
Hematologic toxicities
-
Blood counts acceptable range
- Neutrophils ≥2,000 cells/mm³
- Platelets ≥80,000/mm³
- Hemoglobin >5.3 g/dL
- Reticulocytes ≥80,000/mm³ if hemoglobin <9 g/dL
-
Blood counts toxic range
- Neutrophils <2,000 cells/mm³
- Platelets <80,000/mm³ if hemoglobin <4.5 g/dL
- Reticulocytes <80,000/mm³ if hemoglobin <9 g/dL
- Younger patients with lower baseline counts may safely tolerate ANC down to 1,250/mm³
- Discontinue treatment until hematologic recovery
-
Dosing after hematologic recovery
- Reduce dose by 5 mg/kg/day from the dose associated with hematologic toxicity
- May titrate up or down q8Weeks in 5 mg/kg/day increments
- Patient should be at a stable dose with no hematologic toxicity for 24 weeks
- Permanently discontinue treatment if a patient develops hematologic toxicity twice
Dosing Considerations
Use fetal hemoglobin (HbF) levels to evaluate the efficacy in clinical use
Obtain HbF levels every three to four months; monitor for an increase in HbF of at least two-fold over the baseline value
Verify the pregnancy status of females of reproductive potential before initiating
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (25)
- adenovirus types 4 and 7 live, oral
hydroxyurea decreases effects of adenovirus types 4 and 7 live, oral by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- axicabtagene ciloleucel
hydroxyurea, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG intravesical live
hydroxyurea decreases effects of BCG intravesical live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- BCG vaccine live
hydroxyurea decreases effects of BCG vaccine live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- betibeglogene autotemcel
hydroxyurea, betibeglogene autotemcel. Other (see comment). Avoid or Use Alternate Drug. Comment: Do not take hydroxyurea for at least 1 month before mobilization or expected duration for elimination of the medications, and until all cycles of apheresis are completed. .
- brexucabtagene autoleucel
hydroxyurea, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cholera vaccine
hydroxyurea decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- ciltacabtagene autoleucel
hydroxyurea, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- deferiprone
deferiprone, hydroxyurea. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- didanosine
hydroxyurea, didanosine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Pancreatitis, hepatotoxicity, and peripheral neuropathy have occurred in HIV patients treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, avoid this combination. .
- idecabtagene vicleucel
hydroxyurea, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, intranasal
hydroxyurea decreases effects of influenza virus vaccine quadrivalent, intranasal by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- lisocabtagene maraleucel
hydroxyurea, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles mumps and rubella vaccine, live
hydroxyurea decreases effects of measles mumps and rubella vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- measles, mumps, rubella and varicella vaccine, live
hydroxyurea decreases effects of measles, mumps, rubella and varicella vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- palifermin
palifermin increases toxicity of hydroxyurea by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, hydroxyurea. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- rotavirus oral vaccine, live
hydroxyurea decreases effects of rotavirus oral vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- smallpox (vaccinia) vaccine, live
hydroxyurea decreases effects of smallpox (vaccinia) vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- stavudine
hydroxyurea, stavudine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pancreatitis, hepatotoxicity, and peripheral neuropathy have occurred in HIV patients treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, avoid this combination. .
- tisagenlecleucel
hydroxyurea, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tofacitinib
hydroxyurea, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- typhoid vaccine live
hydroxyurea decreases effects of typhoid vaccine live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- varicella virus vaccine live
hydroxyurea decreases effects of varicella virus vaccine live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- zoster vaccine live
hydroxyurea decreases effects of zoster vaccine live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
Monitor Closely (96)
- abatacept
hydroxyurea, abatacept. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.
- acalabrutinib
acalabrutinib, hydroxyurea. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- adalimumab
hydroxyurea, adalimumab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.
- aldesleukin
aldesleukin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- alefacept
hydroxyurea, alefacept. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.
- alemtuzumab
alemtuzumab, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- allopurinol
allopurinol, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- azacitidine
azacitidine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- azathioprine
azathioprine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- belatacept
belatacept and hydroxyurea both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- belimumab
hydroxyurea, belimumab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of infection.
- bendamustine
bendamustine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- bupivacaine implant
hydroxyurea, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- busulfan
busulfan, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- carboplatin
carboplatin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- carmustine
carmustine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- certolizumab pegol
hydroxyurea, certolizumab pegol. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.
- chlorambucil
chlorambucil, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- cidofovir
cidofovir, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- cisplatin
cisplatin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- cladribine
cladribine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- clofarabine
clofarabine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- clozapine
clozapine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Avoid combination. Combination may increase risk of myelosuppression.
- cyclophosphamide
cyclophosphamide, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- cytarabine
cytarabine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- dacarbazine
dacarbazine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- dactinomycin
dactinomycin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- dasatinib
dasatinib, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- daunorubicin
daunorubicin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- decitabine
decitabine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- dengue vaccine
hydroxyurea decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
hydroxyurea, denosumab. Other (see comment). Use Caution/Monitor. Comment: Combination therapy may lead to increased risk of infection.
- dexrazoxane
dexrazoxane, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- dichlorphenamide
dichlorphenamide, hydroxyurea. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis.
- docetaxel
docetaxel, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- doxorubicin
doxorubicin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- doxorubicin liposomal
doxorubicin liposomal, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- echinacea
echinacea decreases effects of hydroxyurea by Other (see comment). Use Caution/Monitor. Comment: Echinacea may decrease therapeutic effects of immunosuppressants.
- epirubicin
epirubicin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- escitalopram
escitalopram, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- estramustine
estramustine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- etanercept
hydroxyurea, etanercept. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.
- etoposide
etoposide, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- fingolimod
hydroxyurea increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- flucytosine
flucytosine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- fludarabine
fludarabine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- fluorouracil
fluorouracil, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- ganciclovir
ganciclovir, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- gemcitabine
gemcitabine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- golimumab
hydroxyurea, golimumab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.
- idarubicin
idarubicin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- ifosfamide
ifosfamide, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
ifosfamide, hydroxyurea. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration with ifosfamide may increase the risk of immunosuppression and myelosuppression. - infliximab
hydroxyurea, infliximab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.
- influenza virus vaccine quadrivalent, cell-cultured
hydroxyurea decreases effects of influenza virus vaccine quadrivalent, cell-cultured by Other (see comment). Use Caution/Monitor. Comment: Immunosuppressants may decrease the therapeutic effects of vaccines.
- interferon alfa 2b
interferon alfa 2b, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Cutaneous vasculitic toxicities (eg, vasculitic ulcerations and gangrene) were reported during therapy with hydroxyurea in patients with a history of, or currently receiving, interferon therapy.
- interferon beta 1a
interferon beta 1a, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Cutaneous vasculitic toxicities (eg, vasculitic ulcerations and gangrene) were reported during therapy with hydroxyurea in patients with a history of, or currently receiving, interferon therapy.
- interferon gamma 1b
interferon gamma 1b, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Cutaneous vasculitic toxicities (eg, vasculitic ulcerations and gangrene) were reported during therapy with hydroxyurea in patients with a history of, or currently receiving, interferon therapy.
- irinotecan
irinotecan, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- irinotecan liposomal
irinotecan liposomal, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- ixabepilone
ixabepilone, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- leflunomide
hydroxyurea, leflunomide. Other (see comment). Use Caution/Monitor. Comment: Combination therapy may lead to increased risk of infection.
- lenalidomide
lenalidomide, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- lomustine
lomustine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
lomustine, hydroxyurea. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration with lomustine may increase the risk of immunosuppression and myelosuppression. - melphalan
melphalan, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- mercaptopurine
mercaptopurine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- methotrexate
methotrexate, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- mitomycin
mitomycin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- mitoxantrone
mitoxantrone, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- mycophenolate
hydroxyurea, mycophenolate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.
- natalizumab
natalizumab, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Avoid combination. Potential for increased risk of concurrent infection.
- nelarabine
nelarabine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- ofatumumab SC
ofatumumab SC, hydroxyurea. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- oxaliplatin
oxaliplatin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- paclitaxel
paclitaxel, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- paclitaxel protein bound
paclitaxel protein bound, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- peginterferon alfa 2a
peginterferon alfa 2a, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Cutaneous vasculitic toxicities (eg, vasculitic ulcerations and gangrene) were reported during therapy with hydroxyurea in patients with a history of, or currently receiving, interferon therapy.
- pentostatin
pentostatin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- pralatrexate
pralatrexate, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- probenecid
hydroxyurea increases levels of probenecid by Other (see comment). Use Caution/Monitor. Comment: Dosage adjustment of probenecid may be needed.
- procarbazine
procarbazine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- pyrimethamine
pyrimethamine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- siponimod
siponimod and hydroxyurea both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
hydroxyurea decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
hydroxyurea decreases effects of sipuleucel-T by Other (see comment). Use Caution/Monitor. Comment: Avoid combination. Immunosuppressants may decrease clinical efficacy of sipuleucel-T. - temozolomide
temozolomide, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- teniposide
teniposide, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- thioguanine
thioguanine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- thiotepa
thiotepa, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Avoid combination. Combination may increase risk of myelosuppression.
- tocilizumab
hydroxyurea, tocilizumab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of infection.
- topotecan
topotecan, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- trastuzumab
trastuzumab, hydroxyurea. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, hydroxyurea. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- ublituximab
ublituximab and hydroxyurea both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- ustekinumab
hydroxyurea, ustekinumab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of infection.
- vinblastine
vinblastine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- vinorelbine
vinorelbine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- zidovudine
hydroxyurea, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
zidovudine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
Minor (0)
Adverse Effects
>10%
Infections (39.8%)
Other infections (22.7%)
Bacterial infections (16%)
Gastrointestinal disorders (13.1%)
Neutropenia (12.6%)
1-10%
Viral infections (9.9%)
Fever (7.7%)
Thrombocytopenia (7.4%)
Other gastrointestinal disorders (7.4%)
Headache (7.4%)
Vitamin D deficiency (6.2%)
Other not SCD-related reactions (5.7%)
Anemia (4.2%) Skin reactions (3.7%)
Parvovirus B19 infections (3.7%)
Other skin and subcutaneous tissue disorders (3.2%)
Other nervous system disorders (2.7%)
Respiratory thoracic and mediastinal disorders (2.7%)
Constipation (2.5%)
Nausea (2.5%)
Other metabolic and nutrition disorders (2%)
Weight gain (2%)
Renal and urinary disorders (2%)
Frequency Not Defined
Nausea
Vomiting
Constipation
Diarrhea
Mucositis
Acute pulmonary reactions (rare)
Genetic mutation (long-term use)
Myelosuppression
Secondary leukemia (long-term use)
Elevated BUN, Cr
Hyperuricemia
Renal failure
Rash
Hyperpigmentation
Skin ulcer
Gangrenous disorder
Postmarketing Reports
Infections and infestations: Parvovirus B19 infection
Blood and lymphatic system disorders: bone marrow depression including neutropenia (<2 X 10^9/L), reticulocytopenia (<80 X 10Postmarketing Reports^9/L), macrocytosis, thrombocytopenia (<80 X 10^9/L), anemia (hemoglobin <4.5 g/dL); hemolytic anemia
Gastrointestinal disorders: Nausea, gastrointestinal disturbances, vomiting, gastrointestinal ulcer, severe hypomagnesemia, stomatitis
Hepatobiliary disorders: Elevation of hepatic enzymes
Skin and subcutaneous tissue disorders: Skin reactions (oral, ungula and cutaneous pigmentation), oral mucositis, rash, melanonychia, alopecia, leg ulcers, cutaneous dryness, nail hyperpigmentation, atrophy of skin and nails, scaling, violet papules, cutaneous lupus erythematosus
Renal and urinary disorders: Dysuria, elevations in blood urea nitrogen
Immune disorders: Systemic lupus erythematosus
Metabolism and nutrition disorders: Anorexia
Nervous system disorders: Dizziness, drowsiness, disorientation, hallucinations, and convulsions
Respiratory disorders: Diffuse pulmonary infiltrates, dyspnea, and pulmonary fibrosis, interstitial lung disease, pneumonitis, alveolitis, allergic alveolitis and cough
Reproductive system and breast disorders: Oligospermia, azoospermia, amenorrhea
General disorders: Fever, chills, malaise, edema, and asthenia
Investigations: Weight gain
Hypersensitivity: Drug-induced fever (pyrexia) (>39°C, >102°F) requiring hospitalization reported concurrently with gastrointestinal, pulmonary, musculoskeletal, hepatobiliary, dermatological or cardiovascular manifestations; onset typically occurred within 6 weeks of initiation and resolved upon discontinuation of hydroxyurea; upon re- administration fever re-occurred typically within 24 hours
Warnings
Black Box Warnings
Myelosuppression
- Severe myelosuppression may occur
- Do not give if bone marrow function is markedly depressed
- Monitor blood counts at baseline and throughout treatment
- Interrupt treatment and reduce dose as necessary
Malignancies
- Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype, and is thus unequivocally genotoxic and a presumed transspecies carcinogen that implies a carcinogenic risk to humans; advise sun protection and monitor patients for malignancies
- In patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemias have been reported
- It is unknown whether this leukemogenic effect is secondary to hydroxyurea or is associated with the patients' underlying disease
- The physician and patient must very carefully consider the potential benefits relative to the undefined risk of developing secondary malignancies
- Advise sun protection and monitor patients for malignancies
Contraindications
Hypersensitivity
Severe anemia, bone marrow depression
WBC <2500/mm³, platelets <100,000/mm³
Pregnancy, lactation
Cautions
Risk of cutaneous vasculitic toxicities in patients with myeloproliferative disorders, especially with history of or concurrent interferon therapy; avoid use in patients with wounds on the legs (leg ulcers)
Erythrocyte abnormalities reported; self-limiting megaloblastic erythropoiesis reported early in treatment, unrelated to vitamin B12 or folic acid deficiency
Hyperuricemia may occur; adequate hydration, dosage adjustment, or initiation of uricosuric agents may be necessary
Interferes with analytical analyses of the enzymes (urease, uricase, and lactate dehydrogenase) used in the determination of urea, uric acid and lactic acid, rendering falsely elevated results
Macrocytosis is often seen early in the course of treatment; morphologic change resembles pernicious anemia, but is not related to vitamin B12 or folic acid deficiency; prophylactic folic acid is recommended
Skin cancer reported in patients receiving long-term therapy; advise protection from sun exposure and monitor for development of secondary malignancies
Fetal harm may occur when hydroxyurea is administered to a pregnant woman (see Pregnancy)
Hemolytic anemia
- Cases of hemolytic anemia in patients treated for myeloproliferative diseases reported
- Patients who develop acute jaundice or hematuria in presence of persistent or worsening of anemia should have laboratory tests evaluated for hemolysis (eg, measurement of serum lactate dehydrogenase, haptoglobin, reticulocyte, unconjugated bilirubin levels, urinalysis, and direct and indirect antiglobulin [Coombs] tests)
- In the setting of confirmed diagnosis of hemolytic anemia and in absence of other causes, discontinue therapy
Pulmonary toxicity
- Interstitial lung disease including pulmonary fibrosis, lung infiltration, pneumonitis, and alveolitis/allergic alveolitis (including fatal cases) reported in patients treated for myeloproliferative neoplasm
- Safety and effectiveness not established for use in treatment of myeloproliferative neoplasms and use not approved by the FDA
- Monitor patients developing pyrexia, cough, dyspnea, or other respiratory symptoms frequently, investigate and treat promptly; discontinue therapy and manage with corticosteroids
Myelosuppression
- Evaluate hematologic status prior to and every two weeks during treatment
- Provide supportive care and modify dose or discontinue therapy as needed
- Recovery from myelosuppression is usually observed within 15 days when therapy is interrupted; resume therapy after interruption at a lower dose
- Monitor hematologic parameters more frequently in patients with hepatic impairment receiving therapy
- In patients receiving long-term hydroxyurea for myeloproliferative disorders (a condition for which this drug is not approved), secondary leukemia has been reported
- Some patients, treated at recommended initial dose of 15 mg/kg/day in adults or 20 mg/kg/day in children, have experienced severe or life-threatening myelosuppression
Leukemia
- Secondary leukemia reported in patients treated long-term for sickle cell disease; leukemia also reported in patients with sickle cell disease and no prior history of treatment with drug
- All patients should be followed up on long-term basis with regular blood counts to detect development of leukemia
Drug interactions overview
- Pancreatitis, hepatotoxicity, and peripheral neuropathy have occurred when hydroxyurea was administered concomitantly with antiretroviral drugs, including didanosine and stavudine
- Concomitant use with a live virus vaccine may potentiate the replication of the vaccine virus and/or may increase the adverse reactions of the vaccine virus and result in severe infections
- Interference with uric acid, urea, or lactic acid assays may falsely elevate results in patients treated with hydroxyurea
Pregnancy & Lactation
Pregnancy
There are no studies with the use in pregnant females
Limited data are available on use during pregnancy is insufficient to inform drug-associated risks
In case of an exposure to hydroxyurea of pregnant female patients or pregnant partners of male patients, a careful follow-up with adequate clinical, biological and ultrasonographic examinations should be considered
Advise pregnant women of the potential risk to a fetus; verify the pregnancy status of females of reproductive potential prior to initiating therapy
Fertility
- Based on findings in animals and humans, male fertility may be compromised by treatment; azoospermia or oligospermia has been observed in men; before initiating therapy, inform male patients about the possibility of sperm conservation
Contraception
- Females of reproductive potential: Use effective contraception during and for at least 6 months after therapy
- Males of reproductive potential: Use effective contraception during and after treatment for at least 1 year
Animal data
- Drugs that affect DNA synthesis, such as hydroxyurea, may be potential mutagenic agents
- Hydroxyurea administration to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose
- In rats and rabbits, fetal malformations were observed with partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, and missing lumbar vertebrae
- Embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays
Lactation
Not recommended during treatment
Unknown whether hydroxyurea is excreted in human milk, the effects of hydroxyurea on the breastfed child, or the effects of hydroxyurea on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
The precise mechanism by which hydroxyurea produces its cytotoxic and cytoreductive effects is not known. However, various studies support the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein.
The mechanisms by which hydroxyurea produces its beneficial effects in patients with sickle cell anemia (SCA) are uncertain. Known pharmacologic effects of hydroxyurea that may contribute to its beneficial effects include increasing hemoglobin F levels in red blood cells (RBCs), decreasing neutrophils, increasing the water content of RBCs, increasing deformability of sickled cells, and altering the adhesion of RBCs to endothelium.
Absorption
Duration: up to 24 hr
Peak Plasma Time: 1-4 hr
Distribution
Vd: 0.5 L/kg
Protein binding: 75-80%
Metabolism
Metabolized (60%) by liver and GI tract
Metabolites: CO2, urea
Elimination
Half-Life: 2-4 hr
Excretion: Urine (40% of administered dose in sickle cell anemia patients)
Administration
Oral administration
Capsules
- Swallow capsule whole; do NOT open, break, or chew capsule because hydroxyurea is a cytotoxic drug
- Prophylactic administration of folic acid is recommended
Tablets
- Administer dose qDay, with a glass of water
- Do not split the 100-mg tablets into smaller parts
- Patients unable to swallow tablets: Disperse tablets immediately before use in a small quantity of water in a teaspoon
- Hydroxyurea is a cytotoxic drug; follow applicable special handling and disposal procedures
Storage
Capsules
- Store at room temperature, 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
- Keep tightly closed
Tablets
- Store at room temperature, 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
- Keep tightly closed
- Store broken 1000-mg tablets in the bottle and use within 3 months
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| hydroxyurea oral - | 500 mg capsule |  | |
| hydroxyurea oral - | 500 mg capsule |  | |
| Hydrea oral - | 500 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
hydroxyurea oral
HYDROXYUREA - ORAL
(hi-DROX-ee-you-REE-uh)
COMMON BRAND NAME(S): Droxia, Hydrea, Siklos
WARNING: This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: signs of infection (such as sore throat that doesn't go away, cough, fever, chills), easy bruising/bleeding, pale skin, unusual tiredness.Hydroxyurea may cause other cancers (such as secondary leukemia, skin cancer). Protect your skin from the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you notice any symptoms of cancer, such as swollen glands, sudden weight loss, night sweats, or unusual skin growths/moles.
USES: This medication is used by people with sickle cell anemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions. Some brands are also used to treat certain types of cancer (such as chronic myelogenous leukemia, squamous cell carcinomas).
HOW TO USE: Read the Medication Guide if available from your pharmacist before you start taking hydroxyurea and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your weight, medical condition, lab results, and response to treatment. Your treatment may be stopped for a short time if your blood counts are too low. Keep all medical and lab appointments.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.If you are using the capsules, swallow the them whole. Do not crush, chew, or open the capsules.If you are using the tablets, swallow your dose with a glass of water. Only split a tablet if it has a score line and your doctor has instructed you to do so. If you have trouble swallowing, you may dissolve the whole or split tablet in a small amount of water in a teaspoon and swallow it right away.Wash hands before and after handling the medication or its container. You and/or your caregiver should wear disposable gloves when handling this medication or its container. If powder from the tablet or capsule spills, wipe it up right away with a wet paper towel and throw away in a closed container such as a plastic bag. Clean the spill area right away with soap and water. Make sure not to breathe the powder from the tablets/capsules.Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets/capsules.Tell your doctor if your condition does not get better or if it gets worse.
SIDE EFFECTS: See also Warning Section.Nausea, vomiting, loss of appetite, mouth sores, diarrhea, or constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: skin problems (such as ulcers, darkened/blackened/reddened skin), mental/mood changes (such as confusion, hallucinations), seizures, shortness of breath, yellowing eyes/skin, dark/bloody urine, signs of kidney problems (such as change in the amount of urine).Get medical help right away if you have any very serious side effects, including: chest pain.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before taking hydroxyurea, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia), HIV infection, high uric acid level in the blood, radiation treatment.Hydroxyurea can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using hydroxyurea before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug.It is unknown if this medication affects sperm. If you plan to father a child, discuss the risks and benefits of this medication with your doctor.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using hydroxyurea. Hydroxyurea may harm an unborn baby. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 1 year after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.Hydroxyurea passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: didanosine, stavudine.This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose include: swelling/scaling of hands and feet.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, kidney/liver function) must be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.Your doctor may direct you to also take folic acid while you are taking hydroxyurea due to the risk of anemia. Ask your doctor for details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised June 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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