droxia
Droxia (Hydroxyurea) is a medication used to treat Brain Neoplasms, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma.
Hydroxyurea · by Waylis Therap
Key facts
- Active ingredient
- Hydroxyurea
- Form
- Capsule
- Strength
- Hydroxyurea 200MG · Hydroxyurea 300MG · Hydroxyurea 400MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Waylis Therap
- Half-life
- about 2 to 4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$5.86 for 30 — not your price
- FDA application
- NDA016295
- FDA boxed warning
- Yes — see the boxed warning
What is Droxia?
From the FDA label:DROXIA ® (hydroxyurea capsules, USP) is available for oral use as capsules containing 200 mg, 300 mg, and 400 mg hydroxyurea. Inactive ingredients include citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants: FD&C Blue No. 1 and FD&C Green No. 3 (200 mg capsules); D&C Red No. 28, D&C Red No. 33, and FD&C Blue No. 1 (300 mg capsules); D&C Red No. 28, D&C Red No. 33, and D&C Yellow No. 10 (400 mg capsules). Hydroxyurea is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. The empirical formula is CH 4 N 2 O 2 and it has a molecular weight of 76.05. Its structural formula is: Chemical Structure
How to use
Initial dose: 15 mg/kg once daily. Monitor the patient's blood count every two weeks. ( 2.1 ) The dose may be increased by 5 mg/kg/day every 12 weeks until a maximum tolerated dose or 35 mg/kg/day is reached if blood counts are in an acceptable range. ( 2.1 ) The dose is not increased if blood counts are between the acceptable range and toxic. Discontinue DROXIA until hematologic recovery if blood counts are considered toxic. Treatment may then be resumed after reducing the dose by 2.5 mg/kg/day from the dose associated with hematological toxicity. ( 2.1 ) Renal impairment: Reduce the dose of DROXIA by 50% in patients with creatinine clearance less than 60 mL/min. ( 2.2 , 8.6 , 12.3 ) 2.1 Dosing Information Table 1: Dosing Recommendation Based on Blood Count Dosing Regimen Dose Dose Modification Criteria Monitoring Parameters Initial Recommended Dosing 15 mg/kg/day as a single dose once daily based on the patient's actual or ideal weight, whichever is less. Monitor the patient's blood count every 2 weeks [see Warnings and Precautions (5.1) ] . Dosing Based on Blood Counts In an acceptable range Increase dose 5 mg/kg/day every 12 weeks Maximal dose: 35 mg/kg/day Maximal dose is the highest dose that does not produce toxic blood counts over 24 consecutive weeks. Increase dosing only if blood counts are in an acceptable range. Do not increase if myelosuppression occurs. Blood…
Side effects
The following clinically significant adverse reactions are described in detail in other labeling sections: Myelosuppression [see Warnings and Precautions (5.1) ] Hemolytic anemia [see Warnings and Precautions (5.2) ] Malignancies [see Warnings and Precautions (5.3) ] Vasculitic toxicities [see Warnings and Precautions (5.5) ] Risks with concomitant use of antiretroviral drugs [see Warnings and Precautions (5.7) ] Macrocytosis [see Warnings and Precautions (5.8) ] Pulmonary Toxicity [see Warnings and Precautions (5.9) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions (≥30%) are hematological, gastrointestinal symptoms, and anorexia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Waylis Therapeutics LLC at 1-844-200-7910 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience In 299 patients treated for sickle cell anemia in the Multicenter Study of Hydroxyurea in Sickle Cell Anemia, the most common adverse reactions were hematologic, with neutropenia, and low reticulocyte and platelet levels necessitating temporary cessation in almost all patients. Hematologic recovery usually occurred in two weeks. Other…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Myelosuppression: DROXIA may cause severe myelosuppression. 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 [see Warnings and Precautions (5.1) ] . Malignancies: DROXIA is carcinogenic. Advise sun protection and monitor patients for malignancies [see Warnings and Precautions (5.3) ] . WARNING: MYELOSUPPRESSION AND MALIGNANCIES See full prescribing information for complete boxed warning. Myelosuppression: DROXIA may cause severe myelosuppression. 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. ( 5.1 ) Malignancies: DROXIA is carcinogenic. Advise sun protection and monitor patients for malignancies. ( 5.3 )
Warnings
Important safety information
Hemolytic anemia: Monitor blood counts throughout treatment. If hemolysis persists, discontinue DROXIA. ( 5.2 ) Embryo-Fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. ( 5.4 , 8.1 , 8.3 ) Vasculitic toxicities: Institute treatment and discontinue DROXIA if this occurs. ( 5.5 ) Live Vaccinations: Avoid live vaccine use in a patient taking DROXIA. ( 5.6 ) Risks with concomitant use of antiretroviral drugs: Pancreatitis, hepatotoxicity, and neuropathy have occurred. Monitor for signs and symptoms in patients with HIV infection using antiretroviral drugs; discontinue DROXIA and implement treatment. ( 5.7 ) 5.1 Myelosuppression Hydroxyurea causes severe myelosuppression. Treatment with DROXIA should not be initiated if bone marrow function is markedly depressed. Bone marrow suppression may occur, and leukopenia is generally its first and most common manifestation. Thrombocytopenia and anemia occur less often and are seldom seen without a preceding leukopenia. Some patients, treated at the recommended initial dose of 15 mg/kg/day, have experienced severe or life-threatening myelosuppression. Evaluate hematologic status prior to and during treatment with DROXIA. Provide supportive care and modify dose or discontinue DROXIA as needed. Recovery from myelosuppression is usually rapid when therapy is interrupted. 5.2 Hemolytic Anemia Cases of hemolytic anemia in patients treated with hydroxyurea for myeloproliferative diseases have been reported [see Adverse Reactions (6.1) ] . Patients who develop acute jaundice or hematuria in the presence of persistent or worsening of anemia should have laboratory tests evaluated for hemolysis (e.g., 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 the absence of other causes, discontinue DROXIA. 5.3 Malignancies Hydroxyurea is a human carcinogen. In patients receiving long-term hydroxyurea for myeloproliferative disorders, secondary leukemia has been reported. Secondary leukemia has also been reported in patients treated with long-term hydroxyurea for sickle cell disease. Leukemia has also been reported in patients with sickle cell disease and no prior history of treatment with hydroxyurea. All patients using DROXIA should be followed up on a long-term basis with regular blood counts to detect development of leukemia. Skin cancer has also been reported in patients receiving long-term hydroxyurea. Advise protection from sun exposure and monitor for the development of secondary malignancies. 5.4 Embryo-Fetal Toxicity Based on the mechanism of action and findings in animals, DROXIA can cause fetal harm when administered to a pregnant woman. Hydroxyurea was embryotoxic and teratogenic in rats and rabbits at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m2 basis. Advise pregnant women of the potential risk to a fetus [see Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during and after treatment with DROXIA for at least 6 months after therapy. Advise males of reproductive potential to use effective contraception during and after treatment with DROXIA for at least 1 year after therapy [see Use in Specific Populations (8.1 , 8.3) ] . 5.5 Vasculitic Toxicities Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy. If cutaneous vasculitic ulcers occur, institute treatment and discontinue DROXIA. 5.6 Live Vaccinations Avoid use of live vaccine in patients taking DROXIA. Concomitant use of DROXIA with a live virus vaccine may potentiate the replication of the virus and/or may increase the adverse reaction of the vaccine because normal defense mechanisms may be suppressed by DROXIA. Vaccination with live vaccines in a patient receiving DROXIA may result in severe infection. Patient's antibody response to vaccines may be decreased. Consider consultation with a specialist. 5.7 Risks with Concomitant Use of Antiretroviral Drugs Pancreatitis, hepatotoxicity, and peripheral neuropathy have occurred when hydroxyurea was administered concomitantly with antiretroviral drugs, including didanosine and stavudine [see Drug Interactions (7.1) ] . 5.8 Macrocytosis DROXIA may cause macrocytosis, which is self-limiting, and is often seen early in the course of treatment. The morphologic change resembles pernicious anemia, but is not related to vitamin B 12 or folic acid deficiency. This may mask the diagnosis of pernicious anemia. Prophylactic administration of folic acid is recommended. 5.9 Pulmonary Toxicity Interstitial lung disease including pulmonary fibrosis, lung infiltration, pneumonitis, and alveolitis/allergic alveolitis (including fatal cases) have been reported in patients treated for myeloproliferative neoplasm. Safety and effectiveness have not been established for the use of DROXIA in the treatment of myeloproliferative neoplasms and the use is not approved by the FDA. Monitor patients developing pyrexia, cough, dyspnea, or other respiratory symptoms frequently, investigate and treat promptly. Discontinue DROXIA and manage with corticosteroids. [see Adverse Reactions (6.1) ] . 5.10 Laboratory Test Interference Interference with Uric Acid, Urea, or Lactic Acid Assays is possible, rendering falsely elevated results of these in patients treated with hydroxyurea [see Drug Interactions (7.2) ] . Hydroxyurea may falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems and may lead to hypoglycemia if sensor glucose results are relied upon to dose insulin. If a patient using a CGM is to be prescribed hydroxyurea, consult with the CGM prescriber about alternative glucose monitoring methods [see Drug Interactions (7.2) ] .
Who should not take Droxia
DROXIA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. In patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. ( 4 )
Overdose — what happens if you take too much
Acute mucocutaneous toxicity has been reported in patients receiving hydroxyurea at dosages several times the therapeutic dose. Soreness, violet erythema, edema on palms and soles followed by scaling of hands and feet, severe generalized hyperpigmentation of the skin, and stomatitis have been observed.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Antiretroviral drugs. (7.1) Laboratory Test Interference. ( 7.2 ) 7.1 Increased Toxicity with Concomitant Use of Antiretroviral Drugs Pancreatitis In patients with HIV infection during therapy with hydroxyurea and didanosine, with or without stavudine, fatal and nonfatal pancreatitis have occurred. Hydroxyurea is not indicated for the treatment of HIV infection; however, if patients with HIV infection are treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, close monitoring for signs and symptoms of pancreatitis is recommended. Permanently discontinue therapy with DROXIA in patients who develop signs and symptoms of pancreatitis. Hepatotoxicity Hepatotoxicity and hepatic failure resulting in death have been reported during postmarketing surveillance in patients with HIV infection treated with hydroxyurea and other antiretroviral drugs. Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine, and stavudine. Avoid this combination. Peripheral Neuropathy Peripheral neuropathy, which was severe in some cases, has been reported in patients with HIV infection receiving hydroxyurea in combination with antiretroviral drugs, including didanosine, with or without stavudine. 7.2 Laboratory Test Interference Interference with Uric Acid, Urea, or Lactic Acid Assays Studies have shown that there is an analytical interference of hydroxyurea with the enzymes (urease, uricase, and lactate dehydrogenase) used in the determination of urea, uric acid, and lactic acid, rendering falsely elevated results of these in patients treated with hydroxyurea. Interference with Continuous Glucose Monitoring Systems Hydroxyurea may falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems and may lead to hypoglycemia if sensor glucose results are relied upon to dose insulin. If a patient using a CGM is to be prescribed hydroxyurea, consult with the CGM prescriber about alternative glucose monitoring methods.
How long does Hydroxyurea stay in your body?
The elimination half-life of hydroxyurea is about 2 to 4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The SIKLOS label states this under "Elimination" in §12.3 — it is the elimination half-life, and the label reports only this one phase (it does not break out a separate distribution/alpha phase). Hydroxyurea is not a prodrug, and the label names no active metabolite: up to 60% of an oral dose is cleared by saturable liver metabolism plus a minor breakdown route by urease from gut bacteria, with about 40% of the dose recovered in urine. Kidney impairment matters — exposure (mean AUC) was 64% higher in people with creatinine clearance under 60 mL/min and in those with end-stage renal disease, and the label directs a dose reduction in those patients. For liver impairment, the label explicitly says there are no data supporting specific dose-adjustment guidance. It gives no separate half-life for older adults; it notes pharmacokinetics are similar between children (4 to 17 years) and adults. Worth knowing: most other hydroxyurea labels (Hydrea, Droxia, Xromi, and the generics) state no half-life at all — SIKLOS is the label that carries this number. This is a plasma-clearance figure, not a drug-test detection window and not dosing guidance; hydroxyurea's biological effect on blood counts outlasts the drug's time in plasma.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: SIKLOS (hydroxyurea) tablets — FDA label, §12.3 Pharmacokinetics (DailyMed).
May treat (source: NIH RxClass)
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Droxia treat?
- Droxia (Hydroxyurea) may be used to treat brain neoplasms, non-small-cell lung carcinoma, renal cell carcinoma, squamous cell carcinoma, head and neck neoplasms, leukocytosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Droxia cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $5.86 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Droxia?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Droxia. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Droxia?
- Droxia is marketed by Waylis Therap. You can see Waylis Therap's full profile, rating, and other products on pharmaranks.
- Is Droxia a brand-name or generic drug?
- Droxia is a brand-name product with the active ingredient Hydroxyurea.
- Is Droxia available over the counter?
- No. Droxia is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Droxia come in?
- Droxia is currently marketed as capsule, per the FDA's National Drug Code Directory.
- Is Droxia FDA-registered?
- Droxia is on record with the U.S. FDA under application number NDA016295. You can verify this on its official FDA label.
- Is Droxia safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Droxia. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Droxia?
- Droxia's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described in detail in other labeling sections: Myelosuppression [see Warnings and Precautions (5.1) ] Hemolytic anemia [see Warnings and Precautions (5.2) ] Malignancies [see Warnings and Precautions (5.3) ] Vasculitic toxicities [see Warni… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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