{
 "query": "hydroxyurea",
 "ingredient": "hydroxyurea",
 "slug": "hydroxyurea",
 "rxcui": "5552",
 "brands": [
  "Droxia",
  "Siklos",
  "Hydrea",
  "Xromi"
 ],
 "names": [
  "hydroxyurea"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 16
  },
  "boxed_warning": "WARNING: MYELOSUPPRESSION and MALIGNANCIES WARNING: MYELOSUPPRESSION and MALIGNANCIES See full prescribing information for complete boxed warning . Myelosuppression : SIKLOS 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 : Hydroxyurea is carcinogenic. Advise sun protection and monitor patients for malignancies. ( 5.2 ) Myelosuppression: SIKLOS may cause severe myelosuppression. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary [see Warnings and Precautions (5.1) ] . Malignancies: Hydroxyurea is carcinogenic. Advise sun protection and monitor patients for malignancies [see Warnings and Precautions (5.2) ] .",
  "indications_and_usage": "\u00ae is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises SIKLOS is an antimetabolite, indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. ( 1 )",
  "contraindications": "is contraindicated in: Patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation [see Adverse Reactions (6) ]. Patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. ( 4 )",
  "warnings_and_cautions": "Embryo-Fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. ( 5.3 , 8.1 , 8.3 ) Cutaneous vasculitic toxicities (incl. leg ulcers): Institute treatment and discontinue SIKLOS and/or reduce dose if this occurs. ( 5.4 ) Risks with concomitant use of antiretroviral drugs: Pancreatitis, hepatotoxicity, and neuropathy have occurred. Monitor for signs and symptoms patients with HIV infection using antiretroviral drugs; discontinue SIKLOS, and implement treatment. ( 5.5 ) Concomitant use with live virus vaccine: increased risk of severe infections. ( 5.6 ) Hemolytic Anemia: Monitor blood counts throughout treatment. If hemolysis persists, discontinue SIKLOS. ( 5.9 ) 5.1 Myelosuppression Hydroxyurea causes severe myelosuppression. Do not initiate treatment with hydroxyurea in patients 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 in adults or 20 mg/kg/day in childr...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Vasculitic toxicities (including Leg Ulcers) [see Warnings and Precautions (5.4) ] Risks with concomitant use of antiretroviral drugs [see Warnings and Precautions (5.5) ] Risk with concomitant use of live virus vaccine [see Warnings and Precautions (5.6) ] Macrocytosis [see Warnings and Precautions (5.7) ] Hemolytic Anemia [see Warnings and Precautions (5.9) ] Most common adverse reactions to SIKLOS (incidence > 10%) include infections and neutropenia in children and infections and headache and dry skin in adults. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact the marketer Medunik at 1 844-884-5520 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience 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. The safety of SIKLOS has been assessed i...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Test Interference ( 5.8 ) 11/2023 Drug interactions, Test Interference ( 7.3 ) 11/2023",
  "information_for_patients": "Advise the patient or caregiver to read the FDA-approved patient labeling (Instructions for Use and Medication Guide). There is a risk of myelosuppression. Emphasize the importance of monitoring blood counts every two weeks throughout the duration of therapy to patients taking SIKLOS [see Warnings and Precautions (5.1) ] . Advise patients to report signs and symptoms of infection or bleeding immediately. Advise patients that there is a risk of cutaneous vasculitic toxicities and secondary malignancies including leukemia. Advise use of sun protection [see Warnings and Precautions (5.1) ] . Advise females of reproductive potential of the potential risk to a fetus should they become pregnant while taking SIKLOS. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise females and males of reproductive potential to use contraception during and after treatment with SIKLOS [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1 , 8.3) ] . Advise females to discontinue breastfeeding during treatment with SIKLOS [see Use in Specific Populations (8.2) ] . Advise male patients of potential risk to fertility [see Use in Specific Population...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 11/2023 MEDICATION GUIDE SIKLOS (See \u2013 k \u2013 los) (hydroxyurea) tablets What is the most important information I should know about SIKLOS? SIKLOS can cause serious side effects including: Low blood cell counts are common with SIKLOS, including low red blood cells, white blood cells, and platelets, and can be severe and life-threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and every 2 weeks during treatment with SIKLOS. Your healthcare provider may change your dose or tell you to stop taking SIKLOS if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms: fever or chills body aches feeling very tired shortness of breath unusual headache bleeding or unexplained bruising Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking SIKLOS for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective cloth...",
  "clinical_studies": "Pediatric Patients with Sickle Cell Disease The efficacy of SIKLOS was assessed in the European Sickle Cell Disease Cohort study (ESCORT HU) [NCT02516579]. This is an open-label single-arm study of 405 pediatric patients with sickle cell disease from 2-18 years of age, of which 141 had not been previously treated with hydroxyurea prior to enrollment. Evaluable patients had at least 12 months follow-up (median [range] 23 months [12,80]). Median (range) hemoglobin F percentages were 5.6% (1.3, 15.0) at baseline and 12.8% (2.1, 37.2) at least 6 months (the value closest to 6 months collected between 5 and 14 months) after initiation of SIKLOS treatment, with median (range) change of 5.9% (-2.2, 34.7) in 47 patients. Median (range) hemoglobin levels were 8.2 g/dL (3.7, 14.2) at baseline, 8.8 g/dL (0.7, 13.1) at 6 months (the value closest to 6 months collected between 5 and 7 months), and 8.9 g/dL (5.5, 13.2) at 12 months (the value closest to 12 months collected between 10 and 14 months) after initiation of SIKLOS treatment. The median (range) change was 0.5 g/dL (-4.6, 6.1) in 63 patients at 6 months (the post-baseline value closest to 6 months collected between 5 and 7 months) and 0...",
  "brand_name": "Siklos",
  "manufacturer": "Medunik",
  "application_number": "NDA208843",
  "pharm_class_epc": [
   "Antimetabolite [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260107",
  "set_id": "76957c0d-0f98-4376-bb06-eee651adc09d",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 19017,
  "serious": 14218,
  "death": 2601,
  "hospitalization": 7139,
  "primary_suspect": 18992,
  "top_reactions": [
   [
    "Off Label Use",
    2213
   ],
   [
    "Fatigue",
    1434
   ],
   [
    "Sickle Cell Anaemia With Crisis",
    1394
   ],
   [
    "Diarrhoea",
    1282
   ],
   [
    "Nausea",
    1159
   ],
   [
    "Headache",
    983
   ],
   [
    "Anaemia",
    972
   ],
   [
    "Death",
    915
   ],
   [
    "Haemoglobin Decreased",
    854
   ],
   [
    "Product Dose Omission Issue",
    836
   ],
   [
    "Drug Ineffective",
    829
   ],
   [
    "Pain",
    783
   ],
   [
    "Pyrexia",
    782
   ],
   [
    "Dyspnoea",
    720
   ],
   [
    "Pneumonia",
    693
   ]
  ],
  "by_year": {
   "2019": 1695,
   "2020": 1957,
   "2021": 2019,
   "2022": 1923,
   "2023": 1724,
   "2024": 1382,
   "2025": 1260,
   "2026": 560
  },
  "by_year_primary": {
   "2019": 1694,
   "2020": 1957,
   "2021": 2018,
   "2022": 1915,
   "2023": 1712,
   "2024": 1379,
   "2025": 1260,
   "2026": 560
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 10,
  "nda": 3,
  "anda": 7,
  "first_approval": "19671207",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 29,
  "labeling_recent": 8,
  "sponsors": [
   "BARR",
   "BARR LABS INC",
   "LEADING",
   "NOVA LABS LTD",
   "PH HEALTH",
   "QILU",
   "ROXANE",
   "THERAVIA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/07/1967"
 },
 "trials": {
  "total": 355,
  "completed": 205,
  "terminated": 38,
  "with_results": 86,
  "industry": 108,
  "phase3": 76,
  "results_share": 0.4195121951219512,
  "terminated_share": 0.10704225352112676
 },
 "pubmed": {
  "rct": 164,
  "meta": 37,
  "recent_rct": 19,
  "cochrane": [
   {
    "pmid": "36047926",
    "title": "Hydroxyurea (hydroxycarbamide) for sickle cell disease",
    "year": "2022"
   },
   {
    "pmid": "30882896",
    "title": "Hydroxyurea (hydroxycarbamide) for transfusion-dependent \u03b2-thalassaemia",
    "year": "2019"
   },
   {
    "pmid": "28426137",
    "title": "Hydroxyurea (hydroxycarbamide) for sickle cell disease",
    "year": "2017"
   },
   {
    "pmid": "27755646",
    "title": "Hydroxyurea for reducing blood transfusion in non-transfusion dependent beta thalassaemias",
    "year": "2016"
   },
   {
    "pmid": "14974044",
    "title": "Concomitant hydroxyurea plus radiotherapy versus radiotherapy for carcinoma of the uterine cervix",
    "year": "2004"
   },
   {
    "pmid": "11406036",
    "title": "Hydroxyurea for sickle cell disease",
    "year": "2001"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 4352.66,
  "records": 37,
  "by_name": [
   [
    "Xromi",
    3500.0
   ],
   [
    "Siklos",
    852.66
   ]
  ],
  "names_checked": [
   "hydroxyurea",
   "Droxia",
   "Siklos",
   "Hydrea",
   "Xromi"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 526088,
  "beneficiaries": 111871,
  "spend": 14159215.799999999,
  "by_brand": [
   {
    "brand": "Hydroxyurea",
    "claims": 521514,
    "per_claim": 24.916387077,
    "is_generic": true
   },
   {
    "brand": "Droxia",
    "claims": 3444,
    "per_claim": 48.004401858,
    "is_generic": false
   },
   {
    "brand": "Siklos",
    "claims": 765,
    "per_claim": 1256.112183,
    "is_generic": false
   },
   {
    "brand": "Hydrea",
    "claims": 365,
    "per_claim": 106.07706849,
    "is_generic": false
   }
  ],
  "per_claim": 26.914158467784855
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3199,
  "fills": 526088,
  "per_million": 6080.731740697374,
  "ratio": 2.1960426448235126,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 58,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "6,081 FDA reports naming it as the suspect drug per million Medicare fills, 2.2x the median drug on this site (-7)",
    "Death appears in 1.5x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 64,
   "letter": "C",
   "why": [
    "164 randomized trials and 37 systematic reviews/meta-analyses indexed in PubMed",
    "6 independent Cochrane review(s) exist",
    "Only 42% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "8 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $4,353 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (7 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 71,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are fatigue, sickle cell anaemia with crisis, diarrhoea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}