Hydroxyurea Schedule (India)

Schedule H

Hydroxyurea Routes

Oral

Hydroxyurea Formulations

Formulation Strengths Available

Capsule 500 mg

Tablet 500 mg, 1000 mg

Hydroxyurea Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

✦ Chronic Myeloid Leukaemia (CML) — Palliative or Cytoreductive

Parameter Details

Starting dose 20–30 mg/kg/day orally as single dose or in two divided doses

Titration Adjust weekly based on WBC response and tolerance

Usual maintenance dose 20–25 mg/kg/day

Maximum dose 35 mg/kg/day (short-term use only)

Clinical Notes:

Monitor CBC with differential 2–3 times weekly during initial titration phase

Now largely replaced by tyrosine kinase inhibitors (imatinib) as first-line; used when TKIs unavailable or for rapid cytoreduction

Hold therapy if WBC falls below 2,500/mm³ or platelets below 100,000/mm³

✦ Polycythaemia Vera

Parameter Details

Starting dose 15–20 mg/kg/day orally

Titration Adjust every 1–2 weeks based on haematocrit and WBC response

Usual maintenance dose 500–1000 mg/day

Maximum dose 2000 mg/day in divided doses

Clinical Notes:

Target haematocrit: <45% in males, <42% in females

Target WBC: <10,000/mm³

Concurrent phlebotomy may be required initially

Specialist haematology supervision mandatory

✦ Sickle Cell Disease — Prevention of Vaso-Occlusive Crises

Parameter Details

Starting dose 15 mg/kg/day orally (10 mg/kg/day if baseline cytopenia present)

Titration Increase by 5 mg/kg every 8 weeks based on tolerance and haematological response

Usual maintenance dose 20–30 mg/kg/day

Maximum dose 35 mg/kg/day

Clinical Notes:

Primary mechanism: Increases HbF levels, thereby reducing sickling

Clinical benefit: Reduces frequency of painful crises, acute chest syndrome, and transfusion requirements

Clinical response takes 2–3 months; continue long-term if effective

Administer as single daily dose; can be taken with or without food

Drug is included in NLEM for sickle cell disease management

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Notes

Essential Thrombocythaemia Starting: 500 mg/day; titrate to 500–1500 mg/day based on platelet response Long-term Specialist only; target platelet count <400,000/mm³; based on Indian haematology practice

Myelofibrosis (symptomatic) 500–1000 mg/day; titrate per counts Long-term OFF-LABEL — Specialist only; for leucocytosis/thrombocytosis control

Severe Psoriasis (HIV-associated, refractory) 500–1000 mg/day Short intermittent courses OFF-LABEL — Specialist only; limited evidence from case series

Hydroxyurea Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

✦ Sickle Cell Disease (Age ≥2 years)

Parameter Details

Eligibility Children ≥2 years of age; use actual body weight

Starting dose 15–20 mg/kg/day orally as single dose

Titration Increase by 5 mg/kg every 8 weeks if tolerated and response inadequate

Usual maintenance dose 20–25 mg/kg/day

Maximum dose 35 mg/kg/day

Weight-based Dosing Reference (using 500 mg capsules/tablets):

Body Weight (kg) Starting Dose Maximum Dose

10–15 250 mg/day 500 mg/day

16–25 500 mg/day 750–1000 mg/day

26–35 500–750 mg/day 1000–1250 mg/day

36–50 750–1000 mg/day 1500–1750 mg/day

50 1000 mg/day 2000 mg/day

Monitoring Requirements:

CBC with reticulocyte count every 2–4 weeks during titration

Once stable: CBC every 4–8 weeks

Monitor HbF levels every 3–6 months to assess response

Clinical effect takes 3–6 months to manifest

Clinical Notes:

Indicated for: reduction in VOC frequency, prevention of acute chest syndrome, reducing transfusion burden

Mandatory haematology specialist supervision

Capsules may be opened and contents mixed with water for children unable to swallow whole

Secondary Indications — Paediatric Doses (Off-label, if any)

No established off-label paediatric indications in Indian practice

Age Restriction Statement:

Not recommended below 2 years of age except under paediatric haematology specialist supervision with documented benefit-risk assessment

Hydroxyurea Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation
≥60	mL/min No adjustment required
30–59	mL/min Reduce starting dose by 50%; monitor CBC closely
<30	mL/min Start at 50% of standard dose; very close monitoring essential
Haemodialysis	Administer after dialysis session on dialysis days; supplemental dose not typically required
Peritoneal dialysis	Limited data; use reduced dose with frequent monitoring

Note: Enhanced myelotoxicity risk in renal impairment; CBC monitoring should be more frequent (twice weekly initially)

Hydroxyurea Hepatic adjustment

Severity	Recommendation
Mild impairment (Child-Pugh A)	Standard starting dose; monitor LFTs monthly
Moderate impairment (Child-Pugh B)	Consider 50% starting dose; titrate cautiously; close hepatic monitoring
Severe impairment (Child-Pugh C)	Avoid use unless benefit clearly outweighs risk; specialist supervision mandatory

Hydroxyurea Contraindications

Known hypersensitivity to hydroxyurea or any excipient

Severe bone marrow suppression (baseline ANC <2,000/mm³ or platelets <80,000/mm³)

Pregnancy (teratogenic — contraindicated unless life-threatening condition with no alternative)

Concurrent use with didanosine + stavudine combination (fatal hepatotoxicity and pancreatitis)

Severe uncontrolled infection

Hydroxyurea Cautions

Pre-existing bone marrow suppression or recent myelosuppressive therapy

Renal impairment (dose reduction required; enhanced toxicity risk)

Hepatic impairment

History of leg ulcers or poor wound healing (drug may exacerbate)

Concurrent antiretroviral therapy (increased pancreatitis risk)

History of prior malignancy (long-term use associated with secondary leukaemia risk)

Elderly patients (reduced marrow reserve)

Patients receiving concurrent myelosuppressive agents

Avoid live vaccines during therapy

Hydroxyurea Pregnancy

Parameter Details

Safety Category Contraindicated (Teratogenic in animal studies; limited human data suggest risk)

Preferred Alternatives Phlebotomy for polycythaemia vera; supportive care and transfusion for sickle cell disease

When May Be Used Only if life-threatening condition with no safer alternative; joint haematology-obstetric team decision required

Contraception Effective contraception mandatory during treatment and for 6 months after discontinuation (both sexes)

Monitoring If exposure occurs: detailed fetal anomaly scanning; genetic counselling

Hydroxyurea Lactation

Parameter Details

Compatibility Not compatible with breastfeeding

Drug Levels in Milk Moderate (excreted in breast milk in significant amounts)

Preferred Alternative Formula feeding if mother requires hydroxyurea

Recommendation Avoid breastfeeding during therapy and for at least 1 week after final dose

Infant Monitoring Not applicable — breastfeeding contraindicated

Hydroxyurea Elderly

Parameter Recommendation

Starting Dose Use lower end of dosing range (10–15 mg/kg/day)

Titration Slower titration; extend intervals between dose adjustments

Special Risks Increased myelosuppression risk; age-related renal decline affects clearance; fatigue and malaise more pronounced

Monitoring More frequent CBC (weekly initially); baseline and periodic renal function assessment

Hydroxyurea Major drug interactions

Interacting Drug Mechanism/Effect Recommendation

Zidovudine (AZT) Additive myelosuppression; severe neutropenia and anaemia Avoid combination; if essential, very close CBC monitoring

Didanosine + Stavudine Fatal hepatotoxicity and pancreatitis reported Contraindicated combination

Live vaccines Risk of disseminated vaccine infection due to immunosuppression Avoid during therapy and until immune recovery

Other myelosuppressive agents (cyclophosphamide, methotrexate) Profound bone marrow suppression Use with extreme caution; dose reduction and close monitoring required

Hydroxyurea Moderate drug interactions

Interacting Drug Mechanism/Effect Recommendation

Clozapine Additive neutropenia risk Avoid if possible; if used, monitor WBC/ANC weekly

Allopurinol May increase risk of skin reactions Monitor for cutaneous toxicity

Interferon alpha Enhanced myelosuppression Monitor CBC closely; may require dose adjustment of either drug

Antineoplastic agents (busulfan, cytarabine) Additive bone marrow toxicity Coordinate with oncology; stagger dosing if feasible

ACE inhibitors May potentiate leucopenia Clinical monitoring advised

Hydroxyurea Common Adverse effects

Myelosuppression (leucopenia, thrombocytopenia, anaemia)

Nausea, vomiting, anorexia

Diarrhoea, constipation

Mucocutaneous effects: skin rash, hyperpigmentation (especially nails and skin folds), nail changes

Alopecia (usually reversible)

Fatigue, malaise

Headache, dizziness

Leg ulcers (with chronic use)

Hydroxyurea Serious Adverse effects

Adverse Effect Clinical Notes

Severe myelosuppression Neutropenic sepsis possible; requires immediate drug discontinuation and supportive care

Secondary leukaemia Reported with long-term use; particularly in patients with prior exposure to other cytotoxic agents

Pancreatitis Especially with concurrent antiretroviral therapy; discontinue if suspected

Hepatotoxicity Monitor LFTs; discontinue if significant elevation

Pulmonary toxicity Interstitial pneumonitis/fibrosis reported; discontinue if respiratory symptoms develop

Severe cutaneous reactions (SJS/TEN) Rare; immediate discontinuation required

Vasculitic ulcers Particularly leg ulcers; may require drug withdrawal

Hydroxyurea Monitoring requirements

Phase Parameters

Baseline CBC with differential and reticulocyte count; LFTs; RFTs; pregnancy test (females of childbearing potential)

During Titration CBC weekly for first 4–6 weeks, then every 2 weeks until stable

Maintenance (Stable) CBC every 4–8 weeks; LFTs and RFTs every 3 months

Sickle Cell Disease HbF levels every 3–6 months to assess therapeutic response

Long-term Annual dermatological examination (risk of skin malignancies); monitor for secondary malignancy signs

Thresholds for Dose Modification Hold if: ANC <2,000/mm³, platelets <80,000/mm³, Hb falls >2 g/dL below baseline, or reticulocytes <80,000/mm³ with Hb <9 g/dL

Hydroxyurea Brands in India

Brand Name Manufacturer

Hydrea Bristol-Myers Squibb

Myelostat Intas

Cytodrox Cipla

Hycibin Hetero

Novastat-HU Novartis

Oncoxyurea Neon Labs

Hydrox Sun Pharma

Hydroxyurea Price range (INR)

Formulation	Approximate Price (per tablet)
Capsule/Tablet 500 mg	₹5–20 per unit
Tablet 1000 mg	₹40–60 per unit

Notes:

NPPA price controls applicable under NLEM for sickle cell disease indication

Available free under National Sickle Cell Anaemia Mission and state tribal health programmes in endemic regions (Chhattisgarh, Madhya Pradesh, Jharkhand, Odisha, Maharashtra, Gujarat)

Hydroxyurea Clinical pearls

Delayed therapeutic effect in sickle cell disease: Clinical benefits (reduced VOCs, improved HbF) take 2–3 months to manifest; counsel patients regarding need for continued adherence

Myelosuppression is the dose-limiting toxicity: Regular CBC monitoring is non-negotiable for all indications; temporary dose holds are common

Preferred disease-modifying agent for sickle cell in resource-limited settings where haematopoietic stem cell transplant is unavailable; significantly reduces morbidity

Teratogenicity counselling essential: Ensure documented contraception counselling for all patients of reproductive age prior to initiation

Renal impairment requires dose reduction: Halve the starting dose if CrCl <60 mL/min; monitor more frequently

Leg ulcers may develop with chronic use: Examine lower extremities periodically; drug discontinuation often required for healing

Now second-line for CML: TKIs (imatinib) have replaced hydroxyurea as first-line; reserved for rapid cytoreduction or resource-limited settings

Hydroxyurea Tags

hydroxyurea; sickle cell disease; CML; polycythaemia vera; cytoreduction; myelosuppression; HbF induction; teratogenic; renal-adjustment required; haematology; NLEM India

Hydroxyurea Version

RxIndia v1.1 — 27-01-2026

Hydroxyurea Reference

CDSCO Product Information

National Formulary of India (NFI)

NLEM 2022 (National List of Essential Medicines)

API Textbook of Medicine, 11th Edition

AIIMS Clinical Guidelines — Haematology 2022

ICMR Guidelines on Sickle Cell Disease Management

National Sickle Cell Anaemia Mission — MoHFW

IAP Drug Formulary

WHO EML (supportive reference for sickle cell indication)

Indian Journal of Hematology and Blood Transfusion — Clinical practice recommendations

RxIndia

The Drug Registry

Hydroxyurea