Hydroxycarbamide oral solution
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral solution of hydroxycarbamide.
Drugs List
Therapeutic Indications
Uses
Prevention of recurrent vaso-occlusive crises in sickle cell syndrome
Prevention of vaso-occlusive complications of Sickle Cell Disease.
Unlicensed Uses
Cervical cancer: in conjunction with radiotherapy
Leukaemia - chronic myeloid
Management of thrombocythemia
Treatment of polycythemia vera
Dosage
Dosing should be based on the patient's body weight (kg).
A six month trial on the maximum tolerated dose is required prior to considering discontinuation due to treatment failure.
Adults
Sickle Cell Disease
Initial Dose: 15mg/kg/day.
Maintenance Dose: 20 to 25mg/kg/day.
Dose can be increased by 5mg/kg/day every eight weeks and continued until mild myelosuppression (absolute neutrophil count 1500 to 4000 per microlitre) is achieved, up to a maximum dose of 35mg/kg/day. Once maximum tolerated dose is established, full blood counts with white cell differential, reticulocyte count and platelet counts should be performed every two to three months.
Polycythaemia Vera (unlicensed)
15 to 20mg/kg/day.
Essential Thrombocythaemia (unlicensed)
15mg/kg/day.
Chronic Myeloid Leukaemia (unlicensed)
Initial Dose: 40mg/kg/day.
Maintenance Dose: 20mg/kg/day.
Cancer of the Cervix (unlicensed)
20 to 30mg/kg/day or 80mg/kg every three days.
Children
(See Dosage; Adult)
Patients with Renal Impairment
Creatinine clearance less than or equal to 60ml/minute: Reduce initial dose by 50%.
Additional Dosage Information
Full blood cell count with white cell differential and reticulocyte count should be monitored once a month for the first two months following treatment initiation. If neutropenia or thrombocytopenia occurs, temporarily withhold treatment and perform full blood count with white cell differential weekly. When blood counts have recovered, resume hydroxycarbamide treatment at a dose 5mg/kg/day lower than that given before onset of cytopenias.
Contraindications
Children under 2 years
Breastfeeding
HIV patients receiving highly active anti-retroviral therapy
Myelosuppression
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Severe hepatic impairment
Precautions and Warnings
Elderly
History of radiotherapy
Leg ulcer
Mild hepatic impairment
Renal impairment - creatinine clearance below 60ml/minute
Live virus vaccine should not be given for 6 months after treatment
May exacerbate previously existing erythema
Reduce dose in patients with creatinine clearance below 60ml/min
Advise patient ability to drive or operate machinery may be impaired
Correct severe anaemia before starting treatment
Give pre-treatment counselling and consideration of sperm cryopreservation
May be increased risk of skin cancer
Treatment to be initiated and supervised by a specialist
Contains parabens
Avoid contact of prepared solution with skin and mucous membranes
Monitor full blood count and differential WBC before and during therapy
Monitor renal and hepatic function before and during treatment
Monitor reticulocyte count at regular intervals
Monitor serum folic acid levels regularly
Perform regular white blood cell and platelet counts
Discontinue if evidence of significant bone marrow depression
Discontinue if patient is attempting to conceive
Discontinue/review treatment if cutaneous vasculitic ulcers develop
Reduce dose and/or alter dose interval in elderly patients
Male: May cause infertility
Female: Ensure adequate contraception during treatment
Male: Contraception required during and for 3 months after treatment
Advise patient on appropriate sun protection methods
Pregnancy and Lactation
Pregnancy
Hydroxycarbamide is contraindicated during pregnancy.
Use of hydroxycarbamide during pregnancy is contraindicated by the manufacturer. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out. Patients should stop treatment 3 to 6 months before pregnancy. The patient should be instructed to contact a doctor if pregnancy is suspected.
Lactation
Hydroxycarbamide is contraindicated during breastfeeding.
Use of hydroxycarbamide when breastfeeding is contraindicated by the manufacturer. Hydroxycarbamide is present in human breast milk at concentrations similar to maternal levels.
Side Effects
Alopecia
Anaemia
Azoospermia
Bleeding
Bone marrow depression
Chills
Constipation
Cutaneous lupus erythematosus
Cutaneous vasculitis
Decreased appetite
Decreased vitamin D
Dermatomyositis
Diarrhoea
Disturbances of gastrointestinal function
Dizziness
Drowsiness
Dry skin
Dyspnoea
Dysuria
Elevation of liver enzymes
Fever
Gangrene
Hallucinations
Headache
Hepatitis
Hepatotoxicity
Hyperpigmentation
Hypomagnesaemia
Increased risk of skin cancer
Leg ulcers
Leukaemia
Macrocytosis
Malaise
Melaena
Mucositis
Nausea
Neutropenia
Oligospermia
Pancreatitis
Parvovirus B19 infection
Peripheral neuropathy
Peripheral oedema
Rash
Respiratory disorders
Reticulocytosis
Seizures
Skin ulcer
Stomatitis
Thrombocytopenia
Vomiting
Weight gain
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2019
Reference Sources
Summary of Product Characteristics: Xromi 100mg/ml oral solution. Nova Laboratories Limited. Revised January 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.