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A - Regimen Name

HYDR Regimen
Hydroxyurea


Disease Site
Hematologic - Leukemia - Chronic Myeloid (CML)

Intent
Palliative

Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.


Rationale and Uses

May be used upfront to improve blood counts, reduce risk of leukostasis, and as a bridge to TKI initiation. Same rationale at end of life care in refractory patients,


Supplementary Public Funding

hydroxyurea
ODB - General Benefit (hydroxyurea) (ODB Formulary)

 
B - Drug Regimen

hydroxyurea
30 to 40 mg /kg PO Daily
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D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated.

Dose may be adjusted based on WBC count:

WBC count (x 109/L)
Dose (mg/kg/day)
> 50
30 to 40
< 20
20
≤ 10
≤ 10
 < 5
Hold

Discontinue if disease enters accelerated phase; treat as ALL or AML (depending on the transformation phenotype).

 

 

 

Dosage with toxicity

Toxicity
Action
 
ANC < 1 x 109/L or platelets < 100 x 109/L
Hold. Re-assess after 3 days. Resume when counts return to acceptable levels.
 
Mild to moderate anemia
Transfuse if symptomatic, do not interrupt
 
Severe mucositis or gastric distress
Hold until ≤ grade 1
 
Severe/refractory anemia
Hold, transfuse, restart when recovered
 
Vasculitis
Discontinue
 



Hepatic Impairment

No data available, but no adjustment appears to be required


Renal Impairment

Use with caution in patients with renal impairment.

Creatinine Clearance (mL/min) % Usual dose
>60 100%
10-60 50%
<10 Discontinue

Dosage in the Elderly

May be more sensitive to toxic effects. Consider dosage adjustment.


 
F - Adverse Effects

Refer to hydroxyurea drug monograph(s) for additional details of adverse effects.


Most Common Side Effects

Less Common Side Effects, but may be Severe or Life-Threatening

 

  • Myelosuppression +/- infection, bleeding
  • Nausea, vomiting (mild)
  • Rash (may be severe)
  • Fever

 

 

  • Pneumonitis
  • Secondary malignancies
  • Pancreatitis
  • Hepatic failure
  • Cutaneous vasculitis/ulcers, gangrene
  • CNS effects (headache, dizziness, hallucinations, seizure)
  • Hypersensitivity reactions (serum sickness)
  • Radiation recall         
  • Dermatomyositis
  • Tumour lysis syndrome
 
G - Interactions

Refer to hydroxyurea drug monograph(s) for additional details


  • Avoid antiretrovirals (didanosine +/- stavudine) given increased incidence of pancreatitis, liver failure and neurotoxicity
  • Caution and monitor with cytarabine, other myelosuppressive agents or radiation therapy given increased risk of myelosuppression
  • Hyrdoxyurea may interfere with enzymatic assays (unknown clinical relevance)
 
H - Drug Administration and Special Precautions

Refer to hydroxyurea drug monograph(s) for additional details


Administration:

  • Oral self-administration; drug available by outpatient prescription.
  • If patient is unable to swallow capsules, may empty the capsule contents into a glass of water and take orally immediately. Some inert material used as vehicle in the capsule may not dissolve and float on the surface.
  • To minimize the risk of exposure, always wash hands before and after handling hydroxyurea. Always wear impervious gloves when handling hydroxyurea capsules or packaging.
  • Do not allow the drug powder to contact the skin and mucous membranes. Avoid inhaling the powder when opening the capsules.

Contraindications:

  • Patients with marked myelosuppression (WBC < 2.5 x 109/L or platelets < 100 x 109/L), or severe anemia
  • Patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component in its formulation
  • Use with extreme caution in combination with antiretrovirals in patients with HIV

Warnings/precautions:

  • Avoid live the use of live vaccines
  • Contains lactose; carefully consider use in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption

Pregnancy & lactation:

  • Hydroxyurea is not recommended for use in pregnancy or breastfeeding. 
  • Adequate contraception should be used by both sexes during treatment, and for at least 12 months after the last dose.
 
I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Recommended Clinical Monitoring

  • CBC; baseline and at each visit (start with 3 times weekly due to rapid action of hydroxyurea, and modify based on patient response)
  • Baseline and periodic renal function tests
  • Clinical toxicity assessment of skin, gastrointestinal and neurologic symptoms, infection, bleeding; at each  visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

Liver function tests; Baseline and regular


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J - Administrative Information

Outpatient prescription for home administration


 
K - References

Hehlmann R, Heimpel H, Hasford J, et al. Randomized comparison of interferon-α with busulfan and hydroxyurea in chronic myelogenous leukemia. Blood 1994; 84: 4064-4077.

Hehlmann R, Heimpel H, Hasford J, et al. Randomized comparison of busulfan and hydroxyurea in chronic myelogenous leukemia: prolongation of survival by hydroxyurea. The German CML Study Group. Blood 1993; 82: 393-407.

Hydroxyurea drug monograph, Cancer Care Ontario.

January 2018 added rationale


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
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