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A - Regimen Name

 

MEDR Regimen
Medroxyprogesterone

 

 

Disease Site
Gynecologic - Endometrial

 

 

Intent
Adjuvant
Curative

 

 

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

Fertility-preserving treatment for endometrial cancer

 

 

Supplementary Public Funding

medroxyprogesterone
ODB - General Benefit (medroxyprogesterone)
 

 

 
B - Drug Regimen

 

medroxyprogesterone
 
400 to 600 mgPODaily
(Outpatient prescription in multiples of 100mg tablets)
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C - Cycle Frequency

 

CONTINUOUS TREATMENT

Depending on response (refer to References)

 

 
D - Premedication and Supportive Measures
 
Antiemetic Regimen:

Not applicable

Other Supportive Care:

Prophylaxis with low-dose aspirin was used in some clinical trials (Ushijima et al.)

 
E - Dose Modifications

 

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and may be considered.

 

Dosage with toxicity

 

Toxicity
Dose
Myelosuppression
Continue treatment
Vaginal bleeding
Hold and investigate

Ophthalmic vascular disease

Discontinue

Arterial or vascular thromboembolism

Discontinue
↑ LFTs
Hold until ≤ ULN; discontinue if no recovery

 

 

 

Hepatic Impairment

Do not use in patients with abnormal LFTs.

 

Renal Impairment

No information found

 

Dosage in the Elderly

No adjustment required. There is an increased risk of arterial thromboembolism and breast cancer in patients ≥ 75 years.

 

 
F - Adverse Effects

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

 
Most Common Side Effects 

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

  • Abdominal pain, bloating
  • Vaginal bleeding, hormone deprivation symptoms
  • Fluid retention
  • Headache
  • Arterial thromboembolism
  • Venous thromboembolism
  • Arrhythmia
  • Secondary malignancy
  • Hypersensitivity
  • Osteoporosis
  • Visual changes
 
G - Interactions

Refer to medroxyprogesterone drug monograph(s) for additional details

 
H - Drug Administration and Special Precautions

Refer to medroxyprogesterone drug monograph(s) for additional details

 
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

Suggested Clinical Monitoring

  • Blood glucose in diabetes; Baseline and regular
  • Blood pressure; Baseline and as indicated
  • Cholesterol and triglycerides; Baseline and as indicated
  • Electrolytes (calcium); Baseline and as indicated
  • Liver function tests; Baseline and regular

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J - Administrative Information

Outpatient prescription for home administration

 
 
 
K - References

Medroxyprogesterone drug monograph, Cancer Care Ontario.

Columbo N et al. Int J Gynecol Cancer 2016;26:2-30 (ESMO-ESGO-ESTRO Consensus Conference)

Rodolakis A et al. Int J Gynecol Cancer 2015:25:1258-65 (ESGO Task Force)

Ushijima K et al. J Clin Oncol 2007;25:2798-2803.

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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.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.