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DOCEPRED
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.
Treatment of metastatic castration-resistant prostate cancer
prednisone
ODB - General Benefit
(prednisone)
(ODB Formulary
)
Low
Other Supportive Care:
DEXAMETHASONE Pre- & Post medication should be administered to prevent anaphylaxis and fluid retention. (i.e. Dexamethasone 8mg PO 12 h, 3 h and 1 h pre-docetaxel.)
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 could be considered.
Up to 10 cycles were given in the phase III clinical trial.
Dosage with toxicity
|
Toxicity (worst in previous cycle)
|
Docetaxel dose* |
|
Febrile neutropenia / Grade 4 ANC ≥ 7 d |
75%
|
|
Grade 3 skin/ neuro/ major organ/ non-hematologic toxicity |
75%
|
|
Any occurrence of cystoid macular edema |
Hold and investigate; refer patient promptly an ophthalmic examination. Discontinue if confirmed. |
| Grade 4 skin/ neuro/ major organ/ non-hematologic toxicity OR Recurrence of Grade 3 toxicity after prior dose reduction |
Discontinue
|
|
* Do not retreat until ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and non-hematologic/organ toxicity ≤ grade 2. |
|
Hypersensitivity
Hypersensitivity reactions may occur within a few minutes following the initiation of docetaxel infusion.
|
Toxicity
|
Action
|
|
Mild hypersensitivity reaction
|
↓ infusion rate (and/ or hold) and use beta-agonists, antihistamines, antipyretics, and/or corticosteroids as appropriate. Consider premedication for next infusion. |
|
Moderate hypersensitivity reaction
|
Hold and use beta-agonists, antihistamines, antipyretics, and/or corticosteroids as appropriate; complete infusion at ↓ rate if possible. Use premedication for next infusion. |
|
Severe hypersensitivity reaction or Pulmonary Toxicity
|
Hold and manage symptoms aggressively with beta-agonists, antihistamines, antipyretics, and/or corticosteroids. Discontinue permanently and do not re-challenge |
Hepatic Impairment
Patients with hepatic impairment have a higher risk of severe adverse effects, including fatal gastrointestinal hemorrhage, sepsis and myelosuppression.
| Bilirubin |
AST and/or ALT |
|
Alkaline Phosphatase |
Docetaxel dose |
||
| > ULN | AND | Any | AND | Any |
Do not treat. Discontinue if treatment already started. |
|
| Any | AND |
> 1.5 X ULN
|
AND |
> 2.5 x ULN |
||
Renal Impairment
No adjustment required.
Dosage in the Elderly
No adjustment required, but caution should be exercised in elderly patients with poor performance status who are receiving docetaxel.
Refer to DOCEtaxel drug monograph(s) for additional details of adverse effects.
|
Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
|
Refer to DOCEtaxel drug monograph(s) for additional details
- Avoid concomitant use with CYP3A4 inhibitors. If must use together, consider decreasing docetaxel dose (50% for strong inhibitors).
- Caution with CYP3A4 inducers and substrates
- Avoid concurrent use with dronedarone
Refer to DOCEtaxel drug monograph(s) for additional details
Administration:
- Refer to the respective product monographs for preparation instructions. Mix in 250mL D5W or NS to a maximum concentration of 0.3-0.74 mg/mL. For doses over 200mg, use a larger volume of the infusion vehicle so the maximum concentration is not exceeded.
- Infuse through main IV line over 1 hour.
- In order to minimize patients' exposure to DEHP leaching from PVC bags or sets, use polyolefin or polypropylene infusion bags and polyethylene-lined administration sets.
- To minimize hypersensitivity reactions, docetaxel infusion should be started at a slow rate, then increased incrementally to planned rate.
- Monitor patient for signs of alcohol intoxication (due to alcohol content in formulation) during and after the infusion.
- Injection site recall reactions (recurrence of skin reaction at a previous extravasation site after docetaxel is administered at a different site) have been observed.
Contraindications:
- Patients who have a history of severe hypersensitivity reactions to docetaxel, to other drugs formulated with polysorbate 80 or polyethylene glycol 300, or to any components of the formulation
- Patients with baseline neutrophil counts of <1.5 x 109/L
- Patients with severe liver impairment
Other Warnings/Precautions:
- Patients with:
- bilirubin > ULN or
- AST and/or ALT > 1.5 x ULN and ALP > 2.5 x ULN or
- ANC < 1.5 x 109/L
- (refer to dose modifications section)
- Use with caution in patients with pre-existing effusions or ascites.
- Use with caution in patients who have hypersensitivity to paclitaxel.
- Docetaxel contains ethanol (± 1g/m2; refer to respective product monographs) and may cause drowsiness. Patients should be cautioned regarding driving and the use of machinery immediately after receiving the infusion. Ethanol may be harmful to patients at risk of adverse effects such as those with alcoholism, liver disease, epilepsy and children. Cases of alcohol intoxication have been reported.
Pregnancy/Lactation:
- Docetaxel is contraindicated in pregnancy and lactation. Adequate contraception must be used by both sexes, during docetaxel treatment and for at least 6 months after the last dose. Fertility may be affected.
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, including nadir counts; baseline and before each dose
- Liver function tests; baseline and before each dose
- Clinical toxicity assessment of infection, bleeding, neurotoxicity, fluid retention, hypersensitivity, lethargy, cutaneous reactions, thromboembolism, musculoskeletal pain, cardiovascular, ophthalmic, GI or respiratory effects, or enterocolitis with neutropenia; at each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Tannock IF, de Wit R, Berry W, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351(15): 1502-12.
June 2021 removed docetaxel NDFP funding info
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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