Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
Severe weather warning in your area. Please stay indoors and stay safe. Read more
regimen-monograph
PACL-FAC
A - Regimen Name
PACL-FAC Regimen
PACLitaxel then Fluorouracil-ADRIAMYCIN ® (DOXOrubicin)-Cyclophosphamide
Disease Site
Breast
Intent
Neoadjuvant
Adjuvant
(Locally advanced/Inflammatory Breast Cancer)
Adjuvant
(Locally advanced/Inflammatory Breast Cancer)
Regimen Category
Local : A regimen not widely used by Regional Cancer Centres in this disease site.
B - Drug Regimen
Paclitaxel (Taxol®) (x12 weeks)
| PACLitaxel
(Round to nearest 3mg) |
80 mg /m² | IV over 1 hour | Weekly |
|
THEN FAC: (x 4 cycles) |
|||
| fluorouracil
(Round to nearest 25mg) |
500 mg /m² | IV | Day 1 |
| DOXOrubicin
(Round to nearest 1mg) |
50 mg /m² | IV | Day 1 |
|
(Continued on next page)
|
|||
| cyclophosphamide
(Round to nearest 10mg) |
500 mg /m² | IV | Day 1 |
C - Cycle Frequency
Paclitaxel: REPEAT WEEKLY For 12 weeks
followed by
FAC: REPEAT EVERY 21 DAYS For 4 cycles
followed by
FAC: REPEAT EVERY 21 DAYS For 4 cycles
D - Premedication and Supportive Measures
Antiemetic Regimen:
Low (Paclitaxel)
Moderate (FAC)
Other Supportive Care:
- Taxol (Paclitaxel) cycles only: Patients should be pretreated with a corticosteroid as well as an antihistamine and a H2 Blocker. For example:
- Dexamethasone 10mg IV 30 minutes before Paclitaxel
- Diphenhydramine 50mg IV 30 minutes before Paclitaxel
- Ranitidine 50mg IV 30 minutes before Paclitaxel
E - Dose Modifications
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.
Dosage with toxicity
Hematologic Toxicities: See appendix 6 for general recommendations.
Neurotoxicity:
| Grade | Action |
| Grade 3 or 4 | Reduce Paclitaxel to 80% usual dose Reduce Paclitaxel to 30mg/m2 or OMIT |
Hepatic Impairment
| Bilirubin | Action |
| 1-2 x ULN | REDUCE Doxorubicin to 50% dose |
| 2-4 x ULN | REDUCE Doxorubicin to 25% dose and REDUCE Paclitaxel to 60mg/m2 |
| > 4 x ULN | STOP treatment of Doxorubicin and Fluorouracil |
Renal Impairment
Cyclophosphamide:
Renal failure may lead to the reduced excretion of metabolites and increased toxicity. Significant falls in clearance (25-80%) with increased exposure have been documented in patients with renal impairment. Dose reduction (25- 50%) should be considered in patients with mild to moderate renal impairment. Patients with moderate renal impairment receiving high doses or severe renally impaired patients (CrCl < 10 mL/min) are at particular risk and should be treated at a reduced dose and with extreme caution.
Renal failure may lead to the reduced excretion of metabolites and increased toxicity. Significant falls in clearance (25-80%) with increased exposure have been documented in patients with renal impairment. Dose reduction (25- 50%) should be considered in patients with mild to moderate renal impairment. Patients with moderate renal impairment receiving high doses or severe renally impaired patients (CrCl < 10 mL/min) are at particular risk and should be treated at a reduced dose and with extreme caution.
F - Adverse Effects
Refer to PACLitaxel, fluorouracil, DOXOrubicin, cyclophosphamide drug monograph(s) for additional details of adverse effects
• Bolus 5FU regimens have more myelosuppression and GI effects but less Hand-Foot Syndrome, compared to prolonged infusions.
Most Frequently Occurring Adverse Effects
- Nausea and vomiting
- Cystitis
- Myelosuppression
- Cardiotoxicity
- Stomatitis and diarrhea
- Alopecia
- Vesicant (Doxorubicin)
- Peripheral neuropathy
- Hypersensitivity reactions (Paclitaxel)
- Myalgia and arthralgia
G - Interactions
Refer to PACLitaxel, fluorouracil, DOXOrubicin, cyclophosphamide drug monograph(s) for additional details
H - Drug Administration and Special Precautions
Refer to PACLitaxel, fluorouracil, DOXOrubicin, cyclophosphamide drug monograph(s) for additional details
I - Recommended Clinical Monitoring
Recommended Clinical Monitoring
- Clinical toxicity assessment (including stomatitis, cardiotoxicity, local toxicity, cystitis, hypersensitivity, and neuropathy)
- CBC before each cycle
- Baseline and regular liver and renal function tests
- Cardiac examination especially with risk factors (including prior therapy with Epirubicin, Mitoxantrone, or other cardiotoxic drug), or a cumulative doxorubicin dose of > 450 mg/m2
- Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
back to top
K - References
Green A, Buzdar T, Smith N et al. Weekly paclitaxel followed by FAC as primary systemic chemotherapy of operable breast cancer improves pathologic complete emission rates when compared to every 3-week paclitaxel therapy followed by FAC-final results of a prospective phase III randomized trial. ASCO Proceedings 2002 (Abstract #135).
PEBC Advice Documents or Guidelines
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.
Last Updated: July 27, 2026
