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.
CAPEGEMC
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 cholangiocarcinoma in patients who are not considered candidates for surgery with curative intent, but who are willing and able to tolerate treatment with chemotherapy. Phase III trials have not been conducted.
capecitabine
ODB - General Benefit
(capecitabine)
| gemcitabine | 1000 mg /m² | IV | Days 1 and 8 |
| capecitabine | 650 mg /m² | PO | BID* Days 1 to 14 |
|
(*Total daily dose 1300mg/m2/day; Outpatient prescription in 150mg and 500mg tablets)
|
|||
REPEAT EVERY 21 DAYS
Until evidence of disease progression or unacceptable toxicity
Low
No routine prophylaxis for capecitabine
Other Supportive Care:
- Topical emollients (e.g. hand creams, udder balm) may ameliorate the manifestations of hand-foot syndrome in patients receiving capecitabine.
- Supportive care should be provided, including loperamide for diarrhea.
Also refer to CCO Antiemetic Recommendations.
Doses should be modified according to the protocol by which the patient is being treated.
Patients should be tested for DPD deficiency before starting treatment with capecitabine. Refer to the DPD Deficiency Guidance for Clinicians for more information.
In patients with unrecognized DPD deficiency, acute, life-threatening toxicity may occur; if acute grade 2-4 toxicity develops, treatment should be stopped immediately and permanent discontinuation considered based on clinical assessment of the toxicities.
Dosage with toxicity
Gemcitabine - Dose on Day 1 of Cycle:
|
Worst Toxicity in Previous Cycle
|
Dose for next cycle*
|
||
|
Non-hematologic
(related organ)
|
|
Hematologic
|
% Full Dose
|
|
Grade 3
|
or
|
Febrile neutropenia, thrombocytopenic bleeding |
75%*
|
|
Grade 4
|
|
|
Consider discontinuing, or ↓ to 75%*
|
|
Day 8/15 holds in > 1 cycle |
75%*
|
||
|
|
|
Discontinue
|
Gemcitabine - Dose on Day 8 of Cycle:
|
Toxicity on Day 8 of cycle |
|
||||
|
Non-hematologic
(related organ) |
|
Hematologic
|
Gemcitabine (% Full Dose) |
||
|
AGC
(x 106/L)
|
|
Platelets
(x 106/L)
|
|||
|
≤ grade 2
|
and
|
> 1000
|
and
|
> 100,000
|
100%
|
|
≤ grade 2
|
and
|
500-1000
|
or
|
50,000-100,000
|
Consider Omit
or ↓ to 75%
|
|
Grade 3 or 4
|
or
|
< 500
|
or
|
< 50,000
|
Omit, ↓ to 75% at restart (if applicable) for non-hematologic toxicity
|
|
Pneumonitis |
|
-
|
|
-
|
Discontinue
|
Capecitabine:
|
Toxicity†
|
Action During a Course of Therapy
|
Dose Adjustment for Next Cycle (% of starting dose)
|
|
Grade 1
|
Maintain dose level
|
Maintain dose level
|
|
Grade 2
1st appearance
2nd appearance
3rd appearance
4th appearance
|
Interrupt until resolved to grade 0-1
Interrupt until resolved to grade 0-1
Interrupt until resolved to grade 0-1 Discontinue treatment permanently
|
100%
75%
50%
--
|
| Toxicity (Continued) | Action During a Course of Therapy | Capecitabine Dose Adjustment for Next Cycle (% of starting dose) |
|
Grade 3
1st appearance
2nd appearance
3rd appearance OR any evidence of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis |
Interrupt until resolved to grade 0-1
Interrupt until resolved to grade 0-1
Discontinue treatment permanently
|
75%
50%
--
|
|
Grade 4
1st appearance, including SJS, TENS, OR
cardiotoxicity OR
acute renal failure
2nd appearance
|
Discontinue permanently
OR If physician deems it to be in the patient’s best interest to continue and no evidence of Stevens-Johnson syndrome or toxic epidermal necrolysis, interrupt until resolved to grade 0-1. Discontinue permanently
|
Discontinue
OR
50%
- |
Hepatic Impairment
Gemcitabine: Use with caution in patients with hepatic impairment (cirrhosis, hepatitis, metastases, etc.); initial dose reduction should be considered if the patient is treated, especially in hyperbilirubinemia.
Capecitabine: Use dose modification table above for increases in bilirubin. In patients with mild to moderate hepatic impairment due to liver metastases exposure is increased, but no dose adjustment is necessary, although caution should be exercised. The use of capecitabine in patients with severe hepatic impairment has not been studied.
Renal Impairment
| Creatinine clearance (mL/min) | Gemcitabine (% previous dose) | Capecitabine (% previous dose) |
| 51-80 | 100% | 100% |
| 30-50 | 100% | 75% |
| <30 | Consider discontinuing or ↓ |
Discontinue |
Refer to gemcitabine, capecitabine drug monograph(s) for additional details of adverse effects
|
Most Common Side Effects |
Less Common Side Effects, but may be |
|
|
Refer to gemcitabine, capecitabine drug monograph(s) for additional details
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 before each cycle and on day 8. Interim counts should be done in first cycle and repeated if dose modifications necessary.
- Baseline and regular liver and renal function tests
- Clinical toxicity assessment (flu-like symptoms, fatigue, edema, pulmonary, rash, hand-foot syndrome, diarrhea, dehydration, infection, bleeding, stomatitis); at each visit
- INR or PT; baseline and regular if on anticoagulants
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Capecitabine and gemcitabine drug monographs, Cancer Care Ontario.
Knox JJ, Hedley D, Oza A, et al. Combining gemcitabine and capecitabine in patients with advanced biliary cancer: a phase II trial. J Clin Oncol. 2005;23:2332-8.
Riechelmann RP, Townsley CA, Chin SN, et al. Expanded phase II trial of gemcitabine and capecitabine in advanced biliary tract cancer. Cancer 2007;110:1307–12.
April 2023 Updated DPD deficiency information in the Dose Modifications section
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.