MFOLFIRINOX
Conroy T, Hammel P, Hebbar M, et al. FOLFIRINOX or gemcitabine as adjuvant therapy for pancreatic cancer. N Engl J Med 2018;379:2395-406. DOI: 10.1056/NEJMoa1809775
Cancer Type: Gastrointestinal Pancreas Type of Content: Regimen Regimen Code:MFOLFIRINOX
Intent: Adjuvant Regimen Category:Evidence-informed
Drugs Used: oxaliplatin leucovorin irinotecan fluorouracil Regimen Monograph Name:MFOLFIRINOX_GI_PAN_A
Regimen Monograph Body:
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.
This 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). 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.
Adjuvant therapy in patients with resected pancreatic cancer
oxaliplatin | 85 mg /m² | IV over 2 hours | Day 1 |
|
|||
leucovorin | 400 mg /m² | IV over 2 hours | Day 1 |
|
|||
irinotecan | 150 mg /m² | IV over 90 minutes, concurrently with leucovorin | Day 1 |
|
|||
fluorouracil | 2400 mg /m² | IV continuous infusion over 46 hours (single dose) | Start on Day 1 |
REPEAT EVERY 14 DAYS
For a usual total of 12 cycles unless disease progression or unacceptable toxicity occurs
Moderate
Moderate
Consider G-CSF in patients with high risk of febrile neutropenia. See G-CSF recommendations.
Other Supportive Care:
- Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
- For irinotecan cholinergic adverse effects (early diarrhea):
- Unless contraindicated, atropine 0.25-1mg IV/SC may be given
- Prophylactic atropine may be considered in patients who have experienced cholinergic symptoms
- Loperamide must be provided. Diarrhea (including abdominal cramps) may be severe and delayed with irinotecan.
- Give loperamide 4mg at the onset of diarrhea, then 2mg q2h until patient is diarrhea-free for 12 hours. During the night the patient may take 4mg of loperamide every 4 hours.
- May consider antibiotics for patients with ileus, fever or febrile neutropenia.
- Avoid mucositis prophylaxis with ice chips as cold temperatures can precipitate or exacerbate acute neurological symptoms of oxaliplatin.
Premedication for oxaliplatin (prophylaxis for infusion reactions):
- There is insufficient evidence that routine prophylaxis with pre-medications reduces IR rates.
- Consider corticosteroids and H1-receptor antagonists ± H2-receptor antagonists in high-risk patients (i.e. ≥ cycle 6, younger age, female gender, prior platinum exposure, platinum-free interval ≥ 3 years).
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 fluorouracil. 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
Do not start new cycle until platelets ≥ 100 x 109/L and ANC ≥ 1.5 x 109/L, recovery from diarrhea (to baseline without loperamide for at least 24 hours), and other non-hematologic toxicities have recovered to ≤grade 2.
Doses should be adjusted based on the worst preceding toxicity. Do not re-escalate dose if reduced for toxicity.
No dose adjustment is required for leucovorin. Leucovorin should be omitted if fluorouracil is omitted.
Dose Levels:
Drug | Dose level 0 (mg/m2) |
Dose level -1* (mg/m2) |
Irinotecan | 150 | 120 |
Oxaliplatin | 85 | 60 |
Fluorouracil infusion | 2400 | 1800 |
* If further dose reduction is required, consider a 20% dose reduction or discontinuing the regimen.
Dose Modifications:
Toxicity
|
Occurrence
|
Irinotecan dosea,b,c
|
Oxaliplatin dosea,b,c
|
Fluorouracil dosea,b,c
|
Febrile neutropenia OR
Grade 4 ANC > 7 d OR
Delay 1-2 weeks for ≥ Grade 2 ANC
|
1st
|
↓ 1 dose level
|
No change
|
|
2nd
|
Maintain same dose level
|
↓ 1 dose level
|
||
3rd | Consider further dose reduction, or only keep fluorouracil infusion if necessary |
|||
≥ grade 3 platelets OR Delay 1-2 weeks for platelets <100 x 109/L |
1st
|
No change
|
↓ 1 dose level
|
No change
|
2nd
|
↓ 1 dose level
|
Maintain same dose level
|
↓ 1 dose level
|
|
3rd | Discontinue | Maintain same dose level |
||
Diarrhea ≥ grade 3 OR Diarrhea with fever or ≥ Grade 3 ANC |
1st
|
↓ 1 dose level
|
No change
|
No change
|
2nd
|
Maintain same dose level
|
↓ 1 dose level
|
↓ 1 dose level
|
|
3rd | Discontinue | Maintain same dose level | Maintain same dose level | |
Grade 3 or 4 mucositis or hand-foot syndrome | - | No change | No change | ↓ 1 dose level |
Grade 2 persistent neurotoxicity |
-
|
No change
|
↓ 1 dose level
|
No change
|
Grade 3 neurotoxicity (recovers prior to next cycle) | - | No change | ↓ 1 dose level | No change |
Grade 3 persistent neurotoxicity OR Grade 4 neurotoxicity |
Any | No change | Discontinue | No change |
Grade 2 other non-hematological |
-
|
Consider ↓
|
Consider ↓
|
Consider ↓
|
Grade 3 other non-hematological |
-
|
↓ 1 dose level
|
↓ 1 dose level
|
↓ 1 dose level
|
Pneumonitis | Any | Discontinue | Discontinue | Discontinue |
Grade 4 other non-hematological OR RPLS OR Hemolytic uremic syndrome or any signs of microangiopathic hemolytic anemia |
Any | Discontinue | Discontinue | Discontinue |
Pharyngolaryngeal dysesthesia |
-
|
-
|
↑ infusion to 6 hours
|
-
|
aDo not treat until ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, diarrhea resolved to baseline and other toxicity ≤ grade 2. Do not re-escalate dose if reduced for toxicity. |
Management of Oxaliplatin Infusion-related reactions:
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
Grade | Management | Re-challenge |
1 or 2 |
Restart:
|
|
3 or 4 |
|
|
Hepatic Impairment
Transaminases |
Bilirubin^ |
Irinotecan dose |
Oxaliplatin dose |
5FU dose |
|
|
1 to 1.5 X ULN or Gilbert's |
Consider ↓ |
No change |
No change |
|
> 3 to 5 X ULN* |
and/or |
>1.5 to 4 X ULN |
Omit |
No change |
Consider ↓ (e.g. 75% of previous dose) |
>5 to 10 X ULN | and/or | >1.5 to 4 X ULN | Omit | No change | Consider ↓ (e.g. 50-75% of previous dose) |
> 10 X ULN |
and/or |
> 4 X ULN |
Omit |
No info found |
Omit |
* or >5 X ULN with liver metastases |
^ If bilirubin ↑, consider investigating for reversible causes such as biliary obstruction and re-evaluate after stent.
Renal Impairment
Creatinine Clearance (mL/min) |
oxaliplatin
(% previous dose) |
fluorouracil
(% previous dose) |
irinotecan
(% previous dose) |
≥50
|
No change
|
No change
|
No change
|
30 to < 50 |
Caution
|
No change
|
No change
|
<30
|
Discontinue
|
Consider dose reduction
|
Caution
|
Refer to oxaliplatin, leucovorin, irinotecan, fluorouracil 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 oxaliplatin, leucovorin, irinotecan, fluorouracil drug monograph(s) for additional details
- Use of fluorouracil within 4 weeks of treatment with brivudine, sorivudine (and chemically related analogues) is contraindicated.
- Azole antifungals are contraindicated with irinotecan (discontinue one week before the first dose of irinotecan).
- Avoid concomitant use of metronidazole and fluorouracil if possible.
- Avoid concomitant use of strong CYP3A4 inhibitors and inducers with irinotecan.
- Avoid concomitant use of prochlorperazine (on same day of irinotecan treatment), turmeric and azatanavir with irinotecan.
- Thiazide diuretics may decrease renal excretion of fluorouracil; consider an alternative antihypertensive.
- Monitor INR closely while on concomitant warfarin and fluorouracil or oxaliplatin; adjust warfarin dose accordingly.
- Monitor phenytoin levels if used concurrently with fluorouracil.
- Monitor for toxicity when oxaliplatin is used with other drugs that are nephrotoxic, prolong QT or are associated with rhabdomyolysis.
- Caution with the concurrent use of cimetidine due to interference with fluorouracil metabolism; fatal cases have been reported.
Refer to oxaliplatin, leucovorin, irinotecan, fluorouracil drug monograph(s) for additional details
Oxaliplatin:
-
Oxaliplatin is administered by intravenous infusion.
-
Oxaliplatin should always be administered before fluorouracil.
-
May be mixed in 250-500 mL bag of D5W only. Do not mix oxaliplatin with NS, chloride containing or alkaline solutions, or with fluorouracil.
-
Administer by slow infusion. Concentration must be between 0.2 to 0.7 mg/mL
-
Infuse IV over 2 hours. Increasing infusion time to 6 hours may decrease acute toxicity such as pharyngolaryngeal dysesthesia.
-
Do not mix oxaliplatin with other drugs in the same infusion bag or infusion line.
-
If another drug is given before oxaliplatin, flush infusion line with D5W before giving oxaliplatin. Flush the line with D5W after oxaliplatin before giving a subsequent drug.
-
The compatibility of oxaliplatin solution for infusion has been tested with representative, PVC-based, administration sets.
-
Do not use with injection equipment containing aluminum, as this can degrade platinum compounds.
-
Unopened vials should be stored at 15-30°C; protect from light.
Leucovorin:
- Leucovorin may be diluted in 250mL D5W.
-
Leucovorin should not be mixed in the same infusion as 5-fluorouracil as a precipitate may form.
-
Keep refrigerated; protect from light.
Irinotecan:
-
Mix in 500mL bag D5W in a concentration range between 0.12 to 3 mg/mL; infuse IV over 90 minutes.
-
Infusion may be given at the same time as leucovorin in separate D5W bags using a Y-site.
-
Avoid freezing irinotecan and its admixtures since this may result in drug precipitation.
-
Do not admix with other drugs.
-
Protect from light.
-
Prior to the initial irinotecan treatment, patients should be given a sufficient supply of loperamide and instructed on its appropriate use.
Fluorouracil:
IV CONTINUOUS INFUSION:
- Refer to local guidelines on preparation of fluorouracil IV infusion.
-
Continuous infusion via central line or PICC using CADD infusion pump, infusor bottle or similar device
- Incompatible with doxorubicin, epirubicin, diazepam, methotrexate and cytarabine; line must be flushed between administrations of fluorouracil and these agents.
-
Store at room temperature (15 to 25ºC). Protect from light.
Refer to Section L - Other Notes section for Information on the Antidote for Fluorouracil Overdose.
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
Contraindications:
-
Hypersensitivity to fluorouracil, irinotecan, leucovorin, oxaliplatin or to other platinum agents (e.g. cisplatin, carboplatin) or to any component of the formulation.
-
Patients with severe renal impairment (CrCl < 30 mL/min), with oxaliplatin
-
Patients with poor nutritional state
-
Patients with depressed bone marrow function (prior pelvic irradiation / marrow infiltration)
-
Patients with potentially serious infections
-
Patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity, with fluorouracil. Refer to the DPD Deficiency Guidance for Clinicians for more information.
-
Avoid in patients with hereditary fructose intolerance since the irinotecan formulation contains sorbitol.
-
Avoid the use of live or live attenuated vaccines.
-
Fluorouracil should not be used within 4 weeks of treatment with brivudine, sorivudine or their chemically related analogues. (See interactions section)
-
Irinotecan should not be co-administered with azole antifungals (ketoconazole etc. See Interactions section)
Warnings/Precautions:
-
Oxaliplatin may result in dizziness or visual disturbances (including transient vision loss) in some patients; patients should exercise caution in driving or operating machinery.
-
Do not give oxaliplatin intraperitoneally.
-
Irinotecan is not recommended for use in patients with ECOG performance status 3 or 4, or in patients with moderate or severe increases in bilirubin.
-
Carefully monitor and consider irinotecan dose reduction for elderly patients, patients with poor performance status (= 2), limited marrow reserve, 3rd space accumulation, Gilbert’s syndrome and patients with reduced UGT1A1 activity; they may be more susceptible to the toxic effects of irinotecan.
-
Concurrent administration of irinotecan with irradiation is not recommended. Patients with prior pelvic or abdominal irradiation are at an increased risk of severe myelosuppression following irinotecan therapy.
-
Use fluorouracil with extreme caution in patients who:
-
have undergone recent major surgery,
-
have renal or hepatic impairment,
-
have widespread bone marrow involvement,
-
have previous use of other myelosuppressive chemotherapeutic agents,
-
have a history of high dose irradiation to bone marrow-bearing areas,
-
have a history of heart disease,
-
or are suspected to have DPD deficiency. Refer to the DPD Deficiency Guidance for Clinicians for more information.
-
Pregnancy/Lactation:
-
This regimen is contraindicated for use in pregnancy. Adequate contraception should be used by patients and their partners while on treatment and after the last treatment dose. Recommended methods and duration of contraception may differ depending on the treatment. Refer to the drug monograph(s) for more information.
-
Breastfeeding is contraindicated during this treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if available).
-
Fertility effects: Yes
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.
Recommended Clinical Monitoring
- CBC; baseline and before each cycle
- Liver and renal function tests; baseline and before each cycle
- Electrolytes, including magnesium; baseline and before each cycle
- INR for patients on warfarin; baseline and as clinically indicated
- Routine toxicity rating of diarrhea and other GI effects, fatigue, cholinergic symptoms, hypersensitivity, pneumonitis, bleeding, infection, dehydration, pancreatitis, neuropathy, thromboembolism, local reactions, skin (including rash, hand-foot syndrome), ophthalmic and cardiac toxicity.
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- Blood glucose, especially in patients with diabetes; Baseline and regularly
back to top
Conroy T, Hammel P, Hebbar M, et al. FOLFIRINOX or gemcitabine as adjuvant therapy for pancreatic cancer. N Engl J Med 2018;379:2395-406. DOI: 10.1056/NEJMoa1809775
November 2023 Modified Pregnancy/lactation section
Diarrhea can be severe, with either immediate or delayed onset. Patients must be instructed in the use of Loperamide as treatment for diarrhea, and must have a supply of this drug upon starting Irinotecan treatments.
Antidote for Fluorouracil Overdose:
Uridine triacetate is a prodrug of uridine and is a specific antidote for treating fluorouracil overdose or severe early onset toxicities. If available, consider administering as soon as possible (i.e. within 96 hours) for suspected overdose. If not available, treatment is symptomatic and supportive.
For usage approval and supply, contact Health Canada’s Special Access Program (SAP) (Phone: 613-941-2108. On-call service is available for emergencies). Uridine triacetate (Vistogard®) is supplied by its manufacturer in the United States (Wellstat Therapeutics).
The recommended dosing and administration for uridine triacetate in patients ≥18 years is:
- 10 grams (1 packet of coated granules) orally every 6 hours for 20 doses in total, without regards to meals.
- Granules should not be chewed. They should be mixed with 3 to 4 ounces of soft foods such as applesauce, pudding or yogurt.
- The dose should be ingested within 30 minutes of preparation, followed by at least 4 ounces of water.
- Refer to the prescribing information on dose preparation for NG-tube or G-tube use.
Additional resources on the management of fluorouracil infusion overdose:
- Management of Fluorouracil Infusion Overdose Guideline (Alberta Health Services)
- Management of Fluorouracil Infusion Overdose at the BCCA - Interim Guidance (BC Cancer Agency)
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.
MFOLFIRINOX Treatment
This handout gives general information about this cancer treatment.
You will learn:
-
who to contact for help
-
what the treatment is
-
how it is given
-
what to expect while on treatment
This handout was created by Ontario Health (Cancer Care Ontario) together with patients and their caregivers who have also gone through cancer treatment. It is meant to help support you through your cancer treatment and answer some of your questions.
This information does not replace the advice of your health care team. Always talk to your health care team about your treatment.
My cancer health care provider is: _____________________________________________
During the day I should contact: _______________________________________________
Evenings, weekends and holidays: _____________________________________________
This page gives general information about this cancer treatment.
You will learn:
-
who to contact for help
-
what the treatment is
-
how it is given
-
what to expect while on treatment
This information was created by Ontario Health (Cancer Care Ontario) together with patients and their caregivers who have also gone through cancer treatment. It is meant to help support you through your cancer treatment and answer some of your questions.
This information does not replace the advice of your health care team. Always talk to your health care team about your treatment.
mFOLFIRINOX is the code name of your pancreatic cancer treatment regimen. Most people call this regimen FOLFIRINOX. A regimen is a combination of medications to treat cancer.
This regimen name is made up of one or more letters from the names of the 4 medications in your treatment.
Here are the names of the medications in this regimen:
FOL = FOLinic acid (also called leucovorin)
F = Fluorouracil (also called 5-FU)
IRIN = IRINotecan
OX = OXaliplatin
Treatment is divided into cycles. Each cycle is 2 weeks long. Your health care team will tell you how many cycles you need.
Here is a picture of the schedule for FOLFIRINOX treatment:
Cycle 1 FOLFIRINOX (2 weeks)
Repeat FOLFIRINOX (2 weeks)
Your health care team will tell you how many cycles you will have.
During each 2-week cycle, you will have FOLFIRINOX treatment on day 1 at the hospital. Your nurse will also start an IV of fluorouracil that will continue at home for a total of 46 hours. See below for more information.
Each cycle looks like this:
Day 1
Treatment Day:
Go to the hospital for FOLFIRINOX
treatment.
Fluorouracil infusion will
continue for 46 hours.
2
Fluorouracil infusion continues at home.
3
Fluorouracil infusion continues at home. A nurse will disconnect it.
4
No FOLFIRINOX Treatment
5
6
7
8
9
10
11
12
13
14
Remember To:
-
Tell your health care team about all of the other medications you are taking.
-
Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.
You will have a blood test to check for hepatitis B before starting treatment. See the Hepatitis B and Cancer Medications pamphlet for more information.
Your health care team may ask you to have a blood test to check for DPD deficiency before starting treatment.
- DPD deficiency is when you have low or no activity of an enzyme called DPD (dihydropyrimidine dehydrogenase). A deficiency can cause you to have severe side effects from fluorouracil.
- See the Testing for people taking capecitabine or 5-fluorouracil (5-FU) pamphlet for more information.
The medications in your treatment are given through an IV (injected into a vein) at the hospital on day 1 of your treatment. You will also be given a device to take home that will continue to give you fluorouracil at home. The device looks like a bottle. It slowly gives you fluorouracil over 46 hours.
Your health care team may suggest that you get a PICC line or a Port-a-Cath.
-
These are special IV’s used to give medicines and fluids into larger veins.
-
A PICC or Port-a-Cath can be safer for some medications that can cause reactions
when given through an IV in your hand. -
If you have a PICC or Port-a-Cath you do not need an IV (needle) put into your arm
every time you come for treatment.
- Talk to your healthcare team about the benefits and risks of a PICC or a Port-a-Cath to see if one of these options is right for you.
You will have a blood test before each treatment cycle to make sure it is safe for you to get treatment.
To Prevent Nausea and Vomiting
You will be given medications to help prevent nausea (feeling like throwing up) and vomiting (throwing up) before they start.
- These are called anti-nausea medications and include medications such as ondansetron (Zofran®), granisetron (Kytril®), dexamethasone or others.
To Treat Diarrhea
The Irinotecan in your treatment regimen can cause diarrhea. Diarrhea is when you have loose bowel movements (watery poo) or you need to have bowel movements (go poo) more often than usual. Diarrhea may start a few days after your treatment.
You will be given a medication called loperamide (Imodium®) to help treat your diarrhea. Take this medication only if you need it.
Keep your loperamide with you all the time. When diarrhea starts, take the loperamide right away.
If you start to have diarrhea:
- Take 2 tablets (4mg) of loperamide right away.
- Take 1 tablet (2mg) every 2 hours after that.
- During the night you may take 2 tablets (4mg) every 4 hours.
- Keep taking loperamide until you have no diarrhea for 12 hours.
This treatment causes cold sensitivity.
One of the medications in your treatment (oxaliplatin) can cause an unusual side effect where different parts of your body may become very sensitive to cold. This can cause discomfort from things such as cold food, cold drinks and cool or cold temperatures.
How does the cold sensitivity feel?
You may feel:
- Numbness or tingling in your fingers and toes. Sometimes it can be painful and feel like burning, which may be severe.
- Tightness in your throat or jaw
- Like it is hard to swallow
- Like it is hard to breathe, or that you have pressure on your chest
Tightness in your throat will usually go away after a few hours. If it lasts longer, or if you have trouble breathing, contact your health care team or get emergency help right away.
How can I help prevent sensitivity to cold?
- Avoid the cold as much as possible.
- If you must go outside in the cold, protect your face and mouth with a scarf or high-neck sweater, wear mittens and warm socks.
- Only eat and drink things that are room temperature or warmer. Do not drink cold drinks or put ice cubes in anything you drink. Do not eat cold foods, such as ice cream.
- Avoid direct exposure to air conditioning, such as in your car.
- Take shallow breaths when you are exposed to cold air (such as from a freezer or when you are outside in winter).
- Wear gloves if you need to touch cold objects, such as items in the freezer.
- Do not use an ice pack on any part of your body.
-
DO tell your health care team about any other medical conditions that you have such as problems with nerves in hands and feet (numbness or tingling), heart, liver, lung or kidney problems, diabetes, or any allergies.
-
DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.
-
DO protect your skin from the sun. Wear a long-sleeved shirt, long pants and a hat. Apply sunscreen with UVA and UVB protection and an SPF of at least 30. Your skin may be more sensitive to the sun and you could develop a bad sunburn or rash more easily.
-
DO talk to your health care team about your risk of getting other cancers and heart problems with this treatment.
-
DO consider asking someone to drive you to and from the hospital on your treatment days. You may feel drowsy or dizzy after your treatment.
- DO NOT take any other medications, such as vitamins, over the counter (non-prescription) drugs, or natural health products without checking with your health care team.
- DO NOT start any complementary or alternative therapies, such as acupuncture or homeopathic medications, without checking with your health care team.
- DO NOT eat or drink grapefruit, starfruit, Seville oranges or their juices (or products that contain these) while on this treatment. They may increase side effects.
- DO NOT smoke or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.
-
DO tell your health care team about any other medical conditions that you have such as problems with nerves in hands and feet (numbness or tingling), heart, liver, lung or kidney problems, diabetes, or any allergies.
-
DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.
-
DO protect your skin from the sun. Wear a long-sleeved shirt, long pants and a hat. Apply sunscreen with UVA and UVB protection and an SPF of at least 30. Your skin may be more sensitive to the sun and you could develop a bad sunburn or rash more easily.
-
DO talk to your health care team about your risk of getting other cancers and heart problems with this treatment.
-
DO consider asking someone to drive you to and from the hospital on your treatment days. You may feel drowsy or dizzy after your treatment.
- DO NOT take any other medications, such as vitamins, over the counter (non-prescription) drugs, or natural health products without checking with your health care team.
- DO NOT start any complementary or alternative therapies, such as acupuncture or homeopathic medications, without checking with your health care team.
- DO NOT eat or drink grapefruit, starfruit, Seville oranges or their juices (or products that contain these) while on this treatment. They may increase side effects.
- DO NOT smoke or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.
Yes, the medications in this regimen can interact with other medications, vitamins, foods and natural health products. Interactions can make the treatment not work as well or cause severe side effects.
Tell your health care team about all of your:
- prescription and over-the-counter (non-prescription) medications
- natural health products such as vitamins, herbal teas, homeopathic medicines, and other supplements
Check with your health care team before starting or stopping any of them.
If you are taking seizure medications (such as phenytoin), your health care team will monitor your blood levels closely and may change your dose.
If you are taking a blood thinner (such as warfarin), your health care team may need extra blood tests and may change your dose.
- Anti-inflammatory medications such as ibuprofen (Advil® or Motrin®), naproxen (Aleve®) or Aspirin®.
- Over-the-counter products such as dimenhydrinate (Gravol®)
- Natural health products such as St. John’s Wort
- Supplements such as vitamin C
- Alcoholic drinks
- Tobacco
- All other drugs, such as marijuana or cannabis (medical or recreational)
-
Always check your temperature to see if you have a fever before taking any medications for fever or pain (such as acetaminophen (Tylenol®) or ibuprofen (Advil®)).
-
Fever can be a sign of infection that may need treatment right away.
-
If you take these medications before you check for fever, they may lower your temperature and you may not know you have an infection.
-
How to check for fever:
Keep a digital (electronic) thermometer at home and take your temperature if you feel hot or unwell (for example, chills, headache, mild pain).
-
You have a fever if your temperature taken in your mouth (oral temperature) is:
-
38.3°C (100.9°F) or higher at any time
-
-
OR
-
38.0°C (100.4°F) or higher for at least one hour.
-
If you do have a fever:
-
Try to contact your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
-
Ask your health care team for the Fever pamphlet for more information.
If you do not have a fever but have mild symptoms such as headache or mild pain:
- Ask your health care team about the right medication for you. Acetaminophen (Tylenol®) is a safe choice for most people.
Talk to your health care team before you start taking ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or ASA (Aspirin®), as they may increase your chance of bleeding or interact with your cancer treatment.
Talk to your health care team if you already take low dose aspirin for a medical condition (such as a heart problem). It may still be safe to take.
Talk to your health care team about:
- How this treatment may affect your sexual health.
- How this treatment may affect your ability to have a baby, if this applies to you.
This treatment may harm an unborn baby. Tell your health care team if you or your partner are pregnant, become pregnant during treatment, or are breastfeeding.
- If there is any chance of pregnancy happening, you and your partner together must use 2 effective forms of birth control at the same time while you are on treatment. Talk to your health care team about which birth control options are best for you, and how long you should use them after your last treatment dose.
- Do not breastfeed while on this treatment. Talk to your health care team about how long to wait before you start breastfeeding after your last treatment dose, if this applies to you.
The following table lists side effects that you may have when getting FOLFIRINOX treatment. The table is set up to list the most common side effects first and the least common last. It is unlikely that you will have all of the side effects listed and you may have some that are not listed.
Read over the side effect table so that you know what to look for and when to get help. Keep this paper during your treatment so that you can refer to it if you need to.
Very Common Side Effects (50 or more out of 100 people) | |
Side effects and what to do | When to contact health care team |
Neuropathy (Tingling, numb toes or fingers) (May be severe) What to look for?
What to do?
For some people, symptoms of neuropathy may continue long after treatment ends. If you continue to have bothersome symptoms, talk to your health care team for advice. |
Talk to your health care team, especially if you have trouble doing tasks like doing up buttons, writing, moving, or if you have severe pain or numbness |
Low neutrophils (white blood cells) in the blood (neutropenia) When neutrophils are low, you are at risk of getting an infection more easily. Ask your health care team for the Neutropenia (Low white blood cell count) pamphlet for more information. What to look for?
You have a fever if your temperature taken in your mouth (oral temperature) is:
What to do? If your health care team has told you that you have low neutrophils:
If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away. |
If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you MUST get emergency medical help right away. |
Low platelets in the blood When your platelets are low, you are at risk for bleeding and bruising. Ask your health care team for the Low Platelet Count pamphlet for more information. What to look for?
What to do? If your health care team has told you that you have low platelets:
If you have signs of bleeding:
If you have bleeding that does not stop or is severe (very heavy), you must get emergency medical help right away |
Talk to your health care team if you have any signs of bleeding. If you have bleeding that doesn’t stop or is severe (very heavy), you MUST get emergency help right away. |
Anemia (low red blood cells) (May be severe) What to look for?
What to do? If your health care team has told you that you have anemia (low red blood cells):
|
Talk to your health care team if it does not improve or if it is severe |
Nausea and vomiting What to look for?
What to do? To help prevent nausea:
|
Talk to your health care team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if it is severe |
Fatigue What to look for?
What to do?
Ask your health care team for the Fatigue pamphlet for more information. |
Talk to your health care team if it does not improve or if it is severe |
Hair thinning or loss What to look for?
What to do?
|
Talk to your health care team if this bothers you |
Liver problems Your health care team may check your liver function with a blood test. Liver changes do not usually cause any symptoms.
If you have any symptoms of liver problems, get emergency medical help right away. |
Get emergency medical help right away |
Diarrhea and other early side effects of irinotecan that start during treatment or within 24 hours What to look for?
What to do?
|
Tell your health care team right away if you have any of these symptoms |
Diarrhea that starts more than 24 hours after treatment.
What to do? If you have diarrhea:
Ask your health care team for the Diarrhea pamphlet for more information. |
Talk to your health care team if no improvement after 24 hours of taking diarrhea medication or if severe (more than 7 times in one day) |
Low appetite, weight changes What to look for?
Ask your health care team for the Loss of Appetite pamphlet for more information. |
Talk to your health care team if it does not improve or if it is severe |
Common Side Effects (25 to 49 out of 100 people) | |
Side effects and what to do | When to contact health care team |
Mouth sores (May be severe) What to look for?
To help prevent mouth sores:
If you have mouth sores:
Ask your health care team for the Oral Care (Mouth Care) pamphlet for more information. |
Talk to your health care team as soon as you notice mouth or lip sores or if it hurts to eat, drink or swallow |
Sensation that you are not breathing properly This can be caused by drinking cold fluids or inhaling cold air. What to look for?
What to do?
Problems with breathing and swallowing can be unpleasant. They should only last a few minutes. If they do not go away quickly or if you also feel chest pain, speak with your health care team as soon as possible. If severe, get emergency medical help right away. |
Talk to your health care team if it does not improve. Get emergency medical help right away if it is severe. |
Constipation What to look for?
To help prevent constipation:
To help treat constipation:
Ask your health care team for the Constipation Pamphlet for more information. |
Talk to your health care team if it does not improve or if it is severe |
Eye problems What to look for?
What to do?
|
Talk to your health care team as soon as possible |
Less Common Side Effects (10 to 24 out of 100 people) | |
Side effects and what to do | When to contact health care team |
Cough and feeling short of breath (May be severe) What to look for?
What to do?
|
Talk to your health care team. If you are not able to talk to your health care team for advice, and you have a fever or severe symptoms, you MUST get emergency medical help right away. |
Rash; dry, itchy skin What to look for?
What to do? To prevent and treat dry skin:
Rash may be severe in some rare cases and cause your skin to blister or peel. If this happens, get emergency medical help right away |
Talk to your health care team if it does not improve or if it is severe |
Trouble Sleeping Your medications may cause trouble sleeping. It may get better once your body gets used to the medication or when your treatment ends. What to look for?
What to do? Talk to your health care team if it does not improve or if it is severe. |
Talk to your health care team if it does not improve or if it is severe |
Headache; Mild joint, muscle pain or cramps What to look for?
What to do?
Ask your health care team for the Pain pamphlet for more information.
|
Talk to your health care team if it does not improve or if it is severe |
Dizziness What to look for?
|
Talk to your health care team if it does not improve or if it is severe |
Mild swelling What to look for?
What to do?
|
Talk to your health care team if it does not improve or if it is severe |
Swelling inside your nose
What to do?
|
Talk to your health care team if it does not improve or if it is severe |
Rash on your hands and feet (hand-foot syndrome) What to look for?
What to do? To help prevent Hand-foot syndrome:
Ask your health care team for the Hand-foot syndrome pamphlet for more information. |
Talk to your health care team if it does not improve or if it is severe |
Flushing What to look for?
What to do? Talk to your health care team if no improvement or if severe. |
Talk to your health care team if it does not improve or if it is severe |
Heartburn; upset stomach; bloating
What to do?
|
Talk to your health care team if it does not improve or if it is severe |
Taste changes What to look for?
What to do?
|
Talk to your health care team if it does not improve or if it is severe |
Allergic reaction What to look for?
|
Get emergency medical help right away for severe symptoms |
Other rare, but serious side effects are possible with this treatment.
If you have any of the following, talk to your cancer health care team or get emergency medical help right away:
-
Pain and swelling or hardening of a vein in your arm or leg
-
Sudden confusion, seizure, trouble speaking, or difficulty moving your arms or legs, or weakness on one side of your body
-
Irregular heartbeat, fainting (passing out)
-
Any severe pain in your belly
-
Severe belly pain, severe bloating or feeling of fullness
-
Leg weakness that may spread to the upper body, trouble with eye or face movements
-
Severe weakness, problems with your balance, or having falls
-
Unusual muscle spasms, tremors, irregular or jerky movements
-
Severe fatigue, muscle pain
-
Any changes in your eye sight
-
Redness or rash in areas where you had radiation before
-
Signs of kidney problems, such as weight gain that is not normal for you, new pain in your lower back, changes in urination (peeing) such as less urine (pee) than usual or urine (pee) that is red-brown coloured
-
Ringing in your ears or changes to your hearing
October 2023 Updated " How will this medication affect sex, pregnancy and breastfeeding" section
For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.
The information set out in the medication information sheets, regimen information sheets, and symptom management information(for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.
A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace 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.


