XELOX

Langue Anglais

Regimen Monograph References:

Capecitabine and oxaliplatin drug monographs, Cancer Care Ontario.

Haller DG, Tabernero J, Maroun J, et al. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol 2011 Apr 10;29(11):1465-71.

National Comprehensive Cancer Network. Colon Cancer (Version 2.2017). https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed June 30, 2017.

Pectasides D, Karavasilis V, Papaxoinis G, Gourgioti G, Makatsoris T, Raptou G, et al. Randomized phase III clinical trial comparing the combination of capecitabine and oxaliplatin (CAPOX) with the combination of 5-fluorouracil, leucovorin and oxaliplatin (modified FOLFOX6) as adjuvant therapy in patients with operated high-risk stage II or stage III colorectal cancer. BMC Cancer. 2015;15:384.

Schmoll H-J, Tabernero J, Maroun J, et al. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol 2015 Nov 10;33(32):3733-40.

Cancer Type: Gastrointestinal Colorectal Small bowel and appendix Type of Content: Regimen Regimen Code:

XELOX

Intent: Adjuvant Regimen Category:

Evidence-Informed

Funding Program:

ODB - General Benefit

Funding Instance:

capecitabine Drugs Used: oxaliplatin capecitabine Regimen Monograph Name:

XELOX_GI_COLSBA_A

Regimen Monograph Body:

Regimen Monograph

A - Regimen Name

XELOX Regimen

Capecitabine (Xeloda®)-Oxaliplatin

Disease Site

Gastrointestinal

Colorectal
Small bowel and appendix

Intent

Adjuvant

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

For the adjuvant treatment of stage III and high risk stage II colorectal, small bowel or appendiceal cancer

Supplementary Public Funding

capecitabine
ODB - General Benefit (capecitabine) (ODB Formulary)

B - Drug Regimen

oxaliplatin

130 mg /m²

Day 1

capecitabine

1000 mg /m²

BID, Days 1 to 14

C - Cycle Frequency

REPEAT EVERY 21 DAYS

For a total of 8 cycles unless disease progression or unacceptable toxicity occurs

D - Premedication and Supportive Measures

Antiemetic Regimen:

Moderate
No routine prophylaxis for capecitabine

Febrile Neutropenia Risk:

Low

Also refer to CCO Antiemetic Recommendations.

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.

Oxaliplatin premedication (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).

Other Supportive Care

Topical emollients (e.g. hand creams, udder balm) therapy may ameliorate the manifestations of hand-foot syndrome in patients receiving capecitabine.
Standard antidiarrheal agents (e.g. loperamide) should be initiated, as medically appropriate, as early as possible.
Patients should be counselled about cold avoidance prior to receiving oxaliplatin, since cold temperatures can precipitate or exacerbate acute neurological symptoms.

E - Dose Modifications

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

Do not retreat until ANC ≥ 1.5 x 10⁹ /L, platelet counts ≥ 100 x 10⁹ /L and major organ toxicity has resolved to ≤ grade 1.

Oxaliplatin

Neurotoxicity was graded based on the following scales in some adjuvant colorectal cancer trials.

Neurotoxicity Grade	Description
1	No change
2	Mild paresthesias, loss of deep tendon reflexes
3	Mild or moderate objective sensory loss, moderate paresthesias
4	Severe objective sensory loss or paresthesias that interfere with function

Dose Modifications

Toxicity Grade	Oxaliplatin Dose^
Persistent¹ Grade 2 neurotoxicity	↓ 25%
Transient¹ Grade 3 neurotoxicity	↓ 25%
Persistent¹ Grade 3 neurotoxicity or any Grade 4 neurotoxicity	Discontinue
≥ Grade 3 GI toxicity (after prophylaxis) OR ≥ Grade 3 Platelets OR ≥ Grade 3 Neutropenia (including febrile neutropenia)	↓ 25%
Sepsis / septic shock	Discontinue
Other ≥ grade 3 related organ toxicity²	Consider ↓ 25%
Pharyngolaryngeal dysesthesia	Hold; then increase duration of infusion to 6 hours³
Pneumonitis	Hold, investigate; discontinue permanently if confirmed.
Anaphylactic-like reaction	Discontinue
PRES/RPLS
Hemolytic uremic syndrome or any signs of microangiopathic hemolytic anemia
Disseminated intravascular coagulation (DIC)
QT prolongation
Intestinal ischemia or duodenal ulcer
Symptoms of rhabdomyolysis

^Do not re-treat until the ANC ≥ 1.5 x 10⁹/L and the platelets ≥ 100 x 10⁹/L, GI and neurotoxicities have resolved and other non-hematologic toxicities ≤ grade 1.
¹ Transient = >7days - <1 cycle; persistent = ≥ 1 cycle
² For skin toxicity, reduce capecitabine dose only (see table below)
³ If oxygen saturation is normal, an anxiolytic agent may be given

Capecitabine

Dose modifications are mandatory for gastrointestinal, dermatological toxicity and hyperbilirubinemia. Practitioner may elect not to reduce dose for other toxicities unlikely to become serious or life-threatening.

Missed or omitted doses of capecitabine should not be replaced. Doses should not be re-escalated if reduced for toxicity.

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	Hold until resolved to ≤ grade 1 Hold until resolved to ≤ grade 1 Hold until resolved to ≤ grade 1 Discontinue treatment permanently	100% 75% 50% Not applicable
Grade 3 1st appearance 2nd appearance 3rd appearance OR any evidence of Stevens-Johnson syndrome (i.e. sloughing)	Hold until resolved to ≤ grade 1 Hold until resolved to ≤ grade 1 Discontinue treatment permanently	75% 50% Not applicable
Grade 4 1st appearance 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 1. Discontinue permanently	Discontinue or 50% Not applicable

Management of Infusion-related reactions:

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.

Oxaliplatin:

Grade

Management

Re-challenge

1 or 2

Stop or slow the infusion rate.
Manage the symptoms.

Restart:

After symptom resolution, restart with pre-medications ± reduced infusion rate

Consider pre-medications* and infusing at a reduced infusion rate prior to re-challenge.
May consider adding oral montelukast ± oral acetylsalicylic acid.

3 or 4

Stop treatment.
Aggressively manage symptoms.

Re-challenge is discouraged, especially if vital signs have been affected.
Consider desensitization if therapy is necessary.

* Up to 50% of patients can experience recurrent reactions during re-challenge despite using pre-medications (e.g. corticosteroid and H1/H2-receptor antagonist).

Hepatic Impairment

Hepatic Impairment	Oxaliplatin (% previous dose)	Capecitabine (% previous dose)*
Mild	No dose adjustment required	No starting dose adjustment necessary
Moderate	No dose adjustment required	No starting dose adjustment necessary
Severe	No data available	No data available

*use capecitabine dose modification table above for hepatotoxicity during treatment

Renal Impairment

Creatinine Clearance (mL/min)	oxaliplatin (% previous dose)	capecitabine (% previous dose)
51-80	No change	100%, with close monitoring
30-50	Caution	75 % (use with caution)
<30	Discontinue	CONTRAINDICATED

Dosage in the Elderly

For oxaliplatin, patients ≥ 65 years had a higher incidence of GI toxicity, myelosuppression, syncope and fatigue. No dose adjustments were needed but caution should be exercised.

For capecitabine, older patients are more susceptible to the effects of fluoropyrimidine-based therapies with increased grade 3 / 4 adverse effects, especially when used in combination. Starting dosage adjustment is not recommended, but dose modifications should be performed for toxicity (see tables above).

Dosage based on gender:

Women may be at higher risk of severe (grades 3-4) neutropenia in adjuvant treatment of colorectal cancer.

F - Adverse Effects

Refer to oxaliplatin, capecitabine 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

Sensory neuropathy (may be severe)
Myelosuppression +/- infection, bleeding (may be severe)
Nausea, vomiting
Hand-foot syndrome
Increased LFTs (may be severe)
Diarrhea (may be severe)

Fatigue
Mucositis
Pharyngolaryngeal dysesthesia (with oxaliplatin)
Alopecia (generally mild)

Constipation
↑ Bilirubin
Edema
Rash
Hyperglycemia
Musculoskeletal pain
Anorexia
Weight changes
Dysgeusia
Injection-site reactions (with oxaliplatin)
Abnormal electrolytes
Hypersensitivity

Arterial/Venous thromboembolism
QT interval prolonged
Cardiotoxicity
GI obstruction, perforation
INR / prothrombin increased
Disseminated intravascular coagulation
Hemolytic uremic syndrome
Hemolysis
Idiopathic thrombocytopenic purpura
Hepatic failure
Nephrotoxicity
Pancreatitis
Pneumonitis
Rhabdomyolysis
PRES/RPLS
Leukoencephalopathy
Veno-occlusive disease
Guillain-Barre syndrome
Eye disorders

G - Interactions

Refer to oxaliplatin, capecitabine drug monograph(s) for additional details

Concomitant use with sorivudine or analogues is contraindicated, given the increased risk of capecitabine toxicity (may be fatal). Wait at least 4 weeks after sorivudine (or chemically related analogues) treatment before starting capecitabine.
Avoid concomitant administration with phenytoin; capecitabine may increase levels. Monitor phenytoin levels if must be given together.
Monitor PT/INR when this treatment is administered with warfarin or other anticoagulants; adjust anticoagulant dose accordingly.
Caution with the use of proton pump inhibitors and monitor for reduced effectiveness of capecitabine; consider switching to a magnesium and aluminum hydroxide-containing antacid.
Caution and monitor with the coadministration of leucovorin as this may increase capecitabine toxicity.
Monitor for toxicity when using oxaliplatin with other nephrotoxic drugs, QT -prolonging drugs or drugs associated with rhabdomyolysis.

H - Drug Administration and Special Precautions

Refer to oxaliplatin, capecitabine drug monograph(s) for additional details

Administration:

Oxaliplatin

Oxaliplatin is administered by intravenous infusion.
May be mixed in 250-500 mL bag (D5W only). Do not mix oxaliplatin with NS, chloride containing or alkaline solutions.
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.

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.

Capecitabine:

Oral self-administration; drug available by outpatient prescription.
Doses are given orally approximately 12 hours apart, within 30 minutes after the end of a meal.
Swallow tablets whole; do not crush or cut tablets.
If a capecitabine dose is missed, skip this and give the next dose at the usual time. Missed or omitted doses should not be replaced.
Store tablets at 15ºC to 30ºC in the original package.

Contraindications:

Patients who have a known hypersensitivity to capecitabine, 5-fluorouracil, oxaliplatin, other platinum agents (e.g. cisplatin), or any ingredient in the formulation or component of the container
Patients with severe renal impairment (CrCl <30 mL/min)
Patients who are pregnant or breastfeeding
Patients with known near or complete absence of DPD (dihydropyrimidine dehydrogenase) deficiency. Refer to the DPD Deficiency Guidance for Clinicians for more information.
Concomitant use with sorivudine or related analogues (i.e. brivudine), given potential fatal drug interaction.

Warnings/Precautions:

Patients should be counselled about cold avoidance prior to receiving oxaliplatin, as cold temperatures can precipitate or exacerbate acute neurological symptoms.
Oxaliplatin may cause dizziness or visual disturbances in some patients (including transient vision loss); patients should exercise caution when driving or operating machinery.
Use with caution in patients with risk factors for dehydration, pre-existing renal dysfunction or on nephrotoxic agents
Use with caution in patients with a history of cardiovascular disease as well as patients taking anticoagulants such as warfarin (see Drug Interactions section)
Use capecitabine with extreme caution in patients with partial DPD deficiency. Refer to the DPD Deficiency Guidance for Clinicians for more information.
Capecitabine contains lactose and should not be used in patients with hereditary galactose/glucose/lactase disorders.

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

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.

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 and/or PT; Baseline and as clinically indicated if on anticoagulants
Clinical toxicity assessment of GI effects, dehydration, neurotoxicity, infection, bleeding, thromboembolism, hypersensitivity, injection site reaction, rash, hand-foot syndrome, cardiac, respiratory and ophthalmic effects; At each visit
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Administrative Information

Outpatient prescription for home administration (capecitabine)

Approximate Patient Visit

2 hours

Pharmacy Workload (average time per visit)

17.14 minutes

Nursing Workload (average time per visit)

44.167 minutes

K - References

Capecitabine and oxaliplatin drug monographs, Cancer Care Ontario.

National Comprehensive Cancer Network. Colon Cancer (Version 2.2017). https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed June 30, 2017.

PEBC Advice Documents or Guidelines

November 2023 Modified Pregnancy/lactation section

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.

Regimen Info Sheet Name: XELOX (Colorectal) Regimen Info Sheet Body:

XELOX 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.

Who do I contact if I have questions or need help?

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.

What is this treatment?

XELOX is the code name of your cancer treatment regimen.

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 2 medications in your treatment.

Here are the names of the medications in this regimen:

XEL = Capecitabine (also known as XELoda®)

OX = OXaliplatin

Treatment is divided into cycles. Each cycle is 3 weeks long. Your health care team will tell you how many cycles you need.

Here is a picture of the schedule for XELOX treatment:

Cycle 1

XELOX

(3 weeks)

Repeat 

XELOX

(3 weeks)

Your health care 
team will tell you
how many cycles 
you will have.

During each 3 week cycle you will have oxaliplatin treatment on day 1 at the hospital. You will also take capecitabine tablets on day 1 and continue these at home for 14 days. (2 weeks on, 1 week off).

Each cycle looks like this:

Day 1

Hospital treatment day:
Go to the hospital for oxaliplatin treatment.

Take your capecitabine (morning and evening).

Take your capecitabine (morning and evening)

NO XELOX Treatment

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 capecitabine.
See the Testing for people taking capecitabine or 5-fluorouracil (5-FU) pamphlet for more information.

How is this treatment given?

Oxaliplatin is given through an IV (injected into a vein) at the hospital.

Capecitabine is given as tablets that you swallow.

Your health care team will tell you how many capecitabine tablets you need to take.
Do not take your medicine more often or for longer than you have been told to.
You may need tablets of different strengths to get the right dose. Make sure you look at the tablets closely so that you take the right dose.
Take capecitabine two times each day. Space each dose about 12 hours apart.
Swallow the tablets whole with a full glass of water. Take with food, up to 30 minutes after eating a meal (for example, right after breakfast and dinner).
Do not crush or chew the capecitabine tablets.
If you forget to take a dose, do not take an extra dose to make up for the missed dose. Follow the instructions given to you or talk to your health care team if you are unsure about what to do. If you are unable to talk to your healthcare team, take your next dose at the usual time.
If you vomit (throw up) after taking your medication, do not take another dose until you have talked to your health care team. If you are unable to talk to your health care team, take your next dose at the usual time.

You will have a blood test before each treatment cycle to make sure it is safe for you to get treatment.

Warning: If you take too much capecitabine by accident, or if you think a child or a pet may have swallowed your capecitabine, you must call the Ontario Poison Control Center right away at: 1-800-268-9017.

What other medications are given with this 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 capecitabine in your treatment regimen can cause diarrhea. Diarrhea is when you have loose bowel movements (watery poo) or you need to go poo (have bowel movements) 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 after each loose bowel movement (watery poo).
Do not take more than 8 tablets every day.

What other important things should I know about this treatment?

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.

This treatment may cause Hand-Foot Syndrome

Hand-foot syndrome is a side-effect of capecitabine treatment that affects the skin on your hands and the bottoms of your feet. It usually starts with tingling or swelling of your skin. Your skin can become painful, red and numb. In worse cases, your skin may start to peel and you can get blisters or sores. This may start days or weeks after your treatment begins.

You can help to prevent symptoms of hand-foot syndrome by doing these things:

Keep your skin moist, especially in the skin folds.
Gently apply moisturizer cream or lotion to the inside of your hands and bottom of your feet as needed. Choose a fragrance-free cream that contains lanolin (like Bag Balm®, Udderly Smooth®) or urea 10% (like Uremol 10®).
Do not let your hands and feet get too hot. Wash sweat from your skin. Bathe or shower in lukewarm water and gently pat yourself dry.
Do not do activities that cause rubbing or pressure on your skin, like heavy-duty washing, gripping tools, typing, playing musical instruments, and driving.
Wear gloves while cleaning to protect your skin from things like laundry detergent, bleach, cleaning products, and dish soap.
Wear loose fitting clothes and loose fitting, comfortable shoes with cushioned soles. Do not walk in bare feet.
Drink 6–8 glasses of liquids each day unless your health care team told you otherwise.

DO this while on treatment

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, if you have or had personal or family history of severe side effects with other drugs (especially a drug called fluorouracil), any allergies or intolerances.
DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.
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 do this while on treatment

Stop Icon

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 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 this while on treatment

Check Mark Icon

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, if you have or had personal or family history of severe side effects with other drugs (especially a drug called fluorouracil), any allergies or intolerances.
DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.
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 do this while on treatment

Stop Icon

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 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.

Will this treatment interact with other medications or natural health products?

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 take seizure medications (such as phenytoin), your health care team may 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.

Talk to your health care team BEFORE taking or using these :

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
Grapefruit juice
Alcoholic drinks
Tobacco
All other drugs, such as marijuana or cannabis (medical or recreational)

What should I do if I feel unwell, have pain, a headache or a fever?

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.

How will this treatment affect sex, pregnancy and breast feeding?

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.

How should I safely store and handle the medications in this treatment?

Oxaliplatin is given and stored at the hospital.

Capecitabine:

Keep capecitabine tablets in the original packaging at room temperature in a dry place, away from heat and light.
Keep out of sight and reach of children and pets.
Do not throw out any unused capecitabine tablets at home. Bring them to your pharmacy to be thrown away safely.

How to safely touch your capecitabine

If you are a patient:

Wash your hands before and after touching capecitabine.
Swallow each pill whole. Do not crush or chew your pills.

If you are a caregiver:

Wear nitrile or latex gloves when touching capecitabine tablets.
Wash your hands before putting on your gloves and after taking them off, even if your skin did not touch the pills.
Throw out your gloves after each use. Do not re-use gloves.
Do not touch capecitabine if you are pregnant or breastfeeding.

What to do if anti-cancer medication gets on your skin or in your eyes

If medication gets on your skin:

Wash your skin with a lot of soap and water.
If your skin gets red or irritated, talk to your health care team.

If medication gets in your eyes:

Rinse your eyes with running water right away. Keep water flowing over your open eyes for at least 15 minutes.

What are the side effects of this treatment?

The following table lists side effects that you may have when getting XELOX 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? Numbness or tingling that most often happens in your hands, arms, legs or feet but can happen elsewhere in the body as well. It can sometimes be painful and feel like burning, which may be severe. What to do? Talk to your health care team if you have any of the symptoms described above. Numbness and tingling may slowly get better after your treatment ends. Avoid exposure to cold as it can trigger this side effect. Do not use ice packs on your body. Dress warmly and cover all of your skin if you must go outside in cold temperatures. Wear gloves to touch cold objects. Avoid breathing deeply when exposed to cold air. In rare cases, numbness and tingling 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) (May be severe) 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? If you feel hot or unwell (for example if you have chills or a new cough), you must check your temperature to see if you have a fever. Do not take medications that treat a fever before you take your temperature (for example, Tylenol® (acetaminophen), or Advil® (ibuprofen)). Do not eat or drink anything hot or cold right before taking your temperature. 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. What to do? If your health care team has told you that you have low neutrophils: Wash your hands often to prevent infection. Check with your health care team before getting any vaccines, surgeries, medical procedures or visiting your dentist. Keep a digital thermometer at home so you can easily check for a fever. If you have a fever: 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? Watch for signs of bleeding: bleeding from your gums unusual or heavy nosebleeds bruising easily or more than normal black coloured stools (poo) or blood in your stools (poo) coughing up red or brown coloured mucus dizziness, constant headache or changes in your vision heavy vaginal bleeding red or pink coloured urine (pee) What to do? If your health care team has told you that you have low platelets: Tell your pharmacist that your platelet count may be low before taking any prescriptions or over-the-counter medication. Check with your healthcare team before you go to the dentist. Take care of your mouth and use a soft toothbrush. Try to prevent cuts and bruises. Ask your health care team what activities are safe for you. Your treatment may have to be delayed if you have low platelets. Your health care team may recommend a blood transfusion. If you have signs of bleeding: If you have a small bleed, clean the area with soap and water or a saline (saltwater) rinse. Apply pressure for at least 10 minutes. 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 medical help right away.
Nausea and vomiting What to look for? Nausea is feeling like you need to throw up. You may also feel light-headed. You may feel nausea within hours to days after your treatment. What to do? To help prevent nausea: It is easier to prevent nausea than to treat it once it happens. If you were given anti-nausea medication(s), take them as prescribed, even if you do not feel like throwing up. Drink clear liquids and have small meals. Get fresh air and rest. Do not eat spicy, fried foods or foods with a strong smell. Limit caffeine (like coffee, tea) and avoid alcohol. If you have nausea or vomiting: Take your rescue (as-needed) anti-nausea medication(s) as prescribed. Ask your health care team for the Nausea & Vomiting pamphlet for more information. Talk to your health care team if: nausea lasts more than 48 hours vomiting lasts more than 24 hours or if it is severe	Talk to your healthcare team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if it is severe
Rash on your hands and feet (hand-foot syndrome) (May be severe) What to look for? Tingling or swelling of the skin on the palms of your hands and the bottoms of your feet. This can become painful, red and numb. In worse cases your skin may start to peel and you can get blisters or sores. This may happen days or weeks after you start treatment. What to do? To help prevent Hand-foot syndrome: Do not do activities that cause rubbing or pressure on your skin, like heavy-duty washing, gripping tools, typing, playing musical instruments, and driving. Moisturize your hands and feet often, especially in the skin folds. Wear loose, comfortable footwear and clothes. Rest and try to keep off your feet. Do not let your hands and feet get too hot. 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
Liver problems Your health care team may check your liver function with a blood test. Liver changes do not usually cause any symptoms. What to look for? Rarely, you may develop yellowish skin or eyes, unusually dark pee or pain on the right side of your belly. This may be severe. What to do? If you have any symptoms of liver problems, get emergency medical help right away.	Get emergency medical help right away
Diarrhea (May be severe) What to look for? Loose, watery, unformed stool (poo) that may happen days to weeks after you get your treatment. What to do? If you have diarrhea: Take anti-diarrhea medication if your health care team prescribed it or told you to take it. Do not eat foods or drinks with artificial sweetener (like chewing gum or ‘diet’ drinks), coffee and alcohol. Eat many small meals and snacks instead of 2 or 3 large meals. Drink at least 6 to 8 cups of liquids each day, unless your health care team has told you to drink more or less. Talk to your health care team if you can’t drink 6 to 8 cups of liquids each day when you have diarrhea. You may need to drink special liquids with salt and sugar, called Oral Rehydration Therapy. Talk to your health care team if your diarrhea does not improve after 24 hours of taking diarrhea medication or if you have diarrhea more than 7 times in one day. 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)

Common Side Effects (25 to 49 out of 100 people)
Side effects and what to do	When to contact health care team
Fatigue What to look for? Feeling of tiredness or low energy that lasts a long time and does not go away with rest or sleep. What to do? Be active. Aim to get 30 minutes of moderate exercise (you are able to talk comfortably while exercising) on most days. Check with your health care team before starting any new exercise. Pace yourself, do not rush. Put off less important activities. Rest when you need to. Ask family or friends to help you with things like housework, shopping, and child or pet care. Eat well and drink at least 6 to 8 glasses of water or other liquids every day (unless your health care team has told you to drink more or less). Avoid driving or using machinery if you are feeling tired. 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
Mouth sores What to look for? Round, painful, white or gray sores inside your mouth that can occur on the tongue, lips, gums, or inside your cheeks. In more severe cases they may make it hard to swallow, eat or brush your teeth. They may last for 3 days or longer. What to do? To help prevent mouth sores: Take care of your mouth by gently brushing and flossing regularly. Rinse your mouth often with a homemade mouthwash. To make a homemade mouthwash, mix 1 teaspoonful of baking soda and 1 teaspoonful of salt in 4 cups (1L) of water. Do not use store-bought mouthwashes, especially those with alcohol, because they may irritate your mouth. If you have mouth sores: Avoid hot, spicy, acidic, hard or crunchy foods. Your doctor may prescribe a special mouthwash to relieve mouth sores and prevent infection. Talk to your health care team as soon as you notice mouth or lip sores or if it hurts to eat, drink or swallow. 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 (With oxaliplatin) This can be caused by drinking cold fluids or inhaling cold air. What to look for? Trouble swallowing or talking. Tightness in your jaw. Unusual feelings in your tongue. Feeling like it is hard to breathe or pressure in your chest. What to do? 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. 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). Do not use an ice pack on any part of your body. 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.
Hair thinning or loss (Generally mild) What to look for? Your hair may become thin or fall out during or after treatment. In most cases, your hair will grow back after treatment. The texture or colour may change. In very rare cases, hair loss may be permanent. What to do? Use a gentle soft brush. Do not use hair sprays, bleaches, dyes and perms.	Talk to your health care team if this bothers you

Less Common Side Effects (10 to 24 out of 100 people)
Side effects and what to do	When to contact health care team
Constipation What to look for? Having bowel movements (going poo) less often than normal. Small hard stools (poo) that look like pellets. The need to push hard and strain to have any stool (poo) come out. Stomach ache or cramps. A bloated belly, feeling of fullness, or discomfort. Leaking of watery stools (poo). Lots of gas or burping. Nausea or vomiting. What to do? To help prevent constipation: Try to eat more fiber rich foods like fruits with skin, leafy greens and whole grains. Drink at least 6 to 8 cups of liquids each day unless your health care team has told you to drink more or less. Be active. Exercise can help to keep you regular. If you take opioid pain medication, ask your health care team if eating more fibre is right for you. To help treat constipation: If you have not had a bowel movement in 2 to 3 days you may need to take a laxative (medication to help you poo) to help you have regular bowel movements. Ask your health care team what to do. 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
Mild swelling What to look for? You may have mild swelling or puffiness in your arms and/or legs. Rarely, this may be severe. What to do? To help prevent swelling: Eat a low-salt diet. If you have swelling: Wear loose-fitting clothing. For swollen legs or feet, keep your feet up when sitting.	Talk to your health care team if it does not improve or if it is severe
Rash; dry, itchy skin What to look for? You may have cracked, rough, flaking or peeling areas of the skin. Your skin may look red and feel warm, like a sunburn. Your skin may itch, burn, sting or feel very tender when touched. What to do? To prevent and treat dry skin: Use fragrance-free skin moisturizer. Protect your skin from the sun and the cold. Use sunscreen with UVA and UVB protection and a SPF of at least 30. Avoid perfumed products and lotions that contain alcohol. Drink 6 to 8 cups of non-alcoholic, non-caffeinated liquids each day, unless your health care team has told you to drink more or less. 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
Mild joint, muscle pain or cramps What to look for? New pain in your muscles or joints, muscle cramps, or feeling achy. What to do? Take pain medication (acetaminophen or opioids such as codeine, morphine, hydromorphone, oxycodone) as prescribed. Read the above section: "What should I do if I feel unwell, have pain, a headache or a fever?" before taking acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or Aspirin. These medications may hide an infection that needs treatment or they may increase your risk of bleeding. Rest often and try light exercise (such as walking) as it may help. 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
Taste changes What to look for? Food and drinks may taste different than usual. What to do? Eat foods that are easy to chew, such as scrambled eggs, pasta, soups, cooked vegetables. Taste foods at different temperatures, since the flavour may change. Try different forms of foods, like fresh, frozen or canned. Experiment with non-spicy foods, spices and seasonings.	Talk to your health care team if it does not improve or if it is severe
Allergic reaction (With oxaliplatin) What to look for? Fever, itchiness, rash, swollen lips, face or tongue, chest and throat tightness. It may happen during or shortly after your treatment is given to you and may be severe. What to do? Tell your nurse right away if you feel any signs of allergic reaction during or just after your treatment. Talk to your health care team for advice if you have a mild skin reaction.	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:

Irregular heartbeat, shortness of breath, chest pain, fainting spells
Swelling in your ankles and belly
Pain, swelling and hardening of a vein in an arm or leg
New cough or coughing up blood
Feeling confused, having trouble with speaking, moving your arms or legs, problems with balancing yourself, or trouble with eye or face movements
Seizures
Any sudden changes to your vision (eye sight)
Leg weakness that may spread to the upper body
Severe belly pain, bloating or feeling of fullness and severe constipation
Lower back pain, swelling, peeing less than usual, or new unexpected weight gain

For more information on how to manage your symptoms ask your health care provider, or visit: https://www.cancercareontario.ca/symptoms.

Notes

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.

Regimen Info Sheet (English):

XELOX Colorectal.pdf Regimen Monograph (English):

XELOX_GI_COLSBA_A.pdf Global Date: Vendredi, novembre 3, 2023 Info Sheet Date: Mardi, janvier 16, 2024 AddThis: Universal Date: 2024-01-16 00:00:00 Monograph Status: Null Info Sheet Status: Null Info Sheet Status 10: Hidden Info Sheet Status 11: Hidden Info Sheet Status 12: Hidden Info Sheet Status 13: Hidden Info Sheet Status 14: Hidden Info Sheet Status 15: Hidden Info Sheet Status 16: Hidden Info Sheet Status 17: Hidden Info Sheet Status 18: Hidden Info Sheet Status 19: Hidden Info Sheet Status 2: Hidden Info Sheet Status 20: Hidden Info Sheet Status 3: Hidden Info Sheet Status 4: Hidden Info Sheet Status 5: Hidden Info Sheet Status 6: Hidden Info Sheet Status 7: Hidden Info Sheet Status 8: Hidden Info Sheet Status 9: Hidden QBP Drug Name: NULL NULL QBP Type: NULL NULL QBP Description: NULL NULL Revision Summary:
Patient Info Sheet FR: (XELOX) - Updated "How will this treatment affect sex, pregnancy and breast feeding?" section (Mise à jour de la section « Comment ce traitement influe-t-il sur la vie sexuelle, la grossesse et l’allaitement? ») Info sheet Public Title: XELOX Regimen Info Sheet (French):

XELOX Colorectal pour le patient.pdf