Teva-Capecitabine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-CAPECITABINE is a prescription medication that is used to treat the following types of cancer:

Adjuvant therapy, stage III colon cancer

TEVA-CAPECITABINE is used to treat cancer of the colon following complete surgical removal. The intent of treatment with TEVA-CAPECITABINE is to prevent or delay the recurrence of cancer (cure).

Advanced or metastatic cancer

TEVA-CAPECITABINE is used to treat advanced or metastatic breast cancer. Metastatic means that the cancer has spread outside the breast. When breast cancer has not responded to other chemotherapy medications, TEVA-CAPECITABINE may be one of the choices considered for treatment. Your doctor may prescribe TEVA-CAPECITABINE either alone or in combination with a chemotherapy drug called Taxotere® (also known as docetaxel).

TEVA-CAPECITABINE is also used to treat metastatic colorectal cancer that has spread outside of the colon and/or rectum. TEVA-CAPECITABINE may be one of the choices considered for treatment. Your doctor may prescribe TEVA-CAPECITABINE either alone or in combination with a chemotherapy drug called Eloxatin^® (also known as oxaliplatin).

What it does:

TEVA-CAPECITABINE belongs to a family of medications called the fluoropyrimidines. These medications interfere with the growth of cells that rapidly divide in the body, including cancer cells.

TEVA-CAPECITABINE is an inactive substance on its own. When TEVA-CAPECITABINE is taken, it is changed in the body, mostly within the tumour (cancer

cells). It changes to become the commonly used cancer medication called 5-fluorouracil (also known as 5-FU). In some patients 5-FU will kill cancer cells and decrease the size of the tumour.

When it should not be used:

• If you are allergic to the medicinal ingredient

  (capecitabine) or to 5-fluorouracil.

• If you are allergic to any of the other non-medicinal ingredients it contains (see ‘What the non-medicinal ingredients are’)
• If you suffer from severe kidney disease

• Your body does not have the enzyme DPD

  (dihydropyrimidine dehydrogenase)

• If you are being treated now or have been treated in the last 4 weeks with brivudine, sorivudine or similar classes of substance⁷ as part of herpes zoster (chickenpox or shingles) therapy.

What the medicinal ingredient is:

Capecitabine

What the important non-medicinal ingredients are:

TEVA-CAPECITABINE tablets contain the following non-medicinal ingredients: croscarmellose sodium, hypromellose, iron oxides (yellow and red), lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

What dosage forms it comes in:

TEVA-CAPECITABINE is available as tablets that are taken by mouth. The tablets are coated and oblong shaped.

TEVA-CAPECITABINE tablets come in two strengths: 150 mg tablets are oval biconvex light peach coated tablets with inscription “C” on one side and “150” on the other side. TEVA-CAPECITABINE 150 mg tablets are available in bottles containing 60 tablets or in blister packs containing 60 tablets (10 tablets per blister card and 6 blister cards per carton).

500 mg tablets are oval biconvex light peach coated tablets with inscription “C” on one side and “500” on the other side. TEVA-CAPECITABINE 500 mg tablets are available in bottles containing 120 tablets or in blister packs containing 120 tablets (10 tablets per blister card and 12 blister cards per carton).

WARNINGS AND PRECAUTIONS

⁷ Sorivudine and its chemically related analogues, such

Serious Warnings and Precautions

Serious side effects include:

• Severe dehydration may cause rapid loss of kidney functions including kidney failure that may lead to death.
• Similar to other cancer medicines of the same class, toxicity that may lead to sudden death due to heart problems including irregular heartbeat.
• Severe skin reactions such as hand-and foot syndrome, Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN].
• Severe toxicity due to 5-FU has been associated with deficiency of dihydropyrimidine dehydrogenase (DPD) activity, an enzyme involved in fluorouracil degradation. Deaths have been reported.
• Increased action of other medicines used to thin your blood such as warfarin leading to serious side effects.

BEFORE you use TEVA-CAPECITABINE talk to your doctor or pharmacist if:

• you ever had a bad reaction to capecitabine, 5-FU or

  any of the non-medicinal ingredients.

• you are allergic to other medications, food and dyes.
• you have been told you lack the DPD enzyme.

• you are taking any other medications, including

  those not prescribed by your doctor.

• you are taking warfarin (Coumadin^®). Your doctor

  may need to check the clotting time of your blood more often.

• you are taking phenytoin (Dilantin^®) or

  fosphenytoin (Cerebyx^®). Your doctor may need to check the levels of phenytoin in your blood more often.

• you have any other illnesses or diseases affecting

  your kidneys, liver or heart.

• you are pregnant, plan to become pregnant or are

  breastfeeding.

The safety and effectiveness of TEVA-CAPECITABINE in persons < 18 years of age has not been established.

This information will help your doctor and you decide whether you should use TEVA-CAPECITABINE and what extra care may need to be taken while you are on the medication.

What else should you remember while you are taking TEVA-CAPECITABINE?

• TEVA-CAPECITABINE may impair fertility in

  females and males of reproductive potential.

• Female Patients: If you are of childbearing age you

  should avoid becoming pregnant while taking TEVA-CAPECITABINE and it is recommend to be

  tested to show that you are not pregnant. No research studies have been done with pregnant women. However, studies with animals suggest that TEVA-CAPECITABINE may cause serious harm to an unborn child. An effective method of contraception should be used during treatment and for 6 months after the last dose of TEVA-CAPECITABINE. If the patient becomes pregnant while receiving TEVA-CAPECITABINE, the potential hazard to the fetus must be explained.

  • Male Patients: If you are a male, you are advised not to father a child during treatment. Male patients with female partners of reproductive potential should use effective contraception during treatment and for 3 months following the last dose of TEVA-CAPECITABINE.

    • You should stop breastfeeding during treatment with

      TEVA-CAPECITABINE and for 2 weeks after the final dose.

    • If you are over 65 years old or have a history of heart disease, you may be more sensitive to TEVA-CAPECITABINE. Watch more carefully for possible unwanted effects.
    • If you are over 80 years old, your stomach may be more sensitive to TEVA-CAPECITABINE. Watch more carefully for possible unwanted effects.

Driving and using machines: TEVA-CAPECITABINE may make you feel dizzy, nauseous or tired. It is therefore possible that TEVA-CAPECITABINE could affect your ability to drive a car or operate machines.

If you experience persistent or severe hand-and-foot syndrome while taking TEVA-CAPECITABINE, it can eventually lead to loss of fingerprints, which could impact your identification by fingerprint scan.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with TEVA-CAPECITABINE include:

• Medicine used to treat seizures (eg. Phenytoin and

  Fosphenytoin)

• Blood thinner medicine (eg. warfarin and

  phenprocoumon)

• Medicine used to treat heartburn and acid

  indigestion (eg. Maalox^®)

• Leucovorin, a medicine used to prevent the harmful effects of cancer chemotherapy medication
• Certain medicines used specifically for treating viral infections (eg. sorivudine and brivudine⁸)

⁸ Sorivudine and its chemically related analogues, such

PROPER USE OF THIS MEDICATION

Usual Dose:

Your doctor prescribed TEVA-CAPECITABINE after carefully studying your condition. Other people may not benefit from taking this medicine, even though their problems may seem similar to yours. Do not give your TEVA-CAPECITABINE to anyone else.

The usual dose of TEVA-CAPECITABINE depends on your body surface size. Your doctor will calculate the dose for you.

You may need to take a combination of 150 mg and 500 mg tablets. To get the right dose it is very important that you identify the tablets correctly each time you take TEVA-CAPECITABINE. Taking the wrong tablets could result in an overdose (too much medication) or underdose (too little medication).

Swallow the TEVA-CAPECITABINE tablets whole, with water. Take the tablets within 30 minutes after the end of a meal (breakfast and dinner). TEVA-CAPECITABINE tablets should not be crushed or cut. If you cannot swallow TEVA-CAPECITABINE tablets whole, please speak with your doctor, nurse or pharmacist.

Take the tablets twice a day (morning and evening doses) as your doctor prescribed. Do not take more than your prescribed dose, do not take it more often or for a longer time than your doctor ordered.

TEVA-CAPECITABINE is taken in 21 day cycles. This means you take TEVA-CAPECITABINE for 14 days and then stop taking it for 7 days. It is important to have this rest period. Your doctor will decide how many cycles of treatment you will need.

For the treatment of colon cancer following complete surgical removal, TEVA-CAPECITABINE is usually taken for eight 21-day cycles (i.e. for a total of 24 weeks or approximately 6 months).

Overdose:

If you think you have taken too much TEVA-CAPECITABINE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you forget a dose of TEVA-CAPECITABINE do not take the missed dose at all. Take your next dose at the

usual time and check with your doctor. Do not take a double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Unwanted effects are possible with all medicines. Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are taking TEVA-CAPECITABINE.

Stop taking TEVA-CAPECITABINE and call your doctor immediately if you notice any of the following side effects. Your doctor can then adjust TEVA-CAPECITABINE to a dose that is right for you. This should help to reduce the side effects and stop them from getting worse.

Diarrhea

• an additional 4 bowel movements a day beyond

  what is normal or any diarrhea at night

• if you have a colostomy, an increase in loose,

  watery fluid in your colostomy bag

• any diarrhea in conjunction with soreness of the

  mouth affecting your ability to drink enough fluids Vomiting:

• vomiting more than once in 24 hours, especially if

  in association with diarrhea

Nausea:

• loss of appetite or eating less food than usual each

  day

Stomatitis:

• painful sores, redness or swelling in the mouth or

  throat

Hand-and-foot Syndrome:

• pain, redness, swelling, ulcers or blisters on the

  hands and feet

Infection:

• fever; a temperature of 38.0°C or higher

• signs of infection such as sore throat, cough, or pain

  when you pass urine

Heart problems:

• chest pains, abnormal heart rate, edema of

  extremities

Your doctor may tell you to decrease the dose or stop TEVA-CAPECITABINE treatment for a while. If caught early, most of these side effects usually improve after you stop taking TEVA-CAPECITABINE. If they do not improve within 2 to 3 days, call your doctor again. After side effects have improved, your doctor will tell you

whether to start taking TEVA-CAPECITABINE again and what is the right dose for you.

These unwanted effects may differ when taking TEVA-CAPECITABINE in combination with Taxotere^® (docetaxel). For example, in addition to the unwanted effects mentioned above which may occur with TEVA-CAPECITABINE alone, the following unwanted effects may occur when TEVA-CAPECITABINE is taken in combination with Taxotere^®: hair loss, weakness, fluid retention, nail changes and peripheral neuropathy (numbness, tingling, and burning of the hands and feet), constipation, abdominal pain, indigestion, dry mouth, rash, weakness, pain, taste disturbance, headache, dizziness, inability to sleep, loss or decreased appetite, dehydration, back pain. Please consult your doctor for more information on the possible unwanted effects that may occur when taking TEVA-CAPECITABINE in combination with Taxotere^® (docetaxel).

If you are concerned about these or any other unexpected effects while taking TEVA-CAPECITABINE, talk with your doctor, nurse or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking TEVA-CAPECITABINE, contact your doctor or pharmacist.

HOW TO STORE IT

Keep out of reach and sight of children.

Store at room temperature (15°C to 30°C), in the original labelled container or package.

Special handling using appropriate equipment and disposal procedures, should be taken as TEVA-CAPECITABINE is a cytotoxic drug. Any unused medicinal product or waste material should be disposed in accordance with local requirements.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-

  products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

www.tevacanada.com

Last revised: August 24, 2020