Capecitabine 150mg: Package Insert and Label Information (Page 8 of 9)

15 REFERENCES

1. “OSHA Hazardous Drugs.” OSHA.

http://www.osha.gov/SLTC/hazardousdrugs/index.html.

16 HOW SUPPLIED/STORAGE AND HANDLING

150 mg:

Light pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 150.

150 mg tablets are packaged in bottles of 60 (NDC 72606-554-01).

500 mg:

Dark pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 500.

500 mg tablets are packaged in bottles of 120 (NDC 72606-555-01).

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED.

Capecitabine is a cytotoxic drug. Follow applicable special handling and disposal procedures.

1 Any unused product should be disposed of in accordance with local requirements, or drug take back programs.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Diarrhea

Inform patients experiencing grade 2 diarrhea (an increase of 4 to 6 stools/day or nocturnal stools) or greater or experiencing severe bloody diarrhea with severe abdominal pain and fever to stop taking capecitabine tablets. Advise patients on the use of antidiarrheal treatments (e.g., loperamide) to manage diarrhea. [see Warnings and Precautions (5.2)]

Cardiotoxicity

Advise patients of the risk of cardiotoxicity and to immediately contact their healthcare provider or to go to an emergency room for new onset of chest pain, shortness of breath, dizziness, or lightheadedness [see Warnings and Precautions (5.3)].

Dihydropyrimidine Dehydrogenase Deficiency

Advise patients to notify their healthcare provider if they have a known DPD deficiency. Advise patients if they have complete or near complete absence of DPD activity they are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by capecitabine tablets (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity) [see Warnings and Precautions (5.4)].

Dehydration and Renal Failure

Instruct patients experiencing grade 2 or higher dehydration (IV fluids indicated < 24 hours) to stop taking capecitabine tablets immediately and to call their healthcare provider to correct the dehydration. Advise patients to not restart capecitabine tablets until rehydrated and any precipitating causes have been corrected or controlled [see Warnings and Precautions (5.5)].

Important Administration Instructions

Advise patients to swallow capecitabine tablets whole with water within 30 minutes of a meal. Advise patients and caregivers not to crush or cut capecitabine tablets. Advise patients if they cannot swallow capecitabine tablets whole, to inform their healthcare provider [see Dosage and Administration (2.1)].

Nausea

Instruct patients experiencing grade 2 nausea (food intake significantly decreased but able to eat intermittently) or greater to stop taking capecitabine tablets immediately and to contact their healthcare provider for management of nausea [see Adverse Reactions (6.1)].

Vomiting

Instruct patients experiencing grade 2 vomiting (2 to 5 episodes in a 24-hour period) or greater to stop taking capecitabine tablets immediately and to contact their healthcare provider for management of vomiting [see Adverse Reactions (6.1)].

Hand-and-Foot Syndrome

Instruct patients experiencing grade 2 hand-and-foot syndrome (painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patients’ activities of daily living) or greater to stop taking capecitabine tablets immediately and to contact their healthcare provider. Inform patients that initiation of symptomatic treatment is recommended and hand-and-foot syndrome can lead to loss of fingerprints which could impact personal identification [see Adverse Reactions (6.1)].

Stomatitis

Inform patients experiencing grade 2 stomatitis (painful erythema, edema or ulcers of the mouth or tongue, but able to eat) or greater to stop taking capecitabine tablets immediately and to contact their healthcare provider [see Adverse Reactions (6.1)].

Fever and Neutropenia

Inform patients who develop a fever of 100.5°F or greater or other evidence of potential infection to contact their healthcare provider [see Adverse Reactions (6.1)].

Embryo-Fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with capecitabine and for 6 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6), Use in Specific Populations (8.1 and 8.3)].

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with capecitabine and for 3 months after the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise females not to breastfeed during treatment with capecitabine and for 2 weeks after the last dose [see Use in Specific Populations (8.2)].

Patient Information

Capecitabine Tablets USP, Film Coated

(KAP-e-SYE-ta-been)

What is the most important information I should know about Capecitabine tablets?

Capecitabine tablets can cause serious side effects, including:

  • Capecitabine tablets can interact with blood thinner medicines, such as warfarin (COUMADIN). Taking capecitabine tablets with these medicines can cause changes in how fast your blood clots, and can cause bleeding that can lead to death. This can happen as soon as a few days after you start taking capecitabine tablets, or later during treatment, and possibly even within 1 month after you stop taking capecitabine tablets. Your risk may be higher because you have cancer, and if you are over 60 years of age.
    • Before taking capecitabine tablets, tell your healthcare provider if you are taking warfarin (COUMADIN) or another blood thinner medicine
    • If you take warfarin (COUMADIN) or another blood thinner that is like warfarin (COUMADIN) during treatment with capecitabine tablets, your healthcare provider should do blood tests often, to check how fast your blood clots during and after you stop treatment with capecitabine tablets. Your healthcare provider may change your dose of the blood thinner medicine if needed.

See “What are the possible side effects of capecitabine tablets?” for more information about side effects.

What is capecitabine tablets?

Capecitabine tablets are a prescription medicine used to treat people with:

  • cancer of the colon that has spread to lymph nodes in the area close to the colon (Dukes’ C stage), after they have surgery.
  • cancer of the colon or rectum (colorectal) that has spread to other parts of the body (metastatic).
  • breast cancer that has spread to other parts of the body (metastatic) together with another medicine called docetaxel after treatment with certain other anticancer medicines have not worked.
  • breast cancer that has spread to other parts of the body and has not improved after treatment with paclitaxel and certain other anti-cancer medicines, or who cannot receive any more treatment with certain anti-cancer medicines.

It is not known if capecitabine tablets are safe and effective in children.

Do not take capecitabine tablets if you:

  • have severe kidney problems.
  • are allergic to capecitabine, 5-fluorouracil, or any of the ingredients in capecitabine tablets. See the end of this leaflet for a complete list of ingredients in capecitabine tablets.

Talk to your healtcare provider before taking capecitabine tablets if you are not sure if you have any of the conditions listed above.

Before taking capecitabine tablets, tell your healthcare provider about all your medical conditions, including if you:

See “What is the most important information I should know about capecitabine tablets?”.

  • have had heart problems.
  • have kidney or liver problems.
  • have been told that you lack the enzyme DPD (dihydropyrimidine dehydrogenase)
  • are pregnant or plan to become pregnant. Capecitabine tablets can harm your unborn baby. Your healthcare provider should do a pregnancy test before you start treatment with capecitabine tablets. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with capecitabine tablets.
    • Females who are able to become pregnant should use effective birth control during treatment and for 6 months after the final dose. Talk to your healthcare provider about birth control choices that may be right for you during treatment with capecitabine tablets.
    • Males who have female partners who are able to become pregnant should use effective birth control during treatment and for 3 months after the final dose.
  • are breastfeeding or plan to breastfeed. It is not known if capecitabine tablets passes into your breast milk. Do not breastfeed during treatment with capecitabine tablets and for 2 weeks after the final dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Capecitabine tablets may affect the way other medicines work, and other medicines may affect the way capecitabine tablets works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Capecitabine tablets?

  • Take capecitabine tablets exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much Capecitabine tablets to take and when to take it.
  • Take capecitabine tablets 2 times a day, 1 time in the morning and 1 time in the evening.
  • Take capecitabine tablets within 30 minutes after finishing a meal.
  • Swallow capecitabine tablets whole with water. Do not crush or cut capecitabine tablets. If you cannot swallow capecitabine tablets whole, tell your health care provider.
  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with capecitabine tablets if you develop side effects.
  • If you take too much capecitabine tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of capecitabine tablets?

Capecitabine tablets may cause serious side effects including:

See “What is the most important information I should know about capecitabine tablets?”.

  • Diarrhea. Diarrhea is common with capecitabine tablets and can sometimes be severe. Stop taking capecitabine tablets and call your healthcare provider right away if the number of bowel movements you have in a day increases by 4 or more than is usual for you. Ask your doctor about what medicines you can take to treat your diarrhea. If you have severe bloody diarrhea with severe abdominal pain and fever, call your healthcare provider or go to the nearest emergency room right away.
  • Heart problems. Capecitabine tablets can cause heart problems including: heart attack and decreased blood flow to the heart, chest pain, irregular heartbeats, changes in the electrical activity of your heart seen on an electrocardiogram (ECG), problems with your heart muscle, heart failure, and sudden death. Stop taking capecitabine tablets and call your healthcare provider right away if you get any of the following symptoms:
    • chest pain
    • shortness of breath
    • feeling faint
    • irregular heartbeats or skipping beats
    • sudden weight gain
    • swollen ankles or legs
  • Loss of too much body fluid (dehydration) and kidney failure. Dehydration can happen with capecitabine tablets and may cause sudden kidney failure that can lead to death. You are at higher risk if you have kidney problems before taking capecitabine tablets and also take other medicines that can cause kidney problems.
    Nausea, and vomiting are common with capecitabine tablets. If you lose your appetite, feel weak, and have nausea, vomiting, or diarrhea, you can quickly become dehydrated.
    Stop taking capecitabine tablets and call your doctor right away if you:

    • vomit 2 or more times in a day.
    • are only able to eat or drink a little now and then, or not at all due to nausea.
    • have diarrhea. See “diarrhea” above.
  • Serious skin and mouth reactions.
    • Capecitabine tablets can cause serious skin reactions that may lead to death. Tell your healthcare provider right away if you develop a skin rash, blisters and peeling of your skin. Your healthcare provider may tell you to stop taking capecitabine tablets if you have a serious skin reaction. Do not take capecitabine tablets again if this happens.
    • Capecitabine tablets can also cause “hand and foot syndrome.” Hand and foot syndrome is common with capecitabine tablets and can cause you to have numbness and changes in sensation in your hands and feet, or cause redness, pain, swelling of your hands and feet. Stop taking capecitabine tablets and call your healthcare provider right away if you have any of these symptoms and you are not able to do your usual activities.
      Hand and foot syndrome can lead to loss of fingerprints which could impact your identification.
    • you may get sores in your mouth or on your tongue when taking capecitabine tablets. Stop taking capecitabine tablets and call your doctor if you get painful redness, swelling, or ulcers in your mouth and tongue, or if you are having problems eating.

  • Increased level of bilirubin in your blood and liver problems. Increased bilirubin in your blood is common with capecitabine tablets. Your healthcare provider will check you for these problems during treatment with capecitabine tablets.
  • Decreased white blood cells, platelets, and red blood cell counts. Your healthcare provider will do blood tests during treatment with capecitabine tablets to check your blood cell counts.
    If your white blood cell count is very low, you are at increased risk for infection. Call your healthcare provider right away if you develop a fever of 100.5°F or greater or have other signs and symptoms of infection.

People 80 years of age or older may be more likely to develop severe or serious side effects with capecitabine tablets.

The most common side effects of capecitabine tablets include:

  • diarrhea
  • hand and foot syndrome
  • nausea
  • vomiting
  • stomach-area (abdominal) pain
  • weakness and tiredness
  • increased amounts of red blood cell breakdown products (bilirubin) in your blood

Capecitabine tablets may cause fertility problems in females and males. This may affect the ability to have a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of capecitabine tablets.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Capecitabine tablets?

  • Store capecitabine tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep capecitabine tablets in a tightly closed container.
  • Ask your healthcare provider or pharmacist how to safely throw away any unused capecitabine tablets.

Keep capecitabine tablets and all medicines out of the reach of children.

General information about the safe and effective use of capecitabine tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use capecitabine tablets for a condition for which it was not prescribed. Do not give capecitabine tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about capecitabine tablets that is written for health professionals.

What are the ingredients in capecitabine tablets?

Active ingredient: capecitabine

Inactive ingredients: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides.


This Patient Information has been approved by the U.S. Food and Drug Administration.


Manufactured by:

Shilpa Medicare Limited

Jadcherla — 509301

INDIA


Distributed by:

Celltrion USA, Inc.

Jersey City, NJ 07302

USA

Revised: 11/2019

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