What Oxaliplatin Injection is used for and how to use it
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Oxaliplatin Injection - Consumer Medicine Information

Manufacture: Fresenius Kabi USA, LLC
Country: United States
Condition: Colorectal Carcinoma (Colorectal Cancer), Colorectal Cancer
Class: Alkylating agents
Form: Liquid solution, Intravenous (IV)
Ingredients: Oxaliplatin, water.

What is the Most Important Information I Should Know About Oxaliplatin Injection, USP

Serious side effects can happen in people taking Oxaliplatin Injection, USP including:

  • Serious allergic Oxaliplatin Injection, USP can cause serious allergic reactions, including allergic reactions that may cause death. Oxaliplatin is a platinum base medicine. Serious allergic reactions including death can occur in people who take oxaliplatin and who have had previous allergic reactions to platinum medicines. Serious allergic reactions can happen within a few minutes of your infusion or any time during your treatment with oxaliplatin injection.

Get emergency help right away if you:

  • have trouble
  • feel like your throat is closing

Call your doctor right away if you have any of the following signs or symptoms of an allergic reaction:

  • rash
  • flushed face
  • hives
  • itching
  • swelling of your lips or tongue
  • sudden cough
  • dizziness or feel faint
  • sweating
  • chest pain

See "What are the possible side effects of Oxaliplatin Injection, USP?" for information about other serious side effects.

What is Oxaliplatin Injection, USP

Oxaliplatin is an anti-cancer (chemotherapy) medicine that is used with other anti cancer medicines called 5-fluorouracil and leucovorin to treat people with:

  • stage III colon cancer after surgery to remove the
  • advanced colon or rectal cancer (colorectal cancer).

Oxaliplatin injection with infusional 5-fluorouracil and leucovorin was shown to lower the chance of colon cancer returning when given to patients with stage III colon cancer after surgery to remove the tumor. Oxaliplatin Injection, USP also increases survival in patients with stage III colon cancer.

Oxaliplatin Injection, USP with infusional 5-fluorouracil and leucovorin was also shown to increase survival, shrink tumors and delay growth of tumors in some patients with advanced colorectal cancer. It is not known if Oxaliplatin Injection, USP works in children.

Who Should not use Oxaliplatin Injection, USP

  • Do not use Oxaliplatin Injection, USP if you are allergic to any of the ingredients in oxaliplatin injection or other medicines that contain Cisplatin and carboplatin are other chemotherapy medicines that also contain platinum. See the end of this leaflet for a complete list of the ingredients in oxaliplatin injection.

Ask your doctor if you are not sure if you take a medicine that contains platinum.

What Should I Tell My Doctor Before Treatment With Oxaliplatin Injection, USP

Before receiving Oxaliplatin Injection, USP, tell your doctor if you:

  • have kidney problems
  • have any other medical conditions
  • have had any allergic reactions to any medicines
  • are pregnant or plan to become pregnant. Oxaliplatin Injection, USP may harm your unborn child. You should avoid becoming pregnant while taking oxaliplatin injection. Talk with your doctor about how to avoid pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if oxaliplatin passes into your breast milk. You and your doctor should decide whether you will stop breastfeeding or not take Oxaliplatin Injection, USP.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

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

How is Oxaliplatin Injection, USP Given to Me

  • Oxaliplatin Injection, USP is given to you through your veins (blood vessels).
  • Your doctor will prescribe oxaliplatin injection in an amount that is right for you. Your doctor will treat you with several medicines for your cancer.
  • It is very important that you do exactly what your doctor and nurse have taught you to do.
  • Some medicines may be given to you before Oxaliplatin Injection, USP to help prevent nausea and vomiting.
  • Oxaliplatin Injection, USP is given with 2 other chemotherapy medicines, leucovorin and 5- fluorouracil.
  • Each treatment course is given to you over 2 days. You will receive oxaliplatin injection on the first day only.
  • There are usually 14 days between each chemotherapy treatment course.

Treatment Day 1:

Oxaliplatin and leucovorin are given through a thin plastic tube put into a vein (intravenous infusion or IV) and given for 2 hours. You will be watched by a healthcare provider during this

Right after the oxaliplatin and leucovorin are finished, 2 doses of 5-fluorouracil will be given. The first dose is given right away into your IV tube. The second dose will be given into your IV tube over the next 22 hours, using a pump device.

Treatment Day 2:

You will not get oxaliplatin on Day 2. Leucovorin and 5-fluorouracil will be given the same way as on Day 1.

During your treatment with Oxaliplatin Injection, USP:

  • It is important for you to keep all appointments. Call your doctor if you must miss an appointment. There may be special instructions for you.
  • Your doctor may change how often you get oxaliplatin injection, how much you get, or how long the infusion will take.
  • You and your doctor will discuss how many times you will get oxaliplatin injection.

The 5-fluorouracil will be given through your I.V. with a pump. If you have any problems with the pump or the tube, call your doctor, your nurse, or the person who is responsible for your pump. Do not let anyone other than a healthcare provider touch your infusion pump or tubing.

What are the Possible Side Effects of Oxaliplatin Injection, USP

Oxaliplatin Injection, USP can cause serious side effects, including:

  • Serious allergic See "What is the most important information I should know about oxaliplatin injection?"
  • Nerve problems . Oxaliplatin Injection, USP can affect how your nerves work and make you Tell your doctor right away if you get any signs of nerve problems listed below:
    • very sensitive to cold temperatures and cold objects.
    • trouble breathing, swallowing, or saying words, jaw tightness, odd feelings in your tongue, or chest pressure.
    • pain, tingling, burning (pins and needles, numb feeling) in your hands, feet, or around your mouth or throat, which may cause problems walking or performing activities of daily living.
  • Reversible Posterior Leukoencephalopathy (RPLS). RPLS is a rare condition that affects the brain. Tell your doctor right away if you have any of the following signs and symptoms of RPLS:
    • headache
    • confusion or a change in the way you think
    • seizures
    • vision problems, such as blurriness or vision loss. You should not drive, operate heavy machines, or engage in dangerous activities if you have vision problems while receiving oxaliplatin injection, USP.

The first signs of nerve problems may happen with the first treatment. The nerve problems can also start up to 2 days after treatment. If you develop nerve problems, the amount of oxaliplatin injection in your next treatment may be changed or Oxaliplatin Injection, USP treatment may be stopped.

For information on ways to lessen or help with the nerve problems, see the end of this leaflet, “How can I reduce the side effects caused by cold temperatures?”

  • Lung problems (interstitial fibrosis). Tell your doctor right away if you get a dry cough and have trouble breathing (shortness of breath) before your next treatment. These may be signs of a serious lung disease.
  • Liver problems (hepatotoxicity). Your doctor will do blood tests to check your liver.
  • Harm to an unborn baby. Oxaliplatin Injection, USP may cause harm to your unborn baby. See "What should I tell my doctor before treatment with oxaliplatin injection?"

The most common side effects of oxaliplatin injection include:

  • Decreased blood counts: Oxaliplatin Injection, USP can cause a decrease in neutrophils (a type of white blood cell important in fighting bacterial infections), red blood cells (blood cells that carry oxygen to the tissues), and platelets (important for clotting and to control bleeding).
  • High blood pressure (hypertension)
  • Infection. Call your doctor right away if you get any of the following signs of infection:
    • fever (temperature of 100.5o F or greater)
    • chills or shivering
    • pain on swallowing
    • sore throat
    • cough that brings up mucus
    • burning or pain on urination
    • redness or swelling at intravenous site
  • Bleeding or bruising. Tell your doctor about any signs or symptoms of bleeding or bruising.
  • Diarrhea
  • Nausea
  • Vomiting
  • Constipation
  • Mouth sores
  • Stomach pain
  • Decreased appetite
  • Tiredness
  • Injection site reactions. Reactions may include redness, swelling, pain, tissue damage at the site of injection.
  • Hair loss (alopecia)
  • Dehydration (too much water loss). Call you doctor if you have signs of dehydration including:
    • tiredness
    • thirst
    • dry mouth
    • lightheadedness (dizziness)
    • decreased urination

Tell your doctor if you have any side effect that bothers your or that does not go away. These are not all the possible side effects of oxaliplatin injection. For more information, ask your doctor or pharmacist.

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

How can I Reduce the Side Effects Caused by Cold Temperatures

  • Cover yourself with a blanket while you are getting your oxaliplatin injection infusion.
  • Do not breathe deeply when exposed to cold air.
  • Wear warm clothing in cold weather at all times. Cover your mouth and nose with a scarf or a pull- down cap (ski cap) to warm the air that goes to your lungs.
  • Wear gloves when taking things from the freezer or refrigerator.
  • Drink fluids warm or at room temperature.
  • Always drink through a straw.
  • Do not use ice chips if you have nausea or mouth sores. Ask your healthcare provider or doctor about what you can use.
  • Be aware that most metals are cold to touch, especially in the winter. These include your car door and mailbox. Wear gloves to touch cold objects.
  • Do not run the air-conditioning at high levels in the house or in the car in hot weather.
  • If your body gets cold, warm-up the affected part. If your hands get cold, wash them with warm water.
  • Always let your healthcare provider or doctor know before your next treatment how well you did since your last visit.

This list is not complete and your healthcare provider or doctor may have other useful tips for helping you with these side effects.

General Information About the Safe and Effective use of Oxaliplatin Injection, USP

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet.

This Patient Information leaflet summarizes the most important information about oxaliplatin injection. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about oxaliplatin injection, USP that is written for health professionals.

What are the Ingredients in Oxaliplatin Injection, USP

Active ingredient: oxaliplatin

Concentrate for solution for infusion inactive ingredient: water for injection

Manufactured For

Fresenius Kabi USA, LLC

Lake Zurich, IL 60047 Made in India

For Product Inquiry:

1-800-551-7176 or www.fresenius-kabi.us

451427/Issued: May 2015