Oxaliplatin (Page 9 of 9)

15 REFERENCES

  1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
  2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
  3. American Society of Health-System Pharmacists. (2006) ASHP Guidelines on Handling Hazardous Drugs.
  4. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Oxaliplatin Injection, USP is supplied in clear, glass, single-dose vials containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg per mL. Water for Injection USP is present as an inactive ingredient.

Product Code Unit of Sale Strength Each
775010 NDC 63323-750-10 Individually packaged 50 mg per 10 mL (5 mg per mL) 10 mL Single Dose Vial
775020 NDC 63323-750-20 Individually packaged 100 mg per 20 mL (5 mg per mL) 20 mL Single Dose Vial

The container closure is not made with natural rubber latex.

16.2 Storage

Store at 20°C to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze and protect from light (keep in original outer carton).

16.3 Handling and Disposal

As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of infusion solutions prepared from Oxaliplatin Injection. The use of gloves is recommended. If a solution of Oxaliplatin Injection contacts the skin, wash the skin immediately and thoroughly with soap and water. If Oxaliplatin Injection contacts the mucous membranes, flush thoroughly with water.

Procedures for the handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published [see References (15)]. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

17 PATIENT COUNSELING INFORMATION

Advise patients:

  • To expect side effects of oxaliplatin, particularly its neurologic effects, both the acute, reversible effects and the persistent neurosensory toxicity. Patients should be informed that the acute neurosensory toxicity may be precipitated or exacerbated by exposure to cold or cold objects.
  • To avoid cold drinks, use of ice, and should cover exposed skin prior to exposure to cold temperature or cold objects.
  • Of the risk of low blood cell counts and to contact their physician immediately should fever, particularly if associated with persistent diarrhea, or evidence of infection develop.
  • To contact their physician if persistent vomiting, diarrhea, signs of dehydration, cough or breathing difficulties occur, or signs of allergic reaction appear.
  • To exercise caution when driving and using machines. No studies on the effects of the ability to operate cars and machines have been performed; however, oxaliplatin treatment resulting in an increase risk of dizziness, nausea and vomiting, and other neurologic symptoms that affect gait and balance may lead to a minor or moderate influence on the ability to drive and use machines.
  • Of the potential effects of vision abnormalities, in particular transient vision loss (reversible following therapy discontinuation), which may affect patients’ ability to drive and use machines.

FDA-Approved Patient Labeling

Patient Information

Oxaliplatin Injection (ox-AL-i-PLA-tin)
for intravenous use

Read this Patient Information leaflet carefully before you start receiving Oxaliplatin Injection. There may be new information. It will help you learn more about Oxaliplatin Injection. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment. Ask your doctor about any questions you have.
What is the most important information I should know about Oxaliplatin Injection?

Oxaliplatin Injection can cause serious allergic reactions, including allergic reactions that can lead to death. Oxaliplatin is a platinum base medicine. Serious allergic reactions including death can happen 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 oxaliplatin infusion or any time during your treatment with Oxaliplatin Injection.
Get emergency help right away if you:
• have trouble breathing
• feel like your throat is closing up

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?” for information about other serious side effects.

What is Oxaliplatin Injection?
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 tumor
• advanced colon or rectal cancer (colorectal cancer)

It is not known if Oxaliplatin Injection is effective in children.
Who should not receive Oxaliplatin Injection?
Do not receive Oxaliplatin Injection if you are allergic to any of the ingredients in Oxaliplatin Injection or other medicines that 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 receiving Oxaliplatin Injection?

Before receiving Oxaliplatin Injection, tell your doctor about all of your medical conditions, including if you:

• have an infection
• have lung, liver, or kidney problems
• have or had heart problems such as an abnormal heart test called an electrocardiogram (ECG or EKG), a condition called long QT syndrome, an irregular or slow heartbeat, or a family history of heart problems.
• have had changes in the level of certain blood salt (electrolytes) levels, including potassium, magnesium, and calcium
• are pregnant or plan to become pregnant. Oxaliplatin Injection may harm your unborn baby. Females who are able to become pregnant should avoid becoming pregnant and should use effective birth control during treatment with Oxaliplatin Injection.
• are breastfeeding or plan to breastfeed. It is not known if oxaliplatin passes into your breast milk. You and your doctor should decide if you will receive Oxaliplatin Injection or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter 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 will I receive Oxaliplatin Injection?

  • Oxaliplatin Injection is given to you into your vein through an intravenous (IV) tube.
  • Your doctor will prescribe Oxaliplatin Injection in a dose that is right for you.
  • Your doctor may change how often you receive Oxaliplatin Injection, your dose, or how long your infusion will take.
  • You and your doctor will decide how many Oxaliplatin Injection treatments you will receive.
  • It is very important that you do exactly what your doctor and nurse tell you to do.
  • Some medicines may be given to you before Oxaliplatin Injection to help prevent nausea and vomiting.
  • 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.
  • It is important for you to keep all of your medical appointments. Call your doctor if you miss an appointment. There may be special instructions for you.

Treatment Day 1:

  • Oxaliplatin and leucovorin will be given through a thin plastic tube into a vein (intravenous infusion or IV) and given for 2 hours. You will be watched by a healthcare provider during this time.
  • Right after the oxaliplatin and leucovorin are given, 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.
The 5-fluorouracil will be given through your IV 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 should I avoid while receiving Oxaliplatin Injection?
• Avoid cold temperatures and cold objects. Cover your skin if you go outdoors in cold temperatures.
• Do not drink cold drinks or use ice cubes in drinks.
• Do not put ice or ice packs on your body.
• Oxaliplatin Injection can cause dizziness, vision problems, or vision loss that can affect your ability to drive or use machines. You should not drive or operate machinery if you develop these symptoms while receiving Oxaliplatin Injection.
See “How can I reduce the side effects caused by cold temperatures?” for more information.
Talk with your doctor and nurse about your level of activity during treatment with Oxaliplatin Injection. Follow their instructions.
What are the possible side effects of Oxaliplatin Injection?
Oxaliplatin Injection can cause serious side effects, including:

•See “What is the most important information I should know about Oxaliplatin Injection?”
• Nerve problems. Oxaliplatin Injection can affect how your nerves work and make you feel. Nerve problems may happen with the first treatment or within two days after your treatment of Oxaliplatin Injection. Nerve problems may last a short time (acute) or may become persistent. Symptoms may improve after stopping treatment with Oxaliplatin Injection. Exposure to cold or cold objects may cause or worsen nerve problems. Tell your doctor right away if you get any signs of nerve problems, including:

  • 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.

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?”

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

  • Low white blood cell counts (neutropenia). Oxaliplatin Injection can cause low white blood cells counts. Low blood cell counts are common with Oxaliplatin Injection and can lead to serious infection and death. Tell your doctor right away if you have a fever greater than 100.9°F (38.3°C) or a prolonged fever greater than 100.4°F (38°C) for more than one hour (febrile neutropenia). Call your doctor right away if you get any of the following signs of infection:
      • chills or shivering
      • pain on swallowing
      • sore throat
      • cough that brings up mucus
      • burning or pain on urination
      • redness or swelling at intravenous site
      • persistent diarrhea

  • Lung problems (interstitial fibrosis). Oxaliplatin Injection can cause lung problems that may lead to death. 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.
  • Heart problems. Oxaliplatin Injection can cause heart problems that have led to death. Your doctor may do blood and heart tests during treatment with Oxaliplatin Injection if you have certain heart problem. If you faint (lose consciousness) or have an irregular heartbeat or chest pain during treatment with Oxaliplatin Injection, tell your doctor right away as this may be a sign of a serious heart condition.
  • Muscle problems. Oxaliplatin Injection can cause muscle damage (rhabdomyolysis) which can lead to death. Tell your doctor right away if you have muscle pain and swelling, along with weakness, fever, or red-brown urine.
  • Harm to an unborn baby. See “What should I tell my doctor before receiving Oxaliplatin Injection?”

The most common side effects of Oxaliplatin Injection include:

• Numbness, pain, tingling, and/or burning along the nerves
• Low white blood cells (neutropenia)
• Low platelet count (important for clotting and to control bleeding)
• Low red blood cells (blood cells that carry oxygen to the tissues)
• Nausea
• Changes in liver function tests
• Diarrhea
• Vomiting
• Tiredness
• Mouth sores

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 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 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 doctor know before your next treatment how well you did since your last visit.

Your doctor may have other useful tips for helping you with these side effects.
General information about the safe and effective use of Oxaliplatin Injection
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 that is written for health professionals.
What are the ingredients in Oxaliplatin Injection?
Active ingredient: oxaliplatin
Inactive ingredient: water for injection
This Patient Information has been approved by the U.S. Food and Drug Administration.

logo-1
(click image for full-size original)

Lake Zurich, IL 60047

For Product Inquiry:
1-800-551-7176 or www.fresenius-kabi.com/us

451426B/Revised: October 2018

PACKAGE LABEL PRINCIPAL DISPLAY PANEL- 50 mg per 10 mL- Vial Label

NDC 63323-750-10 775010
Oxaliplatin Injection, USP
50 mg per 10 mL
(5 mg per mL)
For intravenous use only.
MUST BE DILUTED WITH 5% DEXTROSE INJECTION BEFORE USE.
Preservative free.
Cytotoxic agent.
Do not mix or add to sodium
chloride/chloride-containing solutions.

Rx only
Single Dose Vial

vial
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL- 50 mg per 10 mL- Vial Carton Panel
NDC 63323-750-10 775010
Oxaliplatin Injection, USP
50 mg per 10 mL
(5 mg per mL)
For intravenous use only.
MUST BE DILUTED WITH 5% DEXTROSE INJECTION BEFORE USE.
Preservative free.
Cytotoxic agent.
Do not mix or add to sodium chloride/chloride-containing solutions.

Single Dose Vial Rx only

carton
(click image for full-size original)

OXALIPLATIN oxaliplatin injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-750
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXALIPLATIN (OXALIPLATIN) OXALIPLATIN 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-750-10 1 VIAL in 1 BOX contains a VIAL
1 10 mL in 1 VIAL This package is contained within the BOX (63323-750-10)
2 NDC:63323-750-20 1 VIAL in 1 BOX contains a VIAL
2 20 mL in 1 VIAL This package is contained within the BOX (63323-750-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078811 06/11/2010
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 023648251 MANUFACTURE (63323-750)

Revised: 10/2018 Fresenius Kabi USA, LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.