Eloxatin

Diarrhea, changes in taste, mouth sores, nosebleeds, tiredness, headache, dizziness, or trouble sleeping may occur. Nausea and vomiting may be severe in some patients. Your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Temporary hair loss may infrequently occur. Normal hair growth should return after treatment has ended.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: pain/redness/swelling at the injection site, easy or unusual bruising/bleeding, mental/mood changes (e.g., depression), signs of too much body water loss (e.g., decreased urination, increased thirst, dry mouth), muscle cramps, weakness, pain/redness/swelling of the arms/legs, groin/calf pain, fainting.Oxaliplatin can sometimes affect how your nerves work (peripheral neuropathy). Tell your doctor immediately if you develop: sensitivity to cold, trouble breathing/swallowing/speaking, jaw tightness, strange feeling in your tongue, eye pain, chest pressure, numbness/tingling/"pins and needles" sensation of the hands/feet/mouth/throat.You may lessen these types of nerve problems by avoiding cold drinks and ice and by dressing warmly. Tell your doctor immediately if your nerve problems begin to interfere with your normal daily activities (e.g., walking, writing, eating).Get medical help right away if any of these rare but very serious side effects occur: dry cough, shortness of breath, chest pain, black stools, vomit that looks like coffee grounds, vision changes (such as blurred vision, temporary vision loss), seizures, sudden confusion.This medication can lower your body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Eloxatin is part of the drug class:

• Platinum compounds

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

• blood thinners such as warfarin (Coumadin)
• drugs that can decrease kidney function such as
  • acetaminophen (Tylenol)
  • aspirin
  • NSAIDs such as ibuprofen and naproxen
  • acyclovir
  • aminoglycoside medications
  • certain antibiotics
  • ACEIs such as lisinopril or quinapril
  • statins such as rosuvastatin and simvastatin
  • water pills (diuretic medications)

This is not a complete list of Eloxatin drug interactions. Ask your doctor or pharmacist for more information.

 

Avoid cold temperatures and cold objects, including ice, cold drinks, and skin exposure to cold temperatures.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Bupropion
• Cholera Vaccine, Live
• Dasabuvir
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine
• Yellow Fever Vaccine

Antineoplastic agent; platinum-containing compound.1 2

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Oxaliplatin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	50 mg	Eloxatin	Sanofi-Aventis
		100 mg	Eloxatin	Sanofi-Aventis
	For injection concentrate, for IV infusion	5 mg/mL (50, 100, and 200 mg)	Eloxatin	Sanofi-Aventis

• It is used to treat colon cancer.
• It is used to treat colorectal cancer.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to this medicine or any part of Eloxatin.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Long QT on ECG, low magnesium levels, or low potassium levels.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Eloxatin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If you need to store Eloxatin at home, talk with your doctor, nurse, or pharmacist about how to store it.

How Supplied

Eloxatin is supplied in clear, glass, single-use vials with gray elastomeric stoppers and aluminum flip-off seals containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. Water for Injection, USP is present as an inactive ingredient.

NDC 0024-0590-10: 50 mg single-use vial with green flip-off seal individually packaged in a carton.

NDC 0024-0591-20: 100 mg single-use vial with dark blue flip-off seal individually packaged in a carton.

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Do not freeze and protect from light (keep in original outer carton).

Handling and Disposal

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

Eloxatin can cause a severe or life-threatening allergic reaction. Get emergency medical help if you have: hives, itching, sweating; chest pain, warmth or redness in your face, feeling light-headed; sudden cough, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Other drugs may interact with oxaliplatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.