Oxaliplatin-injection

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Unless your doctor tells you otherwise, continue your normal diet.

Do not eat or drink anything that is colder than room temperature for five days after you receive each dose of oxaliplatin.

Oxaliplatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• numbness, burning, or tingling in the fingers, toes, hands, feet, mouth, or throat
• pain in the hands or feet
• increased sensitivity, especially to cold
• decreased sense of touch
• nausea
• vomiting
• diarrhea
• constipation
• gas
• stomach pain
• heartburn
• sores in the mouth
• loss of appetite
• change in the ability to taste food
• weight gain or loss
• hiccups
• dry mouth
• muscle, back, or joint pain
• tiredness
• anxiety
• depression
• difficulty falling asleep or staying asleep
• hair loss
• dry skin
• redness or peeling of the skin on the hands and feet
• sweating
• flushing

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• stumbling or loss of balance when walking
• difficulty with everyday activities such as writing or fastening buttons
• difficulty speaking
• strange feeling in the tongue
• tightening of the jaw
• chest pain or pressure
• cough
• shortness of breath
• sore throat, fever, chills, and other signs of infection
• pain, redness, or swelling in the place where oxaliplatin was injected
• pain when urinating
• decreased urination
• unusual bruising or bleeding
• nosebleed
• blood in urine
• vomit that is bloody or looks like coffee grounds
• bright red blood in stool
• black and tarry stools
• pale skin
• weakness
• problems with vision
• swelling of the arms, hands, feet, ankles, or lower legs

Oxaliplatin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• shortness of breath
• wheezing
• numbness or tingling in the fingers or toes
• vomiting
• chest pain
• slowed breathing
• slowed heartbeat
• tightening of the throat
• diarrhea

Dosage Forms And Strengths

ELOXATIN is supplied in single-use vials containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL.

Storage And Handling

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.

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).

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]. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

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.

Manufactured by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 10/2015

Included as part of the PRECAUTIONS section.

You should not receive this medication if you have ever had an allergic reaction to oxaliplatin or similar medications such as carboplatin (Paraplatin) or cisplatin (Platinol).

To make sure you can safely receive oxaliplatin, tell your doctor if you have any of these other conditions:

• kidney disease;
• liver disease;
• high blood pressure;
• asthma or other breathing disorder;
• a nerve problem; or
• if you are using a blood thinner such as warfarin (Coumadin, Jantoven).

FDA pregnancy category D. Do not use oxaliplatin if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether oxaliplatin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using oxaliplatin.