oxaliplatin 50 mg intravenous solution

Generic name:
Oxaliplatin - injection

Pronunciation
(ox-AL-ih-plah-tin)

Brand name(s)
Eloxatin

Oxaliplatin may rarely cause a severe (possibly fatal) allergic reaction within minutes after a dose. Get medical help right away if you develop any signs of an allergic reaction (such as rash, itching, swelling, trouble breathing, swelling of throat, dizziness).

This medication is used to treat advanced cancer of the colon and rectum. Oxaliplatin is a chemotherapy drug that contains platinum. It is used to slow or stop cancer cell growth.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for other types of cancer (such as testicular cancer).

Read the Patient Information Leaflet if available from your health care professional before you receive oxaliplatin.

This medication is usually given by infusion into a vein over at least 2 hours by a health care professional. It is usually given every 2 weeks along with other medications (such as 5-fluorouracil and leucovorin). The dosage is based on your medical condition, body size, and response to treatment.

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 last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may rarely occur. Normal hair growth should return after treatment has ended.

Remember that this medication has been prescribed because your doctor 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 (such as depression)
• signs of dehydration (such as decreased urination, increased thirst, dry mouth)
• muscle pain/tenderness/weakness/cramps
• signs of kidney problems (such as change in the amount of urine)
• pain/redness/swelling of the arms/legs
• groin/calf pain

Oxaliplatin can sometimes affect how your nerves work (peripheral neuropathy). Tell your doctor right away 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 right away if your nerve problems begin to interfere with your normal daily activities (such as walking, writing, eating).

Get medical help right away if you have any very serious side effects, including:

• severe dizziness
• fainting
• fast/irregular heartbeat
• 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. Tell your doctor right away if you develop any signs of an infection such as sore throat that doesn't go away, fever, or chills.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using oxaliplatin, tell your doctor or pharmacist if you are allergic to it; or to other platinum-containing products (such as cisplatin, carboplatin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney problems
• blood disorders
• bone marrow problems
• nerve disorders

Oxaliplatin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using oxaliplatin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using oxaliplatin safely.

This drug may make you dizzy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Tell your health care professional that you are using oxaliplatin before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults may be more sensitive to the side effects of this drug, especially diarrhea, dehydration, low white blood cell count, tiredness, fainting, and QT prolongation (see above).

This medication can affect fertility in both males and females. Ask your doctor for more details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using oxaliplatin. Oxaliplatin may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 9 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if oxaliplatin passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 3 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• aminoglycosides (such as gentamicin, amikacin)
• amphotericin B
• nonsteroidal anti-inflammatory drugs (such as ibuprofen)
• tacrolimus

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe vomiting, chest pain, shortness of breath, wheezing, very slow heartbeat, numbness/tingling of the arms/legs.

Lab and/or medical tests (such as complete blood counts, liver/kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.