Oxaliplatin

What is Oxaliplatin?

• Oxaliplatin (Eloxatin) is a platinum-based drug used for the treatment of advanced colorectal cancer, Stage III colon cancer.

Oxaliplatin

Oxaliplatin 3D ball

What are the uses of this medicine?

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

• Stage III colon cancer after surgery to remove the tumor
• advanced colon or rectal cancer (colorectal cancer)

How does this medicine work?

• Oxaliplatin (ox al" i pla' tin) is a cisplatin analog with a tetravalent platinum molecule which is referred to as a platinum coordination complex.
• Oxaliplatin acts as an alkylating agent causing cross linking between and within DNA strands leading to inhibition of DNA, RNA and protein synthesis and the triggering of programmed cell death, mostly in rapidly dividing cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to any of the ingredients in Oxaliplatin Injection or other medicines that contain platinum.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Be sure to mention oral anticoagulants ('blood thinners') such as warfarin (Coumadin).

Is this medicine FDA approved?

• Oxaliplatin was patented in 1976 and approved for medical use in 1996.

How should this medicine be used?

Recommended dosage:

• Administer Oxaliplatin Injection in combination with fluorouracil/leucovorin every 2 weeks.

Day 1:

• Oxaliplatin Injection 85 mg/m2 intravenous infusion 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 Injection and leucovorin are given, 2 doses of 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.

Day 2:

• Leucovorin 200 mg/m2 intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m2 intravenous bolus given over 2 to 4 minutes, followed by fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection (recommended) as a 22-hour continuous infusion.

• Reduce the dose of Oxaliplatin Injection to 75 mg/m2 (adjuvant setting) or 65 mg/m2 (advanced colorectal cancer).
• For patients with severe renal impairment (creatinine clearance < 30 mL/min), the initial recommended dose is 65 mg/m².
• Discontinue Oxaliplatin Injection if there are persistent Grade 3 neurosensory events.

Administration:

• Oxaliplatin comes as a solution (liquid) to be injected into a vein.
• Oxaliplatin is administered by a doctor or nurse.
• It is usually given once every fourteen days.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 50 mg/10 mL and 100 mg/20 mL in single-dose vials.

This medicine is available in fallowing brand namesː

• Eloxatin

What side effects can this medication cause?

The most common side effects of this medicine 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

Oxaliplatin Injection can cause serious side effects, including:

• serious allergic reaction
• Nerve problems
• Reversible Posterior Leukoencephalopathy (RPLS)
• neutropenia
• interstitial fibrosis
• hepatotoxicity
• Heart problems
• Muscle problems
• Harm to an unborn baby

What special precautions should I follow?

• Grade 3/4 hypersensitivity, including anaphylactic/anaphylactoid reactions, to oxaliplatin has been observed in cancer patients. Monitor for development of rash, urticaria, erythema, pruritus, bronchospasm, and hypotension.
• Oxaliplatin is associated with two types of neuropathy. Reduce the dose or discontinue Oxaliplatin Injection if necessary.
• Grade 3 or 4 neutropenia occurred in 41 to 44% of patients with colorectal cancer treated with oxaliplatin in combination with flurouracil (FU) and leucovorin compared to 5% with FU plus leucovorin alone. Delay Oxaliplatin Injection until neutrophils are ≥1.5 x 109/L. Withhold Oxaliplatin Injection for sepsis.
• Oxaliplatin has been associated with pulmonary fibrosis, which may be fatal. May need to discontinue Oxaliplatin Injection until interstitial lung disease or pulmonary fibrosis are excluded.
• Hepatotoxicity as evidenced in the adjuvant study by increase in transaminases and alkaline phosphatase was observed. Monitor liver function tests.
• QT prolongation and ventricular arrhythmias including fatal Torsade de Pointes have been reported in postmarketing experiences following oxaliplatin administration. Correct hypokalemia or hypomagnesemia prior to initiating Oxaliplatin Injection.
• Rhabdomyolysis, including fatal cases, has been reported in patients treated with oxaliplatin. Discontinue Oxaliplatin Injection if rhabdomyolysis occurs.
• Based on findings from animal studies and its mechanism of action, Oxaliplatin Injection can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective method of contraception.
• Oxaliplatin therapy is associated with a low rate of transient serum aminotransferase elevations, but is commonly associated with sinusoidal and vascular injury to the liver which can lead to sinusoidal obstruction syndrome and to nodular regenerative hyperplasia with noncirrhotic portal hypertension.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• thrombocytopenia
• hypersensitivity reaction
• myelosuppression
• nausea
• vomiting
• diarrhea
• neurotoxicity

Management of overdosage:

• Patients suspected of receiving an overdose should be monitored, and supportive treatment should be administered.

Can this medicine be used in pregnancy?

• Oxaliplatin Injection can cause fetal harm when administered to a pregnant woman.
• Advise a pregnant woman of the potential hazard to a fetus.

Can this medicine be used in children?

• The effectiveness of Oxaliplatin Injection in children has not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: oxaliplatin
• Concentrate for solution for infusion inactive ingredients: lactose monohydrate and water for injection.

Who manufactures and distributes this medicine?

Manufactured In The Netherlands By:

• Pharmachemie B.V.
• Haarlem, The Netherlands

Manufactured For:

• Teva Pharmaceuticals USA, Inc.
• North Wales, PA

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
• DO NOT FREEZE.
• PROTECT FROM LIGHT.
• Keep in original outer carton.
• Oxaliplatin Injection is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

• Dailymed label info on Oxaliplatin
• FDA Oxaliplatin