Oxaliplatin

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Administer oxaliplatin injection 85 mg/m 2 as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags, followed by fluorouracil on Day 1 of each 14-day cycle. Administer fluorouracil and leucovorin on Day 2 as recommended. ( 2.1 )
• Adjuvant Treatment :
• Continue treatment for up to 12 cycles or unacceptable toxicity. ( 2.1 )
• Advanced Colorectal Cancer :
• Continue treatment until disease progression or unacceptable toxicity. ( 2.1 ) 2.1 Recommended Dosage Administer oxaliplatin injection in combination with fluorouracil and leucovorin every 2 weeks.
• For adjuvant treatment, continue treatment for up to 12 cycles or unacceptable toxicity.
• For advanced colorectal cancer, continue treatment until disease progression or unacceptable toxicity. Day 1 Administer oxaliplatin injection 85 mg/m 2 as an intravenous infusion over 120 minutes and leucovorin 200 mg/m 2 as an intravenous infusion over 120 minutes at the same time in separate bags, followed by fluorouracil 400 mg/m 2 as intravenous bolus over 2 to 4 minutes, followed by fluorouracil 600 mg/m 2 as a 22-hour continuous infusion. Day 2 Administer leucovorin 200 mg/m 2 as an intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m 2 as intravenous bolus over 2 to 4 minutes, followed by fluorouracil 600 mg/m 2 as a 22-hour continuous infusion. Refer to the prescribing information for fluorouracil and leucovorin for additional information. 2.2 Dose Modifications for Adverse Reactions Prolongation of infusion time for oxaliplatin injection from 2 hours to 6 hours may mitigate acute toxicities, such as non-life-threatening infusion-related reactions. Permanently discontinue oxaliplatin injection for any of the following:
• Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )]
• Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions ( 5.4 )]
• Confirmed interstitial lung disease or pulmonary fibrosis [see Warnings and Precautions ( 5.5 )]
• Rhabdomyolysis [see Warnings and Precautions ( 5.8 )] Refer to the fluorouracil and leucovorin prescribing information for dosage modifications for adverse reactions. Dosage Modifications for Adjuvant Treatment Dosage modifications for adverse reactions for adjuvant treatment are presented in Table 1 . Table 1:
• Dosage Modifications for Adjuvant Treatment in Patients with Stage III Colon Cancer Adverse Reactions Severity Oxaliplatin Dosage Modifications Peripheral Sensory Neuropathy [see Warnings and Precautions ( 5.2 )] Persistent Grade 2 Consider reducing oxaliplatin dose to 75 mg/m 2 . Persistent Grade 3 Consider discontinuing oxaliplatin. Grade 4 Discontinue oxaliplatin. Myelosuppression [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )]. Grade 4 neutropenia or febrile neutropenia Delay the next dose until neutrophils greater than or equal to 1.5 × 10 9 /L and platelets greater than or equal to 75 × 10 9 /L. Reduce oxaliplatin dose to 75 mg/m 2 . Grade 3-4 thrombocytopenia Gastrointestinal Adverse Reactions [see Adverse Reactions ( 6.1 )] Grade 3-4 After recovery, reduce oxaliplatin dose to 75 mg/m 2 along with a dose reduction of fluorouracil to 300 mg/m 2 as an intravenous bolus and 500 mg/m 2 as a 22-hour continuous infusion. Dosage Modifications for Advanced Colorectal Cancer Dosage modifications for adverse reactions for advanced colorectal cancer are presented in Table 2 . Table 2:
• Dosage Modifications for Advanced Colorectal Cancer Adverse Reactions Severity Oxaliplatin Dosage Modifications Neuropathy [see Warnings and Precautions ( 5.2 )] Persistent Grade 2 Consider reducing oxaliplatin dose to 65 mg/m 2 . Persistent Grade 3 Consider discontinuing oxaliplatin. Grade 4 Discontinue oxaliplatin. Myelosuppression [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] Grade 4 neutropenia or febrile neutropenia Delay the next dose until neutrophils greater than or equal to 1.5 × 10 9 /L and platelets greater than or equal to 75 × 10 9 /L. Reduce oxaliplatin dose to 65 mg/m 2 . Grade 3-4 thrombocytopenia Gastrointestinal Adverse Reactions [see Adverse Reactions ( 6.1 )] Grade 3-4 After recovery, reduce oxaliplatin dose to 65 mg/m 2 along with a dose reduction of fluorouracil to 300 mg/m 2 as an intravenous bolus and 500 mg/m 2 as a 22-hour continuous infusion . 2.3 Dose Modifications for Patients with Renal Impairment In patients with severe renal impairment (creatinine clearance [CLcr] less than 30 mL/min, calculated by the Cockcroft-Gault equation), reduce the oxaliplatin dose to 65 mg/m 2 [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . 2.4 Preparation and Administration
• Oxaliplatin is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
• Do not freeze.
• Protect the concentrated solution from light.
• Dilute concentrated solution with 250 to 500 mL of 5% Dextrose Injection, USP. Do not dilute with sodium chloride solution or other chloride-containing solutions.
• Store diluted solution for no more than 6 hours at room temperature (20°C to 25°C [68°F to 77°F]) or 24 hours under refrigeration (2°C to 8°C [36°F to 46°F]). Protection from light is not required.
• Visually inspect for particulate matter and discoloration prior to administration and discard if present.
• Do not mix oxaliplatin or administer oxaliplatin through the same infusion line concurrently with alkaline medications or media (such as basic solutions of fluorouracil).
• Flush the infusion line with 5% Dextrose Injection, USP prior to administration of any concomitant medication.
• Do not use needles or intravenous administration sets containing aluminum parts for the preparation or mixing of oxaliplatin. Aluminum has been reported to cause degradation of platinum compounds.
• Administer oxaliplatin as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of oxaliplatin in pediatrics have not been established.
• Safety and effectiveness were assessed across 4 open-label studies in 235 patients aged 7 months to 22 years with solid tumors.
• In a multicenter, open-label, non-comparative, non-randomized study (ARD5531), oxaliplatin was administered to 43 patients with refractory or relapsed malignant solid tumors, mainly neuroblastoma and osteosarcoma.
• The dose limiting toxicity (DLT) was sensory neuropathy at a dose of 110 mg/m 2 .
• The main adverse reactions were:
• paresthesia (60%, grade 3-4:
• 7%), fever (40%, grade 3-4:
• 7%), and thrombocytopenia (40%, grade 3-4:
• 27%).
• No responses were observed.
• In an open-label non-randomized study (DFI7434), oxaliplatin was administered to 26 pediatric patients with metastatic or unresectable solid tumors, mainly neuroblastoma and ganglioneuroblastoma.
• The DLT was sensory neuropathy at a dose of 160 mg/m 2 .
• No responses were observed.
• In an open-label, single-agent study (ARD5021), oxaliplatin was administered to 43 pediatric patients with recurrent or refractory embryonal CNS tumors.
• The most common adverse reactions reported were:
• leukopenia (67%, grade 3-4:
• 12%), anemia (65%, grade 3-4:
• 5%), thrombocytopenia (65%, grade 3-4:
• 26%), vomiting (65%, grade 3-4:
• 7%), neutropenia (58%, grade 3-4:
• 16%), and sensory neuropathy (40%, grade 3-4:
• 5%).
• In an open-label single-agent study (ARD5530), oxaliplatin was administered to 123 pediatric patients with recurrent solid tumors, including neuroblastoma, osteosarcoma, Ewing sarcoma or peripheral PNET, ependymoma, rhabdomyosarcoma, hepatoblastoma, high grade astrocytoma, brain stem glioma, low grade astrocytoma, malignant germ cell tumor and other tumors.
• The most common adverse reactions reported were:
• sensory neuropathy (52%, grade 3-4:
• 12%), thrombocytopenia (37%, grade 3-4:
• 17%), anemia (37%, grade 3-4:
• 9%), vomiting (26%, grade 3-4:
• 4%), increased ALT (24%, grade 3-4:
• 6%), increased AST (24%, grade 3-4:
• 2%), and nausea (23%, grade 3-4:
• 3%).
• The pharmacokinetic parameters of ultrafiltrable platinum were evaluated in 105 pediatric patients during the first cycle.
• The mean clearance in pediatric patients estimated by the population pharmacokinetic analysis was
• 4.7 L/h (%CV, 41%).
• Mean platinum pharmacokinetic parameters in ultrafiltrate were C max of 0.75 ± 0.24 mcg/mL, AUC 0-48h of 7.52 ± 5.07 mcg∙h/mL and AUC inf of 8.83 ± 1.57 mcg·h/mL at 85 mg/m 2 of oxaliplatin and C max of 1.10 ± 0.43 mcg/mL, AUC 0–48h of 9.74 ± 2.52 mcg∙h/mL and AUC inf of 17.3 ± 5.34 mcg·h/mL at 130 mg/m 2 of oxaliplatin.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• In the adjuvant treatment trial [see Clinical Studies ( 14.1 )] , 400 patients who received oxaliplatin with fluorouracil/leucovorin were greater than or equal to 65 years.
• The effect of oxaliplatin in patients greater than or equal to 65 years was not conclusive.
• Patients greater than or equal to 65 years receiving oxaliplatin experienced more diarrhea and grade 3-4 neutropenia (45% vs 39%) compared to patients less than 65 years.
• In the previously untreated advanced colorectal cancer trial [see Clinical Studies ( 14.2 )] , 99 patients who received oxaliplatin with fluorouracil and leucovorin were greater than or equal to 65 years.
• The same efficacy improvements in response rate, time to tumor progression, and overall survival were observed in the greater than or equal to 65 years patients as in the overall study population.
• Adverse reactions were similar in patients less than 65 and greater than or equal to 65 years, but older patients may have been more susceptible to diarrhea, dehydration, hypokalemia, leukopenia, fatigue, and syncope.
• In the previously treated advanced colorectal cancer trial [see Clinical Studies ( 14.3 )] , 55 patients who received oxaliplatin with fluorouracil and leucovorin were greater than or equal to 65 years.
• No overall differences in effectiveness were observed between these patients and younger
• adults.
• Adverse reactions were similar in patients less than 65 and greater than or equal to 65 years, but older patients may have been more susceptible to diarrhea, dehydration, hypokalemia, and fatigue.
• No significant effect of age on the clearance of ultrafiltrable platinum has been observed [see Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following clinically significant adverse reactions are described elsewhere in labeling:
• Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )]
• Peripheral Sensory Neuropathy [see Warnings and Precautions ( 5.2 )]
• Severe Myelosuppression [see Warnings and Precautions ( 5.3 )]
• Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions ( 5.4 )]
• Pulmonary Toxicity [see Warnings and Precautions ( 5.5 )]
• Hepatotoxicity [see Warnings and Precautions ( 5.6 )]
• QT Interval Prolongation and Ventricular Arrhythmias [see Warnings and Precautions ( 5.7 )]
• Rhabdomyolysis [see Warnings and Precautions ( 5.8 )]
• Hemorrhage [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence greater than or equal to 40%) were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. More than 1100 patients with stage II or III colon cancer and more than 4,000 patients with advanced colorectal cancer were treated in trials with oxaliplatin. The most common adverse reactions in patients with stage II or III colon cancer receiving adjuvant treatment were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue and stomatitis. The most common adverse reactions in previously untreated and treated patients with advanced colorectal cancer were peripheral sensory neuropathies, fatigue, neutropenia, nausea, emesis, and diarrhea. Adjuvant Treatment The safety of oxaliplatin in combination with fluorouracil (FU)/leucovorin (LV) was evaluated in patients with stage II or III colon cancer, who had undergone complete resection of the primary tumor in the adjuvant treatment trial [see Clinical Studies ( 14.1 )]. Fatal adverse reactions in patients who received oxaliplatin in the combination arm included sepsis/neutropenic sepsis (n=3), intracerebral hemorrhage (n=2), and eosinophilic pneumonia (n=1). Thromboembolic events occurred in 6% (grade 3-4, 1.2%) of patients in the oxaliplatin arm. Grade 3 or 4 adverse reactions occurred in 70% of patients in the oxaliplatin arm. Grade 3-4 gastrointestinal bleeding occurred in 0.2% of patients. Febrile neutropenia occurred in 0.7% and documented infection with concomitant grade 3-4 neutropenia occurred in 1.1%. Discontinuation due to an adverse reaction occurred in 15% of the patients in the oxaliplatin arm. Tables 5 , 6 , and 7 summarize the adverse reactions reported in patients with colon cancer receiving adjuvant treatment. Table 5:
• Adverse Reactions Reported in Patients with Colon Cancer Receiving Adjuvant Treatment (greater than or equal to 5% of all patients and with greater than or equal to 1% grade 3-4) Adverse Reaction Event coded in WHO-ART dictionary. Oxaliplatin + FU/LV N=1108 FU/LV N=1111 All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%) Neurology Peripheral Sensory Neuropathy 92 12 16 <1 Gastrointestinal Nausea 74 5 61 2 Diarrhea 56 11 48 7 Vomiting 47 6 24 1 Stomatitis 42 3 40 2 Anorexia 13 1 8 <1 Constitutional Symptoms/Pain Fatigue 44 4 38 1 Abdominal Pain 18 1 17 2 Dermatology/Skin Skin Disorder 32 2 36 2 Injection Site Reaction Includes thrombosis related to the catheter. 11 3 10 3 Fever/Infection Fever 27 1 12 1 Infection 25 4 25 3 Allergy/Immunology Allergic Reaction 10 3 2 <1 Table 6:
• Adverse Reactions Reported in Patients with Colon Cancer Receiving Adjuvant Treatment (greater than or equal to 5% of all patients but with less than 1% grade 3-4) Adverse Reaction Event coded in WHO-ART dictionary. Oxaliplatin + FU/LV N=1108 FU/LV N=1111 All Grades (%) All Grades (%) Dermatology/Skin Alopecia No complete alopecia was reported. 30 28 Gastrointestinal Constipation 22 19 Taste Perversion 12 8 Dyspepsia 8 5 Constitutional Symptoms/Pain/Ocular/Visual Epistaxis 16 12 Weight Increase 10 10 Conjunctivitis 9 15 Headache 7 5 Dyspnea 5 3 Pain 5 5 Abnormal Lacrimation 4 12 Neurology Sensory Disturbance 8 1 Allergy/Immunology Rhinitis 6 8 In females, the following grade 3-4 adverse reactions were more frequent:
• diarrhea, fatigue, neutropenia, nausea, and vomiting. In patients greater than or equal to 65 years old, the incidence of grade 3-4 diarrhea and neutropenia was higher than in younger
• adults. Clinically relevant adverse reactions were reported in greater than or equal to 2% and less than 5% of the patients in the oxaliplatin arm (listed in decreasing order of frequency) were pain, leukopenia, weight loss, and cough. Table 7:
• Laboratory-Related Adverse Reactions Occurring in ≥5% of Patients with Colon Cancer Receiving Adjuvant Treatment Laboratory-Related Adverse Reaction Oxaliplatin with FU/LV N=1108 FU/LV N=1111 All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) Hematology Neutropenia 79 41 40 5 Thrombocytopenia 77 2 19 <1 Anemia 76 1 67 <1 Hepatic Increased Transaminases 57 2 34 1 Increased Alkaline Phosphatase 42 <1 20 <1 Hyperbilirubinemia 20 4 20 5 Previously Untreated Advanced Colorectal Cancer The safety of oxaliplatin in combination with fluorouracil (FU)/leucovorin (LV) was evaluated in a randomized trial of patients with previously untreated advanced colorectal cancer [see Clinical Studies ( 14.2 )] . The adverse reaction profile in this trial was similar to that seen in other trials. Tables 8 , 9 , and 10 summarize the adverse reactions reported in the previously untreated advanced colorectal cancer trial. Table 8:
• Adverse Reactions Reported in Patients in the Previously Untreated Advanced Colorectal Cancer Clinical Trial (greater than or equal to 5% of all patients and with greater than or equal to 1% grade 3-4) Adverse Reaction Event coded in WHO-ART dictionary Oxaliplatin + FU/LV N=259 Irinotecan + FU/LV N=256 Oxaliplatin + Irinotecan N=258 All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) Neurology Neuropathy 82 19 18 2 69 7 Paresthesias 77 18 16 2 62 6 Pharyngo-laryngeal Dysesthesias 38 2 1 0 28 1 Neuro-sensory 12 1 2 0 9 1 Neuro NOS Not otherwise specified 1 0 1 0 1 0 Gastrointestinal Nausea 71 6 67 15 83 19 Diarrhea 56 12 65 29 76 25 Vomiting 41 4 43 13 64 23 Stomatitis 38 0 25 1 19 1 Anorexia 35 2 25 4 27 5 Constipation 32 4 27 2 21 2 Diarrhea-colostomy 13 2 16 7 16 3 Gastrointestinal NOS 5 2 4 2 3 2 Constitutional Symptoms/Pain/Ocular/Visual Fatigue 70 7 58 11 66 16 Abdominal Pain 29 8 31 7 39 10 Myalgia 14 2 6 0 9 2 Pain 7 1 5 1 6 1 Abnormal Vision 5 0 2 1 6 1 Neuralgia 5 0 0 0 2 1 Pulmonary Cough 35 1 25 2 17 1 Dyspnea 18 7 14 3 11 2 Hiccups 5 1 2 0 3 2 Hepatic/Metabolic/Laboratory/Renal Hyperglycemia 14 2 11 3 12 3 Hypokalemia 11 3 7 4 6 2 Dehydration 9 5 16 11 14 7 Hypoalbuminemia 8 0 5 2 9 1 Hyponatremia 8 2 7 4 4 1 Urinary Frequency 5 1 2 1 3 1 Hematology/Infection Infection Normal ANC Absolute neutrophil count 10 4 5 1 7 2 Infection Low ANC 8 8 12 11 9 8 Lymphopenia 6 2 4 1 5 2 Febrile Neutropenia 4 4 15 14 12 11 Dermatology/Skin Hand/Foot Syndrome 7 1 2 1 1 0 Injection Site Reaction 6 0 1 0 4 1 Cardiovascular Thrombosis 6 5 6 6 3 3 Hypotension 5 3 6 3 4 3 Table 9:
• Adverse Reactions Reported in Patients in the Previously Untreated Advanced Colorectal Cancer Clinical Trial (greater than or equal to 5% of all patients but with less than 1% grade 3-4) Adverse Reaction Event coded in WHO-ART dictionary. Oxaliplatin + FU/LV N=259 Irinotecan + FU/LV N=256 Oxaliplatin + Irinotecan N=258 All Grades (%) All Grades (%) All Grades (%) Dermatology/Skin Alopecia No complete alopecia was reported. 38 44 67 Flushing 7 2 5 Pruritus 6 4 2 Dry Skin 6 2 5 Hematology/Infection Fever Normal ANC Absolute neutrophil count. 16 9 9 Cardiovascular Edema 15 13 10 Gastrointestinal Taste Perversion 14 6 8 Dyspepsia 12 7 5 Flatulence 9 6 5 Mouth Dryness 5 2 3 Constitutional Symptoms/Pain/Ocular/Visual Headache 13 6 9 Weight Loss 11 9 11 Epistaxis 10 2 2 Tearing 9 1 2 Rigors 8 2 7 Dysphasia 5 3 3 Sweating 5 6 12 Arthralgia 5 5 8 Neurology Insomnia 13 9 11 Depression 9 5 7 Dizziness 8 6 10 Anxiety 5 2 6 Allergy/Immunology Rash 11 4 7 Rhinitis Allergic 10 6 6 Hepatic/Metabolic/Laboratory/Renal Hypocalcemia 7 5 4 Elevated Creatinine 4 4 5 Clinically relevant adverse reactions that occurred in greater than or equal to 2% and less than 5% of the patients in the oxaliplatin and fluorouracil/leucovorin combination arm (listed in decreasing order of frequency) were:
• metabolic, pneumonitis, catheter infection, vertigo, prothrombin time, pulmonary, rectal bleeding, dysuria, nail changes, chest pain, rectal pain, syncope, hypertension, hypoxia, unknown infection, bone pain, pigmentation changes, and urticaria. Table 10:
• Laboratory-Related Adverse Reactions Occurring in ≥5% of Patients in the Previously Untreated Advanced Colorectal Cancer Trial Laboratory-Related Adverse Reaction Oxaliplatin and FU/LV N=259 Irinotecan and FU/LV N=256 Oxaliplatin and Irinotecan N=258 All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) Hematology Leukopenia 85 20 84 23 76 24 Neutropenia 81 53 77 44 71 36 Thrombocytopenia 71 5 26 2 44 4 Anemia 27 3 28 4 25 3 Hepatic Increased AST Aspartate transaminase 17 1 2 1 11 1 Increased Alkaline Phosphatase 16 0 8 0 14 2 Hyperbilirubinemia 6 1 3 1 3 2 Increased ALT Alanine transaminase 6 1 2 0 5 2 Previously Treated Advanced Colorectal Cancer The safety of oxaliplatin in combination with fluorouracil (FU)/leucovorin (LV) was evaluated in a randomized trial in patients with refractory and relapsed colorectal cancer [see Clinical Studies ( 14.3 )] . The adverse reaction profile in this trial was similar to that seen in other trials. Three patients who received oxaliplatin in the combination arm experienced fatal adverse reactions:
• gastrointestinal bleeding and dehydration. Grade 3 and 4 neutropenia were reported in 27% and 17% of patients, respectively, in the oxaliplatin with fluorouracil/leucovorin combination arm. Grade 3-4 increased serum creatinine occurred in 1% of patients in the oxaliplatin with combination fluorouracil/leucovorin arm. Thirteen percent of patients in the oxaliplatin with fluorouracil/leucovorin combination arm discontinued treatment; the most frequent reasons were gastrointestinal adverse reactions, hematologic adverse reactions and neuropathies. Tables 11 , 12 , and 13 summarize the adverse reactions reported in the previously treated advanced colorectal cancer trial. Table 11:
• Adverse Reactions Reported in Patients in the Previously Treated Advanced Colorectal Cancer Trial (greater than or equal to 5% of all patients and with greater than or equal to 1% grade 3-4) Adverse Reaction Event coded in WHO-ART dictionary. Oxaliplatin + FU/LV N=150 Oxaliplatin N=153 FU/LV N=142 All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) Neurology Neuropathy 74 7 76 7 17 0 Acute 56 2 65 5 10 0 Persistent 48 6 43 3 9 0 Constitutional Symptoms/Pain Fatigue 68 7 61 9 52 6 Back Pain 19 3 11 0 16 4 Pain 15 2 14 3 9 3 Gastrointestinal Diarrhea 67 11 46 4 44 3 Nausea 65 11 64 4 59 4 Vomiting 40 9 37 4 27 4 Stomatitis 37 3 14 0 32 3 Abdominal Pain 33 4 31 7 31 5 Anorexia 29 3 20 2 20 1 Gastroesophageal Reflux 5 2 1 0 3 0 Hematology/Infection Fever 29 1 25 1 23 1 Febrile Neutropenia 6 6 0 0 1 1 Cardiovascular Dyspnea 20 4 13 7 11 2 Coughing 19 1 11 0 9 0 Edema 15 1 10 1 13 1 Thromboembolism 9 8 2 1 4 2 Chest Pain 8 1 5 1 4 1 Dermatology/Skin Injection Site Reaction 10 3 9 0 5 1 Hepatic/Metabolic/Laboratory/Renal Hypokalemia 9 4 3 2 3 1 Dehydration 8 3 5 3 6 4 Table 12:
• Adverse Reactions Reported in Patients in the Previously Treated Advanced Colorectal Cancer Clinical Trial (greater than or equal to 5% of all patients but with less than 1% grade 3-4) Adverse Reaction Event coded in WHO-ART dictionary. Oxaliplatin + FU/LV N=150 Oxaliplatin N=153 FU/LV N=142 All Grades (%) All Grades (%) All Grades (%) Gastrointestinal Constipation 32 31 23 Dyspepsia 14 7 10 Taste Perversion 13 5 1 Mucositis 7 2 10 Flatulence 5 3 6 Constitutional Symptoms/Pain/Ocular/Visual Headache 17 13 8 Arthralgia 10 7 10 Epistaxis 9 2 1 Abnormal Lacrimation 7 1 6 Rigors 7 9 6 Allergy/Immunology Rhinitis 15 6 4 Allergic Reaction 10 3 1 Rash 9 5 5 Neurology Dizziness 13 7 8 Insomnia 9 11 4 Dermatology/Skin Hand-Foot Syndrome 11 1 13 Flushing 10 3 2 Alopecia No complete alopecia was reported. 7 3 3 Pulmonary Upper Respiratory Tract Infection 10 7 4 Pharyngitis 9 2 10 Cardiovascular Peripheral Edema 10 5 11 Hepatic/Metabolic/Laboratory/Renal Hematuria 6 0 4 Dysuria 6 1 1 Clinically relevant adverse reactions in greater than or equal to 2% and less than 5% of the patients in the oxaliplatin and fluorouracil/leucovorin combination arm (listed in decreasing order of frequency) were:
• anxiety, myalgia, erythematous rash, increased sweating, conjunctivitis, weight decrease, dry mouth, rectal hemorrhage, depression, ataxia, ascites, hemorrhoids, muscle weakness, nervousness, tachycardia, abnormal micturition frequency, dry skin, pruritus, hemoptysis, purpura, vaginal hemorrhage, melena, somnolence, pneumonia, proctitis, involuntary muscle contractions, intestinal obstruction, gingivitis, tenesmus, hot flashes, enlarged abdomen, and urinary incontinence. Table 13:
• Laboratory-Related Adverse Reactions Occurring in ≥5% of Patients with Previously Treated Advanced Colorectal Cancer Laboratory-Related Adverse Reaction Oxaliplatin and FU/LV N=150 Oxaliplatin N=153 FU/LV N=142 All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) Hematology Anemia 81 2 64 1 68 2 Leukopenia 76 19 13 0 34 1 Neutropenia 73 44 7 0 25 5 Thrombocytopenia 64 4 30 3 20 0 Hepatic Increased ALT Alanine transaminase 31 0 36 1 28 3 Increased AST Aspartate transaminase 47 0 54 4 39 2 Increased Bilirubin 13 1 13 5 22 6 Additional Adverse Reactions The following adverse reactions were observed across clinical trials. Intravenous Site Reactions Injection site reaction, including redness, swelling, and pain, can occur with oxaliplatin. In some cases, skin necrosis has occurred with extravasation. PRES PRES occurred in less than 0.1% of patients . Pulmonary Fibrosis and Interstitial Lung Disease Pulmonary fibrosis, which may be fatal, occurred in less than 1% of patients. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of oxaliplatin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• General: angioedema, anaphylactic shock
• Cardiovascular:
• QT prolongation leading to ventricular arrhythmias, including fatal torsade de pointes; bradyarrhythmia
• Neurological:
• loss of deep tendon reflexes, dysarthria, Lhermitte’s sign, cranial nerve palsies, fasciculations, convulsion
• Hearing and vestibular system: deafness
• Infections: septic shock, including fatal outcomes
• Infusion-related reactions and hypersensitivity reactions: laryngospasm
• Hepatic and gastrointestinal:
• severe diarrhea/vomiting resulting in hypokalemia, colitis (including Clostridium difficile diarrhea), metabolic acidosis, ileus, intestinal obstruction, pancreatitis, sinusoidal obstruction syndrome, perisinusoidal fibrosis which rarely may progress, focal nodular hyperplasia, esophagitis
• Musculoskeletal and connective tissue: rhabdomyolysis, including fatal outcomes
• Platelet, bleeding, and clotting disorders:
• immuno-allergic thrombocytopenia, prolonged prothrombin time and INR in patients receiving anticoagulants
• Blood disorders: secondary leukemia
• Red blood cell: hemolytic uremic syndrome, immuno-allergic hemolytic anemia
• Renal: acute tubular necrosis, acute interstitial nephritis, acute renal failure
• Respiratory:
• interstitial lung diseases (sometimes fatal) and pneumonia (including fatal outcomes)
• Vision:
• decrease of visual acuity, visual field disturbance, optic neuritis and transient vision loss (reversible following treatment discontinuation)
• Injury, poisoning, and procedural complications: fall-related injuries.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Hypersensitivity Reactions Advise patients of the potential risk of hypersensitivity and that oxaliplatin is contraindicated in patients with a history of hypersensitivity reactions to oxaliplatin and other platinum-based drugs.
• Instruct patients to seek immediate medical attention for signs of severe hypersensitivity reaction such as chest tightness; shortness of breath; wheezing; dizziness or faintness; or swelling of the face, eyelids, or lips [see Warnings and Precautions ( 5.1 )].
• Peripheral Sensory Neuropathy Advise patients of the risk of acute reversible or persistent-type neurosensory toxicity.
• Advise patients to
• avoid cold drinks, use of ice, and exposure of skin to cold temperature or cold objects [see Warnings and Precautions ( 5.2 )] .
• Myelosuppression Inform patients that oxaliplatin can cause low blood cell counts and the need for frequent monitoring of blood cell counts.
• Advise patients to contact their healthcare provider immediately for bleeding, fever, particularly if associated with persistent diarrhea, or symptoms of infection develop [see Warnings and Precautions ( 5.3 )] .
• Posterior Reversible Encephalopathy Syndrome Advise patients of the potential effects of vision abnormalities, in particular transient vision loss (reversible following therapy discontinuation), which may affect the patients' ability to drive and use machines [see Warnings and Precautions ( 5.4 )] .
• Pulmonary Toxicity Advise patients to report immediately to their healthcare provider any persistent or recurrent respiratory symptoms, such as non-productive cough and dyspnea [see Warnings and Precautions ( 5.5 )] .
• Hepatotoxicity Advise patients to report signs or symptoms of hepatic toxicity to their healthcare provider [see Warnings and Precautions ( 5.6 )].
• QT Interval Prolongation Advise patients that oxaliplatin can cause QTc interval prolongation and to inform their physician if they have any symptoms, such as syncope [see Warnings and Precautions ( 5.7 )] .
• Rhabdomyolysis Advise patients to contact their healthcare provider immediately for new or worsening signs or symptoms of muscle toxicity, dark urine, decreased urine output, or the inability to urinate [see Warnings and Precautions ( 5.8 )].
• Hemorrhage Advise patients that oxaliplatin may increase the risk of bleeding and to promptly inform their healthcare provider of any bleeding episodes [see Warnings and Precautions ( 5.9 )].
• Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus.
• Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.10 ), Use in Specific Populations ( 8.1 )] .
• Advise females of reproductive potential to use effective contraception during treatment with oxaliplatin and for 9 months after the final dose [see Use in Specific Populations ( 8.3 )] .
• Advise male patients with female partners of reproductive potential to use effective contraception during treatment with oxaliplatin and for 6 months after the final dose [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )] .
• Lactation Advise women not to breastfeed during treatment with oxaliplatin and for 3 months after the final dose [see Use in Specific Populations ( 8.2 )] .
• Infertility Advise females and males of reproductive potential that oxaliplatin may impair fertility [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )] .
• Gastrointestinal Advise patients to contact their healthcare provider for persistent vomiting, diarrhea, or signs of dehydration [see Adverse Reactions ( 6.1 )] .
• Drug Interactions Inform patients about the risk of drug interactions and the importance of providing a list of prescription and nonprescription drugs to their healthcare provider [see Drug Interactions ( 7 )] .
• Manufactured by FAREVA Unterach GmbH for Sandoz Inc., Princeton, NJ 08540

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Injection:
• 50 mg (5 mg/mL) or 100 mg (5 mg/mL) clear, colorless solution in a single-dose vial. Injection:
• 50 mg (5 mg/mL) or 100 mg (5 mg/mL) in a single-dose vial. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Oxaliplatin injection, USP is supplied in clear, glass, single-dose vials with grey rubber stoppers and aluminum flip-off seals containing 50 mg/10 mL or 100 mg/20 mL of oxaliplatin as a sterile, clear, colorless, preservative-free, aqueous solution at a concentration of 5 mg/mL.
• NDC 0781-3315-70:
• 50 mg single-dose vial with green flip-off seal individually packaged in a carton.
• NDC 0781-3317-80:
• 100 mg single-dose vial with dark blue flip-off seal individually packaged in a carton.
• Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• Do not freeze and protect from light (keep in original outer carton).
• Discard unused portion.
• Oxaliplatin injection is a cytotoxic drug.
• Follow applicable special handling and disposal procedures. 1 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.

Quoted from the official label, section “How Supplied”.

What is in it

• Oxaliplatin is a platinum-based drug with the molecular formula C 8 H 14 N 2 O 4 Pt and the chemical name of cis -[(1 R ,2 R )-1,2-cyclohexanediamine- N , N '] [oxalato(2-)- O , O '] platinum.
• Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane(DACH) and with an oxalate ligand as a leaving group.
• The molecular weight is 397.3.
• Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone.
• Oxaliplatin injection, USP for intravenous use is supplied in vials containing 50 mg or 100 mg of oxaliplatin as a sterile, clear, colorless, preservative-free, aqueous solution at a concentration of 5 mg/mL.
• Water for Injection, USP is present as an inactive ingredient. chemical-structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

23 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Oxaliplatin