Platinum-based Drug

Oxaliplatin

Approved 15 Jan 2026IntravenousInjectable

The FDA lists this product in 60 strengths and forms.

Indications

Oxaliplatin injection USP, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. treatment of advanced colorectal cancer. Oxaliplatin injection USP is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.

(1) treatment of advanced colorectal cancer. (1)

Contraindications

Oxaliplatin injection is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)] . History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs. (4, 5.1)

Warnings and precautions

Peripheral Sensory Neuropathy : Acute and delayed neuropathy can occur. Avoid topical application of ice. Reduce the dose or permanently discontinue oxaliplatin injection as recommended. (5.2) Severe Myelosuppression : Delay oxaliplatin injection until neutrophils are greater than or equal to 1.5 × 10 9 /L and platelets are greater than or equal to 75 × 10 9 /L. Withhold oxaliplatin injection for sepsis or septic shock.

Dose reduce after recovery from grade 4 neutropenia, febrile neutropenia, or grade 3-4 thrombocytopenia as recommended. (5.3) Posterior Reversible Encephalopathy Syndrome (PRES) : Permanently discontinue oxaliplatin injection in patients who develop PRES. (5.4) Pulmonary Toxicity : Withhold oxaliplatin injection until investigation excludes interstitial lung disease or pulmonary fibrosis. (5.5) Hepatotoxicity : Monitor liver function tests at baseline, before each subsequent cycle, and as clinically indicated.

(5.6) QT Interval Prolongation : Avoid in patients with congenital long QT syndrome. Monitor electrocardiograms in patients with congestive heart failure, bradyarrhythmias, and electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Correct electrolyte abnormalities prior to initiating oxaliplatin injection and periodically during treatment. (5.7) Rhabdomyolysis : Permanently discontinue oxaliplatin injection if rhabdomyolysis occurs.

Indications

(1) treatment of advanced colorectal cancer. (1)

Contraindications

Warnings and precautions

Adverse reactions

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 Emprise Pharma LLC. at (610) 933-1969 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 injection.

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 injection 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 injection 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 injection arm. Grade 3 or 4 adverse reactions occurred in 70% of patients in the oxaliplatin injection 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 injection 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 * Oxaliplatin Injection + 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† 11 3 10 3 Fever/Infection Fever 27 1 12 1 Infection 25 4 25 3 Allergy/Immunology Allergic Reaction 10 3 2 <1 * Event coded in WHO-ART dictionary † Includes thrombosis related to the catheter 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 * Oxaliplatin Injection + FU/LV N=1108 FU/LV N=1111 All Grades (%) All Grades (%) Dermatology/Skin Alopecia† 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 * Event coded in WHO-ART dictionary † No complete alopecia was reported 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 injection 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 Injection 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 injection 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 * Oxaliplatin Injection + FU/LV N=259 Irinotecan + FU/LV N=256 Oxaliplatin Injection + 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† 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‡ 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 * Event coded in WHO-ART dictionary † Not otherwise specified ‡ Absolute neutrophil count 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 * Oxaliplatin Injection + FU/LV N=259 Irinotecan + F

Our copy of this section ends here. The full text is in the official label at the FDA. Open Drugs@FDA

Oxaliplatin

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Oxaliplatin

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Hypersensitivity Reactions Serious

5.2Peripheral Sensory Neuropathy

5.4Posterior Reversible Encephalopathy Syndrome

Interactions

7.2Use with Nephrotoxic Products

7.3Use with Anticoagulants

Adverse reactions

6.1Clinical Trials Experience

Composition

Strengths and forms

Official product information

At a glance