oxaliplatin injection Adverse Reactions | Pfizer Medical Information

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6 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)]

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 1,100 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*	Oxaliplatin + FU/LV N=1108		FU/LV N=1111
Adverse Reaction*	All Grades (%)	Grade 3–4 (%)	All Grades (%)	Grade 3–4 (%)
* Event coded in WHO-ART dictionary † Includes thrombosis related to the catheter
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

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 + FU/LV N=1108	FU/LV N=1111
Adverse Reaction*	All Grades (%)	All Grades (%)
* Event coded in WHO-ART dictionary † No complete alopecia was reported.
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

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
Laboratory-Related Adverse Reaction	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*	Oxaliplatin + FU/LV N=259		Irinotecan + FU/LV N=256		Oxaliplatin + Irinotecan N=258
Adverse Reaction*	All Grades (%)	Grades 3–4 (%)	All Grades (%)	Grades 3–4 (%)	All Grades (%)	Grades 3–4 (%)
* Event coded in WHO-ART dictionary † Not otherwise specified ‡ Absolute neutrophil count
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

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 + 5-FU/LV N=259	Irinotecan + 5-FU/LV N=256	Oxaliplatin + Irinotecan N=258
Adverse Reaction*	All Grades (%)	All Grades (%)	All Grades (%)
* Event coded in WHO-ART dictionary † No complete alopecia was reported. ‡ Absolute neutrophil count
Dermatology/Skin
Alopecia†	38	44	67
Flushing	7	2	5
Pruritus	6	4	2
Dry Skin	6	2	5
Hematology/Infection
Fever Normal ANC‡	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
Laboratory-Related Adverse Reaction	All Grades (%)	Grades 3–4 (%)	All Grades (%)	Grades 3–4 (%)	All Grades (%)	Grades 3–4 (%)
* Aspartate transaminase † Alanine transaminase
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*	17	1	2	1	11	1
Increased Alkaline Phosphatase	16	0	8	0	14	2
Hyperbilirubinemia	6	1	3	1	3	2
Increased ALT†	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*	Oxaliplatin + FU/LV N=150		Oxaliplatin N=153		FU/LV N=142
Adverse Reaction*	All Grades (%)	Grades 3–4 (%)	All Grades (%)	Grades 3–4 (%)	All Grades (%)	Grades 3–4 (%)
* Event coded in WHO-ART dictionary
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*	Oxaliplatin + FU/LV N=150	Oxaliplatin N=153	5-FU/LV N=142
Adverse Reaction*	All Grades (%)	All Grades (%)	All Grades (%)
* Event coded in WHO-ART dictionary † No complete alopecia was reported.
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†	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
Laboratory-Related Adverse Reaction	All Grades (%)	Grades 3–4 (%)	All Grades (%)	Grades 3–4 (%)	All Grades (%)	Grades 3–4 (%)
* Alanine transaminase † Aspartate transaminase
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*	31	0	36	1	28	3
Increased AST†	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, 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

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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