oxaliplatin injection 6 ADVERSE REACTIONS

Prescribing Information

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=1,108		FU/LV N=1,111
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=1,108	FU/LV N=1,111
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=1,108		FU/LV N=1,111
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 + FU/LV N=259	Irinotecan + 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	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, 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

Medication Guide

MEDICATION GUIDE

Patient Information Oxaliplatin (ox-Al-ah-platin) injection for intravenous use
What is the most important information I should know about Oxaliplatin? Oxaliplatin can cause serious allergic reactions, including allergic reactions that can lead to death. Oxaliplatin is a platinum-based medicine. Serious allergic reactions including death can happen in people who take Oxaliplatin and who have had previous allergic reactions to platinum-based medicines. Serious allergic reactions can happen within a few minutes of your Oxaliplatin infusion or any time during your treatment with Oxaliplatin. Get emergency help right away if you: • have trouble breathing • feel like your throat is closing up • chest tightness Call your doctor right away if you have any of the following signs or symptoms of an allergic reaction:
• rash • flushed face • hives • itching • swelling of your lips or tongue, face or eyelids		• wheezing • sudden cough • dizziness or feel faint • sweating • chest pain
See "What are the possible side effects of Oxaliplatin?" for information about other serious side effects.
What is Oxaliplatin? Oxaliplatin 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) It is not known if Oxaliplatin is safe and effective in children.
Do not receive Oxaliplatin if you are allergic to Oxaliplatin or any of the ingredients in Oxaliplatin or if you are allergic to other platinum-based medicines. See the end of this leaflet for a complete list of the ingredients in Oxaliplatin Injection, USP. Ask your doctor if you are not sure if you have taken a platinum-based medicine.
Before receiving Oxaliplatin, tell your doctor about all of your medical conditions, including if you: • have an infection • have lung, liver, or kidney problems • have bleeding problems • have or had heart problems such as an abnormal heart test called an electrocardiogram (ECG or EKG), a condition called long QT syndrome, an irregular or slow heartbeat, or a family history of heart problems • have had changes in the level of certain blood salt (electrolytes) levels, including potassium, magnesium, and calcium • are pregnant or plan to become pregnant. Oxaliplatin can harm your unborn baby. Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with Oxaliplatin. Females who are able to become pregnant: o Your doctor will do a pregnancy test before you start treatment with Oxaliplatin. o You should use effective birth control (contraception) during treatment with Oxaliplatin and for 9 months after the final dose. Talk to your doctor about forms of birth control that may be right for you. Males with female partners who are able to become pregnant should use effective birth control during treatment with Oxaliplatin and for 6 months after the final dose. • are breastfeeding or plan to breastfeed. It is not known if Oxaliplatin passes into your breast milk. Do not breastfeed during treatment with Oxaliplatin and for 3 months after the final dose. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How will I receive Oxaliplatin? • Oxaliplatin is given to you into your vein through an intravenous (IV) tube. • Your doctor will prescribe Oxaliplatin in a dose that is right for you. • Your doctor may change how often you receive Oxaliplatin, your dose, or how long your infusion will take. • You and your doctor will decide how many Oxaliplatin treatments you will receive. • It is very important that you do exactly what your doctor and nurse tell you to do. • Some medicines may be given to you before Oxaliplatin to help prevent nausea and vomiting. • Each treatment course is given to you over 2 days. You will receive Oxaliplatin on the first day only. • There are usually 14 days (2 weeks) between each chemotherapy treatment course. • It is important for you to keep all of your medical appointments. Call your doctor if you miss an appointment. There may be special instructions for you. Treatment Day 1: • Oxaliplatin 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 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. Treatment Day 2: You will not get Oxaliplatin on Day 2. Leucovorin and fluorouracil will be given the same way as on Day 1. The fluorouracil will be given through your IV with a pump. If you have any problems with the pump or the tube, call your doctor, your nurse, or the person who is responsible for your pump. Do not let anyone other than a healthcare provider touch your infusion pump or tubing.
What should I avoid while receiving Oxaliplatin? • Avoid cold temperatures and cold objects. Cover your skin if you go outdoors in cold temperatures. • Do not drink cold drinks or use ice cubes in drinks. • Do not put ice or ice packs on your body. • Oxaliplatin can cause dizziness, vision problems, or vision loss that can affect your ability to drive or use machines. You should not drive or operate machinery if you develop these symptoms while receiving Oxaliplatin. See "How can I reduce the side effects caused by cold temperatures?" for more information. Talk with your doctor and nurse about your level of activity during treatment with Oxaliplatin. Follow their instructions.
What are the possible side effects of Oxaliplatin? Oxaliplatin can cause serious side effects, including: • See "What is the most important information I should know about Oxaliplatin?" • Nerve problems. Oxaliplatin can affect how your nerves work and make you feel. Nerve problems may happen with the first treatment or within two days after your treatment with Oxaliplatin. Nerve problems may last a short time (acute) or may become persistent. Symptoms may improve after stopping treatment with Oxaliplatin. Exposure to cold or cold objects may cause or worsen nerve problems. Tell your doctor right away if you get any signs of nerve problems, including: o very sensitive to cold temperatures and cold objects o trouble breathing, swallowing, or saying words, jaw tightness, odd feelings in your tongue, or chest pressure o pain, tingling, burning (pins and needles, numb feeling) in your hands, feet, or around your mouth or throat, which may cause problems walking, fall and fall-related injuries, or problems performing activities of daily living For information on ways to lessen or help with nerve problems, see the section "How can I reduce the side effects caused by cold temperatures?" below. • Severe low blood cell counts (myelosuppression). Oxaliplatin when used with fluorouracil and leucovorin can cause low blood cell counts. Low blood cell counts are common with Oxaliplatin when used with fluorouracil and leucovorin and can lead to serious infection and death. Your doctor will do blood tests to check your blood cell counts before starting Oxaliplatin and during treatment. Tell your doctor right away if you have a fever greater than 100.9°F (38.3°C) or a prolonged fever greater than 100.4°F (38°C) for more than one hour (febrile neutropenia). Call your doctor right away if you get any of the following signs of infection:
	o chills or shivering o pain on swallowing o sore throat o cough that brings up mucus		o burning or pain on urination o redness or swelling at intravenous site o persistent diarrhea
• Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain. Tell your doctor right away if you have any of the following signs and symptoms of PRES: o headache o confusion or a change in the way you think o seizures o vision problems, such as blurriness or vision loss
• Lung Problems. Oxaliplatin can cause lung problems that may lead to death. Tell your doctor right away if you get any of the following symptoms as these may be indicators of a serious lung disease:
	o shortness of breath o wheezing o cough
• Liver problems (hepatotoxicity). Your doctor will do blood tests to check your liver when you start receiving Oxaliplatin, and before each treatment course as needed. • Heart problems. Oxaliplatin can cause heart problems that have led to death. Your doctor may do blood and heart tests during treatment with Oxaliplatin if you have certain heart problems. If you faint (lose consciousness), or have an irregular heartbeat or chest pain during treatment with Oxaliplatin, get medical help right away as this may be a sign of a serious heart condition. • Muscle problems. Oxaliplatin can cause muscle damage (rhabdomyolysis) which can lead to death. Tell your doctor right away if you have muscle pain and swelling, along with weakness, fever, red-brown urine, decreased amount of urine or trouble urinating. • Bleeding problems (hemorrhage). Oxaliplatin when used with fluorouracil and leucovorin can cause bleeding problems (hemorrhage) that can lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
	o blood in your stools or black stools (looks like tar) o pink or brown urine o unexpected bleeding, or bleeding that is severe or you cannot control o vomit blood or vomit that looks like coffee grounds o cough up blood or blood clots o increased bruising o dizziness o weakness o confusion o changes in speech o headache that lasts a long time
The most common side effects of Oxaliplatin include:
• numbness, pain, tingling, and/or burning along the nerves • low white blood cells (blood cells important for fighting infection) • 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 may cause fertility problems in males and females. Talk to your doctor if this is a concern for you. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Oxaliplatin. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How can I reduce the side effects caused by cold temperatures? • Cover yourself with a blanket while you are getting your Oxaliplatin infusion. • Do not breathe deeply when exposed to cold air. • Wear warm clothing in cold weather at all times. Cover your mouth and nose with a scarf or a pull-down cap (ski cap) to warm the air that goes to your lungs. • Wear gloves when taking things from the freezer or refrigerator. • Drink fluids warm or at room temperature. • Always drink through a straw. • Do not use ice chips if you have nausea or mouth sores. Ask your doctor about what you can use. • Be aware that most metals are cold to touch, especially in the winter. These include your car door and mailbox. Wear gloves to touch cold objects. • Do not run the air conditioning at high levels in the house or in the car in hot weather. • If your body gets cold, warm-up the affected part. If your hands get cold, wash them with warm water. • Always let your doctor know before your next treatment how well you did since your last visit. Your doctor may have other useful tips for helping you with side effects.
General information about the safe and effective use of Oxaliplatin Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. You can ask your doctor or pharmacist for information about Oxaliplatin Injection, USP that is written for health professionals.
What are the ingredients in Oxaliplatin? Active ingredient: oxaliplatin Concentrate for solution for infusion inactive ingredients: water for injection, tartaric acid, sodium hydroxide Paraplatin® and Platinol® are registered trademarks of Bristol-Myers Squibb Company. Oxaliplatin Injection, USP (concentrate solution for infusion)

This Patient Information has been approved by the U.S. Food and Drug Administration.

Distributed by Hospira, Inc., Lake Forest, IL 60045

LAB-1359-4.0

Revised: 9/2024

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