Lyophilized Oxaliplatin Injection 50 & 100mg

Oxaliplatin should not be administered to patients with a history of known allergy to Oxaliplatin or other platinum compounds.

Cardiovascular

Thromboembolism (9%); thrombosis (6%); hypotension (5%); hypertension, syncope, tachycardia (2% to 5%).

CNS

Overall peripheral sensory neuropathy (92%); neuropathy (82%); paresthesias (77%); fatigue (70%); headache (17%); dizziness, insomnia (13%); neurosensory (12%); depression (9%); anxiety, dysphasia, neuralgia (5%); ataxia, hot flashes, nervousness, somnolence, vertigo (2% to less than 5%); convulsion, cranial nerve palsies, dysarthria, fasciculations, Lhermitte sign, loss of deep tendon reflexes.

Dermatologic

Alopecia (38%); skin disorder (32%); hand-foot syndrome, rash (11%); flushing (10%); dry skin, pruritus (6%); sweating (5%); pigmentation changes, purpura, urticaria (2% to less than 5%).

EENT

Pharyngolaryngeal dysesthesias (38%); epistaxis (16%); rhinitis (15%); conjunctivitis, pharyngitis, tearing (9%); abnormal lacrimation (7%); abnormal vision (5%); deafness, decreased visual acuity, optic neuritis, transient vision loss, visual field disturbances.

GI

Nausea (74%); diarrhea (67%); vomiting (47%); stomatitis (42%); anorexia (35%); abdominal pain (33%); constipation (32%); dyspepsia, taste perversion (14%); flatulence (9%); mucositis (7%); dysphagia, dry mouth, gastroesophageal reflux, hiccups (5%); ascites, enlarged abdomen, gingivitis, hemorrhoids, intestinal obstruction, melena, proctitis, rectal bleeding, rectal pain, tenesmus (2% to less than 5%); colitis, ileus, intestinal obstruction, pancreatitis, severe vomiting/diarrhea resulting in hypokalemia.

Genitourinary

Dysuria, hematuria (6%); urinary frequency (5%); abnormal micturition frequency, urinary incontinence, vaginal hemorrhage (2% to less than 5%); acute interstitial nephritis, acute renal failure, acute tubular necrosis.

Hematologic-Lymphatic

Leukopenia (85%); anemia, neutropenia (81%); thrombocytopenia (77%); febrile neutropenia, lymphopenia (6%); hemolytic uremic syndrome, immunoallergic hemolytic anemia, immunoallergic thrombocytopenia, prolongation of PT and INR in patients receiving anticoagulants.

Hepatic

Perisinusoidal fibrosis, veno-occlusive disease of the liver.

Hypersensitivity

Hypersensitivity (12%); allergic reactions (10%); anaphylactic shock, angioedema.

Lab Tests

Increased transaminases (57%); increased alkaline phosphatase (42%); bilirubinemia (20%); elevated creatine (5% to 10%).

Local

Injection-site reactions (11%); extravasation.

Metabolic-Nutritional

Increased alkaline phosphate (42%); edema (15%); hyperglycemia (14%); hypokalemia, weight loss (11%); peripheral edema, weight increase (10%); dehydration (9%); hypoalbuminemia, hyponatremia (8%); hypocalcemia (7%); metabolic acidosis.

Musculoskeletal

Back pain (19%); myalgia (14%); arthralgia (10%); rigors (8%); ataxia, bone pain, involuntary muscle contractions, muscle weakness (2% to less than 5%).

Respiratory

Cough (35%); dyspnea (20%); upper respiratory tract infection (10%); hemoptysis, hypoxia, pneumonia, pneumonitis (2% to less than 5%); interstitial lung disease, pulmonary fibrosis.

Miscellaneous

Fever (29%); infection (25%); pain (15%); chest pain, sensory disturbance (8%); catheter infections, nail changes (2% to less than 5%); secondary malignancy.