Paclib Adverse Reactions

5 mL & 16.67 mL: Hematologic Effects: Bone marrow suppression is the major and dose-limiting adverse effect. Dose-related myelosuppression is manifested mainly by leukopenia, thrombocytopenia and anemia. The frequency and severity of hematologic toxicity increase with dose, especially at paclitaxel doses exceeding 190 mg/m². Eosinophilia was reported in patients with AIDS-related Kaposi's sarcoma. Few reports of severe hemorrhage were also attributed to paclitaxel.
Dose- and schedule-dependent paclitaxel-induced neutropenia is generally rapidly reversible. The onset of neutropenia usually occurs 8 to 10 days and neutrophil nadirs generally occur at a median of 10 to 12 days after paclitaxel administration. Neutrophil counts commonly recover 15 to 21 days after administration.
Febrile neutropenia associated with infectious episode, including urinary tract infection (UTI) and upper respiratory tract infection (URTI) have been commonly reported.
Acute myeloid leukemia and myelodysplastic syndrome are very rare.
Infectious Complications: Fever was associated with 12% of all paclitaxel courses (as single agent) in patients with solid tumors. Most frequently reported were urinary and respiratory tract infections. Infectious complications, including sepsis, pneumonia and peritonitis were also reported. Infectious episodes were fatal in 1% of all patients.
Hypersensitivity Reactions: Flushing, rash, skin reactions, dyspnea, hypotension, tachycardia, hypertension, chest pains, angioedema, and generalized urticaria. Abdominal pain, pain in the extremities, diaphoresis, cutaneous reactions (e.g., acral erythema, generalized pustular dermatosis, and bullous fixed drug eruption) have also been reported. Chills, shock, and back pain associated with hypersensitivity to paclitaxel have been rarely reported (see Warnings and Precautions).
Cardiovascular Effects: Hypotension and bradycardia are the most common cardiovascular adverse effects of paclitaxel. These are generally asymptomatic and do not require treatment.
ECG abnormalities including nonspecific repolarization, sinus bradycardia, sinus tachycardia, and premature beats were seen in paclitaxel-treated patients.
Chest pain and hypertension are often associated with hypersensitivity reactions.
Severe cardiovascular effects include arrhythmia (e.g., asymptomatic ventricular tachycardia, bigeminy, atrial fibrillation, supraventricular tachycardia, junctional tachycardia), syncope, hypertension, venous thrombosis, and severe conduction abnormalities. Cerebrovascular infarction, vascular toxicity, including myocardial infarction have been reported rarely; AV block has also been reported.
Congestive heart failure and cardiomyopathy associated with acute renal failure have been reported; edema has also been reported.
Nervous System Effects: Peripheral neuropathy manifested as mild paresthesia with numbness and tingling in a stocking-glove distribution have been reported. Burning pain (often associated with hyperesthesia), particularly in the feet, and perioral numbness have also been reported.
Seizures (including tonoclonic seizures), syncope, ataxia, and neuroencephalopathy have occurred rarely during or immediately after administration of paclitaxel. Convulsions, dizziness, headache, and autonomic neuropathy resulting in paralytic ileus have also been reported rarely.
Musculoskeletal Effects: Arthralgia and/or myalgia consisting of pain in the large joints of the arms and legs have been reported. Gabapentin may be beneficial for the management of these conditions.
Gastrointestinal (GI) Effects: Nausea and vomiting, diarrhea, anorexia, taste perversion, mucositis characterized by diffuse ulceration of the lips, oral cavity and pharynx have been reported. Dysphagia and pain reflecting esophageal involvement may also occur. Rare reports of intestinal obstruction, intestinal perforation, pancreatitis, ischemic colitis, and dehydration have been reported. Neutropenic enterocolitis (typhlitis) has been observed despite co-administration of G-CSF.
Adverse GI effects of paclitaxel are generally mild to moderate in severity at current recommended doses.
Dermatologic Effects: Patients receiving paclitaxel may experience reversible alopecia, loss of all body hair including axillary, pubic and extremity hair, eyelashes, and eyebrows. Transient skin changes, nail changes (changes in pigmentation, discoloration of nail bed), radiation recall dermatitis resulting in extensive desquamation and necrosis, and maculopapular rash may occur. Pruritus was reported in patients receiving high-dose paclitaxel.
Hepatic Effects: Abnormalities in liver function test results have occurred; increased serum alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin concentrations have been reported in patients with normal baseline hepatic function. Cumulative hepatic toxicity has been associated with prolonged exposure to paclitaxel. Hepatic necrosis and hepatic encephalopathy resulting in death have occurred rarely. Fatal hepatic coma has also occurred.
A higher trend of elevated liver function test was observed in patients with Kaposi's Sarcoma compared to patients with solid tumors.
Renal Effects: Renal toxicity including acute renal failure and reversible increases in serum creatinine levels have been reported. Patients with Kaposi's Sarcoma and patients treated with paclitaxel and cisplatin have a higher risk of developing renal toxicity or renal failure.
Injection Site Reaction: See Precautions.
Respiratory Effects: Rare reports of interstitial pneumonia, lung fibrosis, pulmonary embolism, pleural effusion, and respiratory failure. Paclitaxel together with radiation therapy may cause radiation pneumonitis and interstitial pneumonia. Transient pulmonary infiltrates has also been reported.
Ocular Effects: High dose paclitaxel may result in loss of visual acuity. Abnormalities observed in visual evoked potentials in some patients suggest persistent damage of the optic nerve. Other visual problems encountered include scintillating scotomata and photopsia which appear to be reversible.
Otic Effects: Ototoxicity (e.g., hearing loss, tinnitus and vertigo) has been reported in patients receiving paclitaxel but very rarely.
Accidental Exposure: Inhalation: Dyspnea, chest pain, burning eyes, sore throat and nausea.
Topical: Tingling, burning and redness.
Others: Asthenia and malaise.
43.4 mL: Peripheral neuropathy (tingling and numbness in hands and feet due to irritation of nerves), neutropenia (low white blood cell count, greater risk of infection), bone and muscle aches, hair loss, fatigue, nausea, vomiting, mild diarrhea, mucositis (irritated mucous membrane in the mouth), amenorrhea (monthly menstrual cycle stops), changes in nails (brittle or yellowed).