Vincristine Side Effects

Please note - some side effects for Vincristine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Vincristine - for the Consumer

Vincristine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Vincristine:

Constipation; hair loss; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cough or sore throat; fever or chills; hearing changes or loss of hearing; mouth sores; muscle weakness; numbness or tingling of your fingers or toes; pain in the bones, muscles, or jaw; pain, redness, or swelling at the injection site; seizures; stomach pain; trouble urinating; unusual bruising or bleeding; vision changes or loss of vision.

Vincristine Side Effects - for the Professional

Vincristine

Prior to the use of this drug, patients and/or their parents/guardian should be advised of the possibility of untoward symptoms.

In general, adverse reactions are reversible and are related to dosage. The most common adverse reaction is hair loss; the most troublesome adverse reactions are neuromuscular in origin.

When single, weekly doses of the drug are employed, the adverse reactions of leukopenia, neuritic pain, and constipation occur but are usually of short duration (ie., less than 7 days). When the dosage is reduced, these reactions may lessen or disappear. The severity of such reactions seems to increase when the calculated amount of drug is given in divided doses. Other adverse reactions, such as hair loss, sensory loss, paresthesia, difficulty in walking, slapping gait, loss of deep–tendon reflexes, and muscle wasting, may persist for at least as long as therapy is continued. Generalized sensorimotor dysfunction may become progressively more severe with continued treatment. Although most such symptoms usually disappear by about the sixth week after discontinuance of treatment, some neuromuscular difficulties may persist for prolonged periods in some patients. Regrowth of hair may occur while maintenance therapy continues.

The following adverse reactions have been reported:

Hepatic veno-occlusive disease has been reported in patients receiving Vincristine, particularly in pediatric patients, as part of standard combination chemotherapy regimens. Some of the patients had fatal outcomes; some who survived had undergone liver transplantation.

Hypersensitivity – Rare cases of allergic–type reactions, such as anaphylaxis, rash and edema, that are temporally related to Vincristine therapy have been reported in patients receiving Vincristine as a part of multidrug chemotherapy regimens.

Gastrointestinal – Constipation, abdominal cramps, weight loss, nausea, vomiting, oral ulceration, diarrhea, paralytic ileus, intestinal necrosis and/or perforation, and anorexia have occurred. Constipation may take the form of upper–colon impaction, and, on physical examination, the rectum may be empty. Colicky abdominal pain coupled with an empty rectum may mislead the physician. A flat film of the abdomen is useful in demonstrating this condition. All cases have responded to high enemas and laxatives. A routine prophylactic regimen against constipation is recommended for all patients receiving Vincristine sulfate injection.

Paralytic ileus (which mimics the “surgical abdomen”) may occur, particularly in young pediatric patients. The ileus will reverse itself with temporary discontinuance of Vincristine sulfate injection and with symptomatic care.

Genitourinary – Polyuria, dysuria, and urinary retention due to bladder atony have occurred. Other drugs known to cause urinary retention (particularly in the elderly) should, if possible, be discontinued for the first few days following administration of Vincristine sulfate injection.

Cardiovascular – Hypertension and hypotension have occurred. Chemotherapy combinations that have included Vincristine sulfate, when given to patients previously treated with mediastinal radiation, have been associated with coronary artery disease and myocardial infarction. Causality has not been established.

Neurologic – Frequently, there is a sequence to the development of neuromuscular side effects. Initially, only sensory impairment and paresthesia may be encountered. With continued treatment, neuritic pain and, later, motor difficulties may occur. There have been no reports of any agent that can reverse the neuromuscular manifestations that may accompany therapy with Vincristine sulfate.

Loss of deep–tendon reflexes, foot drop, ataxia, and paralysis have been reported with continued administration. Cranial nerve manifestations, such as isolated paresis and/or paralysis of muscles controlled by cranial motor nerves including potentially life–threatening bilateral vocal cord paralysis, may occur in the absence of motor impairment elsewhere; extraocular and laryngeal muscles are those most commonly involved. Jaw pain, pharyngeal pain, parotid gland pain, bone pain, back pain, limb pain, and myalgias have been reported; pain in these areas may be severe. Convulsions, frequently with hypertension, have been reported in a few patients receiving Vincristine sulfate. Several instances of convulsions followed by coma have been reported in pediatric patients. Transient cortical blindness and optic atrophy with blindness have been reported. Treatment with vinca alkaloids has resulted in both vestibular and auditory damage to the eighth cranial nerve. Manifestations include partial or total deafness which may be temporary or permanent, and difficulties with balance including dizziness, nystagmus, and vertigo. Particular caution is warranted when Vincristine is used in combination with other agents known to be ototoxic such as the platinum–containing oncolytics.

Pulmonary – See Precautions.

Endocrine – Rare occurrences of a syndrome attributable to inappropriate antidiuretic hormone secretion have been observed in patients treated with Vincristine sulfate. This syndrome is characterized by high urinary sodium excretion in the presence of hyponatremia; renal or adrenal disease, hypotension, dehydration, azotemia, and clinical edema are absent. With fluid deprivation, improvement occurs in the hyponatremia and in the renal loss of sodium.

Hematologic – Vincristine sulfate injection does not appear to have any constant or significant effect on platelets or red blood cells. Serious bone–marrow depression is usually not a major dose–limiting event. However, anemia, leukopenia, and thrombocytopenia have been reported. Thrombocytopenia, if present when therapy with Vincristine sulfate injection is begun, may actually improve before the appearance of bone marrow remission.

Skin – Alopecia and rash have been reported.

Other – Fever and headache have occurred.

Side Effects by Body System

Other

Prior to the use of vincristine, patients should be advised of the possibility of untoward symptoms. Adverse reactions associated with the use of the drug appear to be dose related.

Nervous system

In one study, 61% of the 23 patients treated for lymphoma developed neuropathy, while only 14% of the 37 patients with other malignant diseases developed these symptoms.

A long term study done of the effects of vincristine on the peripheral nervous system of 40 patients, concluded that with a cumulative dose of 12 mg over 18 to 24 weeks, signs and symptoms of vincristine neuropathy are reversible for the majority of patients and the prognosis is good.

There has been a case report of a patient with a familial variant of Charcot-Marie-Tooth syndrome. After receiving two 2 mg dosages, his weakness secondary to peripheral neuropathy rapidly progressed to complete paraplegia.

Acute acoustic nerve palsy has been reported.

Nervous system side effects frequently develop in a sequence. Initially, sensory impairment and paresthesia are most likely to be encountered. Patients may report numbness, pin prick or a tingling sensation. As treatment continues, neuritic pain followed by motor difficulties have been reported. Loss of deep-tendon reflexes, foot drop, wrist drop, slapping gait, ataxia, and paralysis have been reported with continued administration. Cranial nerve manifestations, including isolated paresis and/or paralysis of muscles controlled by cranial nerves, may occur in the absence of motor impairment elsewhere; extraocular and laryngeal muscles are those most commonly involved. Jaw pain, pharyngeal pain, parotid gland pain, bone pain, back pain, limb pain, and myalgias have been reported. Pain in these areas may be severe. Convulsions, frequently with hypertension have occasionally been reported. A case of acute fulminant encephalopathy with severe mental confusion and a focal seizure has been reported. Coma has been reported. The dose-limiting clinical toxicity is neurotoxicity.

Dermatologic

Dermatologic side effects including alopecia (20% to 70%) and rash (infrequent) have been reported. Alopecia is the most common adverse reaction. It is usually reversible. Soft tissue damage has been reported when extravasation takes place.

Respiratory

Acute shortness of breath and severe bronchospasm occur most frequently when vincristine is used in combination with mitomycin. These adverse effects may require aggressive treatment, especially if there is preexisting pulmonary dysfunction. The onset of these reactions may occur minutes to hours after the administration of vincristine and up to 2 weeks following the dose of mitomycin.

Respiratory side effects including acute shortness of breath and severe bronchospasm have been reported following the administration of vinca alkaloids. Progressive dyspnea requiring chronic therapy has been reported.

Gastrointestinal

Constipation may take the form of upper colon impaction and on physical examination, the rectum may be empty. Colicky abdominal pain coupled with an empty rectum may mislead the physician. A flat film of the abdomen is useful in demonstrating this condition. All cases have responded to high enemas and laxatives. Paralytic ileus may reverse itself with temporary discontinuance of the drug and symptomatic care.

Gastrointestinal side effects including constipation, abdominal cramps, anorexia, weight loss, nausea, vomiting, oral ulceration, diarrhea, paralytic ileus, intestinal necrosis, megacolon and/or perforation have been reported.

Hematologic

Hematologic side effects including anemia, leukopenia, thrombocytopenia, and central-nervous-system leukemia have been reported. Myelosuppression is generally mild. The drug does not appear to have any constant or significant effect on platelets or red blood cells.

Cardiovascular

Cardiovascular side effects including both hypertension and hypotension have been reported. In patients who have received mediastinal radiation prior to vincristine as a part of combination chemotherapy, coronary artery disease and myocardial infarction have been reported.

Ocular

Ocular side effects including transient cortical blindness, diplopia, ptosis, photophobia and optic atrophy with blindness have been reported.

Endocrine

Endocrine side effects including pancreatitis and a syndrome attributable to inappropriate antidiuretic hormone have been reported rarely.

The syndrome is characterized by high urinary sodium excretion in the presence of hyponatremia. Renal or adrenal disease, hypotension, dehydration, azotemia, and clinical edema are absent. With fluid deprivation, improvement occurs in the hyponatremia and in the renal loss of sodium. Generally, treatment with vincristine can continue.

Genitourinary

One study of 55 males who received chemotherapy as children, and at the time of the study were over 18, found a 5 fold increase in azoospermia when compared to patients that did not receive vincristine. The study concluded that vincristine may have a previously unrecognized important role in causing possibly irreversible azoospermia when administered in childhood or adolescence.

Genitourinary side effects including polyuria, dysuria, and urinary retention due to bladder atony have been reported. Amenorrhea and azoospermia have been reported in patients receiving combination chemotherapy (which also included an alkylating agent, procarbazine, and prednisone). Clinicians should counsel patients regarding reproductive risks if appropriate.

Oncologic

Oncologic side effects including second malignancies have been reported following the administration of vincristine in combination with chemotherapeutic drugs which are known carcinogens.

Studies in rats and mice have failed to clearly demonstrate evidence of carcinogenesis.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis, rash and edema have been reported rarely in patients receiving vincristine as part of a multidrug chemotherapeutic regimen. Fatal anaphylaxis following the administration of intravenous vincristine has been reported.

Hepatic

Hepatic side effects including a case of fatal hepatitis has been reported following therapy with irradiation and vincristine. A case of moderate transient liver function abnormalities has been confirmed by rechallenge with vincristine.

Other

Other side effects including fever, headache, gynecomastia and visual hallucinations have been reported. Two cases have been reported where patients with recent surgical lesions received intravenous vincristine. In the first patient sloughing occurred at the incision site. In the second patient, the incisional margins became indurated, inflamed and necrotic.

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