VINCASAR PFS (vincristine sulfate)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Charcot-marie-tooth disease
Lactation

There are 5 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Anemia
Neuromuscular disease
Neutropenic disorder
Pregnancy
Thrombocytopenic disorder

There are 3 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Peripheral motor neuropathy
Peripheral neuropathy
Polyneuropathy

There are 25 severe adverse reactions.

More Frequent	Less Frequent
Autonomic neuropathy CNS toxicity	Hyponatremia Injection site sequelae Leukopenia SIADH syndrome Tumor lysis syndrome

Rare/Very Rare
Anaphylaxis Anemia Bronchospastic pulmonary disease Dyspnea Facial nerve disorder Fecal impaction Hepatic veno-occlusive disease Hypertension Hypotension Intestinal ischemic necrosis Intestinal perforation Muscle atrophy Paralysis Paralytic ileus Peripheral motor neuropathy Stomatitis Thrombocytopenic disorder Uric acid nephropathy

There are 23 less severe adverse reactions.

More Frequent	Less Frequent
Alopecia Constipation Neuralgia	Diarrhea Flatulence Hypoesthesia Nausea Paresthesia Peripheral sensory neuropathy Skin rash Vomiting Weight loss

Rare/Very Rare
Abdominal pain with cramps Ataxia Dysuria Edema Fever Headache disorder Hyporeflexia Pharyngitis Polyuria Unsteady gait Urinary retention

Vincristine can cause fetal toxicity when administered to pregnant women, but potential benefits from use of the drug may be acceptable in certain conditions despite the possible risks to the fetus. The drug can induce teratogenic and embryocidal effects in animals at doses that are not toxic to the pregnant animal. Dosages of conventional vincristine that caused resorption of 23-85% of fetuses in pregnant mice and hamsters produced fetal malformations that were present in surviving offspring.

In 5 monkeys receiving single doses of conventional vincristine between days 27-34 of gestation, 3 fetuses were normal at term, while 2 had grossly evident malformations. Administration of liposomal vincristine to pregnant rats during organogenesis caused teratogenicity (skeletal and visceral malformations), decreased fetal weight, increased embryofetal deaths (resorptions, postimplantation losses), and decreased maternal body weight. Fetal malformations were observed in pregnant rats receiving liposomal vincristine at exposure levels that were approximately 20-40% of the human exposure at the recommended dosage.

There are no adequate and controlled studies to date using conventional or liposomal vincristine in pregnant women, and the drugs should be used during pregnancy only in life-threatening situations or severe disease for which safer drugs cannot be used or are ineffective. Women of childbearing potential should be advised to avoid becoming pregnant while receiving conventional or liposomal vincristine. When conventional or liposomal vincristine is administered during pregnancy or the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus.

It is not known whether vincristine or its metabolites are distributed into milk. Because of the potential for serious adverse effects in nursing infants, a decision should be made whether to discontinue nursing or conventional or liposomal vincristine, taking into account the importance of the drug to the woman.

No enhanced Geriatric Use information available for this drug.