Vincasar PFS Side Effects

Generic name: vincristine

Note: This document contains side effect information about vincristine. Some of the dosage forms listed on this page may not apply to the brand name Vincasar PFS.

Some side effects of Vincasar PFS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to vincristine: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking vincristine (the active ingredient contained in Vincasar PFS) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• signs of infection such as fever, chills, sore throat, mouth pain, white patches or sores inside your mouth or on your lips;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• numbness, burning, pain, or tingly feeling;

• bronchospasm (wheezing, chest tightness, trouble breathing);

• stomach pain and tenderness, jaundice (yellowing of the skin or eyes);

• severe constipation;

• painful or difficult urination, urinating more or less than usual or not at all;

• spinning sensation, feeling like you might pass out;

• seizure (convulsions);

• problems with vision, hearing, speech, swallowing, balance, or daily activities;

• sudden numbness or weakness on one side of the body, sudden headache or confusion;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

• pain, burning, redness, swelling, or skin changes where the IV needle was placed.

Less serious side effects of vincristine may include:

• temporary hair loss;

• decreased weight with loss of muscle tissue;

• jaw pain;

• tumor pain, bone pain;

• missed menstrual periods;

• nausea, vomiting, diarrhea, loss of appetite; or

• feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to vincristine: compounding powder, intravenous solution

Other

Prior to the use of vincristine (the active ingredient contained in Vincasar PFS) 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 (the active ingredient contained in Vincasar PFS) 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 (the active ingredient contained in Vincasar PFS) 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 (the active ingredient contained in Vincasar PFS) 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 active ingredient contained in Vincasar PFS) 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 (the active ingredient contained in Vincasar PFS) 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 (the active ingredient contained in Vincasar PFS) 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 (the active ingredient contained in Vincasar PFS) 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 (the active ingredient contained in Vincasar PFS) 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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