Drugs Details

Drugs Info of Oncovin, Vincasar PFS
Drugs Details
  • Drugs Type  : Multum
  • Date : 3rd Jul 2015 04:16 am
  • Brand Name : Oncovin, Vincasar PFS
  • Generic Name : vincristine (Pronunciation: vin KRIS teen)
Descriptions

VINCASAR PFS® (vincristine sulfate injection, USP) is the salt of an alkaloidobtained from a common flowering herb, the periwinkle plant (Vinca rosea Linn.). Originally known as leurocristine, it has also been referred to as LCR and VCR.

Vincristine sulfate is a white to slightly yellow, amorphous powder. It is soluble in methanol, freely soluble in water, but only slightly soluble in 95% ethanol. In 98% ethanol, vincristine sulfate has an ultraviolet spectrum with maxima at 221 nm (e+ 47,100).

VINCASAR PFS (vincristine sulfate injection) ®, a sterile, preservative-free, single use only solution, is available in 1 mg (1 mg/1 mL) and 2 mg (2 mg/2 mL) vials. Each mL contains vincristine sulfate, 1 mg (1.08 mmoL); mannitol, 100 mg; water for injection, q.s. Acetic acid and sodium acetate have been added for pH control. The pH of VINCASAR PFS (vincristine sulfate injection) ranges from 3.5 to 5.5. This product is a sterile solution for cancer/oncolytic use.

 

What are the possible side effects of vincristine (Oncovin, Vincasar PFS)?

Get emergency medical help if you have any of these signs of an allergic reaction: 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...

Read All Potential Side Effects and See Pictures of Vincasar PFS »

What are the precautions when taking vincristine sulfate injection (Vincasar PFS)?

Before using vincristine, tell your doctor or pharmacist if you are allergic to it or to vincristine liposomal; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: nerve/muscle problems (such as numbness/tingling/pain due to neuropathy, demyelinating conditions including Charcot-Marie-Tooth syndrome), liver disease, radiation treatment to the liver, decreased bone marrow function, blood disorders, current infection.

This medication can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to...

Read All Potential Precautions of Vincasar PFS »

Indications

VINCASAR PFS (vincristine sulfate injection) Injection is indicated in acute leukemia.

VINCASAR PFS (vincristine sulfate injection) Injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin†s disease,3non-Hodgkin†s malignant lymphomas 4-6 (lym-phocytic, mixed-cell, histiocytic, undifferentiated, nodular, and diffuse types), rhab-domyosarcoma,7 neuroblastoma,8 and Wilms† tumor.9

Dosage Administration

This preparation is for intravenous use only (see WARNINGS).

Neurotoxicity appears to be dose related. Extreme care must be used in calculating and administering the dose of VINCASAR PFS (vincristine sulfate injection) Injection since overdosage may have a very serious or fatal outcome.

Special Dispensing Information: WHEN DISPENSING VINCRISTINE IN OTHER THAN THE ORIGINAL CONTAINER, IT IS IMPERATIVE THAT IT BE PACKAGED IN THE PROVIDED OVERWRAP WHICH BEARS THE FOLLOWING STATEMENT: "DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION. FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY." (see WARNINGS). A syringe containing a specific dose must be labeled, using the auxiliary sticker provided, to state: "FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY." The concentration of vincristine sulfate contained in all vials is 1 mg/mL. Do not add extra fluid to the vial prior to removal of the dose. Withdraw the solution of VINCASAR PFS (vincristine sulfate injection) into an accurate dry syringe, measuring the dose carefully. Do not add extra fluid to the vial in an attempt to empty it completely.

Caution: It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of VINCASAR PFS (vincristine sulfate injection) may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately and any remaining portion of the dose should then be introduced into anothervein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage will help disperse the drug and may minimize discomfort and the possibility of cellulitis.

VINCASAR PFS (vincristine sulfate injection) must be administered via an intact, free-flowing intravenous needle or catheter. Care should be taken that there is no leakage or swelling occurring during administration (see boxedWARNINGS).

The solution may be injected either directly into a vein or into the tubing of a running intravenous infusion (see Drug Interactions below). Injection of VINCASAR PFS (vincristine sulfate injection) should be accomplished within 1 minute.

The drug is administered intravenously at weekly intervals.

The usual dose of VINCASAR PFS (vincristine sulfate injection) for children is 2 mg/m2. For children weighing 10 kg or less, the starting dose should be 0.05 mg/kg, administered once a week. The usual dose of VINCASAR PFS (vincristine sulfate injection) for adults is 1.4 mg/m2. A 50% reduction in the dose of VINCASAR PFS (vincristine sulfate injection) is recommended for patients having a direct serum bilirubin value above 3mg/dL.19

VINCASAR PFS (vincristine sulfate injection) should not be given to patients while they are receiving radiation therapy through ports that include the liver. When VINCASAR PFS (vincristine sulfate injection) is used in combination with L-asparaginase, VINCASAR PFS (vincristine sulfate injection) should be given 12 to 24 hours before administration of the enzyme in order to minimizetoxicity; administering L-asparaginase before VINCASAR PFS (vincristine sulfate injection) may reduce hepatic clearance of VINCASAR PFS (vincristine sulfate injection) .

Drug Interactions VINCASAR PFS (vincristine sulfate injection) should not be diluted in solutions that raise or lower the pH outside the range of 3.5 to 5.5. It should not be mixed with anything other than 0.9% Sodium ChlorideInjection or Dextrose Injection.

Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Handling and Disposal Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.20-26 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

How Supplied

VINCASAR PFS® Injection (vincristine sulfate injection, USP)

NDC 0013-7456-86 1 mg, 1 mg/1 mL (single dose), flip-top vial (mist graycap) NDC 0013-7466-86 2 mg, 2 mg/2 mL (single dose), flip-top vial (blue cap)

This product should be refrigerated between 2° to 8°C (36° to 46°F). Discard unused solution.

REFERENCES

1. Watanabe K, West WL: Calmodulin, activated cyclic nucleotidephosphodiesterase, microtubules, and vinca alkaloids, Fed Proc1982;41:2292.

2. Nelson RL: The comparative clinical pharmacology and pharmacokinetics of vinde-sine, vincristine, and vinblastine in human patients with cancer. Med Pediatr Oncol 1982; 10:115.

3. DeVita VT Jr, Serpick AA, Carbone PP: Combination chemotherapy in the treatment of advanced Hodgkin†s disease. Ann Intern Med 1970;73:881.

4. Bagley CM Jr, DeVita VT Jr, Berard CW, et al: Advanced lymphosarcoma: Intensive cyclical chemotherapy with cyclophosphamide, vincristine, and prednisone. Ann Intern Med 1972;76:227.

5. Lowenbraun S, DeVita VT, Serpick AA: Combination chemotherapy withnitrogen mustard, vincristine, procarbazine, and prednisone in lymphosarcoma and reticulum cell sarcoma. Cancer 1970;25:1018.

6. Luce JK, Gamble JF, Wilson HE, et al: Combined cyclophosphamide, vincristine, and prednisone therapy of malignant lymphoma. Cancer 1971;28:306.

7. Wilbur JR, Sutow WW, Sullivan MP, et al: Successful treatment of rhabdomyosar-coma with combination chemotherapy and radiotherapy. Am Soc Clin Oncology April 7, 1971.

8. Sullivan MP, Nora AH, Kulapongs P, et al: Evaluation of vincristine sulfate and cyclo-phosphamide chemotherapy for metastatic neuroblastoma.Pediatrics 1969;44:685.

9. Vietti TJ, Sullivan MP, Haggard ME, et al; Vincristine sulfate and radiationtherapy in metastatic Wilms† tumor. Cancer 1970;25:12.

10. International Agency for Research on Cancer. Monograph on the evaluation of the carcinogenic risk of chemicals to humans, suppl 4, October 1982.

11. Grossman SA, Sheidler VR, Gilbert MR: Decreased phenytoin levels in patients receiving chemotherapy. Am J Med 1989;87:505.

12. Roeser HP, Stocks AE, Smith AJ: Testicular damage due to cytotoxicdrugs and recovery after cessation of therapy. Aust NZ J Med 1978;8:250.

13. Chapman R, Sutcliffe SB, Malpas JS: Male gonadal dysfunction in Hodgkin†s disease.

JAMA 1981;245:1323.

14. Sherins RJ, DeVita VT: Effect of drug treatment for lymphoma on male reproductive capacity. Ann Intern Med 1981;79:216.

15. DeVita VT: The consequences of the chemotherapy of Hodgkin†s disease. Cancer 1981;47:1.

16. Horning SJ, Hoppe RT, Kaplan HS, et al: Female reproductive potential after treatment for Hodgkin†s disease. N Engl J Med 1981;304:1377.

17. Blatt J, Poplack DG, Sherins RJ: Testicular function in boys after chemotherapy for acute lymphoblastic leukemia. N Engl J Med 1981;304:1121.

18. Siris ES, Leventhal BG, Vaitukaitis JL: Effects of childhood leukemia and chemotherapy on puberty and reproductive function in girls. N Engl J Med 1976;294:1143.

19. DeVita VT Jr, Hellman S, Rosenberg SA (eds): Cancer, Principles and Practice of Oncology, ed 2. Philadelphia. J.B. Lippincott Co., 1985.

20. Recommendations for the Safe Handling of Parenteral AntineoplasticDrugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.

21. AMA Council Report, Guidelines for Handling Parenteral Antineoplastics, JAMA. 1985; 253 (11): 1590-1592.

22. National Study Commission on Cytotoxic Exposure-Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D.,Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College ofPharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.

23. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983; 1:426-428.

24. Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA-A Cancer Journal for Clinicians. 1983; (Sept/Oct) 258-263.

25. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990; 47:1033-1049.

26. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am J Hosp Pharm. 1986; 43:1193-1204.

Manufactured for: Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation Kalamazoo, MI 49001, USA, Manufactured by: SP Pharmaceuticals, Albuquerque, NM 87109, USA, Revised August 2001. A-817 742 101

Side Effects

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 (i.e., 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 sen-sorimotor 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:

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 chemotherapyregimens.

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 thiscondition. All cases have responded to high enemas and laxatives. A routineprophylactic regimen against constipation is recommended for all patients receiving VINCASAR PFS (vincristine sulfate injection) Injection.

Paralytic ileus (which mimics the "surgical abdomen") may occur, particularly in young children. The ileus will reverse itself with temporary discontinuance of VINCASAR PFS (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 VINCASAR PFS (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 withcoronary artery disease and myocardial infarction. Causality have 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, including isolated paresis and/or paralysis of muscles controlled by cranial motor nerves, may occur in the absence of motor impairment elsewhere; extraocular and laryngeal muscles are those most commonly involved. Jawpain, 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 children. Transient cortical blindnessand optic atrophy with blindness have been reported.

Pulmonary See PRECAUTIONS.

Endocrine Rare occurrences of a syndrome attributable to inappropriateantidiuretic hormone secretion have been observed in patients treated with vincristine sulfate. This syndrome is characterized by high urinary sodiumexcretion in the presence of hypona-tremia; 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 VINCASAR PFS (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 VINCASAR PFS (vincristine sulfate injection) is begun, may actually improve before the appearance ofmarrow remission.

Skin Alopecia and rash have been reported. Other Fever and headache have occurred.

Interactions

VINCASAR PFS (vincristine sulfate injection) should not be diluted in solutions that raise or lower the pH outside the range of 3.5 to 5.5. It should not be mixed with anything other than 0.9% Sodium Chloride Injection orDextrose Injection.

Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Warnings

This preparation is for intravenous use only. VINCASAR PFS (vincristine sulfate injection) Injection should be administered by individuals experienced in the administration of vincristine sulfate.

Syringes containing this product should be labeled, using the auxiliary sticker provided, to state "FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY."

The treatment of patients following intrathecal administration of VINCASAR PFS (vincristine sulfate injection) has included immediate removal of spinal fluid and flushing with Lactated Ringer†s, as well as other solutions and has not prevented ascending paralysis and death. In one case, progressiveparalysis in an adult was arrested by the following treatment initiated immediately after the intrathecal injection:

1. As much spinal fluid was removed as could be safely done through lumbaraccess.

2. The subarachnoid space was flushed with Lactated Ringer†s solution infused continuously through a catheter in a cerebral lateral ventricle at the rate of 150 mL/h. The fluid was removed through a lumbar access.

3. As soon as fresh frozen plasma became available, the fresh frozen plasma, 25 mL, diluted in 1 L of Lactated Ringer†s injection was infused through the cerebral ventricular catheter at the rate of 75 mL/h with removal through the lumbar access. The rate of infusion was adjusted to maintain aprotein level in the spinal fluid of 150 mg/dL.

4. Glutamic acid, 10 g, was given intravenously over 24 hours followed by 500 mg 3 times daily by mouth for 1 month or until neurological dysfunctionstabilized. The role of glutamic acid in this treatment is not certain and may not be essential.

Pregnancy Category D Vincristine sulfate can cause fetal harm when administered to a pregnant woman. When pregnant mice and hamsters were given doses of vin-cristine sulfate that caused the resorption of 23% to 85% of fetuses, fetal malformations were produced in those that survived. Five monkeys were given single doses of vincristine sulfate between days 27 and 34 of their pregnancies; 3 of the fetuses were normal at term, and 2 viablefetuses had grossly evident malformations at term.10 In several animal species, vincristine sulfate can induce teratogenesis as well as embryo death at doses that are nontoxic to the pregnant animal. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

Precautions

General Acute uric acid nephropathy, which may occur after the administration of oncolytic agents, has also been reported with vincristine sulfate. In the presence of leukopenia or a complicating infection, administration of the next dose of VINCASAR PFS (vincristine sulfate injection) Injection warrants careful consideration. If central-nervous-systemleukemia is diagnosed, additional agents may be required because vincristine sulfate does not appear to cross the blood-brain barrier in adequate amounts.

Particular attention should be given to dosage and neurologic side effects if VINCASAR PFS (vincristine sulfate injection) is administered to patients with preexisting neuromuscular disease and when other drugs with neurotoxicpotential are also being used.

Acute shortness of breath and severe bronchospasm have been reported following the administration of vinca alkaloids. These reactions have been encountered most frequently when the vinca alkaloid was used in combination with mitomycin-C and may require aggressive treatment, particularly when there is preexisting pulmonary dysfunction. The onset of these reactions may occur minutes to several hours after the vinca alkaloid is injected and may occur up to 2 weeks following the dose of mitomycin. Progressive dyspnea requiring chronic therapy may occur. VINCASAR PFS (vincristine sulfate injection) should not be readministered.

Care must be taken to avoid contamination of the eye with concentrations of VINCASAR PFS (vincristine sulfate injection) used clinically. If accidental contamination occurs, severe irritation (or, if the drug was delivered under pressure, even corneal ulceration) may result. The eye should be washed immediately and thoroughly.

Laboratory Tests Because dose-limiting clinical toxicity is manifested as neurotoxi-city, clinical evaluation (e.g., history, physical examination) is necessary to detect the need for dosage modification. Following administration of VINCASAR PFS (vincristine sulfate injection) , some individuals may have a fall in the white-blood-cell count or platelet count, particularly when previous therapy or the disease itself has reduced bone-marrow function. Therefore, a complete blood count should be done before administration of each dose. Acute elevation of serum uric acid may also occur during induction of remission in acute leukemia; thus, such levels should be determined frequently during the first 3 to 4 weeks of treatment or appropriate measures taken to prevent uric acid nephropathy. The laboratory performing these tests should be consulted for its range of normal values. Drug Interaction The simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included vincristine sulfate has been reported to reduce blood levels of theanticonvulsant and to increase seizure activity.11 Dosage adjustment should be based on serial blood level monitoring. The contribution of vincristine sulfate to this interaction is not certain. The interaction may result from reduced absorption of phenytoin and an increase in the rate of itsmetabolism and elimination.

Carcinogenesis, Mutagenesis, Impairment of Fertility Neither in vivo nor in vitro laboratory tests have conclusively demonstrated the mutagenicity of this product.10 Fertility following treatment with vincristine sulfate alone formalignant disease has not been studied in humans. Clinical reports of both male and female patients who received multiple-agent chemotherapy that included vincristine sulfate indicate that azoospermia and amenorrhea can occur in postpubertal patients. Recovery occurred many months after completion of chemotherapy in some but not all patients. When the same treatment is administered to prepubertal patients, permanent azoospermia and amenorrhea are much less likely.12-18 Patients who received chemotherapy with vincristine sulfate in combination with anticancer drugs known to be carcinogenic have developed second malignancies. The contributing role of vincristine sulfate in this development has not been determined. No evidence of carcinogenicity was found followingintraperitoneal administration of vin-cristine sulfate in rats and mice, although this study was limited.10

Usage in PregnancyPregnancy Category D. See

WARNINGS

.

 

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to vincristine sulfate in nursing infants, a decision should be made either to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

OverDose

Side effects following the use of VINCASAR PFS (vincristine sulfate injection) Injection are dose related. In children under 13 years of age, death has occurred following doses of vincristine sulfate that were 10 times those recommended for therapy. Severe symptoms may occur in this patient group following dosages of 3 to 4 mg/m2. Adults can be expected to experience severe symptoms after single doses of 3 mg/m2 or more (see ADVERSE REACTIONS). Therefore, following administration of doses higher than those recommended, patients can be expected to experience exaggerated side effects. Supportive care should include the following: (1) prevention of side effects resulting from the syndrome of inappropriate antidiuretic hormonesecretion (preventive treatment would include restriction of fluid intake and perhaps the administration of a diuretic affecting the function of Henle†s loop and the distal tubule); (2) administration of anticonvulsants; (3) use of enemas or cathartics to prevent ileus (in some instances, decompression of the gastrointestinal tract may be necessary); (4) monitoring thecardiovascular system; and (5) determining daily blood counts for guidance in transfusion requirements.

Folinic acid has been observed to have a protective effect in normal mice that were administered lethal doses of vincristine sulfate (Cancer Res., 1963; 23:1390). Isolated case reports suggest that folinic acid may be helpful in treating humans who have received an overdose of vincristine sulfate. It is suggested that 100 mg of folinic acid be administered intravenously every 3 hours for 24 hours and then every 6 hours for at least 48 hours. Theoretically (based on pharmacokinetic data), tissue levels of vin-cristine sulfate can be expected to remain significantly elevated for at least 72 hours. Treatment with folinic acid does not eliminate the need for the above-mentioned supportive measures. Most of an intravenous dose of vincristine sulfate is excreted into the bile after rapid tissue binding (see CLINICAL PHARMACOLOGY). Because only very small amounts of the drug appear in dialysate, hemodialysis is not likely to be helpful in cases of overdosage. An increase in the severity of side effects may be experienced by patients withliver disease that is severe enough to decrease biliary excretion.

Enhanced fecal excretion of parenterally administered vincristine has been demonstrated in dogs pretreated with cholestyramine. There are no published clinical data on the use of cholestyramine as an antidote in humans.

There are no published clinical data on the consequences of oral ingestion of vin-cristine. Should oral ingestion occur, the stomach should be evacuated. Evacuation should be followed by oral administration of activated charcoaland a cathartic.

ContrainDications

Patients with the demyelinating form of Charcot-Marie-Tooth syndrome should not be given VINCASAR PFS (vincristine sulfate injection) Injection. Careful attention should be given to those conditions listed underWARNINGS and PRECAUTIONS.

Clinical Pharamacology

The mechanisms of action of vincristine sulfate remain under investigation.1The mechanism of action of vincristine sulfate has been related to the inhibition of microtubule formation in the mitotic spindle, resulting in an arrest of dividing cells at the metaphase stage.

Central-nervous-system leukemia has been reported in patients undergoing otherwise successful therapy with vincristine sulfate. This suggests that vincristine sulfate does not penetrate well into the cerebrospinal fluid.

Pharmacokinetic studies in patients with cancer have shown a triphasicserum decay pattern following rapid intravenous injection. The initial, middle, and terminal half-lives are 5 minutes, 2.3 hours, and 85 hours respectively; however, the range of the terminal half-life in humans is from 19 to 155 hours. The liver is the major excretory organ in humans and animals; about 80% of an injected dose of vincristine sulfate appears in the feces and 10% to 20% can be found in the urine. Within 15 to 30 minutes after injection, over 90% of the drug is distributed from the blood into tissue, where it remains tightly, but not irreversibly, bound.2 Current principles of cancerchemotherapy involve the simultaneous use of several agents. Generally, each agent used has a unique toxicity and mechanism of action so thattherapeutic enhancement occurs without additive toxicity. It is rarely possible to achieve equally good results with single-agent methods of treatment. Thus, vincristine sulfate is often chosen as part of polychemotherapy because of lack of significant bone-marrow suppression (at recommended doses) and of unique clinical toxicity (neuropathy). See DOSAGE AND ADMINISTRATION for possible increased toxicity when used in combination therapy.

Patient Information

No separate information available. Please, however, refer to WARNINGS andPRECAUTIONS.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

VINCRISTINE - INJECTION

 

(vin-CRISS-teen)

 

COMMON BRAND NAME(S): Oncovin

 

WARNING: This drug is to be given by injection only into a vein. It must not be injected into the spine or into other areas of the body since fatal reactions have occurred.

If vincristine leaks out of the vein into the surrounding area, it may cause serious skin and tissue damage. Tell your health care professional immediately if you experience pain, irritation, redness, or swelling at the injection site. Prompt treatment of the leakage will help reduce discomfort and possible skin damage.

Vincristine injection is different than vincristine liposomal injection. The two drugs have different dosage recommendations.

 

USES: Vincristine is used to treat various types of cancer. It is a cancer chemotherapy drug that is usually used with other chemotherapy drugs to slow or stop cancer cell growth.

 

HOW TO USE: See also Warning section.

This medication is given by injection only into a vein by a health care professional. It is given on a schedule usually at weekly intervals or as directed by your doctor. The dosage is based on your medical condition, body size, and response to treatment. In small children, dosage is also based on weight.

Unless your doctor instructs you otherwise, drink plenty of fluids while using this medication. This helps to reduce some of the side effects to the kidneys.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, weight loss, diarrhea, mouth sores, dizziness, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This medication can also cause constipation, which in some cases may become serious. Consult your doctor or pharmacist about how you can prevent constipation (such as eating a diet high in fiber, drinking plenty of water). Ask about regularly using a stool softener such as docusate, avoiding bulk-forming laxatives, and choosing a stimulant laxative. Tell your doctor or pharmacist promptly if you develop constipation, stomach/abdominal pain, or bloating.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

This medication commonly affects the nerves and muscles in your body. Most of these side effects go away after this medication is stopped, however some effects may persist for a long time. Tell your doctor right away if you have any of the following: painful/difficult urination, change in the amount of urine, pain (including in the joints, back, muscles), numbness/tingling/burning/pain of the feet/hands, weakness, difficulty walking, loss of coordination/balance, inability to move your muscles (including the muscles of your face and other parts of your body), drooping eyelids, hoarseness, trouble speaking.

Tell your doctor right away if you have any serious side effects, including: vision/hearing changes, mental/mood changes (such as depression, hallucinations, confusion), easy bleeding/bruising, severe tiredness.

Get medical help right away if you have any very serious side effects, including: seizures, chest/jaw/left arm pain, signs of liver problems (such as dark urine, persistent nausea, vomiting, stomach/abdominal pain, yellowing eyes/skin).

Trouble breathing may infrequently occur with vincristine treatment, especially when it is given with another chemotherapy drug, mitomycin-C. Patients with lung problems may be more sensitive to this side effect. Long-term treatment of this side effect may be required if it worsens. This effect may occur within minutes to several hours after vincristine is given and up to 2 weeks after the dose of mitomycin-C. Get medical help right away if you have shortness of breath or coughing. If you have this reaction, you should not receive vincristine again.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Vincasar PFS (vincristine sulfate injection) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before using vincristine, tell your doctor or pharmacist if you are allergic to it or to vincristine liposomal; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: nerve/muscle problems (such as numbness/tingling/pain due to neuropathy, demyelinating conditions including Charcot-Marie-Tooth syndrome), liver disease, radiation treatment to the liver, decreased bone marrow function, blood disorders, current infection.

This medication can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy or tired or cause numbness in your hands/feet. Do not drive, use machinery, or do any activity that requires alertness or a sense of touch until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the effects of this drug, especially slowed movement of the gut that may cause vomiting and constipation.

Elderly patients who also take drugs that may cause difficult urination as a side effect may be more sensitive to the effects of this drug on the kidneys (urinary retention). Consult your doctor for more details. See also Drug Interactions.

This medication may reduce fertility in men and women. Consult your doctor for more details.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: digoxin, phenytoin, drugs that may cause nerve damage to the ear (e.g., chemotherapy drugs that contain platinum), drugs affecting liver enzymes that remove vincristine from your body (such as aprepitant, cimetidine, St. John's wort, azole antifungals including itraconazole, macrolide antibiotics including erythromycin, rifamycins including rifabutin, certain anti-seizure medicines including carbamazepine), drugs that may cause difficult urination (e.g., belladonna alkaloids, anticholinergic drugs such as atropine, antispasmodics such as dicyclomine, drugs to treat an overactive bladder such as oxybutynin).

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Laboratory and/or medical tests (e.g., complete blood count, uric acid blood levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

 

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised December 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Oncovin, Vincasar PFS

Generic Name: vincristine (Pronunciation: vin KRIS teen)

  • What is vincristine (Vincasar PFS)?
  • What are the possible side effects of vincristine (Vincasar PFS)?
  • What is the most important information I should know about vincristine (Vincasar PFS)?
  • What should I discuss with my healthcare provider before receiving vincristine (Vincasar PFS)?
  • How is vincristine given (Vincasar PFS)?
  • What happens if I miss a dose (Vincasar PFS)?
  • What happens if I overdose (Vincasar PFS)?
  • What should I avoid while receiving vincristine (Vincasar PFS)?
  • What other drugs will affect vincristine (Vincasar PFS)?
  • Where can I get more information?

What is vincristine (Vincasar PFS)?

 

Vincristine is cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Vincristine is used to treat leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, rhabdomyosarcoma (soft tissue tumors), neuroblastoma (cancer that forms in nerve tissue), and Wilms' tumor.

Vincristine is sometimes used in combination with other cancer medications.

Vincristine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of vincristine (Vincasar PFS)?

 

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the Vincasar PFS (vincristine sulfate injection) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about vincristine (Vincasar PFS)?

 

You should not use this medication if you are allergic to it, or if you have Charcot-Marie-Tooth syndrome.

Do not use vincristine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive vincristine, tell your doctor if you have liver disease, coronary artery disease, or a nerve-muscle disorder such as myasthenia gravis, Lou Gehrig's disease, multiple sclerosis, or muscular dystrophy.

Vincristine is sometimes used in combination with other cancer medications.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when vincristine is injected.

Your blood will need to be tested on a regular basis. Do not miss any scheduled appointments. Contact your doctor at once if you develop signs of infection.

Patient Detailed How Take

What should I discuss with my healthcare provider before receiving vincristine (Vincasar PFS)?

 

You should not use this medication if you are allergic to it, or if you have Charcot-Marie-Tooth syndrome.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • liver disease;
  • a nerve-muscle disorder such as myasthenia gravis, ALS (Lou Gehrig's disease), multiple sclerosis), or muscular dystrophy; or
  • coronary artery disease.

FDA pregnancy category D. Vincristine can cause harm to an unborn baby or cause birth defects. Before you receive vincristine, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether vincristine passes into breast milk or if it could harm a nursing baby. Before you receive this medication, tell your doctor if you are breast-feeding a baby.

How is vincristine given (Vincasar PFS)?

 

Vincristine is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion.

Vincristine is usually given once per week. Follow your doctor's instructions.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any scheduled visits to your doctor.

Patient Detailed Avoid Taking

What happens if I miss a dose (Vincasar PFS)?

 

Call your doctor for instructions if you miss an appointment for your vincristine injection.

What happens if I overdose (Vincasar PFS)?

 

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include extreme thirst with headache, nausea, vomiting, and weakness, or severe forms of the serious side effects listed in this medication guide.

What should I avoid while receiving vincristine (Vincasar PFS)?

 

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Talk to your doctor about ways to avoid constipation while being treated with vincristine.

What other drugs will affect vincristine (Vincasar PFS)?

 

Tell your doctor about all other medications you use, especially:

  • conivaptan (Vaprisol);
  • diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
  • imatinib (Gleevec);
  • isoniazid (for treating tuberculosis);
  • phenytoin (Dilantin);
  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
  • antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
  • an antidepressant such as nefazodone;
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • cancer medicines such as cisplatin (Platinol), carboplatin (Paraplatin), mitomycin (Mutamycin), or oxaliplatin (Elixatin); or
  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).

This list is not complete and there may be other drugs that can interact with vincristine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your doctor or pharmacist can provide more information about vincristine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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