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Vincristine

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Vincristine uses


1 INDICATIONS AND USAGE

Vincristine is a vinca alkaloid indicated for the treatment of adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified (1.1).

1.1 Adult ALL in Second or Greater Relapse

Vincristine® is indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified.

2 DOSAGE AND ADMINISTRATION

For Intravenous Use Only. Fatal if Given by Other Routes.

Vincristine has different dosage recommendations than Vincristine sulfate injection. Verify drug name and dose prior to preparation and administration to avoid overdosage.

Intravenous use only. Do not administer by any other route (2)

Administer Vincristine at a dose of 2.25 mg/m2 intravenously over 1 hour once every 7 days (2.1).

2.1 Recommended Dosage

The recommended dose of Vincristine is 2.25 mg/m2 intravenously over 1 hour once every 7 days.

Vincristine is liposome-encapsulated Vincristine.

2.2 Dose modifications: Peripheral Neuropathy

Vincristine is contraindicated in patients with demyelinating conditions including Charcot-Marie-Tooth syndrome [see Contraindications ]. Patients with preexisting severe neuropathy should be treated with Vincristine only after careful risk-benefit assessment [see Warnings and Precautions (5.3) ]. For dose or schedule modifications guidelines for patients who experience peripheral neuropathy, see Table 1.

Severity of Peripheral Neuropathy Signs and Symptoms Grading based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Modification of Dose and Regimen

If the patient develops Grade 3 (severe symptoms; limiting self-care activities of daily living [ADL]Self-care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.) or persistent Grade 2 (moderate symptoms; limiting instrumental ADLInstrumental ADL: refers to preparing meals, shopping for groceries and clothes, using telephone, managing money, etc.) peripheral neuropathy:

Interrupt Vincristine.

If the peripheral neuropathy remains at Grade 3 or 4, discontinue Vincristine.

If the peripheral neuropathy recovers to Grade 1 or 2, reduce the Vincristine dose to 2 mg/m2.

If the patient has persistent Grade 2 peripheral neuropathy after the first dose reduction to 2 mg/m2:

Interrupt Vincristine for up to 7 days.

If the peripheral neuropathy increases to Grade 3 or 4, discontinue Vincristine.

If peripheral neuropathy recovers to Grade 1, reduce the Vincristine dose to 1.825 mg/m2.

If the patient has persistent Grade 2 peripheral neuropathy after the second dose reduction to 1.825 mg/m2:

Interrupt Vincristine for up to 7 days.

If the peripheral neuropathy increases to Grade 3 or 4, discontinue Vincristine.

If the toxicity recovers to Grade 1, reduce the Vincristine dose to 1.5 mg/m2.

2.3 Preparation and Handling


Procedures for handling and disposal of anticancer drugs should be followed [see References (15) ].

Call [1 888 292 9617] if you have questions about the preparation of Vincristine. Vincristine takes approximately 60 to 90 minutes to prepare. The preparer should have dedicated uninterrupted time to prepare Vincristine due to the extensive monitoring of temperature and time required for the preparation.

Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Vincristine. The preparation steps of Vincristine that involve mixing the Sodium Phosphate Injection, Sphingomyelin/Cholesterol Liposome Injection, and Vincristine Sulfate Injection must be done in a biological safety cabinet or by established pharmacy safety procedures for the preparation of sterile injectable formulations and hazardous drugs. However, the preparation steps that involve placement of the vial in the water bath must be done outside of the sterile area.

Do not use with in-line filters. Do not mix with other drugs.

Water bath process:


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.

Block heater process:

Note: Do NOT use water with the block heater preparation process.

Note: The flotation ring included with the Vincristine kit is not required for the block heater application.


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.

Vincristine Block Heater.jpg

3 DOSAGE FORMS AND STRENGTHS

Vincristine is prepared from the components in the Vincristine Kit. Following the preparation procedure according to section 2.3.2, each single-dose vial of Vincristine (vinCRIStine sulfate LIPOSOME injection) contains 5 mg/31 mL (0.16 mg/mL) Vincristine sulfate.

The final drug product is prepared on site from the components in the Vincristine Kit. After preparation, each single-dose vial of Vincristine (vinCRIStine sulfate LIPOSOME injection) contains 5 mg/31 mL (0.16 mg/mL) Vincristine sulfate (2.3.2).

4 CONTRAINDICATIONS

Vincristine is contraindicated in patients with demyelinating conditions including Charcot-Marie-Tooth syndrome.

Vincristine is contraindicated in patients with hypersensitivity to Vincristine sulfate or any of the other components of Vincristine (vinCRIStine sulfate LIPOSOME injection).

Vincristine is contraindicated for intrathecal administration.

5 WARNINGS AND PRECAUTIONS

5.1 For Intravenous Use Only

Fatal if Given by Other Routes. Death has occurred with intrathecal use.

5.2 Extravasation Tissue Injury

Only administer through a secure and free-flowing venous access line. If extravasation is suspected, discontinue infusion immediately and consider local treatment measures.

5.3 Neurologic Toxicity

Sensory and motor neuropathies are common and are cumulative. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, hyporeflexia, areflexia, neuralgia, jaw pain, decreased vibratory sense, cranial neuropathy, ileus, burning sensation, arthralgia, myalgia, muscle spasm, or weakness, both before and during treatment. Orthostatic hypotension may occur. The risk of neurologic toxicity is greater if Vincristine is administered to patients with preexisting neuromuscular disorders or when other drugs with risk of neurologic toxicity are being given. In the studies of relapsed and/or refractory adult ALL patients, Grade ≥ 3 neuropathy events occurred in 32.5% of patients. Worsening neuropathy requires dose delay, reduction, or discontinuation of Vincristine [see Dosage and Administration ].

5.4 Myelosuppression

Monitor complete blood counts prior to each dose of Vincristine. If Grade 3 or 4 neutropenia, thrombocytopenia, or anemia develops, consider Vincristine dose modification or reduction as well as supportive care measures.

5.5 Tumor Lysis Syndrome

Tumor lysis syndrome may occur in patients with ALL receiving Vincristine. Anticipate, monitor for, and manage.

5.6 Constipation and Bowel Obstruction

Ileus, bowel obstruction, and colonic pseudo-obstruction have occurred. Vincristine can cause constipation [see Adverse Reactions (6) ]. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction, and/or paralytic ileus, considering adequate dietary fiber intake, hydration, and routine use of stool softeners, such as docusate. Additional treatments, such as senna, bisacodyl, milk of magnesia, magnesium citrate, and lactulose may be considered.

5.7 Fatigue

Vincristine can cause severe fatigue. Vincristine dose delay, reduction, or discontinuation may be necessary.

5.8 Hepatic Toxicity

Fatal liver toxicity and elevated levels of aspartate aminotransferase have occurred. Elevated levels of aspartate aminotransferase of Grade ≥3 occurred in 6-11% of patients in clinical trials. Monitor hepatic function tests. Reduce or interrupt Vincristine for hepatic toxicity.

5.9 Embryofetal Toxicity

Vincristine can cause fetal harm when administered to a pregnant woman. Vincristine sulfate liposome injection was teratogenic or caused embryo-fetal death in animals. Women of childbearing potential should avoid becoming pregnant while being treated with Vincristine. There are no adequate and well-controlled studies of Vincristine in pregnant women and there were no reports of pregnancy in any of the clinical studies in the Vincristine clinical development program. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus .

6 ADVERSE REACTIONS

The following adverse reactions are also discussed in other sections of the labeling:


Most commonly reported adverse reactions (incidence ≥ 30%) in clinical studies include constipation, nausea, pyrexia, fatigue, peripheral neuropathy, febrile neutropenia, diarrhea, anemia, decreased appetite, and insomnia (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Talon Therapeutics at 1-888 292 9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Safety Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Integrated Summary of Safety in Relapsed and/or Refractory Ph- Adult Acute Lymphoblastic Leukemia

Vincristine, at a dose of 2.25 mg/m2 weekly, was studied in a total of 83 patients in two trials: study 1 and study 2. Adverse reactions were observed in 100% of patients. The most common adverse reactions (>30%) were constipation (57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral neuropathy (39%), febrile neutropenia (38%), diarrhea (37%), anemia (34%), decreased appetite (33%), and insomnia (32%).

Adverse reactions of Grade 3 or greater were reported in 96% of patients. Adverse reactions of Grade 3 or greater and occurring in ≥ 5% of patients are summarized in Table 2.

Adverse Reactions Grade ≥ 3 Study 1 and 2

(N=83)

n (%)


Blood and Lymphatic System Disorders


47 (56.6)


Febrile Neutropenia

26 (31.3)

Neutropenia

15 (18.1)

Anemia

14 (16.9)

Thrombocytopenia

14 (16.9)

Infections


33 (39.8)


Pneumonia

7 (8.4)

Septic Shock

5 (6.0)

Staphylococcal Bacteremia

5 (6.0)

Neuropathy Including neuropathy-associated adverse reactions.


27 (32.5)


Peripheral Sensory and Motor Neuropathy

14 (16.7)

Constipation

4 (4.8)

Ileus, Colonic Pseudo-Obstruction

5 (6.0)

Asthenia

4 (4.8)

Muscular Weakness

1 (1.2)

Respiratory Thoracic and Mediastinal Disorders


17 (20.5)


Respiratory Distress

5 (6.0)

Respiratory Failure

4 (4.8)

General Disorders and Administration Site Condition


31 (37.3)


Pyrexia

12 (14.5)

Fatigue

10 (12.0)

Pain

7 (8.4)

Gastrointestinal Disorders


21 (25.3)


Abdominal Pain

7 (8.4)

Investigations


20 (24.1)


Aspartate Aminotransferase Increased

6 (7.2)

Vascular Disorders


8 (9.6)


Hypotension

5 (6.0)

Psychiatric Disorders


9 (10.8)


Mental Status Changes

3 (3.6)

Cardiac Disorders


9 (10.8)


Cardiac Arrest

5 (6.0)

Renal and Urinary Disorders


6 (7.2)


Musculoskeletal and Connective Tissue Disorders


7 (8.4)


A total of 75.9% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included febrile neutropenia (20.5%), pyrexia (13.3%), hypotension (7.2%), respiratory distress (6.0%), and cardiac arrest (6.0%).

Dose reduction, delay, or omission occurred in 53% of patients during the treatment.

Twenty-eight percent of patients experienced adverse reactions leading to treatment discontinuation. The most common adverse reactions that caused treatment discontinuation were peripheral neuropathy (10%), leukemia-related (7%), and tumor lysis syndrome (2%).

Adverse reactions related to neuropathy and leading to treatment discontinuation were decreased vibratory sense, facial palsy, hyporeflexia, constipation, asthenia, fatigue, and musculoskeletal pain, each reported in at least 1 patient.

Deaths occurred in 23% of patients in study 1. The non-leukemia related causes of deaths were brain infarct (1), intracerebral hemorrhage (2), liver failure (1), multi system organ failure (2), pneumonia and septic shock (3), respiratory failure (4), pulmonary hemorrhage (1), and sudden cardiac death (1).

7 DRUG INTERACTIONS

No formal drug interaction studies have been conducted with Vincristine. Vincristine is expected to interact with drugs known to interact with non-liposomal Vincristine sulfate.

Simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included non-liposomal Vincristine sulfate have been reported to reduce blood levels of phenytoin and to increase seizure activity.

Vincristine is expected to interact with drugs known to interact with non-liposomal Vincristine sulfate.

7.1 CYP3A Interactions

Vincristine sulfate, the active agent in Vincristine, is a substrate for cytochrome P450 3A isozymes (CYP3A); therefore, the concomitant use of strong CYP3A inhibitors should be avoided (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin). Similarly, the concomitant use of strong CYP3A inducers should be avoided (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John's Wort).

7.2 P-glycoprotein Interactions

Vincristine sulfate, the active agent in Vincristine, is also a substrate for P-glycoprotein (P-gp). The effect of concomitant use of potent P-gp inhibitors or inducers has not been investigated; it is likely that these agents will alter the pharmacokinetics or pharmacodynamics of Vincristine. Therefore the concomitant use of potent P-gp inhibitors or inducers should be avoided.

8 USE IN SPECIFIC POPULATIONS

Pediatric Use: The safety and effectiveness of Vincristine in pediatric patients has not been established

8.1 Pregnancy

Pregnancy Category D [see Warnings and Precautions (5.9) ]

Based on its mechanism of action and findings from animal studies, Vincristine can cause fetal harm when administered to pregnant women.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. In an embryofetal developmental study, pregnant rats were administered Vincristine sulfate liposome injection intravenously during the period of organogenesis at Vincristine sulfate doses of 0.022 to 0.09 mg/kg/day. Drug-related adverse effects included fetal malformations (skeletal and visceral), decreases in fetal weights, increased numbers of early resorptions and post-implantation losses, and decreased maternal body weights Malformations were observed at doses ≥ 0.044 mg/kg/day in animals at systemic exposures approximately 20-40% of those reported in patients at the recommended dose.

8.3 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 in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

8.4 Pediatric Use

The safety and effectiveness of Vincristine in pediatric patients have not been established.

8.5 Geriatric Use

Safety and effectiveness in elderly individuals have not been established. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Renal Impairment

The influence of renal impairment on the safety, efficacy, and pharmacokinetics of Vincristine has not been evaluated.

8.7 Hepatic Impairment

Non-liposomal Vincristine sulfate is excreted primarily by the liver. The influence of severe hepatic impairment on the safety and efficacy of Vincristine has not been evaluated.

The pharmacokinetics of Vincristine was evaluated in patients with moderate hepatic dysfunction (Child-Pugh B) secondary to melanoma liver metastases. The dose-adjusted maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC) of Vincristine in patients with moderate hepatic impairment was comparable to the Cmax and AUC of patients with ALL who had otherwise normal hepatic function.

10 OVERDOSAGE

When Vincristine (vinCRIStine sulfate LIPOSOME injection) was administered at a dose of 2.4 mg/m2, severe toxicities including motor neuropathy of Grade 3, grand mal seizure of Grade 4, and elevated aspartate aminotransferase and hyperbilirubinemia of Grade 4 were reported in 1 patient each. There is no known antidote for overdosage.

11 DESCRIPTION

Vincristine (vinCRIStine sulfate LIPOSOME injection) is Vincristine encapsulated in sphingomyelin/cholesterol liposomes for intravenous administration.

The active ingredient in Vincristine is Vincristine sulfate. Vincristine sulfate is a vinca alkaloid isolated as a 1:1 sulfate salt from the periwinkle plant (Catharanthus roseus). It is a hygroscopic, white to slightly yellowish crystalline powder that is soluble in water. It has a molecular weight of 923.04 (salt form) / 824.98 (base form) and a molecular formula of C46H56N4O10 - H2SO4. The chemical name for Vincristine sulfate is 22-oxovincaleukoblastine and it has the following chemical structure:

Vincristine is encapsulated in a Sphingomyelin/Cholesterol liposome. The lipid components in the liposome are sphingomyelin and cholesterol at a molar ratio of approximately 60:40 (mol:mol).

After preparation, each vial of Vincristine contains 5 mg Vincristine sulfate, 500 mg mannitol, 73.5 mg sphingomyelin, 29.5 mg cholesterol, 36 mg sodium citrate, 38 mg citric acid, 355 mg sodium phosphate, and 225 mg sodium chloride.

Vincristine (vinCRIStine sulfate LIPOSOME injection) appears as a white to off-white, translucent suspension, essentially free of visible foreign matter and aggregates, comprised of sphingomyelin/cholesterol liposomes, with an approximate liposome mean diameter of 100 nm. Greater than 95% of the drug is encapsulated in the liposomes.

The Vincristine Kit component vials for the preparation of Vincristine (vinCRIStine sulfate LIPOSOME injection) include:

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Vincristine is a sphingomyelin/cholesterol liposome-encapsulated formulation of Vincristine sulfate. Non-liposomal Vincristine sulfate binds to tubulin, altering the tubulin polymerization equilibrium, resulting in altered microtubule structure and function. Non-liposomal Vincristine sulfate stabilizes the spindle apparatus, preventing chromosome segregation, triggering metaphase arrest and inhibition of mitosis.

12.3 Pharmacokinetics

The plasma pharmacokinetics of Vincristine was investigated in 13 adult patients with relapsed ALL who received a Vincristine dose of 2.25 mg/m2 administered as a 1-hour intravenous infusion. The calculated pharmacokinetic parameters for total plasma Vincristine sulfate are given in Table 3. The Vincristine sulfate levels reported in Table 3 reflect liposome-encapsulated drug that may not be immediately bioavailable and may not be directly comparable to plasma levels of Vincristine sulfate after administration of non-liposomal Vincristine sulfate, which is immediately bioavailable.

Variable N Mean SE Median Range

AUC∞ (h∙ng/mL)

13

14566

1766

13680

7036-26074

CL (mL/h)

12

345

100

302

148-783

Cmax (ng/mL)

13

1220

64

1230

919-1720

The plasma clearance (CL) of Vincristine is slow, 345 mL/h, at a dose of 2.25 mg/m2. This is in comparison to the rapid clearance of non-liposomal Vincristine sulfate at 189 mL/min/m2 (11,340 mL/h). The slow clearance of Vincristine contributes to a much higher AUC for Vincristine relative to non-liposomal Vincristine sulfate.

Following intravenous administration of Vincristine, urinary excretion was a minor route of elimination for Vincristine sulfate and its metabolite. Less than 8% of the administered Vincristine dose was eliminated in urine over a 96-hour observation period, which is similar to the urinary excretion of non-liposomal Vincristine sulfate. Following non-liposomal Vincristine sulfate infusion, the main route of Vincristine sulfate excretion was the fecal route, accounting for 69% of the administered dose over 72 hours.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity studies have been conducted with Vincristine or non-liposomal Vincristine sulfate. Based on the mechanism of action and genotoxicity findings in nonclinical studies conducted with non-liposomal Vincristine sulfate, Vincristine may be carcinogenic.

No genotoxicity studies have been conducted with Vincristine. Non-liposomal Vincristine was genotoxic in some in vitro and in vivo studies.

The single- and repeat-dose animal toxicology study results indicate that Vincristine can impair male fertility, consistent with the literature on non-liposomal Vincristine sulfate. Administration of Vincristine liposome injection causes testicular degeneration and atrophy, and epididymal aspermia in rats.

Gonadal dysfunction has been reported in both male and female post-pubertal patients who received multi-agent chemotherapy including non-liposomal Vincristine sulfate. The degree to which testicular or ovarian functions are affected is age-, dose-, and agent-dependent. Recovery may occur in some but not all patients.

13.2 Animal Toxicology and/or Pharmacology

In a repeat-dose comparative toxicology study in rats, Vincristine sulfate liposome injection or non-liposomal Vincristine sulfate was administered to animals intravenously once per week for 6 weeks. Clinical signs of toxicity consistent with neurotoxicity were greater with Vincristine sulfate liposome injection than with non-liposomal Vincristine sulfate at equal Vincristine sulfate doses of 2 mg/m2/week and included uncoordinated movements, weakness, reduced muscle tone, and limited usage of the limbs. Neurological testing indicated drug-induced peripheral neurotoxicity with both drugs. Based on the histopathology examination after 6 weekly doses, Vincristine sulfate liposome injection induced greater peripheral neurotoxicity (nerve fiber degeneration) and secondary skeletal muscle atrophy than the equal dose of non-liposomal Vincristine sulfate. In a separate tissue distribution study in rats, administration of 2 mg/m2 of intravenous liposomal or non-liposomal Vincristine sulfate showed greater accumulation of Vincristine sulfate in sciatic and tibial nerves (as well as the lymph nodes, spleen, and bone marrow) of the animals following Vincristine sulfate liposome injection.

14 CLINICAL STUDIES

14.1 Acute Lymphoblastic Leukemia

Vincristine was studied in an international, open-label, multi-center, single-arm trial (Study 1). Eligible patients were 18 years of age or older with Philadelphia chromosome negative ALL in second or greater relapse or whose disease progressed after two or greater treatment lines of anti-leukemia therapy. Patients had to have achieved a complete remission (CR) to at least one prior anti-leukemia chemotherapy, defined by a leukemia-free interval of equal or more than 90 days. Patients were not eligible for immediate hematopoietic stem cell transplantation (HSCT) at the time of screening and enrollment.

Patients received intravenous Vincristine monotherapy at 2.25 mg/m2 over 60 minutes every 7 days. Concomitant corticosteroids were not permitted beyond Day 5.

The treated population included 65 patients who received at least 1 dose of Vincristine. All of the treated patients had received prior Vincristine sulfate and 80% had evidence of residual neuropathy at study baseline. Among treated patients, 51% were male, 86% were white, 45% were under 30 years of age, 11% were age 65 or older, 48% had undergone prior HSCT, 51% had received 3 or more prior therapies, and 45% were refractory to their immediate prior therapy. Disease characteristics were 85% precursor B-cell ALL and 15% precursor T-cell ALL. In addition, 22 of 65 (34%) treated patients did not receive asparaginase products prior to enrollment. Efficacy results are shown in Table 4.

Study 1

(N=65)

n (%)


Complete remission (CR)

3 (4.6)

CR with incomplete blood count recovery (CRi)

7 (10.8)

CR + CRi

10 (15.4)

(95% CICI = Confidence interval (Clopper-Pearson).)

(7.6 – 26.5)

MEDIAN DURATION of CR or CRi:


Days (95% CI)


Based on the first date of CR or CRi to the date of the last available histologic assessment of the same response (n=8)


28 (7, 36)

Based on the first date of CR or CRi to date of documented relapse, death, or subsequent chemotherapies including hematopoietic stem cell transplant (HSCT) (n=10)

56 (9, 65)

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

The Vincristine Kit contains:

16.1 Storage

Store the Vincristine Kit in the refrigerator at 2°C to 8°C – Do Not Freeze

17 PATIENT COUNSELING INFORMATION

Physicians are advised to discuss the following with patients prior to treatment with Vincristine:

Extravasation Tissue Injury: Advise patients to report immediately any burning or local irritation during or after the infusion [see Warnings and Precautions (5.2) ].

Ability to Drive or Operate Machinery or Impairment of Mental Ability: Vincristine may cause fatigue and symptoms of peripheral neuropathy. Advise patients not to drive or operate machinery if they experience any of these symptoms [see Warnings and Precautions (5.3, 5.7) ].

Gastrointestinal/Constipation: Patients receiving Vincristine may experience constipation. Advise patients how to avoid constipation by a diet high in bulk fiber, fruits and vegetables, and adequate fluid intake as well as use of a stool softener, such as docusate. Instruct patients to seek medical advice if they experience symptoms of constipation such bowel movement infrequency, abdominal pain, bloating, diarrhea, nausea, or vomiting [see Warnings and Precautions (5.6) ].

Pregnancy/Nursing: Advise patients to use effective contraceptive measures to prevent pregnancy during treatment with Vincristine [see Warnings and Precautions (5.9) ]. Instruct patients to report pregnancy to their physicians immediately. Advise patients that they should not receive Vincristine while pregnant or breastfeeding. If a patient wishes to re-start breastfeeding after treatment, she should be advised to discuss the appropriate timing with her physician [see Use in Specific Populations (8.3) ].

Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking [see Drug Interactions (7) ].

Peripheral Neuropathy: Advise patients to contact their physicians if they experience new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the feet or hands [see Warnings and Precautions (5.3) ].

Other: Instruct patients to notify their physicians if they experience fever, productive cough, or decreased appetite [see Warnings and Precautions (5.4) ].

Manufactured for:

Talon Therapeutics, Inc., a wholly-owned subsidiary of Spectrum Pharmaceuticals, Inc.

157 Technology Drive

Irvine, CA 92618

Vincristine pharmaceutical active ingredients containing related brand and generic drugs:


Vincristine available forms, composition, doses:

Price
Injectable; Injection; Vincristine 1 mg
Oncovite tablet0.19 USD
Vincristine 2 mg/2 ml vial18.06 USD

Vincristine destination | category:


Vincristine Anatomical Therapeutic Chemical codes:


Vincristine pharmaceutical companies:


References

  1. "vincristine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  2. "vincristine". http://www.drugbank.ca/drugs/DB0054... (accessed August 28, 2018).
  3. "vincristine: Link to the compound information in Wikipedia.". https://en.wikipedia.org/wiki/Vincr... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Vincristine?

Depending on the reaction of the Vincristine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Vincristine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Vincristine addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Vincristine, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Vincristine consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Two visitors reported doses

What is the dose of Vincristine drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 501mg-1g. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
501mg-1g1
50.0%
1-5mg1
50.0%

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Two visitors reported age

Visitors%
1-51
50.0%
> 601
50.0%

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The information was verified by Dr. Rachana Salvi, MD Pharmacology


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