Vincasar Pfs 1mg/ml Inj, 2ml

Manufacturer TEVA Active Ingredient Vincristine(vin KRIS teen) Pronunciation vin KRIS teen
WARNING: This drug is given into a vein only. If given other ways, this drug can be deadly. If you have questions, talk with the doctor.This drug may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body. @ COMMON USES: It is used to treat cancer.
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Drug Class
Antineoplastic agent
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Pharmacologic Class
Vinca alkaloid; Microtubule inhibitor
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Pregnancy Category
Category D
FDA Approved
Jul 1963
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Vincristine is a chemotherapy medicine used to treat various types of cancer, including leukemias and lymphomas. It works by stopping cancer cells from growing and dividing. It is given as an injection into a vein.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Administer the medication as directed, which typically involves intravenous infusion over a specified period.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the appropriate storage method.

In the event that you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Report any new or worsening numbness, tingling, pain, or weakness in your hands or feet immediately.
  • Report any changes in bowel habits, especially constipation. Your doctor may prescribe laxatives to prevent severe constipation.
  • Maintain good hydration to help with constipation and overall well-being.
  • Avoid live vaccines during treatment and for a period afterward, as your immune system may be weakened.
  • Use effective birth control during treatment and for a period after, as this medication can harm a developing baby.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 1.4 mg/m² IV weekly (max 2 mg per dose)
Dose Range: 0.4 - 2 mg

Condition-Specific Dosing:

Hodgkin's Disease: 1.4 mg/m² IV weekly
Non-Hodgkin's Lymphoma: 1.4 mg/m² IV weekly
Acute Lymphocytic Leukemia (ALL): 1.4 mg/m² IV weekly
Multiple Myeloma: 1.4 mg/m² IV weekly (often in combination)
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Pediatric Dosing

Neonatal: Not established
Infant: 0.05 mg/kg IV weekly (for infants <10 kg or BSA <1 m²)
Child: 1.5-2 mg/m² IV weekly (max 2 mg per dose)
Adolescent: 1.4 mg/m² IV weekly (max 2 mg per dose)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended
Severe: No specific adjustment recommended
Dialysis: Not significantly removed by dialysis; no specific adjustment needed based on renal function alone.

Hepatic Impairment:

Mild: Consider 50% dose reduction if bilirubin >1.5-3 mg/dL or AST >3x ULN
Moderate: Consider 50% dose reduction if bilirubin >1.5-3 mg/dL or AST >3x ULN
Severe: Consider 75% dose reduction if bilirubin >3 mg/dL or AST >5x ULN; use with extreme caution.
Confidence: High

Pharmacology

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Mechanism of Action

Vincristine is a vinca alkaloid that exerts its antineoplastic effect by binding to tubulin, thereby inhibiting the polymerization of tubulin into microtubules. This disruption of microtubule formation leads to the arrest of cells in metaphase (M-phase specific) and subsequent apoptosis. It also interferes with amino acid, cyclic AMP, and glutathione metabolism, and nucleic acid and lipid synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IV administration)
Tmax: Not applicable (IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: 8.4 ± 3.2 L/kg
ProteinBinding: 75-80%
CnssPenetration: Limited

Elimination:

HalfLife: Triphasic elimination: initial (t½α) 5 minutes, intermediate (t½β) 2.3 hours, terminal (t½γ) 85 hours (range 19-155 hours)
Clearance: Not available
ExcretionRoute: Primarily biliary/fecal (80%), renal (12%)
Unchanged: Less than 10% (renal)
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Pharmacodynamics

OnsetOfAction: Immediate (cellular level)
PeakEffect: Not directly measurable for clinical effect; cellular effects are rapid.
DurationOfAction: Dependent on cell cycle and drug exposure; effects persist as long as drug is present and cells are dividing.
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN INTRATHECALLY. Administration of Vincasar Pfs by other routes, including intrathecal, can be fatal. Syringes containing this product should be labeled 'FOR INTRAVENOUS USE ONLY.'
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine or changes in urine output
+ Blood in the urine or significant weight gain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of dehydration, including:
+ Dry skin, mouth, or eyes
+ Thirst, rapid heartbeat, dizziness, or confusion
Severe constipation or stomach pain, which may indicate a serious bowel problem
Urination problems, such as:
+ Difficulty passing urine
+ Pain while urinating
+ Weak or interrupted urine flow
+ Frequent urination
Nervous system problems, including:
+ Abnormal burning, numbness, or tingling sensations
+ Muscle weakness or difficulty walking
+ Changes in balance or coordination
+ Paralysis or loss of eyesight
+ Dizziness, uncontrolled eye movements, or seizures
+ Hearing loss (which may be long-lasting) or throat, neck, or jaw pain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellowing of the skin or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or persist:

Hair loss
Constipation, diarrhea, nausea, vomiting, or decreased appetite
Stomach cramps
Weight loss
Fatigue or weakness
Headache
Back, bone, joint, or muscle pain
Mouth irritation or mouth sores

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Numbness, tingling, pain, or weakness in hands or feet (peripheral neuropathy)
  • Severe constipation, abdominal pain, or inability to pass gas/stool (paralytic ileus)
  • Jaw pain or difficulty speaking (vocal cord paralysis)
  • Muscle cramps or weakness
  • Unusual bruising or bleeding, fever, chills, or signs of infection (rare, but possible myelosuppression)
  • Confusion, headache, seizures (signs of low sodium due to SIADH)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have been diagnosed with Charcot-Marie-Tooth syndrome, a genetic disorder that affects the nerves.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any existing health problems to ensure safe use of this medication.

To guarantee your safety, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that this medication is compatible with all your other medications and health conditions before starting treatment.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests and other laboratory evaluations, as directed by your doctor, are crucial to monitor your condition.

There is a risk of respiratory problems associated with this drug, particularly when used in conjunction with mitomycin. These breathing difficulties can occur within minutes to hours after administration and up to 2 weeks after mitomycin treatment. If you experience any trouble breathing, contact your doctor immediately.

This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia if the counts become severely low. Be vigilant for signs of infection, such as fever, chills, or sore throat, and report any unexplained bruising or bleeding, or feelings of extreme tiredness or weakness, to your doctor promptly.

If you experience gastrointestinal side effects like stomach upset, vomiting, diarrhea, or decreased appetite, consult your doctor, as there may be ways to mitigate these effects. To manage constipation, your doctor may recommend increasing fluid intake, exercising, or adding more fiber to your diet. Additionally, your doctor can discuss the use of stool softeners or laxatives with you.

Older adults (65 years and older) should exercise caution when using this medication, as they may be more susceptible to side effects. Similarly, children should be treated with caution, as the risk of certain side effects may be higher in this population.

This drug may impact fertility, potentially leading to difficulties in becoming pregnant or fathering a child. Although fertility may return to normal, it is essential to discuss any concerns with your doctor.

Women of childbearing potential should be aware that this medication may harm an unborn baby. If you are taking this drug and may become pregnant, it is crucial to use birth control. If you become pregnant, notify your doctor immediately.

If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Exaggerated side effects, particularly severe neurotoxicity (e.g., profound peripheral neuropathy, autonomic neuropathy, paralytic ileus, SIADH)
  • Severe myelosuppression (though less prominent with vincristine than other agents)
  • Hyponatremia

What to Do:

There is no specific antidote for vincristine overdose. Management is supportive and includes: close monitoring of neurological function, CBC, LFTs, and electrolytes; aggressive bowel management; fluid restriction for SIADH; consideration of folinic acid (leucovorin) rescue (though efficacy is debated and not FDA-approved for vincristine overdose); and symptomatic treatment of adverse effects. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Contraindicated Interactions

  • Intrathecal administration (FATAL)
  • Patients with demyelinating Charcot-Marie-Tooth syndrome (due to increased neurotoxicity)
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Major Interactions

  • Strong CYP3A4 inhibitors (e.g., azole antifungals like itraconazole, ketoconazole, posaconazole; macrolide antibiotics like clarithromycin, erythromycin; protease inhibitors like ritonavir, indinavir): May increase vincristine levels and toxicity.
  • Phenytoin/Fosphenytoin: May decrease phenytoin levels, leading to loss of seizure control.
  • Live vaccines: Risk of severe infection in immunosuppressed patients.
  • Other myelosuppressive agents: Increased risk of bone marrow suppression.
  • Other neurotoxic agents (e.g., paclitaxel, cisplatin): Increased risk of neurotoxicity.
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Moderate Interactions

  • CYP3A4 inducers (e.g., carbamazepine, rifampin, St. John's Wort): May decrease vincristine levels.
  • Digoxin: May decrease digoxin absorption.
  • Asparaginase: May increase neurotoxicity if given before vincristine (administer vincristine 12-24 hours before asparaginase).
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Minor Interactions

  • Not specifically documented for minor interactions with significant clinical impact.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with differential and platelets

Rationale: To assess baseline bone marrow function and identify pre-existing cytopenias.

Timing: Prior to initiation of therapy

Liver function tests (LFTs) including bilirubin, AST, ALT, alkaline phosphatase

Rationale: Vincristine is primarily metabolized and excreted by the liver; hepatic impairment necessitates dose adjustment.

Timing: Prior to initiation of therapy

Renal function tests (creatinine, BUN)

Rationale: To assess baseline renal function, although renal excretion is minor.

Timing: Prior to initiation of therapy

Neurological examination (deep tendon reflexes, sensory/motor function)

Rationale: To establish baseline neurological status due to significant neurotoxicity risk.

Timing: Prior to initiation of therapy

Bowel function assessment

Rationale: To assess baseline bowel habits due to risk of constipation and paralytic ileus.

Timing: Prior to initiation of therapy

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Routine Monitoring

Complete Blood Count (CBC) with differential and platelets

Frequency: Prior to each dose

Target: WBC >3,000/mm³, ANC >1,500/mm³, Platelets >100,000/mm³ (may vary based on protocol)

Action Threshold: Hold or reduce dose if significant myelosuppression (though less common with vincristine than other agents); consider growth factors if indicated.

Neurological examination (peripheral neuropathy symptoms, deep tendon reflexes)

Frequency: Prior to each dose and throughout therapy

Target: Absence of new or worsening neuropathy

Action Threshold: Dose reduction or discontinuation if severe or progressive neuropathy (e.g., grade 2 or higher motor neuropathy, significant pain, or functional impairment).

Bowel function assessment

Frequency: Prior to each dose and regularly throughout therapy

Target: Regular bowel movements

Action Threshold: Initiate prophylactic laxatives/stool softeners; hold dose if severe constipation or paralytic ileus develops.

Liver function tests (LFTs)

Frequency: Periodically, especially if hepatic impairment is suspected or worsening

Target: Within acceptable limits for treatment

Action Threshold: Dose reduction or hold if significant elevation (e.g., bilirubin >1.5-3 mg/dL or AST >3x ULN).

Serum electrolytes (especially sodium)

Frequency: Periodically, if SIADH is suspected

Target: Normal sodium levels

Action Threshold: Manage hyponatremia if SIADH develops.

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Symptom Monitoring

  • Peripheral neuropathy (numbness, tingling, pain in hands/feet, weakness, foot drop)
  • Constipation, abdominal pain, bloating, absent bowel sounds (paralytic ileus)
  • Jaw pain, vocal cord paralysis (hoarseness)
  • Muscle cramps, weakness
  • Hyponatremia (due to SIADH: headache, confusion, seizures)
  • Hair loss (alopecia)
  • Fatigue
  • Fever, chills, signs of infection (due to myelosuppression, though rare)

Special Patient Groups

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Pregnancy

Vincristine can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Women of childbearing potential should be advised to avoid becoming pregnant during therapy.

Trimester-Specific Risks:

First Trimester: High risk of major birth defects and fetal death.
Second Trimester: Risk of fetal growth restriction, organ malformations, and other adverse outcomes.
Third Trimester: Risk of fetal growth restriction and potential for neonatal toxicity if exposed near term.
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Lactation

It is not known whether vincristine is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during vincristine therapy.

Infant Risk: L5 (Contraindicated - significant documented risk to infant or drug is contraindicated during breastfeeding).
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Pediatric Use

Vincristine is commonly used in pediatric oncology, particularly for acute lymphoblastic leukemia (ALL) and lymphomas. Dosing is typically based on body surface area (BSA), with a maximum single dose of 2 mg to limit neurotoxicity. Infants under 10 kg or with BSA <1 m² may be dosed by weight (0.05 mg/kg). Children may be more susceptible to neurotoxicity.

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Geriatric Use

No specific dose adjustments are generally recommended based solely on age. However, elderly patients may have reduced hepatic function, pre-existing neuropathies, or comorbidities that increase their susceptibility to vincristine's side effects, particularly neurotoxicity and constipation. Close monitoring and dose adjustments based on toxicity are crucial.

Clinical Information

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Clinical Pearls

  • **FATAL IF GIVEN INTRATHECALLY:** This is the most critical safety warning. Always ensure vincristine is administered intravenously only. Many institutions dispense it in a mini-bag to prevent accidental intrathecal administration.
  • Neurotoxicity is the dose-limiting toxicity, manifesting as peripheral neuropathy (sensory, motor, autonomic), jaw pain, vocal cord paralysis, and SIADH. Monitor for symptoms closely.
  • Constipation and paralytic ileus are common autonomic neuropathic side effects. Prophylactic bowel regimens (stool softeners, laxatives) are essential.
  • Myelosuppression is generally mild and transient with vincristine compared to other chemotherapeutic agents, but monitor CBCs.
  • Hepatic impairment necessitates dose reduction due to primary biliary excretion.
  • Maximum single dose is typically capped at 2 mg to limit neurotoxicity, regardless of calculated BSA dose.
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Alternative Therapies

  • Other vinca alkaloids (e.g., vinblastine, vinorelbine) for different indications or toxicity profiles.
  • Other microtubule-targeting agents (e.g., taxanes like paclitaxel, docetaxel) which have a different mechanism of action on microtubules.
  • Other classes of antineoplastic agents depending on the specific cancer type and stage (e.g., alkylating agents, antimetabolites, topoisomerase inhibitors, targeted therapies, immunotherapies).
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Cost & Coverage

Average Cost: Not available (varies widely by institution, contract, and payer) per 2ml vial (2mg)
Generic Available: Yes
Insurance Coverage: Specialty Tier / Tier 4 (often covered under medical benefit for oncology treatment)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.