Vincasar Pfs 1mg/ml Inj, 1ml

Vincristine is a vinca alkaloid that exerts its antineoplastic effect by binding to tubulin, the structural protein of microtubules. This binding inhibits the polymerization of tubulin into microtubules, leading to the disruption of the mitotic spindle apparatus. This disruption arrests cell division in metaphase, ultimately leading to cell death. It also interferes with amino acid, cyclic AMP, and glutathione metabolism, and calmodulin-dependent Ca2+-transport ATPase activity.

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 or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of dehydration, including:
+ Dry skin, mouth, or eyes
+ Thirst
+ Fast heartbeat
+ Dizziness
+ Fast breathing
+ Confusion
Severe constipation or stomach pain, which may indicate a severe bowel problem
Urination problems, such as:
+ Trouble passing urine
+ Pain while passing urine
+ Weak or dripping urine stream
+ Frequent urination
Nervous system problems, including:
+ Abnormal burning, numbness, or tingling sensations
+ Muscle weakness
+ Difficulty walking or changes in balance
+ Paralysis or inability to move part of the body
+ Vision loss or changes in eyesight
+ Dizziness
+ Uncontrolled eye movements
+ Seizures
+ Hearing loss (which may be long-lasting)
+ Throat, neck, or jaw pain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Most people experience few or no side effects while taking this medication. However, some individuals may encounter the following side effects:

Hair loss
Constipation
Diarrhea
Upset stomach
Vomiting
Decreased appetite
Stomach cramps
Weight loss
Fatigue or weakness
Headache
Back, bone, joint, or muscle pain
Mouth irritation or mouth sores

If you experience any of these side effects or any other symptoms that concern you or do not go away, contact your doctor for guidance. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and reporting them to the FDA.

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 allergic reaction you experienced, including any symptoms that occurred.
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, health conditions, and concerns with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you are using
Vitamins you are taking
Any health problems or medical conditions you have

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.

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.

Be aware that medications like this one can cause breathing problems, particularly when used in combination with mitomycin. These respiratory issues can occur within minutes to hours after administration and up to 2 weeks after receiving mitomycin. If you experience any difficulty breathing, contact your doctor immediately.

This medication can also lead to low blood cell counts, which may increase the risk of bleeding problems, infections, or anemia. If you notice signs of infection, such as fever, chills, or sore throat, or experience unexplained bruising or bleeding, or feel extremely tired or weak, notify your doctor right away.

If you encounter gastrointestinal side effects like stomach upset, vomiting, diarrhea, or decreased appetite, consult your doctor, as they may be able to suggest ways to minimize 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.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Similarly, if the patient is a child, this medication should be used with caution, as the risk of certain side effects may be higher in children.

This medication may affect 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 who may become pregnant should use birth control while taking this medication, as it may harm an unborn baby. If you become pregnant, contact your doctor immediately. If you are breast-feeding, inform your doctor, as they will need to discuss the potential risks to your baby with you.

• Itraconazole
• Posaconazole
• Voriconazole
• Clarithromycin
• Erythromycin
• Ritonavir
• Nelfinavir
• Indinavir
• Phenytoin (decreased phenytoin levels)
• Digoxin (decreased digoxin absorption)

• Other CYP3A4 inhibitors (e.g., diltiazem, verapamil, grapefruit juice)
• Other neurotoxic agents (e.g., paclitaxel, cisplatin, thalidomide, bortezomib)
• Myelosuppressive agents (additive myelosuppression)
• Live vaccines (increased risk of infection)

• Not specifically identified as minor, but general caution with drugs affecting GI motility due to constipation risk.

• Peripheral neuropathy (numbness, tingling, pain in hands/feet, weakness, difficulty walking, foot drop)
• Constipation, abdominal pain, bloating, absent bowel sounds (ileus)
• Jaw pain, parotid pain
• Hoarseness, vocal cord paralysis
• Muscle cramps, weakness
• Hair loss (alopecia)
• Fever, chills, sore throat (signs of infection/myelosuppression)
• Unusual bleeding or bruising
• Shortness of breath, cough
• Confusion, lethargy, headache (signs of SIADH or CNS effects)

Vincristine can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Advise pregnant women of the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment and for at least 6 months after the last dose. Men should use effective contraception during treatment and for at least 3 months after the last dose.

It is not known whether vincristine is excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during treatment with vincristine.

Vincristine is commonly used in pediatric oncology (e.g., acute lymphoblastic leukemia, lymphomas, Wilms' tumor). Dosing is typically weight or body surface area-based. Children may be more susceptible to neurotoxicity, particularly peripheral neuropathy. Close monitoring of neurological function is essential. Constipation is also a common concern.

No specific dose adjustments are generally recommended based solely on age. However, elderly patients may have reduced hepatic function, increased susceptibility to neurotoxicity, and pre-existing comorbidities that may increase the risk of adverse effects. Close monitoring of liver function, neurological status, and bowel function is crucial. Start with lower doses and titrate carefully based on tolerance and toxicity.

• **NEVER ADMINISTER INTRATHECALLY:** This is the most critical warning. Intrathecal administration is almost always fatal. Ensure all syringes are clearly labeled 'FOR INTRAVENOUS USE ONLY'.
• **Peripheral Neuropathy:** This is the dose-limiting toxicity. Monitor for symptoms (numbness, tingling, pain, weakness, foot drop). Dose reduction or discontinuation may be necessary.
• **Constipation:** A very common and potentially severe side effect due to autonomic neuropathy. Prophylactic bowel regimen (stool softeners, laxatives) should be initiated with the first dose and continued throughout therapy.
• **Jaw Pain:** A common early sign of neuropathy, often transient.
• **Hepatic Impairment:** Dose adjustments are essential in patients with liver dysfunction, as vincristine is primarily eliminated via the liver.
• **Extravasation:** Vincristine is a vesicant. Administer through a free-flowing IV line. If extravasation occurs, stop infusion immediately, aspirate any residual drug, and manage according to institutional guidelines (e.g., hyaluronidase, warm compress).
• **Maximum Single Dose:** The maximum single dose is typically 2 mg, regardless of BSA, to limit neurotoxicity.

• Other vinca alkaloids (e.g., Vinblastine, Vinorelbine - though with different toxicity profiles and indications)
• Other antineoplastic agents depending on the specific cancer type and stage (e.g., alkylating agents, antimetabolites, topoisomerase inhibitors, targeted therapies, immunotherapies).

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective use of your medication, never share your prescription with others, and do not take medication prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can contaminate waterways. Many communities offer drug take-back programs, which can be an environmentally friendly way to dispose of unwanted medications.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult 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 amount, and the time it was taken, as this will help healthcare professionals provide the best possible care.