Vincasar PFS

(Generic versions may still be available.)

DRUG DESCRIPTION

VINCASAR PFS® (vincristine sulfate injection, USP) is the salt of an alkaloid obtained 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,...

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 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of nerve/muscle disease (demyelinating form of Charcot-Marie-Tooth syndrome), radiation treatment to the liver.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other nerve/muscle problems (neuromuscular disease, neuropathy), liver disease, decreased bone marrow function, blood disorders, current...

Read All Potential Precautions of Vincasar PFS »


Vincasar PFS Consumer (continued)

SIDE EFFECTS: See also Warning section.

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

Vincristine may also affect the nerves in the intestines, causing gut movement to slow down. This effect can result in constipation, which in some cases may become serious. Consult your doctor or pharmacist about how you can prevent constipation (e.g., maintain a diet adequate in fiber, drink plenty of water, exercise, choose the right type of laxative with a stool softener, avoid bulk-forming laxatives). Tell your doctor or pharmacist promptly if you develop constipation.

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 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 immediately if any of these serious side effects occur: painful/difficult urination, change in the amount of urine, pain (e.g., in the joints, back, muscles, jaw), numbness/tingling/pain of the arms/legs, weakness, difficulty walking, loss of coordination/balance, inability to move your muscles (e.g., muscles of the face, other parts of your body), drooping eyelids, hoarseness, trouble speaking, mental/mood changes (e.g., depression, hallucinations, confusion).

Tell your doctor right away if you have any other serious side effects, including: vision/hearing changes, seizures, unusual bleeding/bruising.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

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.

PRECAUTIONS: Before using vincristine, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of nerve/muscle disease (demyelinating form of Charcot-Marie-Tooth syndrome), radiation treatment to the liver.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other nerve/muscle problems (neuromuscular disease, neuropathy), liver disease, decreased bone marrow function, blood disorders, current infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

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

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 is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use 2 effective forms of birth control (e.g., condoms, birth control pills) while using this medication and for some time afterwards. If you become pregnant or think you may be pregnant, tell your doctor immediately.

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.


Vincasar PFS Patient Information Including Side Effects

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.

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.

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