1 mg/ml solution
for injection
vincristine sulfate
What Vincristine Pfizer is and what it is used for
Vincristine Pfizer contains the active substance vincristine which belongs to a group of medicines called cytostatics ( chemotherapy ), which are used in cancer treatment. Vincristine Pfizer is used in combination with other cytostatics for the treatment of leukemia (blood cancer), malignant lymphoma, and small cell lung cancer.
Vincristine works by inhibiting cell division. Its effect is greatest in cells that grow and divide rapidly, such as e.g. in cancer cells.
The vincristine contained in Vincristine Pfizer may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Vincristine Pfizer
Do not use Vincristine Pfizer
- if you are allergic to vincristine sulfate or any of the other ingredients of this medicine (listed in section 6)
- if you have Charcot-Marie-Tooth disease (muscle disease)
- if you are being treated with radiation over an area that includes the liver
- if you are breastfeeding
Vincristine Pfizer should not be given into the spinal canal (intrathecally).
Warnings and precautions
Talk to your doctor or nurse before using Vincristine Pfizer.
Vincristine Pfizer should only be administered by personnel experienced in vincristine treatment. Vincristine Pfizer must ONLY be given through a vein as either an intravenous injection (IV bolus ) or infusion (IV). Vincristine Pfizer should not be given into the spinal canal (intrathecal), into a muscle ( intramuscular ), or under the skin ( subcutaneous ).
Vincristine Pfizer should be given with caution if you have impaired liver function if you have a neuromuscular disease and during treatment with other neurotoxic drugs (drugs that can damage the nervous system). Elderly patients may be more sensitive to the neurotoxic effects of Vincristine Pfizer.
When chemotherapy is given in conjunction with radiotherapy to an area involving the liver, the use of vincristine should be delayed until the radiotherapy has been completed.
If after receiving Vincristine Pfizer you get symptoms such as a sore throat, fever, chills, or muscle pain (signs of a serious infection ), you should talk to your doctor, who may then want to adjust your treatment.
Tell me right away if you feel a stinging, burning redness, or swelling at the injection site when you are given Vincristine Pfizer. Such pain can occur if the medicine leaks outside the blood vessel and the injection must then be stopped.
The vial’s rubber stopper contains latex which can cause serious allergic reactions.
Other medicines and Vincristine Pfizer
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Vincristine Pfizer can affect or be affected by certain medicines that contain the following active substances:
- allopurinol (medicine against gout ), pyridoxine ( vitamin B6), and isoniazid (medicine against tuberculosis ) – can increase bone marrow inhibition, which leads to a reduced number of blood cells
- mitomycin ( antibiotic ) – can lead to acute spasm of the trachea and/or shortness of breath. These reactions occur either immediately or several hours after injection.
- dactinomycin ( cytostatic drug ) – severe hepatotoxicity has been reported in patients with kidney cancer
- phenytoin ( antiepileptic ) – can reduce the effect of vincristine
- L-asparaginase ( cytostatic ) – can lead to poisoning
- drugs that affect the peripheral nervous system can cause neurotoxicity in combination with vincristine
- medicines that affect hearing function, such as e.g. platinum-containing cancer drugs can if given in combination with vincristine, cause hearing damage
Caution is recommended if you also take drugs that are metabolized by the cytochrome P450 system in the liver, under CYP 3A e.g. itraconazole, fluconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, rifampicin, phenytoin, carbamazepine, St. John’s wort.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Caution is necessary when using Vincristine Pfizer during pregnancy. Vincristine is suspected of causing serious birth defects during pregnancy. During pregnancy, Vincristine Pfizer should only be given on strict indication and after the mother’s needs have been weighed against the risks to the fetus.
Breast-feeding
There is no information on whether Vincristine Pfizer passes into breast milk. Breastfeeding must be discontinued during ongoing vincristine treatment.
Fertility
Fertility (the ability to have children) can be impaired in both men and women given vincristine. Most of the time, this deterioration is temporary and fertility is restored a few months after treatment ends.
Women of childbearing age must use effective contraception during treatment with vincristine.
Driving ability and use of machinery
The medicine is not expected to affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to use Vincristine Pfizer
Vincristine Pfizer is given ONLY through a vein as either an intravenous injection (IV bolus ) or infusion (IV), with a one-week interval between treatments. The dose is determined by the doctor who adjusts it for you. Vincristine Pfizer may only be given by people who have experience with treatment with chemotherapy. The syringe must be correctly placed in the vein before the solution is injected. If something leaks into the tissue surrounding the syringe, it can cause severe irritation.
If you have used too much Vincristine Pfizer
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects that can occur during treatment with vincristine are:
- breathing difficulties
- heart attack (common symptoms are chest pain radiating to the neck and arm, shortness of breath, and cold sweat) (has been reported (to occur in an unknown number of users)
- convulsions followed by coma in children (reported uncommonly)
If any of these conditions occur, immediate contact with healthcare is required.
Other side effects that may occur:
Very common: affects more than 1 in 10 users:
- Reduced number of blood platelets, which increases the risk of bleeding or bruising.
- Decreased number of red blood cells, which can make the skin pale and cause weakness or shortness of breath (anemia).
- Low sodium levels in the blood, can cause confusion, muscle twitching, and abnormal heart rhythms.
- Weakness in the foot and ankle, which can lead to dropping foot or the foot hitting the ground with each step.
- Tingling and crawling in the skin.
- Constipation (difficulty emptying the bowels or delayed bowel emptying).
- Abdominal pains.
- Nausea or vomiting.
- Hair loss.
- Muscle pain.
- Skeletal pains.
- Weight loss.
Common (affects more than 1 in 100 users):
- Decreased number of white blood cells.
- Paralysis of cranial nerves (especially to the eye and vocal cord functions).
- Loss of deep tendon reflexes.
- Inability to coordinate muscle movements ( ataxia ).
- Numbness and tingling in fingers and toes.
- Nerve damage.
- Paralysis (paresis).
- Changes in blood pressure et.
- Sore throat.
- Absence of muscle reflexes in the small intestine (paralytic ileus ).
- Diarrhea.
- Jaw pain.
- Inability to empty the bladder ( urinary retention ).
- Injection site reactions.
Uncommon (affects 1 to 10 users in 1,000):
- Convulsions (especially in children).
- Headache.
- Mouth ulcers – inflammation of the mouth ( stomatitis ).
- Impaired ability to empty the bladder.
- Disturbance during urination, is often associated with burning and pain ( dysuria ).
- Fever.
Rare (affects 1 to 10 users in 10,000):
- Cellulite.
- Allergic reactions ( hypersensitivity reaction, redness, and swelling).
- Low sodium content in the blood (SIADH – delayed ADH secretion ).
- Temporary and permanent blindness.
- Damage to the balance and auditory nerve.
- Temporary or permanent deafness.
- Rash.
Has been reported (occurring in an unknown number of users):
- Blood poisoning.
- Infection.
- Neutropenic sepsis (occurrence of fever and other signs of infection in patients with unusually low white blood cell counts ).
- Granulocytopenia (significant decrease in granulocytes, a type of white blood cell ).
- Breakdown of red blood cells.
- Neutropenia (low white blood cell count ).
- Anorexia.
- Dehydration.
- Hyperuricemia (too much uric acid in the blood).
- Total paralysis (paralysis).
- Loss of sensation.
- Nerve pain.
- Involuntary, jerky movements of the eye.
- Balance difficulties.
- Dizziness.
- Vertigo (spinning sensation).
- Coronary artery disease.
- Shock lung (a condition that causes fluid to leak into the lungs and block oxygen from reaching the organs).
- Spasmodic constriction of the airways and shortness of breath have been reported with the concomitant use of another anticancer drug (mitomycin).
- Tissue death and/or holes through the intestinal wall.
- Pain in the salivary gland.
- Mouth ulcers.
- Stomach ulcer.
- Liver disease.
- Muscle wasting.
- Pain in arms or legs.
- Back pain.
- Impaired kidney function.
- Increased urine production.
- Gait disturbance.
- Difficulty walking.
Prophylactic measures should be taken to prevent constipation.
When the treatment is suspended, the side effects generally disappear after a few weeks to several months. However, muscle and nerve-related side effects may persist. Symptoms such as a pillowy feeling and crawling in the fingers and toes can persist for several months after exposure to treatment.
How to store Vincristine Pfizer
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C-8 °C). Store the vial in the outer carton. Light sensitive.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is vincristine sulfate 1 mg/ml
- Other ingredients are mannitol and water for injections
Appearance and package sizes of the medicine
Vincristine Pfizer 1 mg/ml solution for injection is packaged in glass vials. The glass bottle is enclosed in a protective plastic shrink film – Onco-Tain. This reduces the risk of contamination if the glass bottle breaks.
Vincristine Pfizer is available in pack sizes 5×1 ml and 5×2 ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer AB
191 90 Sollentuna
Telephone: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
Pfizer Service Company BVBA
Hoge Wei 10
1930 Zaventem
Belgium