Patient Medication Information: uses, side effects, how to take - Paclitaxel for Injection (Teva Canada)
ABOUT THIS MEDICATION
What the medication is used for:
PACLITAXEL FOR INJECTION is a prescription cancer medicine. It is injected into a vein and it is used to treat different types of tumors. The tumors include advanced ovary and breast cancer. The tumors also include certain lung cancers (non-small cell) in people who cannot have surgery or radiation therapy. PACLITAXEL FOR INJECTION may also be used to treat AIDS-related Kaposi’s sarcoma.
What it does:
Under normal conditions, the cells in your body divide and grow in an orderly, controlled way. Cell division and growth are necessary for the human body to perform its functions and to repair itself, when necessary. Cancer cells are different from normal cells because they are not able to control their own growth. The reasons for this abnormal growth are not yet fully understood.
A tumor is a mass of unhealthy cells that are dividing and growing fast and in an uncontrolled way. When a tumor invades surrounding healthy body tissue it is known as a malignant tumor. A malignant tumor can spread (metastasize) from its original site to other parts of the body if not found and treated early.
PACLITAXEL FOR INJECTION is a type of medical treatment called chemotherapy. The purpose of chemotherapy is to kill cancer cells or prevent their growth.
All cells, whether they are healthy cells or cancer cells, go through several stages of growth. During one of the stages, the cell starts to divide. PACLITAXEL FOR INJECTION may stop the cells from dividing and growing, so they eventually die. In addition, normal cells may also be affected by PACLITAXEL FOR INJECTION causing some of the side effects. (See SIDE EFFECTS AND WHAT TO DO ABOUT THEM, below.)
When it should not be used:
Patients who have a history of hypersensitivity (allergic reactions) to PACLITAXEL FOR INJECTION or other drugs containing Cremophor® EL* (macrogolglycerol ricinoleate), like cyclosporine or teniposide, should not be given PACLITAXEL FOR INJECTION.
In addition, PACLITAXEL FOR INJECTION should not be given to patients with dangerously low white blood cell counts.
What the medicinal ingredient is:
Paclitaxel
What the nonmedicinal ingredients are:
Each mL of PACLITAXEL FOR INJECTION contains paclitaxel 6 mg, macrogolglycerol ricinoleate (Cremophor) 527 mg, dehydrated ethanol 49.7% v/v and anhydrous citric acid 2 mg.
What dosage forms it comes in:
PACLITAXEL FOR INJECTION is available in multidose vials of 5 mL and 16.7 mL and pharmacy bulk vial of 50 mL containing respectively 30 mg, 100 mg and 300 mg paclitaxel at a concentration of 6 mg/mL.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
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BEFORE you use PACLITAXEL FOR INJECTION talk to your doctor or pharmacist if:
you are pregnant, become pregnant or plan to become pregnant while taking PACLITAXEL FOR INJECTION. PACLITAXEL FOR INJECTION could harm the unborn child when given to a pregnant woman. Women should avoid becoming pregnant while they are undergoing treatment with PACLITAXEL FOR INJECTION.
you are nursing a baby while taking PACLITAXEL FOR INJECTION. Studies have shown PACLITAXEL FOR
INJECTION to be present in the breast milk of animals receiving the drug, it may be present in human breast milk as well. Therefore, nursing a baby while taking PACLITAXEL FOR INJECTION is NOT recommended.
The safety and effectiveness of paclitaxel in paediatric patients have not been established. PACLITAXEL FOR INJECTION contains dehydrated alcohol; consideration should be given to possible CNS and other effects of ethanol. Children may be more sensitive than the adults to the effects of ethanol.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with PACLITAXEL FOR INJECTION including:
Cisplatin
Doxorubicin
If you are taking any other medication on prescription or over the counter, let your doctor know before start of the therapy. Drug interactions with foods, herbal products, homeopathic preparations, and laboratory tests have not been established.
PROPER USE OF THIS MEDICATION
Usual dose:
The dose you are given depends on how big you are. It varies with your body surface area. Technically this is measured in square metres (m2), but actually is worked out from your height and weight.
PACLITAXEL FOR INJECTION is injected into a vein [intravenous (I.V.) infusion]. Before you are given PACLITAXEL FOR INJECTION, you will have to take certain medicines (premedications) to prevent or reduce the chance you will have a serious allergic reaction. Such reactions have occurred in a small number of patients while receiving PACLITAXEL FOR INJECTION and have been rarely fatal. Your doctor will tell you about complete information on pretreatment with other drugs. (See SIDE EFFECTS AND WHAT TO DO ABOUT THEM, below)
Overdose:
In the case of an overdose your doctor will stop the therapy and treat the symptoms.
Missed Dose:
Your doctor will set the times at which you are to receive this medicine. If you think you may have missed a dose, contact your doctor as soon as possible.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Most patients taking PACLITAXEL FOR INJECTION experience side effects, although it is not always possible to tell whether such effects are caused by PACLITAXEL FOR INJECTION another medicine they may be taking, or the cancer itself.
Allergic reactions. Allergic reactions can vary in degrees of severity. They may cause death in rare cases. When a severe allergic reaction develops, it usually occurs at the time the medicine is entering the body (during PACLITAXEL FOR INJECTION infusion). Allergic reactions may cause trouble breathing, very low blood pressure, sudden swelling, and/or hives or rash. The likelihood of a serious allergic reaction is lowered by the use of several kinds of medicines that are given to you before the PACLITAXEL FOR INJECTION (paclitaxel) Injection infusion.
Heart and blood vessel (cardiovascular) effects. PACLITAXEL FOR INJECTION may cause a drop in heart rate (bradycardia) and low blood pressure (hypotension). The patient usually does not notice these changes. These changes usually do not require treatment. Your heart function, including blood pressure and pulse, will be monitored while you are receiving the medicine. You should notify your doctor if you have a history of heart disease.
Infections due to low white blood cell count. Among the body’s defenses against bacterial infections are white blood cells. Between your PACLITAXEL FOR INJECTION treatment cycles, you will often have blood tests to check your white blood cell counts. PACLITAXEL FOR INJECTION usually causes a brief drop in white blood cells. If you have a fever (temperature above 38°C) or other sign of infection, tell your doctor right away. Sometimes serious infections develop that require treatment in the hospital with antibiotics. Serious illness or death could result if such infections are not treated when white blood cell counts are low.
Hair loss. Complete hair loss, or alopecia, almost always occurs with PACLITAXEL FOR INJECTION. This usually involves the loss of eyebrows, eyelashes, and pubic hair, as well as scalp hair. It can occur suddenly after treatment has begun, but usually happens 14 to 21 days after treatment. Hair generally grows back after you’ve finished your PACLITAXEL FOR INJECTION treatment.
Joint and muscle pain. You may get joint and muscle pain a few days after your PACLITAXEL FOR INJECTION treatment. These symptoms usually disappear in a few days. Although pain medicine may not be necessary, tell your doctor if you are uncomfortable.
Irritation at the injection site. PACLITAXEL FOR INJECTION sometimes causes irritation at the site where it enters the vein. Reactions may include discomfort, redness, swelling, inflammation (of the surrounding skin or of the vein itself), and ulceration (open sores). These reactions are usually caused by the I.V. (intravenous) fluid leaking into the surrounding area. If you notice anything unusual at the site of the injection (needle), either during or after treatment, tell your doctor right away.
Low red blood cell count. Red blood cells deliver oxygen to tissues throughout all parts of the body and take carbon dioxide from the tissues by using a protein called hemoglobin. A lowering of the volume of red blood cells may occur following PACLITAXEL FOR INJECTION treatment causing anemia. Some patients may need a blood transfusion to treat the anemia. Patients can feel tired, tire easily, appear pale, and become short of breath. Contact your doctor if you experience any of these symptoms following PACLITAXEL FOR INJECTION treatment.
Mouth or lip sores (mucositis). Some patients develop redness and/or sores in the mouth or on the lips. These symptoms might occur a few days after the PACLITAXEL FOR INJECTION treatment and usually decrease or disappear within one week. Talk with your doctor about proper mouth care and other ways to prevent or reduce your chances of developing mucositis.
Numbness, tingling, or burning in the hands and/or feet (neuropathy). These symptoms occur often with PACLITAXEL FOR INJECTION and usually get better or go away without medication within several months of completing treatment. However, if you are uncomfortable, tell your doctor so that he/she can decide the best approach for relief of your symptoms.
Stomach upset and diarrhea. Some patients experience nausea, vomiting, and/or diarrhea following PACLITAXEL FOR INJECTION use. If you experience nausea or stomach upset, tell your doctor. Diarrhea will usually disappear without treatment; however, if you experience severe abdominal or stomach area pain and/or severe diarrhea, tell your doctor right away.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
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| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Stomach upset, nausea, vomiting, and/or diarrhea | Τ | ||
| Low red blood cell count, anemia, feel tired, tire easily, appear pale, and become short of breath. | Τ | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||||
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| Numbness, tingling, or burning in the hands and/or feet (neuropathy). | Τ | |||||
| Irritation at the injection site. Reactions may include discomfort, redness, swelling, inflammation (of the surrounding skin or of the vein itself), and ulceration (open sores). | Τ | Τ | ||||
| Joint and muscle pain. | Τ | |||||
| Hair loss. Complete hair loss, or alopecia, loss of eyebrows, eyelashes, and pubic hair, as well as scalp hair. | Τ | |||||
| Heart and blood vessel (cardiovascular) effects, drop in heart rate (bradycardia) and low blood pressure (hypotension). | Τ | |||||
| Allergic reactions. trouble breathing, very low blood pressure, sudden swelling, and/or hives or rash. | Τ | Τ | ||||
Talk with your doctor or other healthcare professional to discuss ways to prevent or reduce some of these side effects
This is not a complete list of side effects. For any unexpected effects while taking PACLITAXEL FOR INJECTION, contact your doctor or pharmacist.
HOW TO STORE IT
Store all drugs properly and keep them out of the reach of children.
The expiry date is printed on the label. Do not use after this date.
PACLITAXEL FOR INJECTION should be stored at room temperature (15-30oC). Retain in the original package and protect from light.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by: toll-free telephone: 866-234-2345 toll-free fax 866-678-6789 By email: cadrmp@hc-sc.gc.ca By regular mail: National AR Centre Marketed Health Products Safety and Effectiveness Information Division Marketed Health Products Directorate Tunney’s Pasture, AL 0701C Ottawa ON K1A 0K9 NOTE: Before contacting Health Canada, you should contact your physician or pharmacist. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at: 1-800-268-4127 ext. 5005
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9