Patient Medication Information: uses, side effects, how to take - Apo-Paclitaxel Injectable
ABOUT THIS MEDICATION
What the medication is used for:
APO-PACLITAXEL INJECTABLE belongs to a group of medicines called antineoplastic or cytotoxic drugs. APO-PACLITAXEL INJECTABLE is used alone or in combination with other medications to treat ovarian cancer, breast cancer, lung cancer and advanced AIDS-related Kaposi’s Sarcoma.
Sarcoma is a cancer that develops in connective tissues such as cartilage, bone, fat, muscle, blood vessels, or fibrous tissues. Lesions of AIDS-related Kaposi’s Sarcoma may arise on the skin and the mouth and may affect the lymph nodes and other organs, usually the stomach, intestines, lung, liver, and spleen.
What it does:
APO-PACLITAXEL INJECTABLE can kill a wide variety of cancer cells.
When it should not be used:
APO-PACLITAXEL INJECTABLE should not be used if you:
Have a history of severe allergic reactions to paclitaxel or
other drugs containing Cremophor EL /polyethoxylated castor oil.
Have severe baseline neutropenia (<1,500 cells/mm3) ie
abnormally low number of neutrophils, a type of white blood cells or have AIDS-related Kaposi's Sarcoma with baseline or subsequent neutrophil counts of <1,000 cells/mm3.
What the medicinal ingredient is:
Paclitaxel
What the non-medicinal ingredients are:
Polyoxyethylated castor oil, citric acid and dehydrated alcohol.
What dosage forms it comes in:
Injection, 6 mg/mL in multidose vials of 5 mL, 16.7 mL, 25 mL and 50 mL.
WARNINGS AND PRECAUTIONS
Before starting your treatment with APO-PACLITAXEL INJECTABLE, you should receive a treatment with corticosteroids and antihistamines, to minimize the hypersensitivity (allergic) reactions you may experience during treatment with APO-PACLITAXEL INJECTABLE.
Before taking APO-PACLITAXEL INJECTABLE talk to your doctor if:
- You have or have had liver disease.
- You have heart disease.
You are pregnant or may get pregnant. In pregnant women, the use of APO-PACLITAXEL INJECTABLE may cause harm to the unborn baby.
- You are breast-feeding. Breast-feeding should be discontinued for the duration of paclitaxel therapy.
- You have ever had any allergy to paclitaxel or other drugs containing Cremophor EL/ polyoxyethylated castor oil.
You must take adequate contraceptive precautions during treatment with APO- PACLITAXEL INJECTABLE. If pregnancy occurs during your treatment, immediately inform your doctor.
Since APO-PACLITAXEL INJECTABLE contains ethanol, it might affect your ability to drive or operate machinery. Children may be more sensitive than adults to the effects of ethanol.
INTERACTIONS WITH THIS MEDICATION
The following drugs may cause interactions when given along with paclitaxel: cisplatin, ketoconazole, verapamil, diazepam, quinidine, dexamethasone, cyclosporine, teniposide, etoposide, vincristine, testosterone, 17 α-ethinyl estradiol, retinoic acid, quercetin, montelukast, doxorubicin, ritonavir, saquinavir, indinavir and nelfinavir.
PROPER USE OF THIS MEDICATION
APO-PACLITAXEL INJECTABLE should be administered under the supervision of a doctor. Before starting your treatment with APO-PACLITAXEL INJECTABLE, you should receive a treatment with corticosteroids and antihistamines.
APO-PACLITAXEL INJECTABLE will be administered as a diluted infusion intravenously (into a vein).
During treatment, your blood count will be monitored. You may have additional tests performed.
Usual Dose:
- For the treatment of ovarian cancer, breast cancer or lung cancer, paclitaxel is administered intravenously over 3 hours every 3 weeks.
For the treatment of AIDS-related Kaposi’s Sarcoma,
paclitaxel is administered intravenously over 3 hours with a 2-3 week interval between courses.
Overdose:
As APO-PACLITAXEL INJECTABLE is given to you under the supervision of your doctor, it is unlikely that you will receive too much medication. However, if you experience severe side effects after being given the medication, tell your doctor immediately. You may need urgent medical attention. (Refer to side effects section.)
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The following side effects are very common and have been reported with the use of paclitaxel:
- Alopecia (hair loss)
- Nausea
- Vomiting
- Diarrhea
Mucositis (inflammation of the inner membranes of the
mouth, throat, stomach and intestines).
- Injection site reactions
Injection site reactions are usually mild and consist of redness, tenderness, skin discoloration, or swelling at the injection site. Recurrence of skin reactions at the site of reaction is rare.
Other side effects include nail changes (changes in pigmentation or discoloration of nail bed), however are uncommon.
Low blood pressure or decreased heartbeat has been observed during paclitaxel administration.
Joint and muscle pain may occur two or three days after paclitaxel administration and resolve within a few days.
The most frequent significant undesirable effect of paclitaxel is bone marrow suppression (reduction in the number of blood cells). Because APO-PACLITAXEL INJECTABLE may lower your number of blood cells leading to neutropenia (decrease in white blood cells), you may be less able to fight infections. You may experience weakness, fever and infections (e.g. urinary tract infections, upper respiratory infections.
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk with your doctor or pharmacist | Your medication should be withheld or stopped | |
| Only if severe | In all cases | ||
Allergic reactions such as flushing, rash Severe allergic reactions | 9 | 9 | |
| Light-headedness, dizziness or fainting | 9 | ||
| Swelling | 9 | ||
Weakness or tiredness more than usual | 9 | ||
| Fever, sore throat, urinary and upper respiratory infections | 9 | ||
| Bleeding, bruising | 9 | ||
Sensation of numbness, pins or needles in the arms and legs | 9 | ||
| Seizures | 9 | ||
| Change in vision | 9 | ||
| Hearing loss and ringing noise in the ears | 9 | ||
| Swollen ankles, shortness of breath | 9 | ||
| Change in heartbeat | 9 |
This is not a complete list of side effects. For any unexpected effects while taking APO-PACLITAXEL INJECTABLE, contact your doctor or pharmacist.
HOW TO STORE IT
APO-PACLITAXEL INJECTABLE should be stored at room temperature (15-25°C). 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:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Health Canada
Address Locator: 0201C2
Ottawa, ON K1A 1B9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional. This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service, at 1-800-667-4708. This leaflet can also be found at http://www.apotex.ca/products.
Date of Revision: March 3, 2006