Details for: DOXORUBICIN INJECTION, BP
Company: ACCORD HEALTHCARE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02381982 | DOXORUBICIN INJECTION, BP | DOXORUBICIN HYDROCHLORIDE | 2 MG / ML | SOLUTION | INTRAVENOUS |
| 02381982 | DOXORUBICIN INJECTION, BP | DOXORUBICIN HYDROCHLORIDE | 2 MG / ML | SOLUTION | INTRAVESICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Doxorubicin Injection, BP is used alone and in combination
with other anti-cancer medication to produce regression of
tumor in several cancer conditions.
For the treatment of superficial bladder tumor, Doxorubicin
Injection, BP is administered directly in the bladder.
What it does
Doxorubicin Injection, BP is a chemotherapy drug, often used in combination with other drugs to kill cancer cells. Most chemotherapy agents (including Doxorubicin Injection, BP) work by killing rapidly dividing cells, such as cancer cells. This action can affect normal cells as well.
When it should not be used
- For intravenous administration:
- Allergy to Doxorubicin Injection, BP or to any ingredient in the formulation or component of the container of Doxorubicin injection, BP;
- Allergy to other anthracyclines or anthracenediones such as epirubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone or mitomycin C;
- Persistent low blood cell count (myelosuppression);
- Severe liver disease;
- Severe heart disease;
- Recent heart attack;
- Severe irregular heartbeat;
- History of severe cardiac disease;
- Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin and/or other anthracyclines and anthracenediones. Accumulation of anthracyclines doses may be harmful for your heart.
For intravesical administration:
- Blood in urine;
- Urinary tract infections;
- Inflammation of the bladder.
What the medicinal ingredient is
Doxorubicin hydrochloride
What the non-medicinal ingredients are
Sodium Chloride Ph.Eur.
Water for Injection Ph.Eur and
Hydrochloric Acid Ph.Eur for pH adjustment.
What dosage form it comes in
Doxorubicin Injection, BP 2 mg/mL is available in 10 mg (5 mL), 50 mg (25 mL) and 200 mg (100 mL) contained in glass Vials.
Warnings and precautions
Serious Warnings and Precautions
- Doxorubicin Injection, BP should be given under the supervision of a doctor experienced with the use of anticancer drugs.
- Doxorubicin Injection, BP should not be given to you by doctors or nurses experienced in giving chemotherapy.
- If you take Doxorubicin Injection, BP, you may get: Damage to the heart muscle called heart failure. It is a decreased ability of the heart muscle to pump properly. This can lead to shortness of breath, swelling of the legs, irregular heart beat and sudden death. You are more likely to develop this as the dose is increased. It may occur during treatment or up to several years later.
- Risk of new cancers. You are at increased risk for getting certain blood cancers. They are called acute secondary myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). This can happen 1 to 3 years after treatment with ADRIAMYCIN PFS. It is more common if you take it at higher doses or with other cancer treatments. This risk also applies to children.
- Tissue damage. Doxorubicin Injection, BP will cause damage if it leaks out of your vein underneath your skin. You may get blisters or sores that require skin grafts. If it hurts, burns or stings in or around the vein into which the drug is being injected tell the doctor or nurse IMMEDIATELY.
- Low blood cell counts. Doxorubicin Injection, BP can cause a severe decrease in the number of white blood cells, red blood cells, and platelets. This means that you may bruise or bleed more easily, go into shock and need blood transfusions. You may get fever, serious infection, and need treatment in a hospital. Low blood cell counts can lead to death. Your doctor will check your blood cell counts during your treatment and after you stop it. Call your doctor right away if you get severe bleeding, fever or chills with shivering.
- Risk of liver problems. Tell your doctor if you have a history of liver disease. You should not take Doxorubicin Injection, BP if you have a severe liver disease.
BEFORE you use Doxorubicin Injection, BP talk to your doctor or pharmacist if:
- you have low blood cell counts; you have a liver disease;
- you have a heart disease, recent heart attack or irregular heartbeat;
- you are taking other drugs (including calcium channel blockers) or have been previously treated with Doxorubicin Injection, BP or other anti-cancer drugs, including anthracyclines (cardiotoxic drugs);
- you are pregnant, breast-feeding or planning to become pregnant.
As Doxorubicin Injection, BP may be harmful to an unborn
child, women should be advised to avoid becoming pregnant.
Effective contraceptive methods should be used.
As Doxorubicin Injection, BP may cause fertility
impairment and damage chromosomes in sperm, men
undergoing treatment with Doxorubicin Injection, BP
should use effective contraceptive methods.
Interactions with this medication
Combination chemotherapy regimens that contain other
agents with similar action may lead to additive toxicity,
especially with regard to bone marrow/hematologic,
gastrointestinal, and cardiac effects.
Administration of live vaccines to immunosuppressed
patients including those undergoing cytotoxic chemotherapy
should be avoided.
Drug interactions with Doxorubicin Injection, BP and the following drugs have been reported in the literature:
- Paclitaxel;
- Phenobarbital;
- Phenytoin; Streptozocin;
- Cyclophosphamide;
- Cyclosporine;
- 6-mercaptopurine;
- Actinomycin-D.
Proper use of this medication
You may receive Doxorubicin Injection, BP through a vein
in the arm (“intravenously” or “IV”) by your doctor or nurse,
usually in the hospital, outpatient department or clinic.
If you are getting many injections over several weeks or
months, for your convenience, your doctor may insert a
catheter (thin tube) or port into a large vein in your body that
is placed there as long as it is needed. Medicines get
injected through the catheter or port rather than directly into
a vein.
Depending on your medical condition, you may also receive
Doxorubicin Injection, BP by instillation into your bladder
through a catheter inserted into the urinary natural tract.
How much time does it take to get a treatment with
Doxorubicin Injection, BP?
It usually takes about 3-10 minutes to inject Doxorubicin
Injection, BP. However, you may get other medicines
before or after Doxorubicin Injection, BP, so your entire
treatment may last an hour or longer.
If you are administered Doxorubicin Injection, BP by
instillation into your bladder, the solution should generally
be retained in your bladder for 1-2 hours prior to voiding.
How long will I need treatment?
Your doctor will determine the length of your treatment
based on your medical condition, your treatment goals, the
medicines you receive, and how your body responds to
those medicines.
Chemotherapy is usually given in cycles that include rest
periods between treatments. The rest periods give your
body a chance to build healthy new cells and regain your
strength before your next treatment. Doxorubicin
Injection, BP is usually given in treatment cycles of 21
days or 28 days. You may receive 1 dose of Doxorubicin
Injection, BP every 3 or 4 weeks (on Day 1 of the cycle).
Alternately, you may also receive Doxorubicin Injection,
BP instilled into your bladder weekly for 4 weeks and then
monthly. Your treatment cycle will depend on your
medical condition and the other chemotherapy medicines
you are getting.
Will I be able to work?
Some people work full time, while others work part
time or wait until their chemotherapy treatments are
finished. It depends on the type of job you have and the
side effects you experience.
Is it okay to become pregnant or nurse a baby?
No. Doxorubicin Injection, BP can be harmful to an unborn
child.
If there is any possibility that you may become pregnant,
ask your doctor about using birth control to prevent
pregnancy during your treatment with Doxorubicin
Injection, BP. Tell your doctor right away if you become
pregnant during treatment. If you have been nursing, you
should stop before starting treatment with Doxorubicin
Injection, BP. Ask your baby’s doctor to recommend a
formula that would be best for your baby.
What should men consider when taking Doxorubicin
Injection, BP?
Men undergoing treatment with doxorubicin should
use effective contraceptive methods.
What happens after treatment? After you have completed all your chemotherapy treatments, your doctor will check you regularly to make sure the cancer has not returned.
Usual Dose
Overdose
Missed Dose
If you miss your scheduled treatment with the drug, contact your doctor as soon as possible to schedule your next treatment.
Side effects and what to do about them
Like all medicines, Doxorubicin Injection, BP can have side effects.
Common side effects include:
- hair loss, which is temporary and usually starts to grow back within 2 or 3 months after you have finished your treatments.
- increased risk of infection, as a result of low white blood cell count. The signs of infection include fever over 38°C (100°F), chills or sweating, sore throat or coughing, redness or swelling around a cut, wound or a catheter site, a burning feeling when you urinate, unusual vaginal itching or discharge.
- nausea and vomiting,
- fatigue, or feeling tired.
- mouth sores.
- Red coloration of your urine for 1 to 2 days after administration during active therapy
Rare side effects include:
- Severe adverse events such as local tissue damages due to leakage of Doxorubicin Injection, BP from your vein into surrounding tissues with intravenous injection might be observed.
- Damage to the heart muscle, which can cause symptoms such as shortness of breath, swelling in the ankles, and fluid retention. If you have these symptoms, call your doctor right away. There are medicines to treat this condition.
Doxorubicin Injection, BP can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | |
|---|---|---|---|
| Common | |||
| anorexia | ✔ | ||
| diarrhea | ✔ | ||
| infection | ✔ | ||
| hemorrhage | ✔ | ||
| irregular heartbeat, chest pain, swelling of the ankles, shortness of breath / cardiac problems | ✔ | ||
| pain at the site of the injection rash/itch/redness/ skin allergy | ✔ | ||
| Uncommon | |||
| loss of monthly periods | ✔ | ||
| allergy/anaphylaxis | ✔ | ||
| blood clot | ✔ | ||
| digestive inflammation, digestive tract bleeding (bloody stools, bloody vomit), color change of the oral mucosa | ✔ | ||
| dehydration | ✔ | ||
| hot flashes | ✔ | ||
| shock | ✔ | ||
| skin and nail changes , tingling sensation, urticaria | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Doxorubicin Injection, BP, contact your doctor or pharmacist.
How to store
Doxorubicin Injection, BP 2 mg/mL shall be stored under refrigeration (2-8°C), protected from light and retained in carton until time of use. Discard unused solution.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This leaflet is part III of a three-part "Product Monograph" published when Doxorubicin Injection, BP was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about Doxorubicin Injection, BP. Contact your doctor or pharmacist if you have any questions about the drug.
If you want more information about Doxorubicin Injection, BP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website health-products.canada.ca/dpd-bdpp/indexeng.jsp; or by calling the sponsor Accord Healthcare Inc. at 1-866-296-0354.
This leaflet was prepared by:
Accord Healthcare Inc.
3535 Boul. St. Charles, suite 704
Kirkland, Québec
H9H 5B9
Last revised: November 19, 2018