Doxorubicin Hydrochloride Injection (Sandoz Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Doxorubicin Hydrochloride Injection 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 Hydrochloride Injection is administered directly in the bladder.

What it does:

Doxorubicin Hydrochloride Injection is a chemotherapy drug, often used in combination with other drugs to kill cancer cells. Most chemotherapy agents (including Doxorubicin Hydrochloride Injection) 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 hydrochloride or to any ingredient in the formulation or component of the container of Doxorubicin Hydrochloride Injection;
• 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 anthracycline 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 important non-medicinal ingredients are:

Sodium chloride, water for injection and hydrochloric acid for pH adjustment.

What dosage form it comes in:

Doxorubicin Hydrochloride Injection is available in 10 mg (5 mL), 50 mg (25 mL) and 200 mg (100 mL) contained in glass vials.

WARNINGS AND PRECAUTIONS

BEFORE you use Doxorubicin Hydrochloride Injection 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 Hydrochloride Injection or other anti-cancer drugs, including anthracyclines (cardiotoxic drugs);
• you are pregnant, breast-feeding or planning to become pregnant.

As Doxorubicin Hydrochloride Injection may be harmful to an unborn child, women should be advised to avoid becoming pregnant. Effective contraceptive methods should be used.

As Doxorubicin Hydrochloride Injection may cause fertility impairment and damage chromosomes in sperm, men undergoing treatment with Doxorubicin Hydrochloride Injection 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 Hydrochloride Injection 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

How is Doxorubicin Hydrochloride Injection given?

You may receive Doxorubicin Hydrochloride Injection 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 Hydrochloride Injection 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 Hydrochloride Injection?

It usually takes about 3-10 minutes to inject Doxorubicin Hydrochloride Injection. However, you may get other medicines before or after Doxorubicin Hydrochloride Injection, so your entire treatment may last an hour or longer.

If you are administered Doxorubicin Hydrochloride Injection 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 Hydrochloride Injection is usually given in treatment cycles of 21 days or 28 days. You may receive 1 dose of Doxorubicin Hydrochloride Injection every 3 or 4 weeks (on Day 1 of the cycle). Alternately, you may also receive Doxorubicin Hydrochloride Injection 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 Hydrochloride Injection 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 Hydrochloride Injection. Tell your doctor right away if you become pregnant during treatment. If you have been nursing, you should stop before starting treatment with Doxorubicin Hydrochloride Injection. Ask your baby’s doctor to recommend a formula that would be best for your baby.

What should men consider when taking Doxorubicin Hydrochloride Injection?

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.

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 Hydrochloride Injection 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 Hydrochloride Injection 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 Hydrochloride Injection can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. For any unexpected effects while taking Doxorubicin Hydrochloride Injection contact your doctor or pharmacist.

HOW TO STORE IT

Doxorubicin Hydrochloride Injection should be stored under refrigeration (2-8^oC), protected from light and retained in carton until time of use. Discard unused solution.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Report online at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html

Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 1908C

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062

or

by written request at:

110 rue de Lauzon

Boucherville QC

J4B 1E6

or by e-mail at:

medinfo@sandoz.com

Last revised: June 26, 2019.