Patient Medication Information: uses, side effects, how to take - Paclitaxel Injection, USP

ABOUT THIS MEDICATION

What the medication is used for?

This medicine is used to treat:

Ovarian cancer
Breast cancer
Lung cancer
AIDS- related Kaposi’s Sarcoma

What it does?

This medicine belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines.

It works by killing cancer cells and stopping cancer cells from growing and multiplying.

When it should not be used?

If you have an allergy to:

any medicine containing paclitaxel
any of the ingredients listed at the end of this leaflet
any medicines containing PEG 35 castor oil (Cremophor^®EL), such as cyclosporin injection or teniposide injection.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

You must not be given this medicine if you have a very low white blood cell (WBC) count.

Tell your doctor if you have an infection or high temperature. Your doctor may decide to delay your treatment until the infection has gone. A mild illness, such as a cold, is not usually a reason to delay treatment.

If you are pregnant or plan to become pregnant.

What the medicinal ingredient is?

Paclitaxel

What the important nonmedicinal ingredients are?

Anhydrous citric acid, polyoxyl 35 castor oil, dehydrated alcohol.

What dosage forms it comes in?

PACLITAXEL INJECTION, USP 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

Should only be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Patients should be pre-treated with corticosteroids, antihistamines, and H2 antagonists. Should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm³.

BEFORE you use PACLITAXEL INJECTION, USP always talk to your doctor or pharmacist especially if:

you have or have had any of the following medical conditions:
- liver disease
- heart problems
- any blood disorder with a reduced number of red blood cells, white blood cells, or platelets
- any disease of the nerves
- lowered immunity due to diseases such as HIV/AIDS
- lowered immunity due to treatment with medicines such as cyclosporin, or other medicines used to treat cancer (including radiation therapy)
you are pregnant or plan to become pregnant
you are breast-feeding or plan to breast-feed
you have any allergies to this drug or its ingredients
you are receiving radiation therapy
you have experienced symptoms of pseudomembranous colitis (severe or persistent diarrhea that may be watery or bloody, abdominal cramps, fever, pus or mucous in your stool, nausea)
you have experienced symptoms of mucositis (red or swollen mouth and gums, blood or sores in mouth, soreness or pain in mouth or throat, difficulty swallowing or talking, feeling of dryness or pain while eating)

INTERACTIONS WITH THIS MEDICATION

Paclitaxel for Injection interacts with other drugs. Before therapy, talk to your doctor if you are using any other medications (prescription, non-prescription or herbal remedies).

Drugs that may interact with Paclitaxel for Injection include: cisplatin, doxorubicin cimetidine, ketoconazole, verapamil, diazepam, quinidine, dexamethasone, cyclosporine, teniposide, etoposide, vincristine, testosterone, 17 α -ethinyl estradiol, retinoic acid, quercetin, deferasirox, and trimethoprim.

The herbal remedy, St. John’s Wort may also interact with paclitaxel.

PROPER USE OF THIS MEDICATION

Usual dose:

Your doctor will decide what dose of Paclitaxel for Injection you will receive. This depends on your condition and other factors, such as your weight and other chemotherapy medicines you are being given. If you are being treated for Kaposi’s sarcoma, PACLITAXEL INJECTION, USP will be administered at a dose of 135mg/m² with a three week interval between courses or 100mg/m² with a two week interval between courses.

Before you are given Paclitaxel for Injection, you must take some other medicines to prevent allergic reactions occurring during your treatment. You will need to take dexamethasone tablets 12 hours and six hours before your treatment, which your doctor will prescribe for you. You will also be given two different injections 30 to 60 minutes prior to receiving Paclitaxel for Injection. This will minimize the risk of allergic reactions occurring.

Several courses of Paclitaxel for Injection therapy may be needed depending on your response to treatment.

Additional treatment may not be repeated until your blood cell numbers return to acceptable levels and any uncontrolled effects have been controlled. Your doctor will decide.

Overdose:

As Paclitaxel for Injection is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience severe side effects after being given this medicine, tell your doctor or nurse immediately. You may need urgent medical attention.

Symptoms of overdose include the side effects listed below in the ‘Side Effects’ section but are usually of a more severe nature.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Tell your doctor if you notice any of the following and they worry you:

muscle or joint pain on the arms and legs
nausea and vomiting
- hair loss
- diarrhoea
- changes in skin or nail appearance
- soreness or ulceration of the mouth.

The above list includes the more common side effects of your medicine.

In addition, you should have a complete eye and vision examination in case of vision problems. If cystoid macular edema (blurred vision due to swelling of the retina within the eye) is diagnosed, your doctor may stop your treatment.

SERIOUS SIDE EFFEC TS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect		Talk with your doctor or pharmacist				Stop taking drug and get immediate medical help.
Symptom / effect		Only if severe		In all cases
Common	pain, swelling, irritation and redness at the injection site		√
	flushing		√
	light-headedness, dizziness or fainting (due to low blood pressure)		√
	numbness or tingling in the fingers and / or toes		√
	changes in vision		√
	abdominal pain		√
	shortness of breath, wheezing or difficulty breathing				√
	swelling of the face, lips, tongue, or other parts of the body				√
	rash, itching or hives on the skin				√
	extreme weakness or tiredness				√
	seizures (fits)				√
	fast, slow or irregular heart beat				√
	chest pain				√
	yellowing of the skin or eyes				√
	unusual bleeding or bruising (including blood in your stools or urine)				√
	fever, sore throat or other signs of infection.				√
Uncommon	myocardial						√

SERIOUS SIDE EFFEC TS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect	Talk with your doctor or pharmacist	Stop taking drug and get immediate medical help.

Only if severe	In all cases
infarction (severe chest pains possibly radiating to the jaw or arm, sweating, breathlessness and nausea)

grand mal seizures (loss of consciousness and violent muscle contractions), ataxia (lack of muscle group), encephalopathy (effect on the brain) Cardiomyopathy (a disease of the heart muscle) pseudomembranous colitis (severe or persistent diarrhea that may be watery or bloody, abdominal cramps, fever, pus or mucous in your stool, nausea) acute myeloid leukemia or myelodysplastic syndrome (fever, infection, bruising or bleeding easily, breathlessness, blood in urine or stool) tumor lysis syndrome (nausea, shortness of breath, irregular heartbeat, cloudy urine, tiredness, or pain in joints) respiratory failure (sudden worsening or shortness of breath, bluish color on skin, lips, and fingernails, irregular heartbeats, feel sleepy, loss of consciousness) erythema multiforme (rapid formation of a rash followed by the appearance of skin lesions that start on the backs of hands
√ √ √
√ √ √ √ √

SERIOUS SIDE EFFEC TS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect	Talk with your doctor or pharmacist	Stop taking drug and get immediate medical help.

Only if severe

In all cases

and tops of feet before spreading to the trunk)
dermatitis exfoliative (severe skin peeling)
systemic lupus erythematosus (an autoimmune disorder that may affect your skin, joints, kidneys, brain, and other organs)
sclerodema (hardening of the skin and connective tissues (the fibers that provide the framework and support for your body)

√

This is not a complete list of side effects. For any unexpected effects while taking PACLITAXEL INJECTION, USP, contact your doctor or pharmacist.

HOW TO STORE IT

PACLITAXEL INJECTION, USP will be stored in the pharmacy or on the ward. The injection should be stored at room temperature (15-30°C). Retain in the original package and protect from light.

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 (https://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 document can be found at www.mylan.ca.

This full Product Monograph prepared for health professionals, can be obtained by contacting the sponsor Mylan Pharmaceuticals ULC at 1-844 596-9526.

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-844-596-9523

www.mylan.ca

Rx or OTC	Prescription (Rx)?
DIN	02408074
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Paclitaxel 6 MG
Dosage form(s)	Solution
Route(s) of administration	Intravenous
Drug class (WHO ATC)	L Antineoplastic and immunomodulating agents L01 Antineoplastic agents L01C Plant alkaloids and other natural products, antineoplastic drugs L01CD Taxanes, antineoplastic L01CD01 Paclitaxel
Company	MYLAN PHARMACEUTICALS ULC
Current status	Cancelled Pre Market
Current status date	February 24, 2022

Paclitaxel Injection, USP: Uses, Side Effects and Dosage