pegylated liposomal DOXOrubicin

Trade Name:

Caelyx®

Other Names:

Caelyx®

Synonym:

Doxorubicin Hydrochloride Pegylated Liposomes

Appearance:

Red coloured liquid mixed into larger bags of fluids

Monograph Name:

pegylated liposomal DOXOrubicin

Monograph Body:

Drug Monograph

A - Drug Name

pegylated liposomal DOXOrubicin

SYNONYM(S): Doxorubicin Hydrochloride Pegylated Liposomes

COMMON TRADE NAME(S): Caelyx®

B - Mechanism of Action and Pharmacokinetics

Pegylated liposomal doxorubicin is doxorubicin hydrochloride encapsulated in long-circulating liposomes, microscopic vesicles composed of a phospholipid bilayer that are capable of encapsulating active drugs. The Stealth® liposomes are formulated with surface-bound methoxypolyethylene glycol (MPEG), a process often referred to as pegylation, to protect liposomes from detection by the mononuclear phagocyte system and to increase blood circulation time. It is hypothesized that pegylated liposomal doxorubicin molecules are able to penetrate the vasculature of tumours. Incorporation of doxorubicin into a liposomal preparation substantially alters the pharmacokinetic properties of the drug compared with those of the non-liposomal doxorubicin.

Distribution

The pharmacokinetics of pegylated liposomal doxorubicin are non-linear, suggesting that there is a greater than dose-proportional increase in exposure as dose is increased, and that clearance is saturable. Pegylated liposomal doxorubicin distributes mainly in intravascular fluid.

Significantly higher doxorubicin concentrations were found in Kaposi sarcoma lesions than in normal skin.

Cross blood brain barrier?

Unknown

PPB

Approximately 70 % (doxorubicin)

Metabolism

Liposomal doxorubicin undergoes metabolism mainly in the liver.

Active metabolites

Doxorubicinol (major metabolite).

Inactive metabolites

Yes

Elimination

The elimination of doxorubicin is primarily via the biliary system. Very low or absent plasma concentrations of doxorubicin metabolites suggest that the metabolite elimination rate exceeds the metabolite production rate.

Urine

6% (in 72 hours)

Half-life

(apparent mean): 74 hours

C - Indications and Status

Health Canada Approvals:

Ovarian cancer
Kaposi sarcoma (AIDS-related)
Breast cancer

Refer to the product monograph for a full list and details of approved indications.

Other Uses:

Hodgkin lymphoma
Multiple myeloma

D - Adverse Effects

Emetogenic Potential:

Low

Extravasation Potential: Irritant

The following adverse effects were reported mainly in single agent studies in breast cancer.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Arrhythmia (<1%)	E D
	Arterial thromboembolism (<1%)	E D
	Cardiotoxicity (3-9%)	E
	Venous thromboembolism (<1%)	E D
Dermatological	Alopecia (20%)	E
	Hand-foot syndrome (48%)	E
	Nail disorder (<5%)	E
	Radiation recall reaction (rare)	E
	Rash (10%) (may be severe)	I
Gastrointestinal	Abdominal pain (8%)	E
	Anorexia (11%)	I
	Constipation (8%)	E
	Diarrhea (7%)	E
	Dyspepsia (<5%)	E
	Mucositis (23%)	E
	Nausea, vomiting (37%)	I
	Weight changes (≤5%)	E
General	Fatigue (12%)	E
	Pain (<5%)	E
Hematological	Myelosuppression ± infection, bleeding (>10%) (may be severe)	E
Hepatobiliary	↑ LFTs (2%)	E
Hypersensitivity	Infusion related reaction (11-13%)	I
Injection site	Phlebitis (rare)	E
Metabolic / Endocrine	Abnormal electrolyte(s) (≤5%)	E
Neoplastic	Secondary malignancy (rare)	D L
Nervous System	Dysgeusia (<5%)	I E
Respiratory	Cough (1-5%)	E

* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.

** I = immediate (onset in hours to days) E = early (days to weeks)
D = delayed (weeks to months) L = late (months to years)

The most common side effects reported were infusion reactions, hand-foot syndrome, nausea/vomiting, mucositis, alopecia and fatigue.

In general, acute hypersensitivity infusion reactions occur during the first infusion of pegylated liposomal doxorubicin, usually within the first few minutes after the start of the infusion. Symptoms include flushing, rash, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest and throat, and hypotension. These acute reactions do not appear to occur during subsequent cycles of chemotherapy in patients who did not react to the first cycle. Hold the infusion if a patient experiences signs or symptoms of an infusion reaction. These symptoms usually resolve without further therapy; however, some patients may require treatment with antihistamines and/or corticosteroids.

Left ventricular failure is less common than with doxorubicin but is reported and is more common in patients who have received high cumulative lifetime doses of doxorubicin (> 550mg/m²), other anthracyclines or anthracenediones, who have had doxorubicin doses > 400mg/m² plus mediastinal radiation or have other cardiac risk factors. Congestive heart failure and/or myocardiopathy may occur suddenly or may happen several weeks after treatment completion.

A frequent dose-limiting adverse effect of pegylated liposomal doxorubicin is myelosuppression, predominantly leukopenia, with higher incidence and greater severity in patients with Kaposi sarcoma who are immuno-compromised at baseline. In patients with ovarian cancer, myelosuppression is generally mild to moderate, reversible and is not associated with neutropenic infection or sepsis. Growth factor support is infrequently required. Pegylated liposomal doxorubicin does not appear to offer any advantage over standard doxorubicin in terms of hematological adverse events.

Palmar-plantar erythrodysesthesia (PPE; hand-foot syndrome) is another common dose and schedule-related adverse effect associated with pegylated liposomal doxorubicin. The syndrome is characterized by painful, macular reddening skin eruptions, swelling, pain, and, for some patients, desquamation of the skin on the hands and feet. PPE is generally seen after 2 or 3 cycles of treatment but may occur earlier. Strategies to prevent and treat PPE, which may be initiated 4-7 days after treatment, include keeping hands and feet cool, avoiding excessive heat/hot water and keeping them unrestricted. Emollients and petroleum-based balms may also provide some relief.

Pegylated liposomal doxorubicin associated stomatitis is dose and schedule-dependent and occurs in up to 39% of patients. Mouth care with regular rinsing should be encouraged as prophylaxis. Mouth sores usually subside with dosage reduction and treatment delay (see Dosing), along with appropriate stomatitis treatment protocol.

Secondary oral cancers, including fatal cases were reported during treatment and up to 6 years following treatment completion. Patients should be monitored regularly for oral ulceration or discomfort.

E - Dosing

Refer to protocol by which patient is being treated.

Pegylated liposomal doxorubicin is not interchangeable with other doxorubicin formulations.

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.

Dose adjustment is required in patients with history of prior anthracyclines use, prior mediastinal irradiation, concurrent cyclophosphamide therapy, or pre-existing cardiovascular disease.

Adults:

Ovarian or breast cancer:

q4 weeks: 50mg/m² IV

AIDS-related Kaposi Sarcoma:

q2-3 weeks: 20mg/m² IV

Dosage with Toxicity:

Dosage modifications for toxicity differ for ovarian/breast cancer and Kaposi sarcoma. This is due to differences in the population group, immunity status, and dose of pegylated liposomal doxorubicin indicated for specific use.

Ovarian or Breast Cancer:

Worst Toxicity & Toxicity on day of planned dosing	*Action: Week 4-5**	*Action: Week 6**
Grade 1 skin/stomatitis	If was ≥ grade 3, delay for 1-2 weeks; otherwise treat on time	If still grade 1, ↓ dose by 25%
Grade 2 skin/stomatitis	Delay for 1-2 weeks;	If still grade 1 or 2, ↓ dose by 25%
Grade 3 or 4 skin/stomatitis	Delay for 1-2 weeks;	Discontinue if still ≥ grade 3 Consider discontinuing if was grade 4 Otherwise ↓ dose by 25%
Grade 4 ANC, platelets, febrile neutropenia or thrombocytopenic bleeding	↓ dose by 25%
Significant cardiotoxicity	Discontinue
Grade 3 other	↓ dose by 25%
Grade 4 other	Discontinue
*Do not retreat until ANC > 1.5 x 10⁹/L, platelets > 75-100 x 10⁹/L and other toxicity ≤ grade 2 / or as indicated above

AIDS-related Kaposi Sarcoma:

Worst Toxicity & Toxicity on day of planned dosing	*Action: Week 3**	*Action: Week 4**
Grade 1 skin	If was ≥grade 3, delay for 1 week; otherwise treat on time	If still grade 1, ↓ dose by 25%
Grade 1 stomatitis	Treat on time with no dose modification	Not applicable
Grade 2 skin	Delay for 1 week	If still grade 2, ↓ dose by 50% If grade 1, ↓ dose by 25%
Grade 2 stomatitis	Delay for 1 week	If still grade 2, ↓ dose by 25%
Grade 3 skin	Delay for 1 week	If still grade 3, discontinue If grade 2, then ↓ dose by 50% If grade 1, ↓ dose by 25%
Grade 3 stomatitis	Delay for 1 week	If improved, ↓ dose by 25%
Grade 4 skin	Delay for 1 week	If still ≥ grade 3, discontinue If ≤ grade 2, ↓ dose by 50%
Grade 4 stomatitis	Delay for 1 week	If still grade 4, discontinue If improved, ↓ dose by 50%
Grade 3 myelosuppression	↓ dose by 25%
Grade 4 ANC, platelets, febrile neutropenia or thrombocytopenic bleeding	↓ dose by 50%
Significant cardiotoxicity	Discontinue
Grade 3 other	↓ dose by 25%
Grade 4 other	Discontinue or ↓ dose by 50%
*Do not retreat until ANC > 1 x 10⁹/L, platelets > 50-100 x 10⁹/L and other toxicity ≤ grade 2 / or as indicated above

Management of Infusion-related reactions with Anthracyclines:

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.

Grade	Management	Re-challenge
1 or 2	Stop or slow the infusion rate. Manage the symptoms.	Consider pre-medications and administering at a slower infusion rate.
3 or 4	Stop treatment. Aggressively manage symptoms.	Re-challenge is discouraged, especially if vital symptoms have been affected. Consider desensitization if therapy is necessary.

Dosage with Hepatic Impairment:

Bilirubin (µmol/L)	Ovarian, Breast cancer		HIV/AIDS
	% of Standard Dose
	Cycle 1 (% normal dose)	Cycle 2 onwards if cycle 1 tolerated with no changes in liver function tests (% normal dose)	Each cycle (% normal dose)
21-51	75%	100%	50%
>51	50%	75%*	25%

_{* The dosage can be increased for subsequent cycles if tolerated.}

Dosage with Renal Impairment:

No modifications are necessary for mild to moderate renal impairment (creatinine clearance > 30 mL/min). No studies have been done in patients with severe renal impairment.

Dosage in the elderly:

Limited information in patients ≥ 60 years. Use with caution.

Children:

Safety and efficacy not established.

F - Administration Guidelines

Pegylated liposomal doxorubicin is not interchangeable with other doxorubicin formulations.

Pegylated liposomal doxorubicin is administered as an IV infusion.
For dose < 90mg, dilute drug in 250mL D5W.
For dose ≥ 90mg, dilute drug in 500mL D5W.
Only use 5% Dextrose solution for further dilution. Use of other diluents or ones containing bacteriostatic agents (i.e. benzyl alcohol) may cause drug precipitation.
Do not administer as a bolus injection or undiluted solution. The pegylated liposomal doxorubicin infusion line can be connected through the side port of a 5% Dextrose infusion for further diluent, or to minimize risk of thrombosis or extravasation.
Do not use in-line filters. Do not admix pegylated liposomal doxorubicin with other drugs.
To minimize the risk of infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute. If no infusion reaction is observed, subsequent infusions may be administered over 60-minutes (in ovarian or breast cancer) and 30 minutes (for Kaposi sarcoma patients).
The following graduated rate was used for patients who experienced an infusion reaction in the breast clinical trial: 5% of the total dose infused IV over 15 minutes. If tolerated, double the infusion rate for the next 15 minutes. If tolerated, complete the infusion over the next hour for a total infusion time of 90 minutes.
Avoid extravasation. It may occur with or without an accompanying stinging or burning sensation, and even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation occur, the injection or infusion should be immediately terminated and restarted in another vein. Any known or suspected extravasation should be managed promptly.

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.

G - Special Precautions

Contraindications:

Patients who have a history of hypersensitivity reactions to a conventional formulation of doxorubicin, other anthracyclines, anthracenediones, or components of the pegylated liposome
Patients with Kaposi Sarcoma and HIV who have had splenectomy (no experience)

Other Warnings/Precautions:

Use with caution in patients with a history of cardiovascular disease and/or prior anthracycline use
Care should be exercised in patients with diabetes as the infusate is dextrose water
Pegylated liposomal doxorubicin is a unique formulation of doxorubicin and should never be used interchangeably with other formulations of doxorubicin

Other Drug Properties:

Carcinogenicity: Yes

Pregnancy and Lactation:

Mutagenicity: Yes
Embryotoxicity: Documented in animals
Abortifacient effects: Documented in animals
Teratogenicity: Probable
Pregnancy:
Pegylated liposomal doxorubicin is contraindicated in pregnancy.
- Adequate contraception should be used by patients who can become pregnant and their partners during treatment, and for 8 months after the last dose.
- Adequate contraception should be used by patients who produce sperm and their partners during treatment, and for at least 6 months after the last dose.
Breastfeeding:
Pegylated liposomal doxorubicin is contraindicated in breastfeeding.
Fertility effects: Unknown

H - Interactions

AGENT	EFFECT	MECHANISM	MANAGEMENT
barbiturates	↓ efficacy of doxorubicin	↑ clearance of doxorubicin	monitor
cyclophosphamide	exacerbation of hemorrhagic cystitis	uncertain	Caution
cyclophosphamide	↑ cardiotoxicity	uncertain	monitor, adjust as needed
digoxin	↓ digoxin levels	↓ digoxin absorption	monitor digoxin levels and patient
mercaptopurine	↑ hepatotoxicity	uncertain	monitor
quinolones	↓ efficacy of quinolones	↓ absorption of quinolones	monitor, may need to modify dose of quinolones
High dose progesterone	↑ hematologic toxicity	unknown	caution
Calcium channel blockers	↑ cardiotoxicity	additive	avoid
Sorafenib	possibly ↑ doxorubicin toxicity	↑ doxorubicin exposure	caution
cyclosporine	↑ hematologic toxicity	↓ doxorubicin clearance or metabolism	caution
cytarabine	typhlitis	uncertain	caution; treat appropriately
Streptozocin	↑ toxicity of doxorubicin	liver damage due to streptozocin decreasing metabolism of doxorubicin	caution
zidovudine	↓ effect of zidovudine	doxorubicin decreases intracellular activation	avoid
stavudine	↓ effect of stavudine	inhibits stavudine phosphorylation/metabolism	avoid
radiation	↑ toxicity	radiation sensitizer	caution; consider dose modification, especially in patients with prior mediastinal radiation
Paclitaxel followed by doxorubicin	↑ neutropenia and stomatitis	↓ doxorubicin clearance	use paclitaxel after doxorubicin
Dactinomycin	↑ radiation recall pneumonitis	additive effects	caution
phenytoin	↓ phenytoin levels	↑ phenytoin metabolism	caution, check levels
Trastuzumab	↑ cardiotoxicity	additive	avoid anthracycline-based therapy for up to 24 weeks after stopping Trastuzumab
Vincristine	seizures	unknown	caution

I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.

Recommended Clinical Monitoring

Monitor Type	Monitor Frequency
Cardiac function tests (Echo, RNA and/or MUGA scans) for all patients with cardiac risk factors. Regular cardiac function tests before each additional dose over the cumulative dose threshold of 450 mg/m². (Cumulative dose lower for high risk patients)	Baseline and as clinically indicated
CBC	Baseline and at each visit
Liver function tests	Baseline and at each visit
Clinical toxicity assessment for stomatitis, rash, hand-foot syndrome, hypersensitivity, infection, bleeding and cardiac symptoms	At each visit

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Supplementary Public Funding

New Drug Funding Program (NDFP Website )

Liposomal Doxorubicin - Platinum-Resistant Ovarian Fallopian Tube or Primary Peritoneal Cancer
Liposomal DOXOrubicin - Single Agent Treatment of Platinum Sensitive Ovarian Fallopian Tube or Primary Peritoneal Cancer
Liposomal Doxorubicin with Carboplatin - Platinum-Sensitive Recurrent Ovarian Fallopian Tube and Primary Peritoneal Cancer
Liposomal Doxorubicin - HIV-positive Kaposi's Sarcoma

K - References

Coukell AJ, Spencer CM. Polyethylene glycol-liposomal doxorubicin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the management of AIDS-related Kaposi's sarcoma. Drugs. 1997 Mar;53(3):520-38.

McEvoy GK, editor. AHFS Drug Information 2009. Bethesda: American Society of Health-System Pharmacists, p. 1046-55.

Doxorubicin drug monograph, Cancer Care Ontario, 2011.

Product Monograph: Caelyx® (pegylated liposomal doxorubicin). Janssen Inc., October 10, 2013.

Product Monograph: Caelyx® (pegylated liposomal doxorubicin). Baxter Corp., April 2, 2024.

March 2025 Modified Pharmacokinetics, Indications, Other Drug Properties, and Pregnancy/Lactation sections

L - Disclaimer

Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.

Info Sheet Name:

pegylated liposomal doxorubicin (patient)

Info Sheet Introduction:

Pegylated liposomal doxorubicin is used to treat cancers such as breast, ovary, HIV-positive Kaposi sarcoma, and others

Info Sheet Date: Friday, March 7, 2025 Info Sheet body:

pegylated liposomal DOXOrubicin

Pronunciation:

PEG-y-late-ted Lip-o-SO-mal Docs-oh-RUBE-i-sin

Other Name(s):

Caelyx®

Appearance:

Red coloured liquid mixed into larger bags of fluids

This handout gives general information about this cancer medication.

You will learn:

who to contact for help
what the medication is
how it is given
what to expect while on medication

This handout was created by Ontario Health (Cancer Care Ontario) together with patients and their caregivers who have also gone through cancer treatment. It is meant to help support you through your cancer treatment and answer some of your questions.

This information does not replace the advice of your health care team. Always talk to your health care team about your treatment.

Who do I contact if I have questions or need help?

My cancer health care provider is: _____________________________________________

During the day I should contact: _______________________________________________

Evenings, weekends and holidays: _____________________________________________

This page gives general information about this cancer medication.

You will learn:

who to contact for help
what the medication is
how it is given
what to expect while on this medication

This information was created by Ontario Health (Cancer Care Ontario) together with patients and their caregivers who have also gone through cancer treatment. It is meant to help support you through your cancer treatment and answer some of your questions.

This information does not replace the advice of your health care team. Always talk to your health care team about your treatment.

What is this treatment for?

Pegylated liposomal doxorubicin is used to treat cancers such as breast, ovary, HIV-positive Kaposi sarcoma, and others

What should I do before I start this treatment?

Tell your health care team if you have or had significant medical condition(s), especially if you have / had:

liver problems,
heart problems,
prior chemotherapy and/or radiation treatment, or
any allergies.

Remember To:

Tell your health care team about all of the other medications you are taking.
Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.

You will have a blood test to check for hepatitis B before starting treatment. See the Hepatitis B and Cancer Medications pamphlet for more information.

How is this treatment given?

This drug is given through an IV (injected into a vein).
Talk to your health care team about your treatment schedule.
If you missed your treatment appointment, talk to your health care team to find out what to do.

Other medications you may be given with this treatment

To Prevent Nausea and Vomiting

You may be given medications to prevent or stop nausea (feeling like throwing up) and vomiting (throwing up) before they start. These are called anti-nausea medications.

Medications to prevent nausea and vomiting before they start include ondansetron (Zofran®), granisetron (Kytril®), or others.

If you already have nausea and/or vomiting, some anti-nausea medication can stop them from getting worse. You may be given these medications to have at home in case you start to feel nausea or if you vomit.

Medications to stop nausea and vomiting include prochlorperazine (Stemetil®), metoclopramide (Maxeran®), or others.

DO this while on treatment

DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.

DO talk to your health care team about your risk of getting other cancers and heart problems after this treatment.

DO NOT do this while on treatment

Stop Icon

DO NOT use tobacco products (such as smoking cigarettes or vaping) or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.

DO NOT take any other medications, such as vitamins, over-the-counter (non-prescription) drugs, or natural health products without checking with your health care team.

DO NOT start any complementary or alternative therapies, such as acupuncture or homeopathic medications, without checking with your health care team.

DO this while on treatment

Check Mark Icon

DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.

DO talk to your health care team about your risk of getting other cancers and heart problems after this treatment.

DO NOT do this while on treatment

Stop Icon

DO NOT use tobacco products (such as smoking cigarettes or vaping) or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.

DO NOT take any other medications, such as vitamins, over-the-counter (non-prescription) drugs, or natural health products without checking with your health care team.

DO NOT start any complementary or alternative therapies, such as acupuncture or homeopathic medications, without checking with your health care team.

Will this treatment interact with other medications or natural health products?

Yes, this medication can interact with other medications, vitamins, foods and natural health products. Interactions can make this medication not work as well or cause severe side effects.

Tell your health care team about all of your:

prescription and over-the-counter (non-prescription) medications and all other drugs, such as cannabis/marijuana (medical or recreational)
natural health products such as vitamins, herbal teas, homeopathic medicines, and other supplements

Check with your health care team before starting or stopping any of them.

Talk to your health care team BEFORE taking or using these :

Anti-inflammatory medications such as ibuprofen (Advil^® or Motrin^®), naproxen (Aleve^®) or Aspirin^®.
Over-the-counter products such as dimenhydrinate (Gravol^®)
Natural health products such as St. John’s Wort
Supplements such as vitamin C
Grapefruit juice
Alcoholic drinks
Tobacco
All other drugs, such as marijuana or cannabis (medical or recreational)

What to do if you feel unwell, have pain, a headache or a fever

Always check your temperature to see if you have a fever before taking any medications for fever or pain (such as acetaminophen (Tylenol^®) or ibuprofen (Advil^®)).
- Fever can be a sign of infection that may need treatment right away.
- If you take these medications before you check for fever, they may lower your temperature and you may not know you have an infection.

How to check for fever:

Keep a digital (electronic) thermometer at home and take your temperature if you feel hot or unwell (for example, chills, headache, mild pain).

You have a fever if your temperature taken in your mouth (oral temperature) is:
- 38.3°C (100.9°F) or higher at any time
OR
- 38.0°C (100.4°F) or higher for at least one hour.

If you do have a fever:

Try to contact your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
Ask your health care team for the Fever pamphlet for more information.

If you do not have a fever but have mild symptoms such as headache or mild pain:

Ask your health care team about the right medication for you. Acetaminophen (Tylenol^®) is a safe choice for most people.

Talk to your health care team before you start taking ibuprofen (Advil^®, Motrin^®), naproxen (Aleve^®) or ASA (Aspirin^®), as they may increase your chance of bleeding or interact with your cancer treatment.

Talk to your health care team if you already take low dose aspirin for a medical condition (such as a heart problem). It may still be safe to take.

How will this treatment affect sex, pregnancy and breastfeeding?

Talk to your health care team about:

How this treatment may affect your sexual health
How this treatment may affect your ability to have a baby, if this applies to you

This treatment may harm an unborn baby. Tell your health care team if you or your partner are pregnant, become pregnant during treatment, or are breastfeeding.

If there is any chance you may become pregnant, you and your partner together must use 2 effective forms of birth control at the same time until 8 months after your last dose. Talk to your health care team about which birth control options are best for you.
If you are a patient that can get somebody pregnant, you and your partner together must use 2 effective forms of birth control at the same time until 6 months after your last dose. Talk to your health care team about which birth control options are best for you.
Do not breastfeed while on this treatment.

What are the side effects of this treatment?

The following table lists side effects that you may have when getting pegylated liposomal doxorubicin treatment. The table is set up to list the most common side effects first and the least common last. It is unlikely that you will have all of the side effects listed and you may have some that are not listed.

Read over the side effect table so that you know what to look for and when to get help. Refer to this table if you experience any side effects while on pegylated liposomal doxorubicin treatment.

More Common Side Effects
Side effects and what to do	When to contact health care team
Hand-foot syndrome (pain, thinning or reddening palms or feet, including tingling, numbness, peeling) Avoid activities that cause rubbing, pressure or heat exposure to hands and feet (i.e. gripping tools, vigorous washing, hot baths). Apply moisturizer liberally and often to your hands and feet, especially in the creases. Wear loose, comfortable footwear and clothes. Rest and try to keep off your feet. Also see Hand-Foot Syndrome pamphlet.*	Contact your health care team if no improvement or if severe
Nausea and vomiting Drink clear fluids and avoid large meals. Get fresh air and rest. Limit spicy, fried foods or foods with a strong smell. Take anti-nausea drug(s) exactly as directed by your doctor. It is easier to prevent nausea than to treat it. Contact your doctor if nausea lasts more than 48 hours or vomiting for more than 24 hours. Also see Nausea & Vomiting pamphlet.*	Contact your health care team if no improvement or if severe
Mouth sores Maintain good mouth hygiene. Regular teeth brushing with a soft toothbrush or Toothette®, and regular use of alcohol-free mouthwashes. Instead, try a homemade mouthwash: Mix 1 teaspoonful of baking soda and 1 teaspoonful of salt in 4 cups (1L) of water. Avoid hot, spicy, acidic, hard or crunchy foods. Check with your doctor or nurse as soon as you notice sores in mouth/lips or pain with swallowing. Your doctor may prescribe a prescription mouthwash to relieve mouth sores and prevent infection. Also see Mouth Care pamphlet.*	Contact your health care team as soon as possible (office hours)
Hair thinning or loss Use a gentle soft brush; care should be taken with hair sprays, bleaches, dyes and perms. Your hair usually grows back after your treatment ends, but the texture or colour may change.	Talk to your health care team if this bothers you
Tiredness Rest often; take naps if needed. Move slowly when getting up. Eat well-balanced meals and drink plenty of fluids. Light exercise may help. Do not drive a motor vehicle or operate machinery when feeling tired.	Contact your health care team if no improvement or if severe
*Poor Appetite; don't feel like eating; weight loss* Eat foods that you like and try to eat regular small meals. Use meal supplements if possible. See a dietitian.	Contact your health care team if no improvement or if severe
Rash (rarely severe); dry, itchy skin Stay out of the sun; wear sunblock, a hat and cover exposed skin. Use daily moisturizer. If severe, get emergency medical help right away.	Contact your health care team if no improvement or if severe
Sensitivity reaction (usually the first injection only) (flushing, rash, itchiness, facial swelling, headache, chest or throat tightness) Watch for symptoms during and shortly after the infusion Allergic reaction is less common (fever, severe rash, itchiness, swollen face, lip or tongue, chest or throat tightness)	Get emergency medical help right away
*Unusual bleeding or bruising* You may have black stools, cough up blood, blood in your urine, purple or red dots on your skin or bleeding that will not stop. Fever, chills, infection You have a fever if your temperature taken in your mouth (oral temperature) is: 38.3°C (100.9°F) or higher at any time OR 38.0°C (or 100.4°F) or higher for at least one hour. While you are getting chemotherapy treatments: Keep a digital thermometer at home and take your temperature if you feel hot or unwell (for example, chills). Avoid taking medications that treat a fever before you take your temperature (for example, Tylenol®, acetaminophen, Advil® or ibuprofen) as they may hide a fever. Do not eat or drink anything hot or cold right before taking your temperature. Wash your hands often. Check with your doctor before getting any vaccines, surgeries, medical procedures or visiting your dentist. If you have a fever, talk to your health care team or go to the closest emergency room. See our Neutropenia (Low white blood cell count) pamphlet for more information.	Get emergency medical help right away

Less Common Side Effects, but may be Severe
Side effects and what to do	When to contact health care team
Blockage of an artery (blood vessel) in your heart, brain, chest, belly, or limbs; this may result in stroke (sudden loss of vision, speech, or the use of your limb(s)) or heart attack (chest pain, shortness of breath), or pain in chest, belly or limb	Get emergency medical help right away
Heart problems (irregular heartbeat, chest pain, fainting, swelling, shortness of breath)	Get emergency medical help right away
Pain, burning, redness, or swelling on skin where drug was injected Let your healthcare team know right away when this happens, since this drug can harm or irritate tissues if it leaks from the vein during injection.
Blood clot (limb pain or swelling, hardened vein in limb), may occur in lungs (sudden start of coughing, breathing problems, chest pain, coughing blood)	Get emergency medical help right away

For more information on how to manage your symptoms ask your health care provider, or visit: https://www.cancercareontario.ca/symptoms.

Notes

March 2025 Updated drug information sheet to new format

The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.

A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

Info Sheet (English):

pegylated liposomal doxorubicin patient.pdf Info Sheet (French):

DOXOrubicine liposomes pguyls pour le patient.pdf Monograph:

pegylated liposomal DOXOrubicin.pdf Funding Program: New Drug Funding Program Funding Instance:

Liposomal Doxorubicin - Platinum-Resistant Ovarian Fallopian Tube or Primary Peritoneal Cancer
Liposomal DOXOrubicin - Single Agent Treatment of Platinum Sensitive Ovarian Fallopian Tube or Primary Peritoneal Cancer
Liposomal Doxorubicin with Carboplatin - Platinum-Sensitive Recurrent Ovarian Fallopian Tube and Primary Peritoneal Cancer
Liposomal Doxorubicin - HIV-positive Kaposi's Sarcoma

Phonetic Spelling:

PEG-y-late-ted Lip-o-SO-mal Docs-oh-RUBE-i-sin

Eligibility Form:

Liposomal Doxorubicin - HIV-positive Kaposi's Sarcoma

Liposomal Doxorubicin - Platinum-Resistant Ovarian Fallopian Tube or Primary Peritoneal Cancer

Liposomal DOXOrubicin - Single Agent Treatment of Platinum Sensitive Ovarian Fallopian Tube or Primary Peritoneal Cancer

Liposomal Doxorubicin with Carboplatin - Platinum-Sensitive Recurrent Ovarian Fallopian Tube and Primary Peritoneal Cancer Cancer Type: Breast Gynecologic Ovary Hematologic Lymphoma - Hodgkin Multiple Myeloma Sarcoma Kaposi's Sarcoma Type of Content: Drug Monograph Status: Null Info Sheet Status: Null Global Date: Friday, March 7, 2025 Universal Date: 2025-03-07 00:00:00 AddThis: Title URL: pegylatedliposomalDOXOrubicin Drug Display Status: Active Revision Summary:
Drug Monograph: Modified Pharmacokinetics, Indications, Other Drug Properties, and Pregnancy/Lactation sections
Patient Info Sheet EN: Updated drug information sheet to new format