PERTuzumab

Trade Name:

Perjeta®

Appearance:

clear, colourless solution

Monograph Name:

pertuzumab

Monograph Body:

Drug Monograph

A - Drug Name

PERTuzumab

COMMON TRADE NAME(S): Perjeta®

B - Mechanism of Action and Pharmacokinetics

Pertuzumab is a recombinant humanized monoclonal antibody that inhibits the dimerization of HER2 with other HER family receptors, most notably HER3. It binds to a different epitope of the HER2 extracellular domain than trastuzumab. Downstream inhibition of MAP kinase and PI3K cell signaling pathways result in cell growth arrest or apoptosis. Pertuzumab also mediates antibody-dependent cell-mediated cytotoxicity, similar to trastuzumab.

Absorption

Steady state concentration of pertuzumab is reached after the first maintenance dose when the standard pertuzumab regimen is administered (pertuzumab 840 mg IV loading dose followed by 420 mg IV every three weeks).

Metabolism

Not been directly studied. Antibodies are generally cleared by catabolism.

Elimination

Half-life

11.4-12.2 days in metastatic breast cancer; up to 22.3 days in advanced solid tumour patients

C - Indications and Status

Health Canada Approvals:

In combination with trastuzumab and docetaxel for the treatment of patients with HER2- positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
In combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer with lymph node positive and/or hormone receptor negative disease.

D - Adverse Effects

Emetogenic Potential:

Minimal

Extravasation Potential: None

The following adverse effects were observed in ≥ 1% of early breast cancer patients in the phase III pertuzumab clinical trial arm with trastuzumab and chemotherapy. Only adverse effects with a higher incidence than the placebo + trastuzumab and chemotherapy arm are listed. Severe adverse events from other studies or post-marketing, may also be included.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Cardiotoxicity (2%)	E D
	Hypertension (11%)	E
Dermatological	Dry skin (13%)	E
	Other - Radiation-skin reaction (13%)	E D
	Palmar-plantar erythrodysesthesia syndrome (PPES) (9%)	E
	Rash, pruritus (26%)	E
Gastrointestinal	Abdominal pain (12%)	E
	Anorexia, weight loss (24%)	E
	Dehydration (4%)	E
	Diarrhea (71%) (10% severe)	E
	Mucositis (28%)	E
	Nausea, vomiting (69%) (2% severe)	I E
General	Fatigue (49%) (4% severe)	E
Hematological	Myelosuppression ± infection, bleeding (28%) (including febrile neutropenia – 12%)	E
Hypersensitivity	Hypersensitivity (3%) (may be severe)	I
	Infusion related reaction (21%)	I
Metabolic / Endocrine	Abnormal electrolyte(s) (7%) (↓ K, ↓ Mg, ↓PO4)	E
	Tumor lysis syndrome (rare)	I
Nervous System	Dysgeusia (26%)	E
	Paresthesia (18%)	E
Respiratory	Cough, dyspnea (16%)	E
	Interstitial lung disease (rare)	E
	Other - nasopharyngitis (13%)	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 for pertuzumab include diarrhea, nausea, vomiting, fatigue, mucositis, myelosuppression ± infection, bleeding, dysgeusia, rash, pruritus, anorexia, weight loss, infusion related reaction and paresthesia.

Left Ventricular Ejection Fraction (LVEF) decreases and congestive heart failure have been reported with pertuzumab and other drugs that block HER2 activity. Patients who have received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk. In metastatic breast cancer, the addition of pertuzumab did not appear to increase the incidence of left ventricular systolic dysfunction (LVSD) or LVEF decrease as compared to placebo with docetaxel and trastuzumab. However, in a clinical trial with neoadjuvant treated patients, the incidence of reversible LVSD was higher in the pertuzumab/trastuzumab/docetaxel group than the trastuzumab/docetaxel group. In the early breast cancer adjuvant setting, the incidence of symptomatic heart failure was slightly higher in patients treated with pertuzumab (most of these events were reported in anthracycline-treated patients). Approximately half of the pertuzumab-treated patients who experienced symptomatic heart failure recovered.

There appeared to be an increased risk of febrile neutropenia in patients (especially Asian patients) treated with the pertuzumab combination as compared to placebo with docetaxel and trastuzumab, although nadir neutrophil counts were similar between both groups. Febrile neutropenia is most common in cycles 1-3. Mucositis and diarrhea should be treated promptly as these may relate to higher observed rates of febrile neutropenia.

Hypersensitivity reactions, including anaphylaxis, angioedema, and fatal events have been reported. Overall, the majority of hypersensitivity reactions were mild or moderate in severity and resolved upon treatment.

Infusion-related reactions (either during or on the day of infusion), including fatal events, have been associated with pertuzumab. In the early breast cancer clinical trial, the incidence of severe events was approximately 1%. Symptoms included fever, chills, fatigue, headache, hypersensitivity, myalgia, dysgeusia and vomiting. Anaphylaxis has been reported.

Adverse effects were reported less frequently after docetaxel discontinuation in metastatic breast cancer. Most adverse effects in the pertuzumab and trastuzumab arm occurred in < 10% except diarrhea, upper respiratory tract infection, rash, headache, fatigue, and arthralgia.

E - Dosing

Refer to protocol by which patient is being treated.

Patients receiving treatment must have HER2 positive status (score of 3+ by IHC or a ratio of ≥ 2 by ISH) using a validated test.

Pre-medications (prophylaxis for infusion reaction):

No specific premedications were recommended by the manufacturer.
For patients who experienced prior infusion reactions, consider premedication with corticosteroids, antihistamines, and/or antipyretics before subsequent pertuzumab infusions.

Adults:

Pertuzumab Loading Dose:

Intravenous: 840 mg over 60 minutes on Day 1*

Then, start 3 weeks later with:

Pertuzumab Maintenance Dose (q3w):

Intravenous: 420 mg over 30 to 60 minutes on day 1

^*In the pivotal phase III trial in metastatic breast cancer, the loading dose was given on day 1 of cycle 1; trastuzumab and docetaxel were given on day 2. If all 3 medications were tolerated in cycle 1, these were administered on day 1 in subsequent cycles. In adjuvant breast cancer, pertuzumab and trastuzumab were started on Day 1 of the first taxane-containing cycle.

Dosage with Toxicity:

Dose reductions are not recommended. Doses are held or discontinued due to toxicity.

If trastuzumab is withheld, pertuzumab should also be withheld. Discontinue pertuzumab if trastuzumab is discontinued.

Cardiotoxicity

Dose Recommendations for Left Ventricular Dysfunction:

Indication	Pre-Treatment LVEF	Cardiotoxicity During Treatment	Action	LVEF at Re-Assessment	Action
Metastatic Breast Cancer	≥ 50%	Asymptomatic AND LVEF <40% OR 40%–45% with a fall of ≥10% points below pre-treatment value	Hold trastuzumab and pertuzumab x 3 weeks	>45% OR 40%–45% with a fall of <10% points below baseline	Restart trastuzumab and pertuzumab
				<40% OR LVEF 40-45% with a fall of ≥10% points below baseline	Discontinue trastuzumab and pertuzumab
Early Breast Cancer	≥ 55%*	Asymptomatic AND LVEF <50% with a fall of ≥10% points below baseline*		≥50% OR LVEF <10% points below baseline	Restart trastuzumab and pertuzumab
				<50% AND LVEF ≥10% points below baseline	Discontinue trastuzumab and pertuzumab
Any		Symptomatic	Consider discontinuing trastuzumab and pertuzumab.	Not applicable

*For patients receiving anthracycline-based chemotherapy, a LVEF of ≥50% is required after completion of anthracyclines, before starting Trastuzumab and Pertuzumab.

Management of Infusion-related reactions

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.
Manage the symptoms.

Restart:

No specific recommendations can be made at this time.

No specific recommendations can be made at this time.

3 or 4

Stop the infusion.
Aggressively manage symptoms.

Discontinue permanently (do not re-challenge).

Other Toxicities

Toxicity	Recommendation
Reversible chemotherapy-induced myelosuppression	Continue pertuzumab, monitor for complications of neutropenia (i.e. infections) and treat appropriately.
Severe diarrhea	Start anti-diarrheal treatment. Hold pertuzumab if no improvement; restart pertuzumab when diarrhea is under control.

Dosage with Hepatic Impairment:

Has not been studied in hepatic impairment.

Dosage with Renal Impairment:

No adjustment required for mild to moderate renal function. Has not been studied in patients with severe renal impairment (< 30 mL/min).

Dosage in the elderly:

No dose adjustment required. No overall differences in safety and efficacy of pertuzumab were observed between adults ≥65 and under 65 years of age, except for diarrhea, which had a higher incidence in patients ≥65 years.

Dosage based on ethnicity:

An increased incidence of neutropenia and febrile neutropenia was observed in Asian patients in both treatment arms of the pivotal phase III trial in metastatic breast cancer as compared with patients of other races. In adjuvant breast cancer, the incidence of febrile neutropenia in Asian patients was higher in the pertuzumab group than the placebo group. The reason for this difference is unknown.

Children:

Safety and efficacy have not been established.

F - Administration Guidelines

Do not administer as an intravenous push or bolus.
For pertuzumab, trastuzumab, and taxane combination regimens, pertuzumab and trastuzumab may be administered in any order; however, the taxane should be given after pertuzumab and trastuzumab.
Pertuzumab and trastuzumab should not be given concurrently with anthracycline therapy. It should start on Day 1 of the first taxane-containing cycle.
Give loading dose IV over 60 minutes; maintenance dose should be given IV over 30-60 minutes.
Dilute required dose in 250 mL Normal Saline.
Do not use D5W for dilution since pertuzumab is chemically and physically unstable in this solution. Do not admix with other drugs.
Compatible with PVC, polyethylene or non-PVC polyolefin bags.
Avoid shaking the solution in order to avoid foaming.
Monitor for infusion reactions for 60 minutes following the initial pertuzumab infusion and for 30 minutes following subsequent infusions.
Complete the observation period before administering subsequent trastuzumab or chemotherapy.
Refrigerate unopened vials at 2-8°C; protect from light.

Missed Doses:

Re-load pertuzumab if time between 2 sequential infusions is 6 weeks or more. The maintenance dose should follow 3 weeks from the re-loading dose.

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 hypersensitivity to this drug or any of its components.

Other Warnings/Precautions:

Exercise extreme caution with the following patient groups as they have not been studied in clinical trials: Pre-treatment LVEF value of ≤ 50%; a prior history of CHF; decreases in LVEF to <50% during prior trastuzumab adjuvant therapy; conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment or a cumulative prior anthracycline exposure to > 360mg/m² of doxorubicin or its equivalent.
Life-threatening infusion-related reactions associated with the administration of pertuzumab may occur.

Other Drug Properties:

Carcinogenicity: Unknown

Pregnancy and Lactation:

Embryotoxicity: Yes
Fetotoxicity: Yes
Teratogenicity: Yes
Mutagenicity: Unknown
Fertility effects: Unknown
Pertuzumab is not recommended for use in pregnancy. Oligohydramnios, delayed fetal development and embryo/fetal death have been observed in animals.
Adequate contraception should be used by both sexes during treatment, and for 7 months after the last dose.
Monitor for oligohydramnios in patients who become pregnant during pertuzumab therapy. Perform appropriate fetal testing if oligohydramnios occurs
Excretion into breast milk: Probable
Human IgGs are excreted into human milk; breastfeeding is not recommended.
Fertility effects: Unknown

H - Interactions

No evidence of drug-drug interaction between pertuzumab and the following drugs: Trastuzumab, paclitaxel, docetaxel, gemcitabine, erlotinib, capecitabine, carboplatin.

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.

Recommended Clinical Monitoring

Monitor Type	Monitor Frequency
Cardiac assessment (physical exam and either 2D ECHO or MUGA)	Baseline, repeat every 12 weeks during treatment and every 6 months after the end of treatment until 24 months after the last dose
Infusion reactions	60 minutes after the first infusion and 30 minutes after subsequent infusions
CBC	Baseline and at each visit
Clinical toxicity assessment for infection, bleeding, neurotoxicity, hypersensitivity, fatigue, cutaneous reactions, cardiovascular, GI or respiratory effects	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 )

Pertuzumab with Trastuzumab (Biosimilar) - Unresectable Locally Recurrent or Metastatic Breast Cancer

K - References

Product Monograph: Perjeta® (pertuzumab). Hoffmann-La Roche Limited, April 2019.

Prescribing Information: Perjeta® (pertuzumab). Genentech Inc. (US), December 2018.

Baselga J, Cortés J, Kim SB, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012;366(2):109-19.

Keating GM. Pertuzumab: in the first-line treatment of HER2-positive metastatic breast cancer. Drugs. 2012 Feb 12;72(3):353-60.

O'Sullivan CC, Swain SM. Pertuzumab: evolving therapeutic strategies in the management of HER2-overexpressing breast cancer. Expert Opin Biol Ther 2013;13(5):779-90.

Swain SM, Kim SB, Cortés J, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2013;14(6):461-71.

Von Minckwitz G, Procter M, de Azambuja E, et al. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med. 2017 Jul 13;377(2):122-131.

September 2022 Updated NDFP form

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.

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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.

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Info Sheet Name:

pertuzumab (patient)

Info Sheet Introduction:

For treating certain types of breast cancer.
Pertuzumab is usually given along with other medications to treat cancer.

Info Sheet Date: Lundi, septembre 20, 2021 Info Sheet body:

Medication Information Sheet

PERTuzumab (per-TOO-zoo-mab)

This document provides general information about your medication. It does not replace the advice of your health care professional. Always discuss your therapy with your health care professional and refer to the package insert for more details.

Other Name: Perjeta®

Appearance:

clear, colourless solution

What is this medication for?

For treating certain types of breast cancer.
Pertuzumab is usually given along with other medications to treat cancer.

What should I do before I have this medication?

Tell your health care team if you have or had significant medical condition(s), especially if you have / had:
- heart problems (including irregular heartbeat, heart attack, heart failure or uncontrolled high blood pressure) or
- any allergies
Tell your health care team if you have been treated with chemotherapy drugs known as anthracyclines (such as doxorubicin, epirubicin), mitoxantrone, or radiation therapy.
Your health care team may do tests to examine your heart function before starting treatment. This is done to make sure it is safe for you to receive pertuzumab.

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.

How will this medication affect sex, pregnancy and breastfeeding?

Talk to your health care team about:

How this treatment may affect your sexual health.
Symptoms of menopause such as hot flashes, vaginal dryness or changes in your mood, if this applies to you.
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 of pregnancy happening, you and your partner together must use 2 effective forms of birth control at the same time until 7 months after your last treatment dose. Talk to your health care team about which birth control options are best for you.
Do not use hormonal birth control (such as birth control pills), unless your health care team told you that they are safe. Talk to your health care team about the safest birth control for you.
Do not breastfeed while on this treatment.

How is this medication given?

This drug is given through an IV (injected into a vein) . Talk to your health care team about your treatment schedule.
This drug will be given over a longer period of time for the first cycle. If you have no problems with this infusion, it will be given over a shorter time for the following cycles.

You may be given this treatment along with other medications to help prevent side effects or prevent a reaction.
If you missed your treatment appointment, talk to your health care team to find out what to do.

What else do I need to know while on this medication?

Will this medication interact with other medications or natural health products?
- Although this medication is unlikely to interact with other medications, vitamins, foods and natural health products, tell your health care team about all of your:
  - prescription and over-the-counter (non-prescription) medications and all other drugs, such as 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.
What should I do if I 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.

What to DO while on this medication:

DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.
DO consider asking someone to drive you to and from the hospital on your treatment days. You may feel dizzy after your treatment.
DO talk to your health care team about your risk of getting heart problems after this treatment.

What NOT to DO while on this medication:

DO NOT smoke 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.

What are the side effects of this medication?

The following table lists side effects that you may have when getting pertuzumab. Pertuzumab is usually given along with other medications to treat cancer; some of the side effects listed below may be due to those other medications. 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 pertuzumab.

Very Common Side Effects (50 or more out of 100 people)
Side effects and what to do	When to contact health care team
Diarrhea (May be severe) What to look for? Loose, watery, unformed stool (poo) that may happen days to weeks after you get your treatment. What to do? If you have diarrhea: Take anti-diarrhea medication if your health care team prescribed it or told you to take it. Do not eat foods or drinks with artificial sweetener (like chewing gum or ‘diet’ drinks), coffee and alcohol. Eat many small meals and snacks instead of 2 or 3 large meals. Drink at least 6 to 8 cups of liquids each day, unless your health care team has told you to drink more or less. Talk to your health care team if you can’t drink 6 to 8 cups of liquids each day when you have diarrhea. You may need to drink special liquids with salt and sugar, called Oral Rehydration Therapy. Talk to your health care team if your diarrhea does not improve after 24 hours of taking diarrhea medication or if you have diarrhea more than 7 times in one day. Ask your health care team for the Diarrhea pamphlet for more information.	Talk to your health care team if no improvement after 24 hours of taking diarrhea medication or if severe (more than 7 times in one day)
Nausea and vomiting (Generally mild) What to look for? Nausea is feeling like you need to throw up. You may also feel light-headed. You may feel nausea within hours to days after your treatment. What to do? To help prevent nausea: It is easier to prevent nausea than to treat it once it happens. Take your anti-nausea medication(s) as prescribed, even if you do not feel like throwing up. Drink clear liquids and have small meals. Get fresh air and rest. Do not eat spicy, fried foods or foods with a strong smell. Limit caffeine (like coffee, tea) and avoid alcohol. If you have nausea or vomiting: Take your rescue (as-needed) anti-nausea medication(s) as prescribed. Ask your health care team for the Nausea & Vomiting pamphlet for more information. Talk to your health care team if: nausea lasts more than 48 hours vomiting lasts more than 24 hours or if it is severe	Talk to your health care team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if severe

Common Side Effects (25 to 49 out of 100 people)
Side effects and what to do	When to contact health care team
Fatigue What to look for? Feeling of tiredness or low energy that lasts a long time and does not go away with rest or sleep. What to do? Be active. Aim to get 30 minutes of moderate exercise (you are able to talk comfortably while exercising) on most days. Check with your health care team before starting any new exercise. Pace yourself, do not rush. Put off less important activities. Rest when you need to. Ask family or friends to help you with things like housework, shopping, and child or pet care. Eat well and drink at least 6 to 8 glasses of water or other liquids every day (unless your health care team has told you to drink more or less). Avoid driving or using machinery if you are feeling tired. Ask your health care team for the Fatigue pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
Mouth sores What to look for? Round, painful, white or gray sores inside your mouth that can occur on the tongue, lips, gums, or inside your cheeks. In more severe cases they may make it hard to swallow, eat or brush your teeth. They may last for 3 days or longer. What to do? To help prevent mouth sores: Take care of your mouth by gently brushing and flossing regularly. Rinse your mouth often with a homemade mouthwash. To make a homemade mouthwash, mix 1 teaspoonful of baking soda and 1 teaspoonful of salt in 4 cups (1L) of water. Do not use store-bought mouthwashes, especially those with alcohol, because they may irritate your mouth. If you have mouth sores: Avoid hot, spicy, acidic, hard or crunchy foods. Your doctor may prescribe a special mouthwash to relieve mouth sores and prevent infection. Talk to your health care team as soon as you notice mouth or lip sores or if it hurts to eat, drink or swallow. Ask your health care team for the Oral Care (Mouth Care) pamphlet for more information.	Talk to your health care team as soon as you notice mouth or lip sores or if it hurts to eat, drink or swallow
Low neutrophils (white blood cells) in the blood (neutropenia) (May be severe) When neutrophils are low, you are at risk of getting an infection more easily. Ask your health care team for the Neutropenia (Low white blood cell count) pamphlet for more information. What to look for? If you feel hot or unwell (for example if you have chills or a new cough), you must check your temperature to see if you have a fever. Do not take medications that treat a fever before you take your temperature (for example, Tylenol®, acetaminophen, Advil® or ibuprofen). Do not eat or drink anything hot or cold right before taking your temperature. 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 What to do? If your health care team has told you that you have low neutrophils: Wash your hands often to prevent infection. Check with your health care team before getting any vaccines, surgeries, medical procedures or visiting your dentist. Keep a digital thermometer at home so you can easily check for a fever. If you have a fever: If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away.	If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you MUST get emergency medical help right away.
Low platelets in the blood (May be severe) When your platelets are low, you are at risk for bleeding and bruising. Ask your health care team for the Low Platelet Count pamphlet for more information. What to look for? Watch for signs of bleeding: bleeding from your gums unusual or heavy nosebleeds bruising easily or more than normal black coloured stools (poo) or blood in your stools (poo) coughing up red or brown coloured mucus dizziness, constant headache or changes in your vision heavy vaginal bleeding red or pink coloured urine (pee) What to do? If your health care team has told you that you have low platelets: Tell your pharmacist that your platelet count may be low before taking any prescriptions or over-the-counter medication. Check with your healthcare team before you go to the dentist. Take care of your mouth and use a soft toothbrush. Try to prevent cuts and bruises. Ask your health care team what activities are safe for you. Your treatment may have to be delayed if you have low platelets. Your health care team may recommend a blood transfusion. If you have signs of bleeding: If you have a small bleed, clean the area with soap and water or a saline (saltwater) rinse. Apply pressure for at least 10 minutes. If you have bleeding that does not stop or is severe (very heavy), you must get emergency medical help right away.	Talk to your health care team if you have any signs of bleeding. If you have bleeding that doesn’t stop or is severe (very heavy), you MUST get emergency help right away.
Rash; dry, itchy skin What to look for? You may have cracked, rough, flaking or peeling areas of the skin. Your skin may look red and feel warm, like a sunburn. Your skin may itch, burn, sting or feel very tender when touched. The rash may be seen in areas where you have had radiation before. What to do? To prevent and treat dry skin: Use fragrance-free skin moisturizer. Protect your skin from the sun and the cold. Use sunscreen with UVA and UVB protection and a SPF of at least 30. Avoid perfumed products and lotions that contain alcohol. Drink 6 to 8 cups of non-alcoholic, non-caffeinated liquids each day, unless your health care team has told you to drink more or less. Rash may be severe in some rare cases and cause your skin to blister or peel. If this happens, get emergency medical help right away.	Talk to your health care team if no improvement or if severe
Taste changes What to look for? Food and drinks may taste different than usual. What to do? Eat foods that are easy to chew, such as scrambled eggs, pasta, soups, cooked vegetables. Taste foods at different temperatures, since the flavour may change. Try different forms of foods, like fresh, frozen or canned. Experiment with non-spicy foods, spices and seasonings.	Talk to your health care team if it does not improve or if it is severe

Less Common Side Effects (10 to 24 out of 100 people)
Side effects and what to do	When to contact health care team
Low appetite What to look for? Loss of interest in food or not feeling hungry. Weight loss. What to do? Try to eat your favourite foods. Eat small meals throughout the day. You may need to take meal supplements to help keep your weight up. Talk to your health care team if you have no appetite. Ask your health care team for the Loss of Appetite pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
Allergic reaction What to look for? Fever, itchiness, rash, swollen lips, face or tongue, chest and throat tightness. It may happen during or shortly after your treatment is given to you and may be severe. You may be given medicines to prevent or treat this reaction. What to do? Tell your nurse right away if you feel any signs of allergic reaction during or just after your treatment. Talk to your health care team for advice if you have a mild skin reaction.	Get emergency medical help right away for severe symptoms
Neuropathy (Tingling, numb toes or fingers) What to look for? Numbness or tingling of your fingers and toes may happen after starting your treatment. Sometimes it can be painful and feel like burning sensation, which may be severe. What to do? Talk to your health care team if you have symptoms of neuropathy. Numbness and tingling may slowly get better after your treatment ends. In rare cases, it may continue long after treatment ends. If you continue to have bothersome symptoms, talk to your health care team for advice.	Talk to your health care team, especially if you have trouble doing tasks like doing up buttons, writing, moving, severe pain or numbness
Cough and feeling short of breath What to look for? You may have a cough and feel short of breath. Symptoms that commonly occur with a cough are: wheezing or a whistling breathing runny nose sore throat heartburn weight loss fever and chills Rarely this may be severe with chest pain, trouble breathing or coughing up blood. What to do? Check your temperature to see if you have a fever. Read the above section "What should I do if I feel unwell, have pain, a headache or a fever?". If you have a fever, try to talk to your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away. If you have a severe cough with chest pain, trouble breathing or you are coughing up blood, get medical help right away.	Talk to your health care team. If you are not able to talk to your health care team for advice, and you have a fever or severe symptoms, you MUST get emergency medical help right away
Pains or cramps in the belly What to look for? Pain or cramps in your belly. Constipation and diarrhea can cause pain in your belly. What to do? If the pain is severe, gets worse or doesn’t go away, talk to your health care team about other possible causes.	Talk to your health care team if it does not improve or if it is severe
High blood pressure What to look for? There are usually no signs of high blood pressure. Rarely, you may have headaches, shortness of breath or nosebleeds. What to do? Check your blood pressure regularly. Your doctor may prescribe medication to treat high blood pressure. If you have a severe headache get emergency help right away as it may be a sign your blood pressure is too high.	Talk to your health care team if it does not improve or if it is severe

Other rare, but serious side effects are possible.
If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:

irregular heartbeat, shortness of breath, chest pain, fainting spells or swelling in your legs, ankle and belly
lower back pain, pee less than usual, body swelling
severe muscle spasms, cramping, weakness, or twitching, seizures

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:______________________________________________

Other Notes:

____________________________________________________________________________

March 2021 Updated/Revised info sheet

For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.

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):

pertuzumab patient.pdf Info Sheet (French):

pertuzumab pour le patient.pdf Monograph:

pertuzumab.pdf Funding Program: New Drug Funding Program Funding Instance:

Pertuzumab with Trastuzumab (Biosimilar) - Unresectable Locally Recurrent or Metastatic Breast Cancer

Phonetic Spelling:

per-TOO-zoo-mab

Eligibility Form:

Pertuzumab with Trastuzumab (Biosimilar) - Unresectable Locally Recurrent or Metastatic Breast Cancer Cancer Type: Breast Type of Content: Drug Monograph Status: Null Info Sheet Status: Null Global Date: Vendredi, septembre 16, 2022 Universal Date: 2022-09-16 00:00:00 AddThis: Title URL: PERTuzumab Drug Display Status: Active Revision Summary:

Drug Monograph: Updated NDFP form