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palbociclib

Trade Name:

Ibrance™

Appearance:

Tablet or capsule in various strengths and colours

Monograph Name:

palbociclib

Monograph Body:

Drug Monograph

A - Drug Name

palbociclib

COMMON TRADE NAME(S): Ibrance™

B - Mechanism of Action and Pharmacokinetics

Palbociclib is a selective, reversible small molecule inhibitor of cyclin-dependent kinases (CDK) 4 and 6. The drug inhibits cyclin D-CDK 4/6 complex activity, blocking cell cycle progression from G1 to S phase. Palbociclib in combination with an anti-estrogen agent inhibits cell proliferation and induction of cell senescence in estrogen receptor (ER) positive breast cancer models.

Absorption

Bioavailability

46% (mean)

Peak plasma levels

6 to 12 hours (capsule); 4 to 12 hours (tablet)

Time to reach steady state

8 days

Effects with food

Capsule: When administered with food, AUC and C_max increased (up to 21% and 38%, respectively) and exposure variability decreased. Palbociclib capsules should be taken with food.

Tablet: When administered with food, AUC and C_max increased up to 22% and 26%, respectively; food had no significant impact on exposure variability. Palbociclib tablets may be taken with or without food.

Distribution

PPB

85%

Metabolism

Palbociclib undergoes hepatic metabolism via oxidation and sulfonation, primarily by CYP3A and sulfotransferase (SULT2A1) enzymes; acylation and glucuronidation are minor metabolic pathways.

Inactive metabolites

Yes

Elimination

Half-life

29 hours (mean plasma)

Feces

74%

Urine

18%

C - Indications and Status

Health Canada Approvals:

Breast cancer

(Includes conditional approvals)
Refer to the product monograph for a full list and details of approved indications.

D - Adverse Effects

Emetogenic Potential:

Minimal – No routine prophylaxis; PRN recommended

The following adverse effects occurred in patients with breast cancer treated with palbociclib plus fulvestrant in a Phase III study, where the incidence was at least 2% greater than the placebo plus fulvestrant arm. The table also includes severe or life-threatening adverse effects from other sources or post-marketing.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Venous thromboembolism (1%) (pulmonary embolism)	E
Dermatological	Alopecia (15%)	E
	Rash, pruritus (14%)	E
Gastrointestinal	Anorexia (13%)	E
	Constipation (17%)	E
	Diarrhea (19%)	E
	Mucositis (25%)	E
	Nausea, vomiting (29%)	E
General	Edema - limbs (8%)	E
	Fatigue (38%)	E
Hematological	Myelosuppression ± infection, bleeding (79%) (62% severe)	E
Nervous System	Dizziness (11%)	E
	Dysgeusia (6%)	E
	Headache (21%)	E
	Insomnia (11%)	E
Respiratory	Cough, dyspnea (13%)	E
	Pneumonitis (1%)	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 palbociclib include myelosuppression ± infection, bleeding, fatigue, nausea, vomiting, mucositis, headache, diarrhea, constipation, alopecia, rash, pruritus and anorexia.

Neutropenia was the most frequently reported adverse effect with a median onset of 15 days. Febrile neutropenia, including one fatal case, has been was reported in 2% of patients across clinical trials.

Infections were reported more frequently. Patients should be warned of the increased risk of infection and promptly report any occurrences of fever to their health care team.

Severe or life-threatening interstitial lung disease/pneumonitis has been reported in combination with endocrine therapy in clinical trials and post-marketing (including fatal cases).

E - Dosing

Refer to protocol by which patient is being treated.

Pre- and perimenopausal women treated with palbociclib and an aromatase inhibitor or fulvestrant should also be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to local clinical practice.

Adults:

Oral: 125 mg Daily on Days 1 to 21, every 28 days

in combination with an aromatase inhibitor (e.g., letrozole) or fulvestrant. Refer to regimen monographs for dosing details.

Dosage with Toxicity:

Dose Level	Palbociclib Dose (mg/day) for 3 out of 4 weeks
0	125
-1	100
-2	75
-3	If further dose reduction required, discontinue.

Toxicity	Grade	Palbociclib Dose
Hematologic	3	Day 1: Hold and repeat CBC within 1 week. When recovered to Grade ≤ 2, re-start next cycle at same dose. Day 15 of 1st 2 cycles: Continue current dose to complete the cycle. Repeat CBC day 22. If Grade 4 on Day 22, see Grade 4 recommendation below. Consider dose reduction if > 1 week recovery or recurrent Grade 3 neutropenia in subsequent cycles.
	3 with fever ≥ 38.5^oC and/or infection	Hold until recovery to Grade ≤ 2. Restart at the next lower dose.
	4	Hold until recovery to Grade ≤ 2. Restart at the next lower dose.
Symptoms of interstitial lung disease (ILD)/pneumonitis (treatment–related)	Any	Hold dose and investigate; discontinue if severe ILD confirmed.
Other non-hematologic	3 or 4 (if persisting despite medical treatment)	Hold until recovery to Grade ≤ 1 or Grade ≤ 2 (if not considered a safety risk). Restart at the next lower dose.

Dosage with Hepatic Impairment:

Mean fraction of unbound palbociclib in plasma increased with worsening hepatic function.

Hepatic Impairment	Starting Dose
Mild - Moderate (Child-Pugh class A and B)	No dosage adjustment needed.
Severe (Child-Pugh class C)	75 mg once daily (days 1 to 21; q28 days). Monitor for toxicity.

Dosage with Renal Impairment:

No adjustment is required for CrCl > 15 mL/min. There is no data available in patients requiring hemodialysis.

Dosage in the elderly:

No overall differences in efficacy were observed between patients aged 65 and older compared to younger patients. When combined with letrozole, patients ≥ 65 were more likely to experience anemia.

Dosage based on gender:

Gender and body weight had no significant effect on drug exposure.

Dosage based on ethnicity:

No dose modification is required based on pharmacokinetic, safety and efficacy data across Asian and non-Asian populations.

Children:

The safety and efficacy of palbociclib has not been studied in children under 18 years.

F - Administration Guidelines

Palbociclib capsules should be administered with food; palbociclib tablets may be given with or without food.
Capsules or tablets should be swallowed whole and not chewed, crushed, opened, or split prior to administration.
If a patient vomits or misses a dose, an extra dose should not be taken to make up for the vomited or missed dose. The next dose should be taken at the usual time.
Grapefruit, pomegranate, starfruit, Seville oranges, their juices or products should be avoided during palbociclib treatment.
Capsules should be stored at 20 to 25^oC, with excursions permitted between 15 to 30^oC. Tablets should be stored at 15 to 30^oC in original packaging to protect from moisture.

G - Special Precautions

Contraindications:

Patients who are hypersensitive to palbociclib or any ingredient in the formulation or component in the container.

Other Warnings/Precautions:

As fatigue and dizziness have been reported, patients should exercise caution when driving or operating machinery.
Capsules contain lactose; carefully consider use in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.

Other Drug Properties:

Carcinogenicity: Unknown

An increased incidence of microglial cell tumors was observed male rats; the relevance to humans is unknown.

Pregnancy and Lactation:

Genotoxicity: Probable
Mutagenicity: No
Fetotoxicity: Yes

Palbociclib is not recommended for use in pregnancy. Adequate contraception should be used by both sexes during treatment, and for at least 21 days after the last dose (for females) and 97 days after the last dose (for males).
Excretion into breast milk: Unknown

Breastfeeding is not recommended.
Fertility effects: Probable

Animal data suggest that palbociclib may affect male fertility. Sperm preservation should be considered prior to starting treatment in males.

H - Interactions

Palbociclib is a substrate and weak inhibitor of CYP3A and a moderate substrate of P-gp. Drug interactions are possible with strong CYP3A inducers and inhibitors. Palbociclib is not an inhibitor of CYP1A2, 2A6, 2B6, 2C9 and 2D6 and not an inducer of CYP1A2, 2B6, 2C8 and 3A4 in vitro.

The drug has a low potential to inhibit drug transporters P-gp, BCRP, OAT1, OAT3, OCT2, OATP1B1 and OATP1B3. Palbociclib is not a substrate of OATP1B1 and OATP1B3 (in vitro studies).

There are no drug interactions with letrozole or goserelin.

Palbociclib solubility is pH dependent. Drug interactions with proton pump inhibitors are minimized when palbociclib capsules are given with food; food also reduces drug exposure variability of palbociclib capsules.

AGENT	EFFECT	MECHANISM	MANAGEMENT
CYP3A inhibitors (i.e. ketoconazole, clarithromycin, ritonavir, fruit or juice from grapefruit, Seville oranges or starfruit)	↑ palbociclib concentration and/or toxicity	↓ metabolism of palbociclib	Avoid strong CYP3A inhibitors.
Strong and moderate CYP3A inducers (i.e. phenytoin, rifampin, dexamethasone, carbamazepine, phenobarbital, St. John’s Wort, etc)	↓ palbociclib concentration and/or efficacy	↑ metabolism of palbociclib	Avoid CYP3A inducers. If use of moderate inducer cannot be avoided, no dose adjustment to palbociclib is needed.
Antacids and PPIs (e.g. rabeprazole)	↓ palbociclib exposure when PPI and palbociclib capsules given in fasted conditions; minimal effect when palbociclib capsules given with food	Palbociclib has pH-dependent solubility; reduced palbociclib capsule solubility with increasing pH.	To minimize interaction with antacids and PPIs, palbociclib capsules should be given with food.
CYP3A substrates (e.g. cyclosporine, pimozide, tacrolimus, triazolo-benzodiazepines, dihydropyridine calcium-channel blockers, certain HMG-CoA reductase inhibitors)	↑ substrate concentration and/or toxicity	Palbociclib is a weak inhibitor of CYP3A.	Consider reducing the dose of CYP3A substrates with narrow therapeutic indices (e.g. cyclosporine)

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
CBC	Baseline and before each cycle, on day 15 of the first 2 cycles, one week after Grade 3 neutropenia, and as clinically indicated. If neutropenia Grade 2 or less in the first 6 cycles, may monitor every 3rd cycle thereafter
Liver function tests	Baseline and as clinically indicated
Renal function tests	Baseline and as clinically indicated
Clinical toxicity assessment for infection, bleeding, thromboembolism, pneumonitis, rash, headache, mucositis, fatigue and GI effects	At each visit

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

J - Supplementary Public Funding

Exceptional Access Program (EAP Website)

palbociclib - For the treatment of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER 2)-negative, unresectable locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant, according to clinical criteria

K - References

Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35.

Product Monograph: Ibrance (palbociclib). Pfizer Canada Inc. January 24, 2020.

April 2021 Updated indication and dosing description

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:

palbociclib (patient)

Info Sheet Introduction:

For treating certain types of hormone sensitive breast cancer. Palbociclib is given together with another medication.

Info Sheet Date: Tuesday, May 25, 2021 Info Sheet body:

Medication Information Sheet

palbociclib (PAL boe SYE klib)

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: Ibrance™

Appearance:

Tablet or capsule in various strengths and colours

What is this medication for?

For treating certain types of hormone sensitive breast cancer. Palbociclib is given together with another medication.

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:

liver or kidney problems,
lung problems,
active infections, or
any allergies.

Palbociclib capsules contain a small amount of lactose. If you cannot tolerate lactose, talk to your health care team.

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

This medication 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 21 days after your last dose (if you are female) and 97 days after your last treatment dose (if you are male). 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 medication.

How is this medication given?

This medication is usually taken once a day by mouth for 3 weeks followed by a 1 week break with no palbociclib treatment. Talk to your health care team about how and when to take your medication.
Take the dose at about the same time each day.
If you have palbociclib tablets, swallow them whole with a glass of water, with or without food.
If you have palbociclib capsules, swallow them whole with a glass of water, with food.
Do not chew, crush, open, or split the tablets or capsules.
If you vomit (throw up) or miss a dose, skip this and take your next dose as you normally do. Do not take an extra dose to make up for the missed dose.
If you take too much of your medication by accident, or if you think a child or a pet may have swallowed your medication, you must call the Ontario Poison Control Center right away at: 1-800-268-9017.

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

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

This medication can interact with other medications, vitamins, foods and natural health products. Interactions can make the treatment 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 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.

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.
DO NOT eat or drink grapefruit, starfruit, pomegranate, Seville oranges or their juices (or products that contain these) while taking this drug. They may increase the amount of drug in your blood and increase side effects.
DO NOT drive, operate machinery or do any tasks that need you to be alert if you feel tired or dizzy.

How should I safely store this medication?

Do not throw out any unused medications at home. Bring them to your pharmacy to be thrown away safely.
Keep this medication in the original packaging at room temperature in a dry place, away from heat and light. Keep out of sight and reach of children and pets.
How to safely touch oral anti-cancer medications

If you are a patient:
- Wash your hands before and after touching your oral anti-cancer medication.
- Swallow each pill whole. Do not crush or chew your pills.
If you are a caregiver:
- Wear nitrile or latex gloves when touching tablets, capsules or liquids.
- Wash your hands before putting on your gloves and after taking them off, even if your skin did not touch the oral anti-cancer medication.
- Throw out your gloves after each use. Do not re-use gloves.
- Do not touch oral anti-cancer medications if you are pregnant or breastfeeding.
What to do if oral anti-cancer medication gets on your skin or in your eyes

If medication gets on your skin:
- Wash your skin with a lot of soap and water.
- If your skin gets red or irritated, talk to your health care team.
If medication gets in your eyes:
- Rinse your eyes with running water right away. Keep water flowing over your open eyes for at least 15 minutes.

What are the side effects of this medication?

The following table lists side effects that you may have when getting palbociclib. 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 palbociclib.

Very Common Side Effects (50 or more out of 100 people)
Low neutrophils (white blood cells) in the blood (neutropenia) 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.

Very Common Side Effects (50 or more out of 100 people)

Side effects and what to do

When to contact health care team

Low neutrophils (white blood cells) in the blood (neutropenia)

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.

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
Nausea and vomiting (generallly 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. 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 healthcare team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if it is severe
Anemia (low red blood cells) What to look for? You may feel more tired or weaker than normal. Pale skin and cold hands and feet. You may feel short of breath, dizzy or lightheaded. This may occur in days to weeks after your treatment starts. What to do? If your health care team has told you that you have anemia (low red blood cells): Rest often and eat well. Light exercise, such as walking may help. You may need medication or a blood transfusion. If it is very bad, your doctor may need to make changes to your treatment regimen.	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

Less Common Side Effects (10 to 24 out of 100 people)
Side effects and what to do	When to contact health care team
Headache What to look for? Mild headache What to do? Take pain medication (acetaminophen or opioids such as codeine, morphine, hydromorphone, oxycodone) as prescribed. Read the above section: "What should I do if I feel unwell, have pain, a headache or a fever?" before taking acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or Aspirin. These medications may hide an infection that needs treatment or they may increase your risk of bleeding. Ask your health care team for the Pain pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
Low platelets in the blood 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.
Diarrhea 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)
Constipation What to look for? Having bowel movements (going poo) less often than normal. Small hard stools (poo) that look like pellets. The need to push hard and strain to have any stool (poo) come out. Stomach ache or cramps. A bloated belly, feeling of fullness, or discomfort. Leaking of watery stools (poo). Lots of gas or burping. Nausea or vomiting. What to do? To help prevent constipation: Try to eat more fiber rich foods like fruits with skin, leafy greens and whole grains. Drink at least 6 to 8 cups of liquids each day unless your health care team has told you to drink more or less. Be Active. Exercise can help to keep you regular. If you take opioid pain medication, ask your health care team if eating more fibre is right for you. To help treat constipation: If you have not had a bowel movement in 2 to 3 days you may need to take a laxative (medication to help you poo) to help you have regular bowel movements. Ask your health care team what to do. Ask your health care team for the Constipation Pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
Hair thinning or loss What to look for? Your hair may begin to become thin or fall out during or after treatment. In most cases, your hair will grow back after treatment, but the texture or colour may change. In very rare cases, hair loss may be permanent. What to do? Use a gentle soft brush. Do not use hair sprays, bleaches, dyes and perms.	Talk to your health care team if this bothers you
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. 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 it does not improve or if it is severe
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
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
Dizziness What to look for? You may feel light-headed and like you might faint (pass out). What to do? Lay down right away so you do not fall. Slowly get up and start moving once you feel better. Do not drive a motor vehicle or use machinery if you feel dizzy.	Talk to your health care team if it does not improve or if it is severe
Trouble Sleeping Your medications may cause trouble sleeping. It may get better once your body gets used to the medication or when your treatment ends. What to look for? You may find it hard to fall asleep or stay asleep. How well you sleep may change over your treatment. For example, you may have several nights of poor sleep followed by a night of better sleep. You may wake up too early or not feel well-rested after a night's sleep. You may feel tired or sleepy during the day. What to do? Talk to your health care team if it does not improve or if it is severe	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:

Pain, swelling and hardening of the vein in an arm or leg.

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:

____________________________________________________________________________

February 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):

palbociclib patient.pdf Info Sheet (French):

palbociclib pour le patient.pdf Monograph:

palbociclib.pdf Funding Program: Exceptional Access Program Funding Instance:

palbociclib - For the treatment of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER 2)-negative, unresectable locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant, according to clinical criteria

Phonetic Spelling:

PAL boe SYE klib

Cancer Type: Breast Type of Content: Drug Monograph Status: Null Info Sheet Status: Null Global Date: Thursday, April 29, 2021 Universal Date: 2021-05-25 00:00:00 AddThis: Title URL: palbociclib Drug Display Status: Active Revision Summary:
Drug Monograph: Updated indication and dosing description
Patient Info Sheet FR: Updated appearance