Patient Medication Information: uses, side effects, how to take - Nat-Palbociclib
Serious Warnings and Precautions
Take NAT-PALBOCICLIB under the care of a healthcare professional who knows how to use anti-cancer drugs. NAT-PALBOCICLIB can cause the following serious side effect:
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What is NAT-PALBOCICLIB used for?
NAT-PALBOCICLIB is a prescription medicine. It is used in pre/peri-menopausal or post-menopausal women, and men, to treat hormone receptor positive breast cancer that has spread to other parts of the body. It is used with:
- aromatase inhibitors
- fulvestrant: to treat patients whose breast cancer has failed other hormone treatments.
Pre or peri-menopausal women (women who have not gone through menopause) and men treated with a combination of NAT-PALBOCICLIB and aromatase inhibitors and pre/perimenopausal women treated with a combination of NAT-PALBOCICLIB and fulvestrant should also be treated with a medicine that lowers the amount of sex hormones made by the body luteinizing hormone releasing hormone (LHRH) agonist).
How does NAT-PALBOCICLIB work?
Palbociclib belongs to a family of medications called kinase inhibitors. These medications work by stopping cancer cells from dividing and growing. When given together with an aromatase inhibitor or fulvestrant, NAT-PALBOCICLIB may slow down the growth and spread of breast cancer cells.
What are the ingredients in NAT-PALBOCICLIB?
Medicinal ingredients: Palbociclib
Non-medicinal ingredients: Colloidal silicon dioxide, crospovidone, FD&C Blue No 2 Al lake, ferric oxide red (75 mg & 125 mg), hypromellose, iron oxide yellow (100 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol, succinic acid, and titanium dioxide.
NAT-PALBOCICLIB comes in the following dosage forms:
Tablets: 75 mg, 100 mg, 125 mg
Risk of medication error: Be sure to follow the directions on how to take NAT-PALBOCICLIB tablets. These can be taken with or without food.
Do not use NAT-PALBOCICLIB if:
- you are allergic to palbociclib or any of the other ingredients of NAT-PALBOCICLIB (see What are the ingredients in NAT-PALBOCICLIB?).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NAT-PALBOCICLIB. Talk about any health conditions or problems you may have, including if you:
- have fever, chills, or any other signs or symptoms of infection
- have heart problems, including a condition called long QT syndrome
- have liver or kidney problems
- have any other medical conditions
Other warnings you should know about:
NAT-PALBOCICLIB may cause:
- Serious or life-threatening infections. Your healthcare professional will decide when to perform blood tests and will interpret the results.
- Neutropenia and Leukopenia (low white blood cells).
- Anemia (low red blood cells).
- Lung problems (pneumonitis): severe or life-threatening inflammation of the lungs during treatment that can lead to death.
- Blood clots (venous thromboembolism): in the lungs, arms or legs.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Pregnancy, Breastfeeding and Fertility:
Women:
- NAT-PALBOCICLIB should only be used in women who are postmenopausal or women who have not gone through menopause when used with a medicine to stop their ovaries from making estrogen.
- NAT-PALBOCICLIB should not be taken during pregnancy. Talk to your healthcare professional if you are pregnant, think you might be pregnant or plan to become pregnant. NAT-PALBOCICLIB may harm your unborn baby.
- If you are able to become pregnant and are taking NAT-PALBOCICLIB, you should use effective birth control during treatment and for at least 21 days after the final dose. Talk to your healthcare professional about the birth control options that may be right for you.
- Talk to your healthcare professional if you are breastfeeding or planning to breastfeed. It is not known if palbociclib passes into breast milk. You and your healthcare professional should decide if you will take NAT-PALBOCICLIB or breastfeed. You should not do both.
Men:
- If you are a male patient with a female partner who is able to become pregnant, you should use effective birth control during treatment with NAT-PALBOCICLIB and for at least 97 days after the final dose.
- NAT-PALBOCICLIB may affect fertility in men. Male patients should talk to their healthcare professional about sperm preservation before they start therapy with NAT-PALBOCICLIB.
Children and adolescents (under 18 years of age): NAT-PALBOCICLIB should not be used in children and adolescents under 18 years of age.
Driving and using machines: Fatigue and dizziness can occur with NAT-PALBOCICLIB. Give yourself time after taking NAT-PALBOCICLIB to see how you feel before driving or using machinery.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with NAT-PALBOCICLIB:
- medicines for bacterial infections (antibiotics), such as clarithromycin, nafcillin, rifampin and telithromycin
- medicines for fungal infections, such as ketoconazole, itraconazole, posaconazole and voriconazole
- some medicines for high blood pressure, such as bosentan
- HIV medicines, such as saquinavir, ritonavir, indinavir, nelfinavir, lopinavir, efavirenz and etravirine
- antiviral medicines, such as telaprevir
- antidepressant medicines, such as nefazodone
- medicines to treat epilepsy, such as carbamazepine and phenytoin
- medicines to treat certain types of sleep disorders, such as modafinil
- St. John’s wort, an herbal medicine used to treat depression
- medicines to treat high cholesterol (statins), such as rosuvastatin, atorvastatin, simvastatin, and lovastatin.
- grapefruit. Do not drink grapefruit juice or eat grapefruit, or products containing grapefruit extracts, star fruit, pomegranate, Seville oranges or other similar fruits. They may change the amount of NAT-PALBOCICLIB in your body.
Other medicines not listed here may also interact with NAT-PALBOCICLIB
How to take NAT-PALBOCICLIB Tablets:
Always take NAT-PALBOCICLIB tablets exactly as your healthcare professional tells you. Your healthcare professional might adjust your dose if you have certain side effects. Do not change your dose or stop NAT-PALBOCICLIB unless told to do so by your healthcare professional. Check with your healthcare professional if you are not sure.
Take with or without food once a day for 21 days. This is followed by 7 days off (3 weeks on, 1 week off) for a 28 day cycle.
- Swallow whole. Do NOT chew, crush or split the tablets. Do NOT take tablets if they are broken, cracked or look damaged.
- Take your dose of NAT-PALBOCICLIB at approximately the same time each day. • If you vomit after taking a dose of NAT-PALBOCICLIB, do not take an extra dose. Take your next dose at your regular time.
Usual Adult dose:
Recommended starting dose: 125 mg
Tablet: 1 tablet once a day with or without food for 21 days followed by 7 days with no NAT-PALBOCICLIB treatment.
Overdose:
| If you think you, or a person you are caring for, have taken too much NAT-PALBOCICLIB, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
If you miss a day’s dose, do not take an extra dose the next day. Take your next dose at your regular time.
What are possible side effects from using NAT-PALBOCICLIB?
These are not all the possible side effects you may have when taking NAT-PALBOCICLIB. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- shortness of breath
- tiredness or weakness
- cough
- mouth sores
- unusual hair thinning or loss
- nausea, vomiting
- bruising
- loss of appetite
- tingling or abnormal feeling (especially in arms and legs)
- nose bleed
- headache
- constipation
- rash
NAT-PALBOCICLIB can cause abnormal blood test results. Your healthcare professional will do blood tests before, during and after your treatment. These will tell your healthcare professional how NAT-PALBOCICLIB is affecting your blood.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Anemia (low level of red blood cells): fatigue, loss of energy, weakness, shortness of breath | ✓ | ||
| Infections: fever, chills, dizziness, weakness, shortness of breath | ✓ | ||
| Neutropenia and Leukopenia (low level of white blood cells): infection, fever | ✓ | ||
| COMMON | |||
| Diarrhea | ✓ | ||
| Fever | ✓ | ||
Palmar-plantar erythrodysaesthesia syndrome (also called Hand-Foot syndrome): red or swollen palms, thick calluses and blisters of the hands and soles of the feet, tingling or burning, tightness of the skin | ✓ | ||
| Thrombocytopenia (low level of blood platelets): increased tendency to bruise or bleed | ✓ | ||
Venous thromboembolism (blood clots):
| ✓ | ||
| RARE | |||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blister or crust in the center; possibly swollen lips, mild itching or burning skin, fever | ✓ | ||
| UNKNOWN | |||
| Lung problems (pneumonitis): trouble breathing or shortness of breath, cough with or without mucus, chest pain | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
- Store at 15°C to 25°C in the original blister pack to protect from moisture.
- Keep out of reach and sight of children.
If you want more information about NAT-PALBOCICLIB:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://www.natcopharma.ca, or by calling 1-800-296-9329.