Patient leaflet - IBRANCE 100 MG FILM-COATED TABLETS
1. what ibrance is and what it is used for
Ibrance is an anticancer medicine containing the active substance palbociclib.
Palbociclib works by blocking proteins called cyclin-dependent kinase 4 and 6, which regulate cell growth and division. Blocking these proteins can slow down growth of cancer cells and delay the progression of your cancer.
Ibrance is used to treat patients with certain types of breast cancer (hormone receptor-positive, human epidermal growth factor receptor 2-negative) which have spread beyond the original tumour and/or to other organs. It is given together with aromatase inhibitors or fulvestrant, which are used as hormonal anticancer therapies.
2. what you need to know before you take ibrance
Do not take Ibrance
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– if you are allergic to palbociclib or any of the other ingredients of this medicine (listed in section 6).
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– use of preparations containing St. John’s Wort should be avoided while you are taking Ibrance.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Ibrance.
Ibrance may reduce the number of your white blood cells and weaken your immune system. Therefore, you may be at greater risk of getting an infection while you are taking Ibrance.
Tell your doctor, pharmacist or nurse if you experience signs or symptoms of an infection, such as chills or fever.
You will have regular blood tests during treatment to check whether Ibrance affects your blood cells (white blood cells, red blood cells, and platelets).
Ibrance may cause severe or lifethreatening inflammation of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms including:
- difficulty breathing or shortness of breath
- dry cough
- chest pain
Children and adolescents
Ibrance is not to be used in children or adolescents (under 18 years of age).
Other medicines and Ibrance
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Ibrance may affect the way some other medicines work.
In particular, the following may increase the risk of side effects with Ibrance:
- Lopinavir, indinavir, nelfinavir, ritonavir, telaprevir, and saquinavir used to treat HIV infection/AIDS.
- Clarithromycin and telithromycin antibiotics used to treat bacterial infections.
- Voriconazole, itraconazole, ketoconazole, and posaconazole used to treat fungal infections.
- Nefazodone used to treat depression.
The following medicines may have increased risk of side effects when given with Ibrance:
- Quinidine generally used to treat heart rhythm problems.
- Colchicine used to treat gout.
- Pravastatin and rosuvastatin used to treat high cholesterol levels.
- Sulfasalazine used to treat rheumatoid arthritis.
- Alfentanil used for anaesthesia in surgery; fentanyl used in preprocedures as a pain reliever as well as an anaesthetic.
- Cyclosporine, everolimus, tacrolimus, and sirolimus used in organ transplantation to prevent rejection.
- Dihydroergotamine and ergotamine used to treat migraine.
- Pimozide used to treat schizophrenia and chronic psychosis.
The following medicines may reduce the effectiveness of Ibrance:
- Carbamazepine and phenytoin, used to stop seizures or fits.
- Enzalutamide to treat prostate cancer.
- Rifampin used to treat tuberculosis (TB).
- St. John’s Wort, an herbal product used to treat mild depression and anxiety.
Ibrance with food and drink
Ibrance tablets may be taken with or without food.
Avoid grapefruit and grapefruit juice while you are taking Ibrance as it may increase the side effects of Ibrance.
Pregnancy and breast-feeding and fertility
You should not use Ibrance if you are pregnant.
You should avoid becoming pregnant while taking Ibrance.
Discuss contraception with your doctor if there is any possibility that you or your partner may become pregnant.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women of childbearing potential who are receiving this medicinal product, or their male partners should use adequate contraceptive methods (e.g., double-barrier contraception such as condom and diaphragm). These methods should be used during therapy and for at least 3 weeks after completing therapy for females and for at least 14 weeks for males.
Breast-feeding
You should not breast-feed while taking Ibrance. It is not known if Ibrance is excreted in breast milk.
Fertility
Palbociclib may decrease fertility in men.
Therefore, men may consider sperm preservation before taking Ibrance.
Driving and using machines Tiredness is a very common side effect. If you feel unusually tired, take special care when driving or using machines.
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3. how to take ibrance 5. how to store ibrance
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 125 mg of Ibrance taken once a day for 3 weeks followed by 1 week without taking Ibrance. Your doctor will tell you how many tablets of Ibrance to take.
If you experience certain side effects while you are taking Ibrance (see section 4 “Possible side effects”), your doctor may lower your dose or stop treatment, either temporarily or permanently. The dose may be lowered to one of the other available strengths 100 mg or 75 mg.
Take Ibrance once a day at about the same time every day with or without food.
Swallow the tablet whole with a glass of water. Do not chew or crush the tablets. Do not split the tablets prior to swallowing. No tablet should be ingested if it is broken, cracked, or otherwise not intact.
If you take more Ibrance than you should
If you have taken too much Ibrance, see a doctor or go to a hospital immediately. Urgent treatment may be necessary.
Take the carton and this leaflet, so that the doctor knows what you have been taking.
If you forget to take Ibrance
If you miss a dose or vomit, take your next dose as scheduled. Do not take a double dose to make up for the forgotten tablets.
If you stop taking Ibrance
Do not stop taking Ibrance unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them:
Contact your doctor immediately if you have any of these symptoms:
- fever, chills, weakness, shortness of breath, bleeding, or easy bruising which could be a sign of a serious blood disorder.
- difficulty breathing, dry cough or chest pain which could be a sign of inflammation of the lungs.
Other side effects with Ibrance may include:
Very common side effects (may affect more than 1 in 10 people):
Infections
Reduction in white blood cells, red blood cells, and blood platelets
Feeling of tiredness Decreased appetite Inflammation of the mouth and lips (stomatitis), nausea, vomiting, diarrhoea Rash
Hair loss
Weakness
Fever
Abnormalities in liver blood tests Dry skin
Common side effects (may affect up to 1 in 10 people):
Fever with a drop in the white blood cell count (febrile neutropenia)
Blurred vision, increased tearing, dry eye
Alteration in taste (dysgeusia) Nosebleed
Uncommon side effects (may affect up to 1 in 100 people):
Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints and fever (Cutaneous Lupus Erythematosus [CLE]).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the original blister package in order to protect from moisture.
Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
If this medicine becomes discoloured or shows any other signs of deterioration, please contact your pharmacist who will advise you on what to do.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Ibrance contains
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– The active substance is palbociclib.
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– Each film-coated tablet contains
What Ibrance looks like and contents of the pack
– Ibrance 100 mg tablets are supplied as oval, green, film-coated tablets with “Pfizer” on one side and “PBC 100” on the other side.
Ibrance 100 mg is available in blister packs of 21 tablets in a carton.
Ibrance 100 mg is available in blister card with 7 tablets (1 tablet per cell) in a wallet card. Each carton contains 21 tablets (3 wallet cards per carton).
Product Licence Holder and Manufacturer
Procured from within the EU by the Product Licence holder Orifarm UK Ltd., 236 Jubilee House, 3 The Drive, Great Warley, Brentwood, CM13 3FR, UK
Repacked by Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, Czech Republic
Manufactured by Pfizer Manufacturing Deutschland GmbH, Betriebstatte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany
Ibrance 100 mg film-coated tablets PLGB 45985/0510
Leaflet revision date: 06/10/2021
| POM |
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