Patient leaflet - Palbociclib 125 mg film-coated tablets
1. What Palbociclib film-coated tablets are and what they are used for
Palbociclib film-coated tablets are 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.
Palbociclib 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 Palbociclib film-coated tablets
DO NOT take Palbociclib film-coated tablets
- if you are allergic to palbociclib or any of the other ingredients of this medicine (listed in section 6).
- use of preparations containing St. John’s Wort, an herbal product used to treat mild depression and anxiety, should be avoided while you are taking palbociclib.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Palbociclib film-coated tablets.
Palbociclib 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 palbociclib.
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 palbociclib affects your blood cells (white blood cells, red blood cells, and platelets).
Palbociclib may cause blood clots in the veins. Tell your doctor, pharmacist or nurse if you experience signs or symptoms of blood clots in the veins such as pain or stiffness, swelling and redness in the affected leg (or arm), chest pain, shortness of breath or lightheadedness.
Palbociclib may cause severe or life-threatening 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
Palbociclib is not to be used in children or adolescents (under 18 years of age).
Other medicines and palbociclib
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Palbociclib may affect the way some other medicines work. In particular, the following may increase the risk of side effects with palbociclib:
- 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 palbociclib:
- Quinidine generally used to treat heart rhythm problems.
- Colchicine used to treat gout.
- Pravastatin, simvastatin, atorvastatin, fluvastatin and rosuvastatin used to treat high cholesterol levels.
- Sulfasalazine used to treat rheumatoid arthritis.
- Alfentanil used for anaesthesia in surgery; fentanyl used in pre-procedures 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 palbociclib:
- 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.
Palbociclib film-coated tablets with food and drink
Palbociclib tablets may be taken with or without food.
Avoid grapefruit and grapefruit juice while you are taking Palbociclib tablets as it may increase the side effects of palbociclib.
Pregnancy and breast-feeding and fertility
Pregnancy
You should not use palbociclib if you are pregnant.
You should avoid becoming pregnant while taking palbociclib.
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 palbociclib. It is not known if palbociclib is excreted in breast milk.
Fertility
Palbociclib may decrease fertility in men.
Therefore, men may consider sperm preservation before taking palbociclib.
Driving and using machines
Tiredness is a very common side effect of palbociclib. If you feel unusually tired, take special care when driving or using machines.
3. How to take Palbociclib film-coated tablets
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 palbociclib taken once a day for 3 weeks followed by 1 week without taking palbociclib. Your doctor will tell you how many tablets to take.
If you experience certain side effects while you are taking palbociclib (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 Palbociclib tablets 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 Palbociclib film-coated tablets than you should
If you have taken too many Palbociclib film-coated tablets, 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 Palbociclib film-coated tablets
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 Palbociclib film-coated tablets
Do not stop taking palbociclib 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.
- painful swollen leg, chest pain, shortness of breath, rapid breathing or rapid heart rate as these can be signs of blood clots in the vein (which may affect up to 1 in 10 people).
Other side effects with palbociclib 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
Redness, pain, peeling, swelling and blistering of palms of hands and/or soles of feet
(Palmar-Plantar Erythrodysaesthesia Syndrome [PPES])
- Abnormal kidney blood test result (high level of creatinine in the blood)
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]).
A skin reaction that causes red spots or patches on the skin that may look like a target or
“bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.
5. How to store Palbociclib film-coated tablets
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.
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 Palbociclib film-coated tablets contain
The active substance is palbociclib. Palbociclib film-coated tablets come in different strengths:
- Palbociclib 75 mg film-coated tablet: each tablet contains 75 mg palbociclib.
- Palbociclib 100 mg film-coated tablet: each tablet contains 100 mg palbociclib.
- Palbociclib 125 mg film-coated tablet: each tablet contains 125 mg palbociclib.
- The other ingredients are:
Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone, hypromellose, magnesium stearate, succinic acid.
Film-coating: hypromellose (E464), talc (553b), iron oxide red (E172), iron oxide yellow (E172).
What Palbociclib film-coated tablets look like and contents of the pack
Palbociclib 75 mg is supplied as brown round film-coated tablets, debossed with “P75” on one side and plain on other side. And an average thickness of approx. 5.6 mm and a diameter of approx. 11.2 mm.
Palbociclib 100 mg tablets is supplied as yellow oval film-coated tablets, debossed with “P100” on one side and plain on other side. And an average thickness of approx. 6.8 mm, a width of approx. 8.7 mm, and a length of approx. 15.7 mm.
Palbociclib 125 mg tablets is supplied as brown oval film-coated tablets, debossed with “P125” on one side and plain on other side. And an average thickness of approx. 7.0 mm, a width of approx. 9.7 mm, and a length of approx. 16.8 mm.
Palbociclib 75 mg, 100 mg, and 125 mg are available in blister packs of 21 tablets or 63 tablets in a carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
STADA, Linthwaite, Huddersfield, HD7 5QH, UK
Manufacturer
STADA Arzneimittel AG, Stadastrasse 2-18, Bad Vilbel, 61118, Germany STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien, Austria
Clonmel Healthcare Ltd., Waterford Road, E91 D768 Clonmel, Co. Tipperary, Ireland Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola PLA 3000, Malta Laboratori Fundació Dau, C/C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain