IPALIB 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 delays the progression of your cancer. IPALIB is used to treat patients with certain types of breast cancer (hormone receptor [HR]-positive, human epidermal growth factor receptor [HERS] 2-negative) which have spread beyond the original tumour and/or to other organs. It is given together with letrozole as initial endocrine-based therapy in postmenopausal women or fulvestrant, which are used as hormonal anticancer therapies.
1. What IPALIB is and what it is used for
2. What you need to know before you take IPALIB
Do not take IPALIB
- if you are hypersensitive (allergic) to palbociclib or any of the other ingredients of this medicine (listed in section 6).
- use of preparations containing St. John’s Wort should be avoided while you are taking IPALIB.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking IPALIB. IPALIB 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 IPALIB.
Before you take IPALIB Tell your healthcare provider if you:
- have fever, chills, or any other signs or symptoms of infection.
- have liver or kidney problems.
- have any other medical conditions.
- are pregnant, or plan to become pregnant. IPALIB can harm your unborn baby.
You will have regular blood tests during treatment to check whether IPALIB affects your blood cells (white blood cells, red blood cells, and platelets). IPALIB 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
IPALIB is not to be used in children or adolescents (under 18 years of age).
Other medicines and IPALIB
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines) IPALIB may affect the way some other medicines work. In particular, the following may increase the risk of side effects with IPALIB:
- 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 IPALIB:
- 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 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 IPALIB:
- Carbamazepine, felbamate, phenobarbital,primidone and phenytoin, used to stop seizures or fits.
- Enzalutamide to treat prostate cancer.
- Rifampicin, rifapentine and rifabutin used to treat tuberculosis (TB).
- Nevirapine used to treat HIV
- St. John’s Wort, a herbal product used to treat mild depression and anxiety.
IPALIB with food and drink
Avoid grapefruit and grapefruit juice while you are taking IPALIB as it may increase the side effects of IPALIB.
Pregnancy and breastfeeding and fertility
Do not use IPALIB if you are pregnant or breastfeeding your baby. You should avoid becoming pregnant while taking IPALIB. Discuss contraception with your doctor if there is any possibility that you or your partner may become pregnant. If you are pregnant or breastfeeding your baby, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking IPALIB. 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. Breastfeeding You should not breast-feed while taking IPALIB. It is not known if IPALIB is excreted in breast milk. Fertility Palbociclib may decrease fertility in men. Therefore, men may consider sperm preservation before taking IPALIB.
3. How to take IPALIB
Do not share medicines prescribed for you with any other person. 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 usual dose is 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days. When co-administered with IPALIB, the recommended dose of letrozole is 2,5 mg taken orally once daily continuously throughout the 28-day cycle. Please refer to the patient information leaflet of letrozole. When co-administered with IPALIB, the recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter. Please refer to the patient information leaflet of fulvestrant.
Take IPALIB once a day at about the same time every day with food, preferably a meal. Avoid grapefruit and grapefruit products during treatment with IPALIB. Grapefruit may increase the amount of IPALIB in your blood. Swallow the capsule whole with a glass of water. Do not chew or crush the capsules. Do not open the capsules.
If you take more IPALIB than you should
In the event of overdosage, consult your pharmacist or doctor. If neither is available, contact the nearest hospital or poison control center. Take the carton and this leaflet, so that the doctor knows what you have been taking.
If you forget to take IPALIB
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 capsules.
If you stop taking IPALIB
Do not stop taking IPALIB 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
IPALIB can have side effects. Not all side effects reported for IPALIB are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking IPALIB, please consult your healthcare provider for advice. If any of the following happens, stop taking / using IPALIB and tell your doctor immediately or go to the casualty department at your nearest hospital:
- swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
- rash or itching,
- fainting
These are all very serious side effects. If you have them, you may have had a serious reaction to IPALIB. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
Frequent side effects:
- Low red blood cell counts, and low platelet counts are common with IPALIB
- weakness
- nosebleeds
- infections
These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:
Frequent side effects:
- Feeling of tiredness
- Decreased appetite
- Inflammation of the mouth and lips (stomatitis), nausea, vomiting, diarrhoea
- Rash
- Hair loss
- Fever
- Abnormalities in liver blood tests
- Dry skin
- Fever with a drop in the white blood cell count (febrile neutropenia)
- Blurred vision, increased tearing, dry eye
- Alteration in taste (dysgeusia)
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your healthcare professional. You can also report side effects to SAHPRA via the “ 6.04 Adverse Drug Reaction Reporting Form ”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of IPALIB.
5. How to store IPALIB
Store all medicines out of reach of children. Store at or below 25 °C. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).