IBRANCE is an anticancer medicine containing the active substance palbociclib. IBRANCE 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 indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination - with letrozole as initial endocrine-based therapy in postmenopausal women - with fulvestrant in women with disease progression who have received prior endocrine therapy.
1. What IBRANCE is and what it is used for
2. What you need to know before you take IBRANCE
Do not take IBRANCE • if you are hypersensitive (allergic) to palbociclib or any of the other ingredients of IBRANCE (listed in section 6).
Warnings and precautions
Take special care with IBRANCE Tell your doctor, pharmacist or other health care provider if you have fever, chills or any other signs or symptoms of infection. IBRANCE 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 light-headedness. IBRANCE may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Tell your health care provider right away if you have any new or worsening symptoms including:
- difficulty breathing or shortness of breath
- dry cough
- chest pain
Children
The safety and efficacy of IBRANCE in children have not been established.
Other medicines and IBRANCE
Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Medicines that increase the amount of IBRANCE in your blood Simultaneous administration with potent isoenzyme CYP3A inhibitors (e.g. lopinavir, indinavir, nelfinavir, ritonavir, telaprevir, and saquinavir used to treat HIV infection/AIDS; telithromycin antibiotic used to treat bacterial infections; voriconazole, itraconazole, ketoconazole, and posaconazole used to treat fungal infections and nefazodone used to treat depression) should be avoided. Medicines that decrease the amount of IBRANCE in your blood The concomitant administration with strong CYP3A inducers e.g. phenytoin, carbamazepine and rifampicin, St. John’s Wort or moderate CYP3A inducers e.g. bosentan, efavirenz, etravirine, modafinil and nafcillin should be avoided. IBRANCE with food and drink During IBRANCE therapy, avoid eating grapefruit and products containing grapefruit. Grapefruit may increase your plasma concentration of IBRANCE. Take IBRANCE with food.
3. How to take IBRANCE
Do not share medicines prescribed for you with any other person. Always take IBRANCE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. 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 IBRANCE, 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 IBRANCE, 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. IBRANCE should be taken with food. Take your dose at approximately the same time each day. Your doctor may modify the dose of IBRANCE based on your individual safety and tolerability profile, thus it is important to take IBRANCE exactly as instructed. Your doctor will monitor your complete blood count before starting IBRANCE and on day 15 of the first 2 cycles and adjust the dosage if required. If you vomit after taking a dose, do not take another dose. You should take the next prescribed dose at the usual time. IBRANCE capsules should be swallowed whole (do not chew, crush or open them prior to swallowing). No capsule should be ingested if it is broken, cracked, or otherwise not intact. Special populations Elderly population No dose adjustment is necessary if you are 65 years of age or older. Hepatic impairment No dose adjustments are required if you have mild or moderate liver problems. If you have severe liver problems, the recommended dose of IBRANCE is 75 mg once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days. Renal impairment No dose adjustments are required if you have mild, moderate or severe kidney problems. Paediatric population The safety and efficacy of IBRANCE in children and adolescents ≤ 18 years of age have not been established. Your doctor will tell you how long your treatment with IBRANCE will last. Do not stop treatment early. If you have the impression that the effect of IBRANCE is too strong or too weak, tell your doctor or pharmacist. If you take more IBRANCE than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you forget to take IBRANCE Do not take a double dose to make up for forgotten individual doses. You should take the next prescribed dose at the usual time.
4. Possible side effects
IBRANCE can have side effects. Not all side effects reported for IBRANCE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking IBRANCE, please consult your health care provider for advice. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
- Signs or symptoms of infection, such as fever or chills.
- Signs and symptoms of low red blood cell or blood platelet count, such as dizziness, shortness of breath, weakness, bleeding or easier formation of bruises and nose bleeding.
- 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.
These are all serious side effects. You may need urgent medical attention or hospitalisation. Tell your doctor if you notice the following: Frequent side effects • decreased appetite • nose bleeds • stomatitis (inflammation inside the mouth, mouth sores, mouth pain, sore throat and discomfort) • nausea • diarrhoea • vomiting • rash • tiredness • weakness • fever • blurred vision • dry eyes • metallic taste in the mouth • dry skin • redness, pain, peeling, swelling and blistering of palms of hands and/or soles of feet (Palmar - Plantar Erythrodysaesthesia Syndrome [PPES]) Less frequent side effects • inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints and fever (Cutaneous Lupus Erythematosus [CLE]). 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 doctor or pharmacist. 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. By reporting side effects, you can help provide more information on the safety of IBRANCE.
5. How to store IBRANCE
Store all medicines out of reach of children. Store at or below 30 °C. • Do not store in a bathroom. • Do not use after the expiry date stated on the label / carton / bottle. • Return all unused medicine to your pharmacist. • Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).