IBRANCE (palbociclib)<\/p>"},"content":{"rendered":"
IBRANCE (palbociclib)<\/p>\n<\/div>\n
palbociclib<\/p>\n<\/div>\n
Cancer medicine that slows cell growth<\/p>\n<\/div>\n
IBRANCE capsules are taken by mouth and contain 125 mg, 100 mg, or 75 mg of palbociclib, a medicine that blocks certain proteins. Palbociclib has the chemical formula C24H29N7O2. It weighs 447.54 daltons. The full chemical name is 6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one.<\/p>\n
Palbociclib is a yellow to orange powder. It dissolves well in acidic conditions (pH 4 or lower) but does not dissolve as well when conditions are less acidic.<\/p>\n
Other ingredients in the capsules:<\/p>\n
How This Medicine Works<\/strong><\/p>\n Palbociclib stops certain proteins called CDK 4 and 6. These proteins help cancer cells grow and multiply. When the medicine blocks these proteins, it slows down cancer cell growth.<\/p>\n In lab tests, palbociclib slowed the growth of breast cancer cells that need estrogen to grow. It stops the cells from copying themselves by blocking part of their growth cycle.<\/p>\n When palbociclib is used with hormone-blocking medicines, it works better than either medicine alone. The combination makes cancer cells stop growing and may cause them to die.<\/p>\n Tests in mice with breast cancer showed that palbociclib plus letrozole worked better together than each medicine by itself.<\/p>\n Normal bone marrow cells were not permanently damaged by palbociclib and started growing normally again after treatment stopped.<\/p>\n Heart Effects<\/strong><\/p>\n Doctors checked the heart rhythm in 77 breast cancer patients taking palbociclib. The medicine did not cause dangerous changes to heart rhythm when taken as prescribed (125 mg daily for 21 days, then 7 days off).<\/p>\n How Your Body Handles This Medicine<\/strong><\/p>\n Taking the Medicine<\/strong><\/p>\n After you swallow palbociclib, it reaches its highest level in your blood in 6 to 12 hours. About 46% of the medicine gets into your bloodstream. Higher doses put more medicine in your body. It takes about 8 days of daily doses to reach steady levels in your body.<\/p>\n Food Effects<\/strong><\/p>\n Some people (about 13%) absorb very little medicine when they take it without food. Taking palbociclib with food helps these people absorb more medicine. For most people, food doesn’t change how much medicine gets absorbed very much.<\/p>\n Taking the medicine with food increases the amount in your blood by:<\/p>\n How the Medicine Spreads in Your Body<\/strong><\/p>\n About 85% of palbociclib sticks to proteins in your blood. The medicine spreads throughout your body. People with liver problems may have different amounts of free medicine in their blood.<\/p>\n How Your Body Breaks Down the Medicine<\/strong><\/p>\n Your liver breaks down palbociclib into other substances. The main ways this happens are through oxidation and sulfonation processes. Most of the medicine gets changed into other forms before leaving your body. Only small amounts of unchanged medicine are found in urine (7%) and stool (2%).<\/p>\n How the Medicine Leaves Your Body<\/strong><\/p>\n Palbociclib stays in your body for about 29 hours before half of it is gone. Your body gets rid of about 92% of the medicine in 15 days. Most leaves through stool (74%) and some through urine (18%). Most of what leaves your body is the changed forms of the medicine, not the original medicine.<\/p>\n Different Types of Patients<\/strong><\/p>\n Age, Sex, and Weight<\/strong><\/p>\n Studies in 183 cancer patients (ages 22 to 89, weights 38 to 123 kg) showed that being male or female doesn’t change how the medicine works. Age and body weight don’t make important differences in how much medicine stays in your body.<\/p>\n Liver Problems<\/strong><\/p>\n People with liver problems handle this medicine differently:<\/p>\n Kidney Problems<\/strong><\/p>\n People with kidney problems have more medicine in their blood:<\/p>\n The medicine has not been studied in people on dialysis.<\/p>\n Drug Interactions<\/strong><\/p>\n Palbociclib is mainly broken down by liver enzymes called CYP3A and SULT2A1. This medicine can slightly affect how other medicines work.<\/p>\n Medicines That Increase Palbociclib Levels<\/strong><\/p>\n Strong CYP3A blockers like itraconazole can increase palbociclib levels by 87% and peak levels by 34%.<\/p>\n Medicines That Decrease Palbociclib Levels<\/strong><\/p>\n Strong CYP3A activators affect palbociclib levels:<\/p>\n Effect on Other Medicines<\/strong><\/p>\n Palbociclib can increase levels of some other medicines. It increased midazolam levels by 61% and peak levels by 37%.<\/p>\n Stomach Acid Medicines<\/strong><\/p>\n Medicines that reduce stomach acid can affect palbociclib:<\/p>\n When taken with food:<\/p>\n When taken without food:<\/p>\n Transporter Effects<\/strong><\/p>\n Lab tests show palbociclib has low potential to interfere with most drug transporters. It may affect OCT1, P-gp, and BCRP transporters at treatment doses, but P-gp and BCRP are unlikely to affect how well palbociclib is absorbed.<\/p>\n<\/div>\n IBRANCE is used to treat adults with a specific type of breast cancer. This cancer is hormone receptor positive and HER2-negative. The cancer has spread to other parts of the body. IBRANCE is used together with other medicines.<\/p>\n IBRANCE is also used with two other medicines called inavolisib and fulvestrant. This combination treats adults whose cancer has stopped responding to hormone treatment. The cancer must have a specific gene change called PIK3CA mutation. This gene change is found using an FDA-approved test. This treatment is for patients whose cancer came back after completing hormone therapy.<\/p>\n<\/div>\n How to Take IBRANCE<\/strong><\/p>\n Take one 125 mg capsule by mouth once a day for 21 days in a row. Then stop taking it for 7 days. This makes a complete 28-day cycle.<\/p>\n Always take IBRANCE with food.<\/p>\n Take your dose at about the same time each day.<\/p>\n Other Medicines You May Need<\/strong><\/p>\n Your doctor may also give you other cancer medicines to take with IBRANCE. Follow the directions for those medicines too.<\/p>\n Women who still have periods may need an additional hormone shot. Men may also need a hormone shot. Your doctor will tell you if you need this.<\/p>\n Important Rules for Taking IBRANCE<\/strong><\/p>\n Swallow the capsules whole. Do not chew, crush, or open them.<\/p>\n Do not take broken or cracked capsules.<\/p>\n If you throw up or miss a dose, do not take an extra dose. Just take your next dose at the usual time.<\/p>\n If You Have Side Effects<\/strong><\/p>\n Your doctor may need to lower your dose or have you stop taking IBRANCE for a while if you have side effects.<\/p>\n Dose Changes:<\/strong><\/p>\n If you need to go lower than 75 mg, you will need to stop taking IBRANCE.<\/p>\n Blood Count Problems<\/strong><\/p>\n Your doctor will check your blood regularly. If your blood counts get too low, you may need to:<\/p>\n If you get a fever with low white blood cells, call your doctor right away.<\/p>\n Other Side Effects<\/strong><\/p>\n For mild side effects (Grade 1 or 2): You can usually keep taking the same dose.<\/p>\n For serious side effects (Grade 3 or higher): You may need to stop IBRANCE until you feel better, then start again at a lower dose.<\/p>\n Special Situations<\/strong><\/p>\n If you take certain other medicines that affect how IBRANCE works, your doctor may lower your dose to 75 mg daily.<\/p>\n If you have severe liver problems, your doctor will start you at 75 mg daily for 21 days, then 7 days off.<\/p>\n If you have mild or moderate liver problems, you can take the regular dose.<\/p>\n Important Warning<\/strong><\/p>\n Stop taking IBRANCE and call your doctor right away if you have severe lung problems or trouble breathing.<\/p>\n<\/div>\n This medicine comes in three different strengths:<\/p>\n The printing on each capsule helps you identify the right dose.<\/p>\n<\/div>\n None known<\/p>\n<\/div>\n Important Safety Information<\/strong><\/p>\n Low White Blood Cell Count<\/strong><\/p>\n IBRANCE can lower your white blood cells. This happened in 8 out of 10 people who took this medicine. For many people, the white blood cell count dropped to dangerous levels.<\/p>\n This usually happens about 15 days after starting treatment. When white blood cells get very low, it usually lasts about 7 days.<\/p>\n Your doctor will do blood tests before you start IBRANCE and regularly during treatment. You may need to stop taking the medicine or take a lower dose if your white blood cell count gets too low.<\/p>\n Some people get fever when their white blood cells are low. This can be very serious. One person died from an infection. Call your doctor right away if you get a fever.<\/p>\n Lung Problems<\/strong><\/p>\n IBRANCE can cause serious lung problems that can be life-threatening. This is rare but has happened to some people taking this medicine.<\/p>\n Watch for these symptoms:<\/p>\n If you have any of these symptoms, stop taking IBRANCE and call your doctor right away. You may need to stop taking this medicine permanently if you develop serious lung problems.<\/p>\n Pregnancy Warning<\/strong><\/p>\n IBRANCE can harm an unborn baby. Do not take this medicine if you are pregnant.<\/p>\n If you can get pregnant, use birth control while taking IBRANCE and for at least 3 weeks after your last dose. Talk to your doctor about the best birth control method for you.<\/p>\n<\/div>\n Important Note About Side Effects<\/strong><\/p>\n Clinical trials test medicines under different conditions. The side effects seen in one study may not be the same as in another study. The side effects you experience may also be different from what was seen in clinical trials.<\/p>\n PALOMA-2 Study: IBRANCE plus Letrozole<\/strong><\/p>\n This study tested IBRANCE in women with a specific type of breast cancer that had spread. 444 patients took IBRANCE plus letrozole for about 20 months on average.<\/p>\n Dose Changes and Stopping Treatment<\/strong><\/p>\n Most Common Side Effects (happened in 10% or more patients)<\/strong><\/p>\n The most common side effects were:<\/p>\n Serious Side Effects (Grade 3 or higher, happened in 5% or more patients)<\/strong><\/p>\n Blood Test Changes<\/strong><\/p>\n Most patients had changes in their blood tests:<\/p>\n PALOMA-3 Study: IBRANCE plus Fulvestrant<\/strong><\/p>\n This study tested IBRANCE in patients whose cancer got worse after other treatments. 345 patients took IBRANCE plus fulvestrant for about 11 months on average.<\/p>\n Dose Changes and Stopping Treatment<\/strong><\/p>\n Most Common Side Effects (happened in 10% or more patients)<\/strong><\/p>\n Blood Test Changes<\/strong><\/p>\n INAVO120 Study: IBRANCE plus Inavolisib and Fulvestrant<\/strong><\/p>\n This study tested IBRANCE with two other medicines in patients with a specific gene change. 162 patients took this combination for about 9 months on average.<\/p>\n Serious Problems<\/strong><\/p>\n Dose Changes<\/strong><\/p>\n Most Common Side Effects<\/strong><\/p>\n Other Side Effects Reported<\/strong><\/p>\n Some patients also experienced:<\/p>\n Side Effects in Men<\/strong><\/p>\n Based on limited reports, men who take IBRANCE have similar side effects as women.<\/p>\n<\/div>\n Medicines That Make IBRANCE Stronger<\/strong><\/p>\n Some medicines can make IBRANCE work too strongly in your body. This happened when people took itraconazole with IBRANCE – it made IBRANCE 87% stronger.<\/p>\n Do not take these medicines with IBRANCE:<\/p>\n Do not eat grapefruit or drink grapefruit juice while taking IBRANCE.<\/p>\n If you must take one of these medicines with IBRANCE, your doctor will lower your IBRANCE dose.<\/p>\n Medicines That Make IBRANCE Weaker<\/strong><\/p>\n Some medicines can make IBRANCE work less well in your body. When people took rifampin with IBRANCE, it made IBRANCE 85% weaker.<\/p>\n Do not take these medicines with IBRANCE:<\/p>\n How IBRANCE Affects Other Medicines<\/strong><\/p>\n IBRANCE can make some other medicines work stronger in your body. When people took midazolam with IBRANCE, the midazolam became 61% stronger.<\/p>\n Your doctor may need to lower the dose of these medicines if you take them with IBRANCE:<\/p>\n IBRANCE is broken down in your body by enzymes called CYP3A and SULT2A1. IBRANCE can slow down the CYP3A enzyme over time.<\/p>\n<\/div>\n Risk Summary<\/strong><\/p>\n IBRANCE can harm an unborn baby when given to a pregnant woman. This is based on animal studies and how the medicine works. There are no studies in pregnant women to know the exact risk. In animal studies, pregnant rats and rabbits given palbociclib during pregnancy had problems with their babies. The doses used were 4 times higher than what humans take. Pregnant women should know about the possible risk to their baby.<\/p>\n We don’t know the background risk of birth defects and miscarriage for women who might take this medicine. In the general U.S. population, about 2-4% of babies have major birth defects and 15-20% of pregnancies end in miscarriage.<\/p>\n Animal Study Data<\/strong><\/p>\n In a study with female rats, palbociclib was given for 15 days before mating through day 7 of pregnancy. Doses up to 300 mg\/kg\/day did not cause problems with the babies. This dose was about 4 times what humans take.<\/p>\n In studies with pregnant rats and rabbits, the animals got palbociclib during the time when organs form in babies. Pregnant rats got up to 300 mg\/kg\/day and rabbits got up to 20 mg\/kg\/day.<\/p>\n At 300 mg\/kg\/day in rats (which made the mother rats sick), the babies had lower body weights. At 100 mg\/kg\/day or higher in rats, more babies had an extra rib near the neck. At 20 mg\/kg\/day in rabbits (which made the mother rabbits sick), more babies had small toe bones in their front paws.<\/p>\n The doses that caused problems were about 4 times higher than human doses in rats and 9 times higher in rabbits.<\/p>\n Some special mice that were missing certain genes died late in pregnancy due to severe anemia. However, these mouse studies may not predict what happens in humans because the effects on the body are different.<\/p>\n<\/div>\n We don’t know if this medicine passes into breast milk or how it might affect your baby.<\/p>\n This medicine could cause serious harm to a breastfeeding baby. Do not breastfeed while taking IBRANCE and for 3 weeks after your last dose.<\/p>\n<\/div>\n Pregnancy Testing<\/strong><\/p>\n Tests on animals show that IBRANCE can harm an unborn baby if taken during pregnancy.<\/p>\n Women who can get pregnant should take a pregnancy test before starting IBRANCE.<\/p>\n Birth Control<\/strong><\/p>\n Women<\/strong><\/p>\n IBRANCE can harm an unborn baby if taken during pregnancy. Women who can get pregnant should use effective birth control while taking IBRANCE and for at least 3 weeks after the last dose.<\/p>\n Men<\/strong><\/p>\n IBRANCE may damage genes and sperm. Men with female partners who can get pregnant should use effective birth control while taking IBRANCE and for 3 months after the last dose.<\/p>\n Fertility Problems<\/strong><\/p>\n Men<\/strong><\/p>\n Tests on animals show that IBRANCE may make it harder for men to have children.<\/p>\n<\/div>\n IBRANCE has not been proven safe or effective for children.<\/p>\n Doctors tested IBRANCE but could not prove it works in children. They did three studies with 140 children ages 2 to 16 who had cancer that came back or did not respond to other treatments.<\/p>\n The side effects in children were similar to those seen in adults. The amount of medicine that got into children’s bodies was about the same as in adults when the dose was adjusted for body size.<\/p>\n Animal Studies in Young Animals<\/p>\n Scientists gave IBRANCE to young rats for 27 weeks. The rats had problems with blood sugar, including:<\/p>\n These problems happened most in male rats given high doses of the medicine. The problems were worse in young rats than in adult rats. Dogs did not have these same problems.<\/p>\n Young rats also had tooth problems. Their front teeth became discolored and damaged when given high doses of the medicine for 27 weeks.<\/p>\n Scientists have not tested other possible effects of this medicine in young animals.<\/p>\n<\/div>\n In the PALOMA-2 study, 444 patients took IBRANCE. Of these patients, 181 (41%) were 65 years old or older and 48 (11%) were 75 years old or older.<\/p>\n In the PALOMA-3 study, 347 patients took IBRANCE. Of these patients, 86 (25%) were 65 years old or older and 27 (8%) were 75 years old or older.<\/p>\n IBRANCE worked the same way and had the same side effects in older patients compared to younger patients.<\/p>\n<\/div>\n If you have mild or moderate liver problems, you don’t need to change your dose. If you have severe liver problems, take 75 mg once daily for 21 days, then stop for 7 days. This makes a complete 28-day cycle.<\/p>\n Studies show that in people with liver problems, the medicine stays in the body differently:<\/p>\n Check with your doctor about dose changes for your other hormone medicines if you have liver problems.<\/p>\n<\/div>\n You do not need to change your dose if you have kidney problems (as long as your kidneys work at least 15% of normal).<\/p>\n In a study, people with mild, moderate, or severe kidney problems had 39%, 42%, and 31% more medicine in their blood compared to people with normal kidneys. The highest amount of medicine in their blood was 17%, 12%, and 15% higher.<\/p>\n This medicine has not been studied in people who need dialysis (a machine that cleans your blood when your kidneys don’t work).<\/p>\n<\/div>\n How This Medicine Works<\/strong><\/p>\n Palbociclib stops certain proteins called CDK 4 and 6. These proteins help cancer cells grow and multiply. When palbociclib blocks them, it slows down cancer cell growth.<\/p>\n In lab tests, palbociclib worked well against breast cancer cells that need estrogen to grow. It stopped the cancer cells from dividing and making more cells.<\/p>\n When palbociclib was used with hormone-blocking medicines, it worked even better than either medicine alone. The combination made cancer cells stop growing and become old and weak.<\/p>\n Tests in mice with breast cancer showed that palbociclib plus letrozole worked better than either medicine by itself to shrink tumors.<\/p>\n Normal bone marrow cells treated with palbociclib did not become permanently damaged and started growing normally again when the medicine was stopped.<\/p>\n Heart Effects<\/strong><\/p>\n Doctors checked how palbociclib affects heart rhythm in 77 breast cancer patients. The medicine did not cause dangerous changes to heart rhythm when taken at the normal dose of 125 mg daily for 21 days, followed by 7 days off.<\/p>\n How Your Body Handles This Medicine<\/strong><\/p>\n Doctors studied how palbociclib moves through the body in cancer patients and healthy people.<\/p>\n Getting Into Your Body<\/strong><\/p>\n The highest amount of medicine in your blood happens 6 to 12 hours after taking a pill. About 46% of the medicine gets into your bloodstream when you take it by mouth.<\/p>\n Higher doses put more medicine in your blood. It takes about 8 days of daily doses for the medicine to reach steady levels in your body. The medicine builds up to about 2.4 times higher than the first dose.<\/p>\n Taking With Food<\/strong><\/p>\n About 13% of people absorb very little medicine when they take it without food. Taking it with food helps these people get more medicine into their body.<\/p>\n For most people, food increases the amount of medicine absorbed:<\/p>\n Taking the medicine with food helps make sure you get a consistent amount each time.<\/p>\n How It Spreads in Your Body<\/strong><\/p>\n About 85% of the medicine sticks to proteins in your blood. People with liver problems may have more free medicine in their blood. The medicine spreads widely throughout your body.<\/p>\n How Your Body Breaks It Down<\/strong><\/p>\n Your liver breaks down most of this medicine. The liver changes it into different forms that your body can get rid of. Only a small amount of unchanged medicine leaves your body.<\/p>\n Two liver enzymes called CYP3A and SULT2A1 do most of the work breaking down palbociclib.<\/p>\n How It Leaves Your Body<\/strong><\/p>\n It takes about 29 hours for half of the medicine to leave your body. Most of the medicine (74%) leaves through bowel movements. About 18% leaves through urine. Almost all of it is changed into other forms before leaving your body.<\/p>\n Different Types of Patients<\/strong><\/p>\n Age, Sex, and Weight<\/strong><\/p>\n Studies in 183 cancer patients showed that being male or female does not change how the medicine works. Your age and weight also do not make important differences in how much medicine gets in your body.<\/p>\n Liver Problems<\/strong><\/p>\n People with mild liver problems had 17% less medicine in their blood. People with moderate liver problems had 34% more medicine. People with severe liver problems had 77% more medicine compared to people with healthy livers.<\/p>\n Kidney Problems<\/strong><\/p>\n People with mild kidney problems had 39% more medicine in their blood. People with moderate kidney problems had 42% more. People with severe kidney problems had 31% more compared to people with healthy kidneys.<\/p>\n The medicine has not been studied in people on dialysis.<\/p>\n Drug Interactions<\/strong><\/p>\n The liver enzyme CYP3A and SULT2A1 break down this medicine. Palbociclib can slightly affect how your body handles other medicines that use CYP3A.<\/p>\n Medicines That Block CYP3A<\/strong><\/p>\n Taking itraconazole with palbociclib increased the amount of palbociclib in the blood by 87%. This could make side effects worse.<\/p>\n Medicines That Speed Up CYP3A<\/strong><\/p>\n Taking rifampin with palbociclib decreased the amount of palbociclib by 85%. This could make the cancer medicine less effective.<\/p>\n Taking modafinil with palbociclib decreased the amount of palbociclib by 32%.<\/p>\n Other Medicines Affected<\/strong><\/p>\n Palbociclib can increase the amount of some other medicines in your body. When taken with midazolam, it increased that medicine by 61%.<\/p>\n Stomach Acid Medicines<\/strong><\/p>\n Taking acid-blocking medicines like proton pump inhibitors can affect how much palbociclib gets absorbed:<\/p>\n Taking palbociclib with food reduces this problem.<\/p>\n Transport Proteins<\/strong><\/p>\n Palbociclib has low risk of interfering with most transport proteins that move medicines around your body. It might affect some transporters in your stomach and intestines, but this is not expected to cause problems with most other medicines.<\/p>\n Transport proteins are unlikely to significantly change how much palbociclib your body absorbs.<\/p>\n<\/div>\n Heart Rhythm Effects<\/p>\n Doctors tested how this medicine affects heart rhythm in 77 women with breast cancer. They used heart tests (ECGs) and checked drug levels in the blood.<\/p>\n The medicine did not cause big changes to heart rhythm when taken at 125 mg once daily for 21 days, then 7 days off. This makes a complete 28-day treatment cycle.<\/p>\n The medicine had no large effect on heart rhythm (no changes greater than 20 milliseconds).<\/p>\n<\/div>\n How IBRANCE Works in Your Body<\/p>\n IBRANCE has been studied in cancer patients and healthy people to see how it moves through the body.<\/p>\n How Your Body Takes in IBRANCE<\/p>\n IBRANCE reaches its highest level in your blood 6 to 12 hours after you take it. About 46% of the medicine gets into your bloodstream when you take a 125 mg dose by mouth.<\/p>\n Higher doses put more medicine in your body. It takes about 8 days of taking IBRANCE daily for it to build up to steady levels in your body. The medicine builds up about 2.4 times higher than the first dose.<\/p>\n Taking IBRANCE with Food: Some people (about 13 out of 100) don’t absorb IBRANCE well when they take it without food. Taking it with food helps these people get more medicine into their body. Food doesn’t change how much medicine other people get by much.<\/p>\n When taken with a high-fat, high-calorie meal (800 to 1000 calories), IBRANCE levels go up by 21% overall and peak levels go up by 38%. With low-fat, low-calorie food (400 to 500 calories), levels go up by 12% overall and peak levels go up by 27%. With moderate-fat food (500 to 700 calories), levels go up by 13% overall and peak levels go up by 24%.<\/p>\n How IBRANCE Spreads in Your Body<\/p>\n About 85% of IBRANCE sticks to proteins in your blood. The medicine spreads widely throughout your body. People with liver problems may have more free medicine in their blood. Kidney problems don’t seem to change this much.<\/p>\n How Your Body Breaks Down IBRANCE<\/p>\n Your liver breaks down IBRANCE in several ways. The main ways are through oxidation and adding sulfur groups to it. Other smaller ways include adding acetyl and sugar groups.<\/p>\n After taking a 125 mg dose, IBRANCE itself makes up 23% of drug-related material in your blood. The main breakdown product is IBRANCE with a sugar group attached, but this is only 1.5% of the dose you took.<\/p>\n Your body breaks down most of the IBRANCE. Only 2.3% comes out unchanged in stool and 6.9% comes out unchanged in urine. In stool, a sulfur-containing form of IBRANCE makes up 26% of the dose. Two main enzymes called CYP3A and SULT2A1 break down IBRANCE.<\/p>\n How Your Body Gets Rid of IBRANCE<\/p>\n Your body clears IBRANCE at a rate of 63.1 liters per hour. The medicine stays in your body for about 29 hours before half of it is gone.<\/p>\n In healthy men, about 92% of the medicine came out of the body in 15 days. Most (74%) came out in stool, and 18% came out in urine. Most of what came out was breakdown products, not the original medicine.<\/p>\n How IBRANCE Works in Different People<\/p>\n Age, Gender, and Body Weight: Studies in 183 cancer patients (50 men and 133 women, ages 22 to 89, weighing 38 to 123 kg) showed that being male or female doesn’t change how much IBRANCE gets in your body. Age and weight don’t make important differences either.<\/p>\n Liver Problems: People with mild liver problems had 17% less free IBRANCE in their blood. People with moderate liver problems had 34% more, and people with severe liver problems had 77% more free IBRANCE compared to people with normal livers.<\/p>\n Peak levels of free IBRANCE went up by 7% with mild liver problems, 38% with moderate problems, and 72% with severe problems.<\/p>\n Kidney Problems: People with mild kidney problems had 39% more IBRANCE in their blood. People with moderate kidney problems had 42% more, and people with severe kidney problems had 31% more compared to people with normal kidneys.<\/p>\n Peak IBRANCE levels went up by 17% with mild kidney problems, 12% with moderate problems, and 15% with severe problems. Studies in 183 patients showed that mild to moderate kidney problems don’t really change IBRANCE levels much. IBRANCE hasn’t been studied in people on dialysis.<\/p>\n How Other Medicines Affect IBRANCE<\/p>\n IBRANCE is mainly broken down by enzymes called CYP3A and SULT2A1. IBRANCE can weakly block the CYP3A enzyme when you take 125 mg daily.<\/p>\n Medicines That Block CYP3A: Taking itraconazole (200 mg daily) with IBRANCE (125 mg) increased IBRANCE levels by 87% overall and peak levels by 34%.<\/p>\n Medicines That Speed Up CYP3A: Taking rifampin (600 mg daily) with IBRANCE (125 mg) decreased IBRANCE levels by 85% overall and peak levels by 70%. Taking modafinil (400 mg daily) with IBRANCE decreased IBRANCE levels by 32% overall and peak levels by 11%.<\/p>\n Medicines Broken Down by CYP3A: IBRANCE can slow down the breakdown of other medicines. Taking IBRANCE with midazolam increased midazolam levels by 61% overall and peak levels by 37%.<\/p>\n Stomach Acid Medicines: Taking IBRANCE with rabeprazole (a proton pump inhibitor) with food decreased peak IBRANCE levels by 41% but only decreased overall levels by 13%. With food, acid-blocking medicines don’t have much effect on IBRANCE levels.<\/p>\n Taking IBRANCE with rabeprazole without food decreased IBRANCE levels by 62% overall and peak levels by 80%.<\/p>\n How IBRANCE Affects Transport Proteins: IBRANCE has a low chance of blocking most transport proteins that move medicines around your body. It might block OCT1 and could block P-gp or BCRP in your intestines.<\/p>\n How Transport Proteins Affect IBRANCE: Transport proteins P-gp and BCRP probably don’t affect how much IBRANCE gets absorbed when you take normal doses.<\/p>\n<\/div>\n Animal Studies on Cancer Risk<\/strong><\/p>\n Scientists tested this medicine on animals to see if it might cause cancer. In male rats given the medicine for 2 years, some developed brain tumors at high doses (8 times more than humans get). Female rats did not get tumors even at higher doses (5 times more than humans get). Mice given the medicine for 6 months did not get more tumors.<\/p>\n Gene and Cell Changes<\/strong><\/p>\n This medicine can cause problems with chromosomes in some lab tests. But it does not damage genes in bacteria tests or cause broken chromosomes in human blood cells.<\/p>\n Effects on Having Children – Females<\/strong><\/p>\n Female rats given this medicine could still mate and have babies normally. Their reproductive organs stayed healthy even at high doses (4-6 times more than humans get).<\/p>\n Effects on Having Children – Males<\/strong><\/p>\n This medicine can harm male fertility. In male rats and dogs, it caused problems with:<\/p>\n Some of these problems got better after stopping the medicine, but not completely. Male rats had slightly lower fertility and weaker sperm at high doses (20 times more than humans get). They could still mate but had less success making babies.<\/p>\n<\/div>\n\n
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indications<\/h3>\n
dosage_administration<\/h3>\n
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dosage_forms<\/h3>\n
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contraindications<\/h3>\n
warnings<\/h3>\n
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adverse_reactions<\/h3>\n
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interactions<\/h3>\n
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pregnancy<\/h3>\n
lactation<\/h3>\n
females_males_reproductive<\/h3>\n
pediatric<\/h3>\n
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geriatric<\/h3>\n
hepatic_impairment<\/h3>\n
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clinical_pharmacology<\/h3>\n
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pharmacodynamics<\/h3>\n
pharmacokinetics<\/h3>\n
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clinical_studies<\/h3>\n