Description
Abemaciclib is used together with tamoxifen or an aromatase inhibitor (eg, anastrozole, exemestane, letrozole) to treat hormone receptor (HR)-positive, HER-2 negative, node-positive, early breast cancer with a high risk of coming back as determined by your doctor.
Abemaciclib is also used together with an aromatase inhibitor (eg, anastrozole, exemestane, letrozole) as initial hormonal treatment to treat men and postmenopausal women with hormone receptor (HR)-positive, HER-2 negative advanced (cancer that has worsened) or metastatic (cancer that has spread) breast cancer. It is also used alone or together with fulvestrant to treat HR-positive, HER-2 negative advanced or metastatic breast cancer in women who have received hormonal treatment or other cancer medicines that did not work well.
Abemaciclib belongs to the group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of abemaciclib in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abemaciclib in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Levoketoconazole
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Asciminib
- Avacopan
- Belzutifan
- Berotralstat
- Carbamazepine
- Ceritinib
- Dabrafenib
- Daridorexant
- Enasidenib
- Enzalutamide
- Fedratinib
- Fexinidazole
- Fosphenytoin
- Givinostat
- Ketoconazole
- Lanreotide
- Lazertinib
- Lonafarnib
- Lumacaftor
- Mavacamten
- Mavorixafor
- Mitapivat
- Mitotane
- Mobocertinib
- Nirmatrelvir
- Nirogacestat
- Octreotide
- Omaveloxolone
- Palbociclib
- Phenobarbital
- Phenytoin
- Primidone
- Repotrectinib
- Ribociclib
- Rifampin
- Ritlecitinib
- Selpercatinib
- Sotorasib
- St John's Wort
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Infection—May decrease your body's ability to fight infection.
- Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Lung problems (eg, interstitial lung disease, pneumonitis)—Use with caution. May make these conditions worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole. Do not crush, break, or chew it.
Take this medicine at the same time each day, with or without food.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For advanced or metastatic breast cancer with anastrozole, exemestane, fulvestrant, or letrozole:
- Adults—At first, 150 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed or tolerated.
- Children—Use and dose must be determined by your doctor.
- For advanced or metastatic breast cancer used alone:
- Adults—At first, 200 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed or tolerated.
- Children—Use and dose must be determined by your doctor.
- For early breast cancer with anastrozole, exemestane, letrozole, or tamoxifen:
- Adults—At first, 150 milligrams (mg) 2 times a day for up to 2 years. Your doctor may adjust your dose as needed or tolerated.
- Children—Use and dose must be determined by your doctor.
- For advanced or metastatic breast cancer with anastrozole, exemestane, fulvestrant, or letrozole:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you vomit after you take this medicine, do not take another dose on the same day. Wait until your next dose and take it when you normally would.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 3 weeks after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
This medicine may cause diarrhea, which may be severe and lead to dehydration or infections. You may take antidiarrheal medicines (eg, loperamide) if you start to have loose stools. Check with your doctor right away for additional instructions.
Abemaciclib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may cause serious lung or breathing problems (eg, interstitial lung disease or pneumonitis), which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest pain, cough, difficulty with breathing, fever or chills.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may increase your risk of developing blood clots, which may be life-threatening. Check with your doctor right away if you have anxiety, chest pain, confusion, cough, dizziness, lightheadedness, or fainting, fast heartbeat, numbness of the hands, pain, redness, or swelling in the arm or leg, or sudden trouble breathing.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Black, tarry stools
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- chest pain
- chills
- confusion
- cough
- decreased urination
- diarrhea
- difficulty with breathing
- dizziness
- dry mouth
- fainting
- fever
- hoarseness
- increased heart rate
- irregular heartbeat
- lightheadedness
- lower back or side pain
- pain in the chest, groin, or legs, especially the calves
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rapid breathing
- rapid weight gain
- severe, sudden headache
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- sunken eyes
- swollen glands
- thirst
- tingling of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vision changes
- wrinkled skin
Less common
- Anxiety
- bloated stomach
- numbness of the hands
- pain, redness, or swelling in the arm or leg
- pain and fullness in the right upper abdomen or stomach
- weight gain
- yellow eyes and skin
Rare
- Blurred vision
- clay-colored stools
- dark urine
- decreased appetite
- fast heartbeat
- general feeling of discomfort or illness
- itching or skin rash
- loss of appetite
- nausea
- numbness or tingling in the face, arms, or legs
- rapid, shallow breathing
- severe headache
- stomach pain or tenderness
- swelling of the feet or lower legs
- thickening of bronchial secretions
- trouble speaking or walking
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Change in taste
- discoloration of the fingernails or toenails
- loss of taste
- loss or thinning of the hair
- redness or soreness around the fingernails or loosening of the fingernails
- swelling or inflammation of the mouth
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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