Description
Imlunestrant is used to treat estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR-1 mutated advanced or metastatic (cancer that has spread to other parts of the body) breast cancer that has progressed after at least 1 endocrine treatment. Your doctor will test for the presence of the mutation.
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 imlunestrant 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 imlunestrant 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 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
- Apalutamide
- Boceprevir
- Carbamazepine
- Ceritinib
- Clarithromycin
- Cobicistat
- Colchicine
- Cyclosporine
- Digoxin
- Encorafenib
- Enzalutamide
- Erythromycin
- Everolimus
- Fosphenytoin
- Idelalisib
- Indinavir
- Itraconazole
- Ivosidenib
- Ketoconazole
- Lonafarnib
- Lumacaftor
- Mifepristone
- Mitotane
- Nefazodone
- Nelfinavir
- Paritaprevir
- Phenytoin
- Posaconazole
- Relacorilant
- Ribociclib
- Rifampin
- Rifapentine
- Ritonavir
- Rosuvastatin
- Saquinavir
- Sirolimus
- St John's Wort
- Sunitinib
- Tacrolimus
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Kratom
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Liver disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using 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 the instructions carefully. Ask your doctor if you have any questions.
Take this medicine on an empty stomach at about the same time each day, at least 2 hours before or 1 hour after a meal.
Swallow the tablet whole. Do not chew, crush, or split it.
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 breast cancer:
- Adults—400 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For breast cancer:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose and it is 6 hours or more since your usual time, skip the missed dose and go back to your regular dosing schedule.
If you vomit after you take this medicine, do not take another dose the same day. Take your next dose the following day at the regularly scheduled time.
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.
Do not flush this medicine down the toilet.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will 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 get pregnant, your doctor may do tests to make sure you are not pregnant before you start using this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 week after your last dose. Male patients who have female partners should use effective birth control during treatment and for 1 week after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
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:
Less common
- Chest pain
- trouble breathing
Rare
- Black, tarry stools
- bloody stools
- blurred vision
- burning, numbness, tingling, or painful sensations
- chest pain or discomfort
- clay-colored stools
- confusion
- dark urine
- decreased appetite
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever
- headache
- itching
- loss of appetite
- nausea
- no blood pressure or pulse
- pain or discomfort in the arms, jaw, back, or neck
- stomach pain or tenderness
- stopping of the heart
- sweating
- swelling of the feet or lower legs
- unconsciousness
- unsteadiness or awkwardness
- unusual tiredness or weakness
- vomiting
- vomiting of blood or material that looks like coffee grounds
- weakness in the arms, hands, legs, or feet
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
- Constipation
- cough
- diarrhea
- hot flush
- muscle or joint pain
Less common
- Acid or sour stomach
- belching
- heartburn
- indigestion
- stomach discomfort or upset
- 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.
DRG-80010482
