Description
Camizestrant is used in combination with a CDK4/6 inhibitor (eg, abemaciclib, palbociclib, or ribociclib) to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative breast cancer in patients whose cancer has worsened (advanced) or has spread to other parts of the body (metastatic) and has an estrogen receptor-1 (ESR1) mutation during treatment with an aromatase inhibitor and a CDK4/6 inhibitor. 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 camizestrant 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 camizestrant 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Bradycardia (slow heartbeat) or
- Heart rhythm problems (eg, QT prolongation) or
- Liver disease—Use with caution. May make these conditions worse.
- Electrolyte problems—Should be corrected first during treatment with this medicine.
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.
You may take this medicine with or without food at about the same time each day.
Swallow the tablet whole. Do not chew, crush, or cut it. Do not take the tablet if it is broken, cracked, or looks damaged.
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—75 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 within 6 hours since your usual time, take the missed dose. If you miss a dose and it is more than 6 hours since your usual time, skip the missed dose and go back to your regular dosing schedule.
If you vomit after taking a dose, take the next dose at the regular time.
Storage
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store the medicine in its original container. Do not remove the desiccant (drying agent). Throw the medicine away after 30 days if it has been stored in a bottle without a desiccant.
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.
Do not use lansoprazole (Prevacid®), omeprazole (Losec®), siponimod (Mayzent®), or a blood thinner (including warfarin) during treatment with this medicine and for at least 2 weeks after the last dose.
Using this medicine while you are pregnant can harm your unborn baby. If you 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 4 weeks 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.
This medicine can cause heart rhythm problems, including QT prolongation, torsades de pointes, or ventricular arrhythmia. Check with your doctor right away if you have chest pain, dizziness, fainting, fast, pounding, or irregular heartbeat or pulse, palpitations, or trouble breathing.
This medicine may decrease your heart rate. Tell your doctor if you have chest pain or discomfort, lightheadedness, dizziness, or fainting, slow or irregular heartbeat, trouble breathing, or unusual tiredness. Your doctor will check your heart rate during the first 30 days of treatment with this medicine.
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:
Incidence not known
- Chest pain or discomfort
- fast, slow, pounding, or irregular heartbeat
- lightheadedness, dizziness, or fainting
- trouble breathing
- unusual tiredness or weakness
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
- Back pain
- blurred or loss of vision
- difficulty in moving
- disturbed color perception
- double vision
- dry eye
- halos around lights
- joint pain
- muscle pain or stiffness
- nausea
- night blindness
- overbright appearance of lights
- tunnel vision
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-80012050
