Description
Finerenone is used to lower the risk of serious kidney and heart problems (eg, kidney function decline, end-stage kidney disease, cardiovascular death, heart attack, and hospitalization for heart failure) in patients with chronic kidney disease associated with type 2 diabetes.
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 finerenone 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 finerenone 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.
- Boceprevir
- Ceritinib
- Clarithromycin
- Cobicistat
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Levoketoconazole
- Lonafarnib
- Mifepristone
- Nefazodone
- Nelfinavir
- Nirmatrelvir
- Paritaprevir
- Posaconazole
- Ribociclib
- Ritonavir
- Saquinavir
- Telaprevir
- Telithromycin
- Troleandomycin
- Tucatinib
- Voriconazole
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
- Amiodarone
- Amprenavir
- Apalutamide
- Aprepitant
- Atazanavir
- Avacopan
- Bosentan
- Carbamazepine
- Cenobamate
- Cimetidine
- Ciprofloxacin
- Conivaptan
- Crizotinib
- Cyclosporine
- Dabrafenib
- Darunavir
- Delavirdine
- Diltiazem
- Dronedarone
- Duvelisib
- Efavirenz
- Elagolix
- Enzalutamide
- Erythromycin
- Etravirine
- Fedratinib
- Fexinidazole
- Fluconazole
- Fluvoxamine
- Fosamprenavir
- Fosaprepitant
- Fosnetupitant
- Fosphenytoin
- Imatinib
- Ivacaftor
- Larotrectinib
- Lenacapavir
- Letermovir
- Lomitapide
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:
- Adrenal problems or
- Liver disease, severe—Should not be used in patients with these conditions.
Proper Use
Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
You may take this medicine with or without food.
If you are unable to swallow the tablet, you may crush and mix it with water or soft foods, including applesauce.
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):
- To lower the risk of serious kidney and heart problems in patients with chronic kidney disease associated with type 2 diabetes:
- Adults—Dose is based on kidney function and must be determined by your doctor. At first, 10 or 20 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- To lower the risk of serious kidney and heart problems in patients with chronic kidney disease associated with type 2 diabetes:
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.
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, especially during the first few weeks that you take this medicine. Blood tests may be needed to check for unwanted effects.
You should not use this medicine if you are also using efavirenz, itraconazole, or rifampicin.
This medicine may cause hyperkalemia (high potassium in the blood). Check with your doctor right away if you have confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, stomach pain, trouble breathing, or weakness or heaviness of the legs.
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 (eg, potassium 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
- Confusion
- irregular heartbeat
- nausea or vomiting
- nervousness
- numbness or tingling in the hands, feet, or lips
- stomach pain
- trouble breathing
- weakness or heaviness of the legs
Less common
- Blurred vision
- coma
- decreased urine output
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast heartbeat
- headache
- increase thirst
- muscle pain or cramps
- seizures
- sweating
- swelling of the face, ankles, or hands
- unusual tiredness or weakness
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.
CON-XXXXXXXX
