Consumer medicine information

KERENDIA®


Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


 This medicine is new or being used differently. Please report side effects. See the full CMI for further details.

1. Why am I using KERENDIA?

KERENDIA contains the active ingredient finerenone. KERENDIA works by blocking hormones that can damage the kidneys and heart. KERENDIA is used to treat adults with chronic kidney disease and type 2 diabetes. Chronic kidney disease is when your kidneys keep getting worse at removing waste and fluids from your blood. Type 2 diabetes is when your body cannot keep your blood sugar levels normal. KERENDIA slows the worsening of kidney damage. It also lowers the combined risk of dying from heart or blood vessel disease, having a stroke or heart attack, and being hospitalised for heart failure.

For more information, see Section 1. Why am I using KERENDIA? in the full CMI.

2. What should I know before I use KERENDIA?

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use KERENDIA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with KERENDIA and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use KERENDIA?

Take 1 tablet per day with or without food. Your doctor may tell you to take 20 mg or 10 mg once per day, depending on your blood test results.

More instructions can be found in Section 4. How do I use KERENDIA? in the full CMI.

5. What should I know while using KERENDIA?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using KERENDIA.
Things you should not do
  • Do not stop using this medicine suddenly without checking with your doctor.
Driving or using machines
  • KERENDIA has no effect on your ability to drive or use machines.
Looking after your medicine
  • Store KERENDIA in a cool dry place away from moisture, heat and sunlight.

For more information, see Section 5. What should I know while using KERENDIA? in the full CMI.

6. Are there any side effects?

Like all medicines, KERENDIA can cause side effects, although not everybody gets them. Because this is a new medicine, there may be other side effects that are not yet known.

Less serious side effects include hyperkalaemia (high potassium level in the blood), hyponatremia (low sodium level in the blood), hypotension (low blood pressure), glomerular filtration rate decreased (decrease in how well the kidneys filter blood) and hyperuricaemia (high uric acid level in the blood). For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

 This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

KERENDIA®

Active ingredient: finerenone


Consumer Medicine Information (CMI)

This leaflet provides important information about using KERENDIA. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using KERENDIA.

Where to find information in this leaflet:

1. Why am I using KERENDIA?
2. What should I know before I use KERENDIA?
3. What if I am taking other medicines?
4. How do I use KERENDIA?
5. What should I know while using KERENDIA?
6. Are there any side effects?
7. Product details

1. Why am I using KERENDIA?

KERENDIA contains the active ingredient finerenone.

Finerenone is a nonsteroidal mineralocorticoid receptor antagonist (MRA). It works by blocking hormones that can damage the kidneys and heart.

KERENDIA is used to treat adults with chronic kidney disease and type 2 diabetes. Chronic kidney disease is when your kidneys keep getting worse at removing waste and fluids from your blood. Type 2 diabetes is when your body cannot keep your blood sugar levels normal.

KERENDIA slows the worsening of kidney damage.

KERENDIA also lowers the combined risk of dying from heart or blood vessel disease, having a stroke or heart attack, and being hospitalised for heart failure.

2. What should I know before I use KERENDIA?

Warnings

Your doctor decided that you can take KERENDIA and the dose best for you. For those decisions, your doctor used the results of your blood tests. These tests check your potassium level and how your kidneys are working.

After 4 weeks of taking KERENDIA, you will have more blood tests. Your doctor will tell you if you will go on taking your dose as before.

Your doctor may test your blood at other times.

Do not use KERENDIA if:

  • are taking a ‘strong CYP3A4 inhibitor,’ for example
    – itraconazole or ketoconazole, to treat infections caused by a fungus or yeast
    – ritonavir, nelfinavir, or cobicistat, to treat HIV infection
    – clarithromycin, to treat bacterial infections
    – telithromycin, to treat pneumonia
    – nefazodone, to treat depression.
  • have adrenal insufficiency

Check with your doctor if you have:

  • a high level of potassium in your blood (hyperkalaemia) or had that before.
  • severe loss of kidney function (severe renal impairment) or end-stage renal disease (kidney failure).
  • moderate or severe liver damage (moderate or severe hepatic impairment or Child Pugh B or C).

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, think you may be pregnant or plan on becoming pregnant. KERENDIA should not be taken during pregnancy unless clearly necessary. Your doctor will discuss with you the risk to your unborn baby if you take KERENDIA during pregnancy.

If you are female and able to give birth, you should use reliable birth control. Your doctor will explain to you what type of birth control you can use. Tell your doctor if you are breastfeeding or planning to breastfeed. You should not breastfeed while taking KERENDIA. KERENDIA may cause harm to your nursing baby. KERENDIA is not expected to lower the ability to have children (fertility) in men or women.

Use in children

KERENDIA should not be used in children under the age of 18 years.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Talk to your doctor before taking KERENDIA if you are taking:

  • ‘moderate or weak CYP3A4 inhibitors,’ for example
    – erythromycin, to prevent and treat bacterial infections
    – verapamil, to treat high blood pressure, chest pain, and fast heartbeat
    – amiodarone, to treat irregular heartbeat
    – fluvoxamine, to treat depression and ‘obsessive-compulsive disorder (OCD)’

If you take any of these medicines while taking KERENDIA, you may get too much of the active substance, finerenone, in your blood. You may have more side effects.

  • ‘strong or moderate CYP3A4 inducers,’ for example
    – rifampicin, to treat bacterial infections
    – carbamazepine, phenytoin, or phenobarbital, to treat seizures
    – St. John’s Wort, to treat depression
    – efavirenz, to treat HIV infection

If you take any of these medicines while taking KERENDIA, you may not get enough of the active substance, finerenone, in your blood. KERENDIA may not work as expected.

  • medicines that may increase the level of potassium in your blood, for example
    – ‘water pills’ that remove excess water from your body in urine (potassium-sparing diuretics), such as amiloride or triamterene
    – other MRAs like finerenone, such as eplerenone or spironolactone
    – trimethoprim, or a combination of trimethoprim and sulfamethoxazole, to treat bacterial infections
    – potassium supplements

If you take any of these medicines while taking KERENDIA, you may get too much potassium in your blood (hyperkalaemia). This may be dangerous for you.

Always tell your doctor what medicines you take for your medical conditions.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect KERENDIA.

4. How do I use KERENDIA?

How much to take

  • Always take KERENDIA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
  • Take 1 tablet per day.
  • Your doctor may tell you to take 20 mg or 10 mg once per day, depending on your blood test results.

When to take / use KERENDIA

Try to take KERENDIA at the same time every day. This makes it easier for you to remember.

You can take KERENDIA with a glass of water and with or without food.

Swallow the tablet whole.

If you cannot swallow the whole tablet, you can crush it. Mix it with water or soft foods, such as applesauce, and take it right away.

If you forget to use KERENDIA

Do not take 2 tablets on the same day to make up for a missed tablet.

  • If you forget to take KERENDIA at your regular time that day. Take the tablet as soon as you notice.
  • If you miss a day: Take the next tablet on the next day.

If you use too much KERENDIA

If you think that you have used too much KERENDIA, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using KERENDIA?

Things you should do

Take KERENDIA as directed by your doctor.

Do not eat grapefruit or drink grapefruit juice as long as you take KERENDIA. If you do, you may get too much finerenone in your blood. You may have more side effects.

Remind any doctor, dentist or pharmacist you visit that you are using KERENDIA.

Things you should not do

  • Do not take KERENDIA to treat any other complaints, unless your doctor tells you to.
  • Do not stop using this medicine or change the dose of your medicine unless requested by your doctor.
  • Do not give your medicine to anyone else, even if they have the same condition as you.

Driving or using machines

KERENDIA has no effect on your ability to drive or use machines.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

  • Keep this medicine out of the sight and reach of children.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

Like all medicines, KERENDIA can cause side effects, although not everybody gets them.

Talk to your doctor if you get any side effects, including any possible side effects not listed in this leaflet.

Less serious side effects

Less serious side effects What to do
Hyperkalaemia (high potassium level in the blood)

Possible signs may include:

  • weakness or tiredness
  • feeling sick to the stomach
  • numbness in the hands and lips
  • muscle cramps
  • decreased pulse rate

Metabolism and nutrition-related

  • Hyponatremia (low sodium level in the blood)
    Possible signs may include:
    – feeling sick to the stomach
    – tiredness
    – headache
    – confusion
    – muscle weakness, spasms or cramps
  • Hyperuricaemia (high uric acid level in the blood)

Blood pressure-related

  • Hypotension (low blood pressure) Possible signs may include:
    – dizziness
    – lightheadedness
    – fainting

Investigations

  • Glomerular filtration rate decreased (decrease in how well the kidneys filter blood)
Speak to your doctor if you experience any of these side effects.
Your doctor will decide if a blood test is needed. Make sure you discuss the results of your blood test with your doctor.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What KERENDIA contains

Active ingredient finerenone
Other ingredients Tablet core:
Lactose monohydrate,
Cellulose microcrystalline,
Croscarmellose sodium,
Hypromellose 5 cP,
Magnesium stearate,
Sodium laurilsulfate

Tablet coating:
Hypromellose 5 cP,
Talc
Titanium dioxide,
Ferric oxide yellow (20 mg tablet only),
Ferric oxide red (10 mg tablet only)
Potential allergens lactose monohydrate

Do not take this medicine if you are allergic to any of these ingredients.

What KERENDIA looks like

KERENDIA 10mg tablets are pink, oval-oblong tablet with a length of 10 mm and a width of 5 mm, marked ‘10’ on one side and ‘FI’ on the other side (AUST R 350772).

KERENDIA 20mg tablets are yellow, oval-oblong tablet with a length of 10 mm and a width of 5 mm, marked ‘20’ on one side and ‘FI’ on the other side (AUST R 350773).

Who distributes KERENDIA

Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway, Pymble NSW 2073
www.bayer.com.au

This leaflet was prepared in August 2023.

Published by MIMS October 2023