Understanding ADPKD and Importance of Early Detection

(StatePoint) This article is sponsored by Otsuka America Pharmaceutical, Inc.

Each year, September 4 marks Polycystic Kidney Disease (PKD) Awareness Day, an initiative that aims to increase public knowledge and understanding of this often under-recognized genetic condition. On this important observance day and beyond, patients, families and healthcare providers are encouraged to educate themselves and share resources surrounding PKD, which refers to a group of genetic disorders characterized by the growth of cysts in the kidneys that disrupt kidney function over time. One type of polycystic kidney disease is Autosomal Dominant Polycystic Kidney Disease, or ADPKD.

ADPKD represents approximately 90% of all PKD cases, making it the most prevalent inherited kidney disorder. ADPKD not only affects patients with the condition, but also poses a genetic risk among the children of an affected parent, as there is a 50% chance of inheriting this condition from a parent.

Typically, healthy kidneys filter waste and excess fluids from blood, regulate blood pressure, and produce red blood cells. In patients with ADPKD, cysts form in the kidneys that grow over time, leading to increased kidney size and a decline in kidney function. Eventually, this can result in kidney failure, necessitating dialysis or a kidney transplant. Often, damage occurs within the kidneys without any noticeable symptoms for years, leaving patients unaware of their condition.

Most ADPKD patients do not experience symptoms until they are between 30 and 50 years old, which is why it’s important for individuals to work closely with their healthcare providers to assess the need for screening, especially if there is a family history of the disease. Early detection through methods like ultrasound, MRI or CT scans can be vital to establish effective ADPKD management. While this condition can affect each patient differently, understanding one’s family health history can be helpful in recognizing the signs and potential impact.

For adults diagnosed with ADPKD who are at risk of rapid progression, JYNARQUE (tolvaptan) is the only FDA-approved treatment that works to slow the decline of kidney function. In two clinical studies, JYNARQUE slowed the decline of kidney function across chronic kidney disease (CKD) stages 1 to 4. When prescribed JYNARQUE, patients must be enrolled in the Risk Evaluation and Mitigation Strategy Program (REMS), a special safety program that will have the patient’s bloodwork monitored by a nephrologist to reduce the risk of liver injury. JYNARQUE can cause serious liver problems that can lead to the need for a liver transplant or can lead to death. Please see additional Important Safety Information below. For more information, visit www.jynarque.com . Users can also chat with a peer mentor and join in on the online conversations with the ADPKD community at www.jynarque.com/signup .

PKD Awareness Day serves as a crucial reminder for everyone, particularly those with a family history of ADPKD, to engage with their healthcare provider about screening and potential management strategies. Increasing awareness and education about this condition is a vital step toward improving health outcomes for individuals at risk. This observance underscores the community's role in supporting ongoing research and sharing knowledge to effectively combat challenges that ADPKD patients may face.

IMPORTANT SAFETY INFORMATION and INDICATION for JYNARQUE® (tolvaptan)

• Serious liver problems. JYNARQUE can cause serious liver problems that can lead to the need for a liver transplant or can lead to death. Stop taking JYNARQUE and call your healthcare provider right away if you get any of the following symptoms:

- feeling tired

- loss of appetite

- nausea

- right upper stomach (abdomen) pain or tenderness

- vomiting

- fever

- rash

- itching

- yellowing of the skin and white part of the eye (jaundice)

- dark urine

It is important that you have a blood test before you start JYNARQUE to help reduce your risk of liver problems. Your healthcare provider will do a blood test to check your liver:

• before you start taking JYNARQUE

• at 2 weeks and 4 weeks after you start treatment with JYNARQUE

• then monthly for 18 months during treatment with JYNARQUE

• and every 3 months from then on

Because of the risk of serious liver problems, JYNARQUE is only available through a restricted distribution program called the JYNARQUE Risk Evaluation and Mitigation Strategy (REMS) Program.

Do not take JYNARQUE if you:

• have a history of liver problems or have signs or symptoms of liver problems, excluding polycystic liver disease

• cannot feel if you are thirsty or cannot replace fluids by drinking

• have been told that the amount of sodium (salt) in your blood is too high or too low

• are dehydrated

• are allergic to tolvaptan or any of the ingredients in JYNARQUE

• are unable to urinate

Tell your healthcare provider about all your medical conditions, including if you:

• have a history of sodium (salt) levels that are too low

• are pregnant or plan to become pregnant. It is not known if tolvaptan will harm your unborn baby. Tell your healthcare provider if you become pregnant or think that you may be pregnant

• are breastfeeding or plan to breastfeed. It is not known if tolvaptan passes into your breast milk. Do not breastfeed during your treatment with JYNARQUE. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

• Taking JYNARQUE with certain medicines could cause you to have too much tolvaptan in your blood. JYNARQUE should not be taken with certain medications. Your healthcare provider can tell you if it is safe to take JYNARQUE with other medicines

• Do not start taking a new medicine without talking to your healthcare provider

JYNARQUE may cause serious side effects, including:

• Too much sodium in your blood (hypernatremia) and loss of too much body fluid (dehydration). In some cases, dehydration can lead to extreme loss of body fluid called hypovolemia. You should drink water when you are thirsty and throughout the day and night. Stop taking JYNARQUE and call your healthcare provider if you cannot drink enough water for any reason, such as not having access to water, or vomiting or diarrhea. Tell your healthcare provider if you get any of the following symptoms:

- Dizziness

- Fainting

- weight loss

- a change in the way your heart beats

- feeling confused or weak

What should you avoid while taking JYNARQUE?

Do not drink grapefruit juice during treatment with JYNARQUE. This could cause you to have too much tolvaptan in your blood.

The most common side effects of JYNARQUE are:

• thirst and increased fluid intake

• making large amounts of urine, urinating often, and urinating at night

These are not all the possible side effects of JYNARQUE. Talk to your healthcare provider about any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

If you have any questions about your health or medicines, talk to your healthcare professional.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1‑800‑438-9927 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ).

INDICATION:

What is JYNARQUE?

JYNARQUE is a prescription medicine used to slow kidney function decline in adults who are at risk for rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). It is not known if JYNARQUE is safe and effective in children.

Please read FULL PRESCRIBING INFORMATION , including BOXED WARNING, and MEDICATION GUIDE .

June 2024 10US24EBC0066

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