Indication

Parsabiv® (etelcalcetide) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with Read morechronic kidney disease (CKD) on hemodialysis.

Parsabiv® has not been studied in adult patients with parathyroid cancer, primary hyperparathyroidism, or with CKD who are not on hemodialysis and should not be used in these patients.

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Going through chronic kidney disease and hemodialysis can be difficult for any one person to take on.

Especially when you have other problems to watch out for—such as secondary hyperparathyroidism (sHPT). That’s why you have your care team to support you along the way. But they need your help too.

s-hpt-graphic

Learning about sHPT is a great start to being able to work with your care team to manage this condition as well as possible.

Open the dialogue on sHPT

Watch this short video to learn how sHPT can affect you and how it is managed.

What is sHPT?

When your kidneys fail, it becomes difficult for your body to balance levels of important minerals such as calcium and phosphorus. One of the ways your body tries to restore balance is by producing more parathyroid hormone, or PTH. PTH is made by four small glands in your neck.

Over time, these glands can grow larger, and make too much PTH. When this happens, you have a condition called secondary hyperparathyroidism, or sHPT, which is common in people on hemodialysis.

What does too much PTH mean?

Having too much PTH pulls calcium and phosphorus out of your bones and into your blood, making your phosphorus and calcium levels go up. This can add to the calcium and phosphorus you already get from the food you eat, putting you at risk for other serious health problems.

Take a deeper dive into understanding your sHPT.

How is sHPT managed?

The first step is often to make some changes to what you eat to lower your phosphorus level. But everyone is unique, so talk to your dietitian for suggestions—such as how many servings from each food group you can have at each meal.

You can download a dietary guide from the National Kidney Foundation to learn more about limiting phosphorus in the food you eat.

Can medication help?

Managing your diet isn’t the only thing that lowers your sHPT. Your doctor may also prescribe one or more of these medications:

Phosphate binders* help you take in less phosphorus from the food you eat.

Certain types of vitamin D* may help lower the amount of PTH in your body.

Calcimimetics can help lower all three levels: PTH, phosphorus, and calcium.

Parsabiv® is the only calcimimetic that is administered in an IV.

The other calcimimetic option you have is an oral pill that is recommended to take daily.

*Phosphate binders and vitamin D are available by prescription.
This medicine is usually given to you through the dialysis machine, or you may take it as a pill.

Know where you stand with sHPT by asking questions such as, “What medications am I currently taking?”

How will I know if I’m making progress?

Your care team has goals for your PTH, calcium, and phosphorus levels. You will get regular blood tests so they can monitor your levels and decide whether you should stay on, stop, or change treatments.

If you’re not satisfied with your progress, it’s okay to ask about it

Managing your health is a two-way relationship with your doctor and dialysis team to ensure you do what you can to maintain your health, and they do what they can to support you. Below are some questions you can ask your doctor or dialysis care team to help you understand the medication you are taking for sHPT.

If relevant:

  • Why am I being switched back to a medication that I have tried before?
  • Is there a reason you would change them again?
  • How is my current treatment the best one for me?
doctors

Talk to your doctor about which treatment is right for you

Start the conversation with help from our discussion guide.

Important Safety Information

Do not use Parsabiv® (etelcalcetide) if you are allergic to etelcalcetide or any ingredients in Parsabiv®. Allergic reactions, sometimes severe, have happened. Allergic reactions may include itchy rash, hives, swelling of the face, trouble breathing, and low blood pressure.

Low calcium levels: Parsabiv® lowers calcium and can lead to low calcium levels in your blood, sometimes severe. Tell your healthcare provider if you have spasms, twitches, or cramps in your muscles; numbness or tingling in your fingers, toes, or around your mouth; or seizures. Low calcium levels can result in abnormal heart rhythms, known as ventricular arrhythmia. Tell your healthcare provider if you experience unusually fast or pounding heartbeat, if you have or have had heart rhythm problems or heart failure or if you take medicines that can cause heart rhythm problems while receiving Parsabiv®.

Very low calcium levels may increase the possibility of a seizure. Before starting Parsabiv®, tell your healthcare provider if you are taking medication to prevent seizures or have had seizures in the past. Report any seizure episodes while on Parsabiv®.

Do not take Parsabiv® with Sensipar® (cinacalcet) as severe, life-threatening low calcium levels can happen. Tell your healthcare provider if you are taking Sensipar®. When switching from Sensipar® to Parsabiv®, you should stop taking Sensipar® for at least 7 days before starting Parsabiv®.

Your healthcare provider will measure your blood calcium levels before starting and while being treated with Parsabiv®. Parsabiv® should not be started if your calcium levels are too low. Your healthcare provider will be able to tell you if your calcium is too low. While on Parsabiv®, your healthcare provider should perform repeated blood tests to monitor calcium and intact parathyroid hormone (iPTH) levels.

Worsening Heart Failure: Low blood pressure, heart failure, and decreased heart function have happened with Parsabiv®.

Upper Gastrointestinal Bleeding: In medical studies, 2 patients treated with Parsabiv® had upper gastrointestinal (GI) bleeding at the time of death. The exact cause of GI bleeding is unknown and there were too few cases to determine whether these cases were related to Parsabiv®.

Tell your healthcare provider if you have stomach pain, bloody or black stool, or if you vomit bloody or black material. Also tell your healthcare provider if you have nausea or vomiting that is getting worse.

Adynamic Bone Disease: Very low levels of PTH should be avoided to help maintain bone health.

Side Effects: The most common side effects of Parsabiv® are low calcium levels, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and numbness or tingling in the fingers, toes, or around the mouth.

These are not all the possible side effects of Parsabiv®. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indication Parsabiv® is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Parsabiv® has not been studied in adult patients with parathyroid cancer, primary hyperparathyroidism, or with CKD who are not on hemodialysis and should not be used in these patients.

Please see accompanying Parsabiv® full Prescribing Information.

Important Safety Information

Do not use Parsabiv® (etelcalcetide) if you are allergic to etelcalcetide or any ingredients in Parsabiv®. Allergic reactions, sometimes severe, have happened. Allergic reactions may include itchy rash, hives, swelling of the face, trouble breathing, and low blood pressure.

Low calcium levels: Parsabiv® lowers calcium and can lead to low calcium levels in your blood, sometimes severe. Tell your healthcare provider if you have spasms, twitches, or cramps in your muscles; numbness or tingling in your fingers, toes, or around your mouth; or seizures. Low calcium levels can result in abnormal heart rhythms, known as ventricular arrhythmia. Tell your healthcare provider if you experience unusually fast or pounding heartbeat, if you have or have had heart rhythm problems or heart failure or if you take medicines that can cause heart rhythm problems while receiving Parsabiv®.

Very low calcium levels may increase the possibility of a seizure. Before starting Parsabiv®, tell your healthcare provider if you are taking medication to prevent seizures or have had seizures in the past. Report any seizure episodes while on Parsabiv®.

Do not take Parsabiv® with Sensipar® (cinacalcet) as severe, life-threatening low calcium levels can happen. Tell your healthcare provider if you are taking Sensipar®. When switching from Sensipar® to Parsabiv®, you should stop taking Sensipar® for at least 7 days before starting Parsabiv®.

Your healthcare provider will measure your blood calcium levels before starting and while being treated with Parsabiv®. Parsabiv® should not be started if your calcium levels are too low. Your healthcare provider will be able to tell you if your calcium is too low. While on Parsabiv®, your healthcare provider should perform repeated blood tests to monitor calcium and intact parathyroid hormone (iPTH) levels.

Worsening Heart Failure: Low blood pressure, heart failure, and decreased heart function have happened with Parsabiv®.

Upper Gastrointestinal Bleeding: In medical studies, 2 patients treated with Parsabiv® had upper gastrointestinal (GI) bleeding at the time of death. The exact cause of GI bleeding is unknown and there were too few cases to determine whether these cases were related to Parsabiv®.

Tell your healthcare provider if you have stomach pain, bloody or black stool, or if you vomit bloody or black material. Also tell your healthcare provider if you have nausea or vomiting that is getting worse.

Adynamic Bone Disease: Very low levels of PTH should be avoided to help maintain bone health.

Side Effects: The most common side effects of Parsabiv® are low calcium levels, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and numbness or tingling in the fingers, toes, or around the mouth.

These are not all the possible side effects of Parsabiv®. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.

Indication Parsabiv® is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Parsabiv® has not been studied in adult patients with parathyroid cancer, primary hyperparathyroidism, or with CKD who are not on hemodialysis and should not be used in these patients.

Please see accompanying Parsabiv® full Prescribing Information.