Bios | Parsabiv® (etelcalcetide)

Indication and Limitations of Use:

  • Parsabiv® (etelcalcetide) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Read More
  • Parsabiv® has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations. Close
Read Less
Image of Dr. David Henner treating an sHPT patient with CKD on hemodialysis
Individual results may vary

Anna Chambers

Renal Dietitian

Years in Practice:
6+

Location:
Chattanooga, TN

Annette Dillon

RN, Dialysis Facility Manager

Years in Practice:
28+

Location:
LaPlace, LA

Jillian Golan

Renal Dietitian

Years in Practice:
13+

Location:
Philadelphia, PA

Colleen Guffee

Renal Dietitian

Years in Practice:
20+

Location:
Columbia, SC

Linda Roberto

Renal Dietitian

Years in Practice:
43+

Location:
Philadelphia, PA

Dr. David Henner

Nephrologist

Years in Practice:
21+

Location:
Pittsfield, MA

Dr. Abdul Abdellatif

Nephrologist

Years in Practice:
15+

Location:
Houston, TX

Debbie Glidden

Nurse Practitioner

Years in Practice:
18+

Location:
Orlando, FL
Managing the treatments of approximately 170 patients at her clinic keeps Anna Chambers busy, but given her long-time commitment to dialysis treatment, there’s nowhere else she’d rather be.
For Annette Dillon, communication and trust are the foundation for the most patient-focused, high-quality care she and her team can provide.
Jillian Gollan followed her calling to help others into the field of nephrology. She is committed to inspiring patients to achieve their best numbers and does what it takes to improve their situation.
Colleen Guffee and her dialysis team are committed to helping patients overcome challenges in meeting the goals that can improve their lives.
With her years of experience, there isn’t much Linda Roberto hasn’t seen. She brings her vast knowledge and passion to the care of her patients, earning trust and changing lives along the way.
Dr. Henner spends much of his time educating patients and physicians. He practices a dynamic team approach in which nurses, social workers, technicians, and dietitians work together.
Dr. Abdellatif’s patients consistently call him “kind and caring.” He is honored to have received the Compassionate Doctor Award and Patient’s Choice Award for many years.
Ms. Glidden is passionate about nephrology and dialysis. As a nurse practitioner, she enjoys working independently with patients and helping them manage their health.

Dialysis Care Team

  • Anna Chambers, RD
  • Annette Dillon, RN
  • Jillian Golan, RD
  • Colleen Guffee, RD
  • Linda Roberto, RD

Prescribers

  • Dr. Abdul Abdellatif
  • Debbie Glidden, NP
  • Dr. David Henner
In your mind, what is a key challenge in managing sHPT?

Managing lab values is one of my primary areas of focus. And so much of that is beyond our control. Parsabiv® made a difference because patients could now come into the facility for their treatment.

How has Parsabiv® (etelcalcetide) helped your facility perform in terms of overall numbers? Any memorable examples?

I just looked back at our data from 2018, when we first started using Parsabiv® at our clinic. At that time, there was a decrease in the number of patients with PTH greater than 600.

Nephrology nurses rely heavily on their renal dietitians to manage secondary HPT in hemodialysis patients. What do you look for when it comes to that?

As dietitians, if we see the PTH trending up, that’s going to jump out at us. If we can control the phosphorus with diet first and phosphorus binders if needed, it’s easier to manage the PTH. But if we see a patient failing on an oral calcimimetic, or other vitamin D analogs, we might consider a switch to Parsabiv®.

Individual results may vary

play

Looking at Patients Holistically

What is the key to making your team work well together?

I keep everyone informed. They need to understand that we have goals we’re all working toward together. That includes the patients. Our physicians have always been easy to work with and are open to the suggestions of the nursing staff. We are the ones on the front line, looking at labs, algorithms, and best practices. We discuss our ideas and share opinions in meetings and come to consensus together.

How would you describe your relationship with patients?

I work with them to understand why it’s important to be in a better state of health. If their goal is to live longer, they need to take steps to make it happen. I gain their trust, and I think that’s the biggest issue with the dialysis community. They need to trust your judgement and what you’re telling them. They are the reason I’m here.

How do you develop a plan for administering Parsabiv® (etelcalcetide)?*

I usually wait to draw up the medication until the last hour of the patient’s treatment. I keep it in the refrigerator. My technicians tell me when it’s rinse back, and that’s when I give it. We do use the “remember rinse back” tags as a reminder to our technicians to stay consistent.

Individual results may vary

*Please see Parsabiv® prescribing information for full dosing and administration instructions.

play

Managing Multiple Patients

play

Why Parsabiv®?

What brought you into your chosen field?

I would say it’s personal with me. I feel like I’m here for a reason. I am here for these patients. I’m here to help manage their diet and medications, so their labs can get down to within range. They need me to tell them what’s wrong and how they can fix it.

Do you feel as if it’s your responsibility to own the labs?

While I have support staff that help me, I don’t put that on anyone but myself. If a phosphorus, PTH, or calcium is off, I take full ownership of discussing it with the patient. I will reach out to the doctor, especially when I have a concern I want to run by him. At our Quality Improvement meetings, I’m the one reporting the numbers, and I don’t want to report bad numbers. So I take ownership and do whatever I can to inspire patients and empower them to get the numbers where they need to be.

What triggers you to initiate a patient on Parsabiv®?

I'll evaluate a patient's lab values, and if they don't seem to be meeting our goals, I'll present the patient's levels to the doctor. We've had good success with Parsabiv® reducing patient's lab values, and appreciate that it offers control over administration. Doctors have been willing to work with me based on a patient's needs.

Individual results may vary

play

Looking at Patients Holistically

play

Managing Multiple Patients

How would you describe the collaboration between you and the rest of the dialysis team?

It’s funny how it works sometimes. Patients might be more willing to open up to their care technician rather than me or a nurse because they work with them a lot more. At our staff meetings I ask everyone to keep me in the loop in case I’m missing something. A patient may tell me they’re doing fine and tell someone else they’ve been sick for the past week. It’s as if the patients tell the dietitians their social problems and tell the social workers their dietary problems.

How do you educate patients about the need for certain medications for sHPT?

When talking about sHPT, it’s not just about calcium, phosphorus, and PTH. It’s such a big undertaking for them. The diet is hard, and the medication load can be challenging. Patients want to know that it’s all worth it. Setting goals keeps them focused.

What difference has Parsabiv® (etelcalcetide) made for your patients in the treatment of sHPT?

In checking our records, we've generally seen an improvement in PTH levels in many of the patients we've treated with Parsabiv®. In our market, you’ll find that most clinics have incorporated Parsabiv® into their practice.

Individual results may vary

play

Managing Multiple Patients

play

Why Parsabiv®?

“Owning the labs” is a phrase we often hear in this space. Is that how you approach your duties at your facility?

Absolutely. When I train other dietitians, I say that labs are how they grade us. Our superiors don’t see our patient interactions, but they see our numbers. We must own the labs and do whatever we can to improve lives. Once a month, the whole company basically looks at the numbers. I’m very competitive, so I like to win.

Do you look at the numbers in a holistic fashion?

I never look at just one set of labs. I look at the trends, and, of course, the diet. I look at the patients’ body weight. I find out if they’re skipping treatments or shortening their treatment time. If so, their health is not going to be what it should be. And then there’s their home life. I look at the whole picture. Between the nurses, techs, social worker, and me, we work great as a team.

Do you see a difference in the use of Parsabiv®?

Not having to remember to take another pill is an important option to have for these patients. I initiated them on Parsabiv® and it helped.

Individual results may vary

play

Looking at Patients Holistically

play

Why Parsabiv®?

What was treating sHPT like prior to calcimimetics?

In the past, when I would think about treating secondary hyperparathyroidism, it was a lot like juggling. Treatment for me could include prescribing my patients phosphate binders and vitamin D. Sometimes, the phosphate binders would cause my patient’s calcium levels to go up. And if you give vitamin D, that could raise the calcium and phosphorus; so in those instances it would feel like you’re kind of chasing your tail.

What impact has Parsabiv® (etelcalcetide) had on your patients and the treatment of sHPT?

Parsabiv® has had a huge impact on what we do at our practice in regards to the way we treat sHPT. For myself, and most of my colleagues, we routinely write Parsabiv® for appropriate patients. And I see that trend continuing because we have seen good results when managing sHPT with Parsabiv®.

What would you say to any clinicians out there who are wondering if Parsabiv® could be right for their patients?

I would say, if you have a patient who you believe could benefit from a treatment like Parsabiv® (etelcalcetide), you have to advocate for them. And I do that every day. Ultimately, we’ve got to do what we feel is right for our patients. I couldn’t sleep at night unless I felt today, I did all I can for my patients. That’s my responsibility—and I think most nephrologists feel the same way.

Individual results may vary

play

Early Experience

play

Parsabiv® in Practice

play

Care Team Dynamics

What were your expectations when you first started to prescribe Parsabiv®?

I was cautiously optimistic that Parsabiv® (etelcalcetide) would help because now we are in control of administering the medication to our patients. Parsabiv® further justified my belief in calcimimetics.

Can you share a patient success story that makes you especially proud?

I have this one patient with sHPT—she had a wake-up call when I recommended she meet with a surgeon. Up until then, she wasn’t very active in her care. As soon as Parsabiv® (etelcalcetide) came out, she was the first patient in her dialysis unit to receive it. We initiated her on 5 milligrams, 3 times a week at the end of hemodialysis, and we titrated her dose based on her labs. We didn’t even need to titrate to the maximum dose and in a few months her PTH was in normal range. Her PTH is still in range without me having to significantly change her dose. Her secondary hyperparathyroidism is well managed and she is more active in her care.

What was it like to be able to deliver good news to a patient?

It feels great to share good news with patients because frankly these are people who may not be used to hearing a lot of good news. That’s really inspiring to me, and now I am working very closely with my care team to monitor and identify other patients who may be appropriate for Parsabiv® (etelcalcetide).

Individual results may vary

play

Early Experience

play

Parsabiv® in Practice

play

Making a Difference

play

Care Team Dynamics

How do you go about starting a new patient on Parsabiv®?

First and foremost, I will write Parsabiv® when I feel it’s important for us to control administration. We initiate Parsabiv® (etelcalcetide) for appropriate patients in order to manage their sHPT. We start them out at the approved dose, which is 5 mg 3 times a week, at the end of hemodialysis. It’s important to ensure that a patient’s serum calcium is at or above the lower limit of normal before initiating Parsabiv®. Following initiation, check the patient’s calcium levels after 1 week, then every 4 weeks after that. Also, you need to check the patient’s PTH levels after 4 weeks, then continue to check PTH based on whatever your practice does. Of course, all dosing and monitoring information can be found in the package insert.

Once you’ve decided to prescribe Parsabiv®, you need to work with your dialysis organization to make sure you get that patient on Parsabiv®.

Why do you think Parsabiv® (etelcalcetide) is worth advocating for?

I cannot stress enough the peace of mind I have knowing that I control administration with Parsabiv®. I’ve been in dialysis over 30 years and I’ve seen what these patients go through. It’s not an easy life. That’s why I fight for Parsabiv®—I do it for my patients because I care about them, and I’ve seen the difference Parsabiv® can make. And that’s what matters most to me. It works.

How does your care team work together to make things run smoothly?

We work together to establish great communication, which relates to everyone knowing what our treatment goals are for sHPT—aligning on what labs we want to achieve and how to get there. Also knowing what triggers exist when it’s time to start a new therapy.

Individual results may vary

play

Parsabiv® in Practice

play

Making a Difference

play

Care Team Dynamics



Icon_Efficacy

EFFICACY

See how Parsabiv® performed
in clinical trials and its use in real-world outcomes

Real-World Evidence graphic

REAL-WORLD EVIDENCE

See an analysis from
hundreds of real-world treatment experiences

See More

Important Safety Information for Parsabiv®

Contraindication: Parsabiv® (etelcalcetide) is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity reactions, including face edema and anaphylactic reaction, have occurred.

Hypocalcemia: Parsabiv® lowers serum calcium and can lead to hypocalcemia, sometimes severe. Significant lowering of serum calcium can cause QT interval prolongation and ventricular arrhythmia. Patients with conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due

Close

Important Safety Information for Parsabiv®

Contraindication: Parsabiv® (etelcalcetide) is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity reactions, including face edema and anaphylactic reaction, have occurred.

Hypocalcemia: Parsabiv® lowers serum calcium and can lead to hypocalcemia, sometimes severe. Significant lowering of serum calcium can cause QT interval prolongation and ventricular arrhythmia. Patients with conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due to Parsabiv®. Closely monitor corrected serum calcium and QT interval in patients at risk on Parsabiv®.

Significant reductions in corrected serum calcium may lower the threshold for seizures. Patients with a history of seizure disorder may be at increased risk for seizures if they develop hypocalcemia due to Parsabiv®. Monitor corrected serum calcium in patients with seizure disorders on Parsabiv®.

Concurrent administration of Parsabiv® with another oral calcimimetic could result in severe, life-threatening hypocalcemia. Patients switching from cinacalcet to Parsabiv® should discontinue cinacalcet for at least 7 days prior to initiating Parsabiv®. Closely monitor corrected serum calcium in patients receiving Parsabiv® and concomitant therapies known to lower serum calcium.

Measure corrected serum calcium prior to initiation of Parsabiv®. Do not initiate in patients if the corrected serum calcium is less than the lower limit of normal. Monitor corrected serum calcium within 1 week after initiation or dose adjustment and every 4 weeks during treatment with Parsabiv®. Measure PTH 4 weeks after initiation or dose adjustment of Parsabiv®. Once the maintenance dose has been established, measure PTH per clinical practice.

Worsening Heart Failure: In Parsabiv® clinical studies, cases of hypotension, congestive heart failure, and decreased myocardial performance have been reported. Closely monitor patients treated with Parsabiv® for worsening signs and symptoms of heart failure.

Upper Gastrointestinal Bleeding: In clinical studies, 2 patients treated with Parsabiv® in 1253 patient years of exposure had upper gastrointestinal (GI) bleeding at the time of death. The exact cause of GI bleeding in these patients is unknown and there were too few cases to determine whether these cases were related to Parsabiv®.

Patients with risk factors for upper GI bleeding, such as known gastritis, esophagitis, ulcers or severe vomiting, may be at increased risk for GI bleeding with Parsabiv®. Monitor patients for worsening of common Parsabiv® GI adverse reactions and for signs and symptoms of GI bleeding and ulcerations during Parsabiv® therapy.

Adynamic Bone: Adynamic bone may develop if PTH levels are chronically suppressed.

Adverse Reactions: In clinical trials of patients with secondary HPT comparing Parsabiv® to placebo, the most common adverse reactions were blood calcium decreased (64% vs. 10%), muscle spasms (12% vs. 7%), diarrhea (11% vs. 9%), nausea (11% vs. 6%), vomiting (9% vs. 5%), headache (8% vs. 6%), hypocalcemia (7% vs. 0.2%), and paresthesia (6% vs. 1%).

Indication

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

Limitations of Use: Parsabiv® has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations.

Limitations of Use:

Parsabiv® has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations.

Please see Parsabiv® (etelcalcetide) full Prescribing Information.