Indication

Parsabiv® (etelcalcetide) 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.

What is sHPT?

When your kidneys fail, your parathyroid glands can make too much parathyroid hormone (PTH)2,3

Chart

Too much PTH can make your phosphorus and calcium levels go up4-6

What’s the goal?

Your dialysis care team may have goal ranges for your PTH, phosphorus, and calcium levels.

Parsabiv® is part of their plan to get and keep your levels in range.

 

P = phosphorus; Ca = calcium.

Why did my doctor prescribe Parsabiv®?

It’s a treatment for secondary HPT in adult patients with chronic kidney disease (CKD) on hemodialysis1

Parsabiv® (etelcalcetide) acts on your parathyroid glands and causes them to release less PTH1

chart

When PTH goes down, your bones release less phosphorus and calcium.4,5

One treatment that can help lower the 3 key levels1

Your doctor may also prescribe other medicines to treat your secondary HPT:

  • Phosphate binders* help you absorb less phosphorus from the food you eat4
  • Certain types of vitamin D* may help lower your PTH. This medicine is usually given to you through the dialysis machine, or you may take it as a pill3,7

*Phosphate binders and vitamin D are available by prescription.
HPT = hyperparathyroidism.

How will Parsabiv®
be given to me?

Parsabiv® is given at the end of your hemodialysis session, three times a week, through the tube (bloodline) that connects you to the machine1

IV delivery means your nurse or other healthcare provider will administer it for you

pill

 

bottle

 

Keep in mind: You shouldn’t be started on Parsabiv® if you have low calcium levels. (You can ask your doctor about normal ranges for calcium.)1

Pill shown is not actual size
Vial is for illustrative purposes only

What are possible
side effects?

You may experience side effects while taking Parsabiv® (etelcalcetide)1

Some patients reported potential symptoms of a condition called hypocalcemia (low calcium levels), including spasms, twitches, or cramps in your muscles; numbness or tingling in your fingers, toes, or around your mouth; or seizures.

During studies of Parsabiv®, some patients reported other various side effects like diarrhea, nausea, and vomiting.

What if I feel
side effects?

Talk to your heathcare provider right away.

After talking to your healthcare provider, you can report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call
1-800-FDA-1088 (332-1088).

FDA = Food and Drug Administration.

What if my dialysis care team is switching me from Sensipar® (cinacalcet) to Parsabiv®?

Stop taking Sensipar® for at least 7 days before you start Parsabiv® (etelcalcetide)

You need to stop taking Sensipar® tablets at least 7 days before you can start Parsabiv®. You cannot be on both drugs at the same time.1

chart chart

Keep in mind: You shouldn’t be started on Parsabiv® if you have low calcium levels. (You can ask your doctor about normal ranges for calcium.)

 

Pills shown are not actual size
Vial is for illustrative purposes only

Is there
coverage support 
for Parsabiv®?

Contact Amgen Assist® at 1-800-272-9376 Monday through Friday, 8:00 am to 8:00 pm ET, for coverage and reimbursement support 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.

References: 1. Parsabiv® (etelcalcetide) prescribing information, Amgen. 2. Rodriguez M, Nemeth E, Martin D. The calcium-sensing receptor: a key factor in the pathogenesis of secondary hyperparathyroidism. Am J Physiol Renal Physiol. 2005;288:F253-F264. 3. Komaba H, Shiizaki K, Fukagawa M. Pharmacotherapy and interventional treatments for secondary hyperparathyroidism: current therapy and future challenges. Expert Opin Biol Ther. 2010;10:1729-1742. 4. Goodman WG. Calcium and phosphorus metabolism in patients who have chronic kidney disease. Med Clin North Am. 2005;89:631-647. 5. Goodman WG. The consequences of uncontrolled secondary hyperparathyroidism and its treatment in chronic kidney disease. Semin Dial. 2004;17:209-216. 6. Streja E, Lau WL, Goldstein L, et al. Hyperphosphatemia is a combined function of high serum PTH and high dietary protein intake in dialysis patients. Kidney Int Suppl (2011). 2013;3:462-468. 7. Tentori F, Wang M, Bieber BA, et al. Recent changes in therapeutic approaches and association with outcomes among patients with secondary hyperparathyroidism on chronic hemodialysis: the DOPPS study. Clin J Am Soc Nephrol. 2015;10:98-109.

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®.