Parsabiv® (etelcalcetide) is a treatment for secondary hyperparathryoidism, or sHPT, in adult patients with chronic kidney disease on hemodialysis.
What does Parsabiv® do?
Parsabiv® lowers the PTH, phosphorus, and calcium levels in your blood
Parsabiv® acts on your parathyroid glands and causes them to release less parathyroid hormone (PTH). When your PTH goes down, your bones release less phosphorus and calcium.
How is Parsabiv® given?
Parsabiv® is given by your nurse or other care team member at the end of your hemodialysis, three times a week, through an IV.
Keep in mind that you shouldn’t be started on Parsabiv® if you have low calcium levels. You can ask your doctor or nurse about normal ranges for calcium.
Pill shown is not actual size. Vial is for illustrative purposes only.
You may experience side effects while taking Parsabiv® (etelcalcetide)
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 such as diarrhea, nausea, and vomiting.
Talk to your healthcare provider right away if you feel side effects
After talking to your doctor and/or care team, you can report negative side effects of prescription drugs to the US Food and Drug Administration.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).
If you need help paying for your Parsabiv® prescription, please 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 and to see if you qualify.
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
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.