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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You may have been switched because of changes made in 2021 to the amount Medicare pays for calcimimetics, including Parsabiv®. We know this can be frustrating, and the best course of action is to talk with your doctor or dialysis care team. Know that it’s okay to ask why you’ve been switched from Parsabiv® to another medication.
Below are some questions you can ask to help you understand why a change in medication was necessary.
Why am I being switched back to a medication that I have tried before? Is there a reason you would change it again? How is my current treatment the best one for me? These questions are included in a discussion guide that you can download and take to your next dialysis session or doctor visit.
Medicaid pays for Parsabiv®, but coverage varies by state. Check with your state Medicaid office to understand coverage.
Contact Amgen Assist® at 1-800-272-9376 Monday through Friday, 9:00 am to 8:00 pm ET, for reimbursement support information.
Calcimimetics can help treat sHPT in adult patients with chronic kidney disease on hemodialysis. They can help lower the levels of parathyroid hormone (PTH), phosphorus, and calcium in your blood.
Parsabiv® acts on your parathyroid glands and causes them to release less parathyroid PTH. When your PTH goes down, your bones release less phosphorus and calcium.
Your dialysis care team will give you Parsabiv® through your IV at the end of your dialysis sessions.
No, Parsabiv® can only be given to you through an IV at the end of your dialysis sessions.
That may depend on your progress. Talk to your doctor or nurse about whether you can stop taking your prescribed calcimimetic.
These treatments for sHPT are often used together, but talk to your doctor or nurse about your specific situation.
Yes, work with your healthcare team to determine if Parsabiv® is right for you.
Your doctor will monitor your lab values for PTH, phosphorus, and calcium. Be sure to ask your doctor if you have questions about your progress.
Calcium, phosphorus, and PTH are the important lab values your doctor will monitor. Talk with your care team if you have any concerns.
You should always talk to your doctor or nurse if you have issues, questions, or concerns about your medications.
Contact your doctor right away if you have any side effects.
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.
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.
