Parsabiv

Parsabiv is a prescription medication used to treat secondary hyperparathyroidism (sHPT) in adults with chronic kidney disease (CKD) on hemodialysis. 

Parsabiv belongs to a group of drugs called calcium-sensing receptor agonists. When the kidneys fail, the parathyroid glands can make too much parathyroid hormone (PTH). Too much PTH can make phosphorus and calcium levels go up. Parsabiv acts on the parathyroid glands and causes them to release less parathyroid hormone (PTH).

Parsabiv is available in injectable form to be given directly into a vein by a health care professional. 

Common side effects include low blood calcium levels, muscle spasms, and diarrhea. 

Parsabiv is a prescription medication used to treat secondary hyperparathyroid (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Parsabiv. See the “Parsabiv Precautions” section. 

Common side effects include:

• low calcium levels
• muscle spasms
• diarrhea
• nausea
• vomiting
• headache
• hypocalcemia
• numbness or tingling in the fingers, toes, or around the mouth 

This is not a complete list of Parsabiv side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported. 

Serious side effects have been reported with Parsabiv including the following:

Low blood calcium levels (hypocalcemia): 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.

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.

Do not take Parsabiv if you:

• are allergic to etelcalcetide or any ingredients in Parsabiv. Allergic reactions including itchy rash, hives, and swelling of the face have happened.
• are currently taking Sensipar as severe, life-threatening low calcium levels can happen.
• have low calcium levels. 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.

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.

No known food interactions. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Parsabiv, there are no specific foods that you must exclude from your diet when receiving this medication. 

Before taking Parsabiv, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Parsabiv or to any of its ingredients
• are taking Sensipar. You cannot be on both drugs at the same time. When switching from Sensipar to Parsabiv, you should stop taking Sensipar for at least 7 days before starting Parsabiv.
• have or have had heart rhythm problems or heart failure or if you take medicines that can cause heart rhythm problems
• are taking medication to prevent seizures or have had seizures in the past
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant. 

There are no well-controlled studies that have been done in pregnant women. Parsabiv should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Parsabiv crosses into human milk, however, studies in rats showed the active ingredient in Parsabiv was present in the milk at concentrations similar to plasma. Because of the potential for Parsabiv to cause adverse effects in breastfed infants including hypocalcemia, Parsabiv is not recommended while breastfeeding. 

Parsabiv is given at the end of your hemodialysis session, three times a week, through the tube (bloodline) that connects you to the machine. Your healthcare provider will administer it for you.

The recommended starting dose is 5 mg administered by intravenous bolus injection three times per week at the end of hemodialysis treatment.

The maintenance dose is individualized and determined by titration based on parathyroid hormone (PTH) and corrected serum calcium response. The dose range is 2.5 to 15 mg three times per week.

Parsabiv is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.