Parsabiv Side Effects

Generic name: etelcalcetide

Medically reviewed by Drugs.com. Last updated on Mar 20, 2025.

Note: This document provides detailed information about Parsabiv.

Applies to etelcalcetide: intravenous solution Side Effects associated with etelcalcetide. Some dosage forms listed on this page may not apply specifically to the brand name Parsabiv.

Applies to etelcalcetide: intravenous solution.

Precautions

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine may cause hypocalcemia (low calcium levels in the blood). Tell your doctor if you have numbness and tingling around the mouth, fingertips, or feet, muscle spasms, seizures, or fast or uneven heartbeat after receiving this medicine.

If you are rapidly gaining weight, having shortness of breath, chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

This medicine may cause stomach bleeding. Tell your doctor right away if you have bloody or black, tarry stools, vomiting of blood or material that looks like coffee grounds, severe stomach pain, or constipation.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Parsabiv

Along with its needed effects, etelcalcetide (the active ingredient contained in Parsabiv) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking etelcalcetide:

Other side effects of Parsabiv

Some side effects of etelcalcetide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to etelcalcetide: intravenous solution.

General adverse events

The most commonly reported adverse effects have included hypocalcemia, muscle spasms, diarrhea, nausea, vomiting, headache, and paresthesia.^[Ref]

Hypersensitivity

• Common (1% to 10%): Hypersensitivity reactions including pruritic rash, urticaria, face edema
• Postmarketing reports: Anaphylactic reaction

Nervous system

• Common (1% to 10%): Headache, paresthesia
• Postmarketing reports: Seizures secondary to hypocalcemia

Cardiovascular

• Common (1% to 10%): QTcF interval increase, heart failure hospitalization
• Frequency not reported: Hypotension, congestive heart failure, decreased myocardial performance

During clinical trials, 1.2% of patients receiving this drug experienced a QTcF interval increase greater than 60 msec compared to 0% of placebo patients. The incidence of maximum post-baseline predialysis QTcF greater than 500 msec was 4.8% and 1.9% in those receiving this drug and placebo, respectively.

During clinical trials, heart failure requiring hospitalization occurred in 2% of patients receiving this drug compared with 1% of placebo patients. Reductions in corrected serum calcium may be associated with congestive heart failure, however, a causal relationship to this drug could not be completely excluded.

Gastrointestinal

• Very common (10% or more): Diarrhea (11%), nausea (11%)
• Common (1% to 10%): Vomiting
• Frequency not reported: Upper gastrointestinal bleeding

Musculoskeletal

• Very common (10% or more): Muscle spasms (12%)
• Common (1% to 10%): Myalgia

Immunologic

• Common (1% to 10%): Anti-drug binding antibody formation

During clinical studies 7.1% (71/995) patients treated fro up to 6 months tested positive for binding anti-etelcalcetide antibodies. No evidence of altered pharmacokinetic profile, clinical response, or safety profile was associated with the development of these antibodies. If formation of anti-etelcalcetide biding antibodies is associated with a clinically significant event, Amgen can be contacted at 1-800-77-AMGEN (1-800-772-6436) to discuss antibody testing.

Metabolic

• Very common (10% or more): Blood calcium decreased (64%); hypophosphatemia (18%)
• Common (1% to 10%): Hypocalcemia, hyperkalemia
• Postmarketing reports: Hypocalcemia with concomitantly administered products known to lower serum calcium (e.g. cinacalcet, denosumab)

Blood calcium decreases include asymptomatic reductions in calcium below 7.5 mg/dL or clinically significant asymptomatic reductions in corrected serum calcium between 7.5 and less than 8.3 mg/dL that required medical management. Hypocalcemia includes symptomatic reductions in corrected serum calcium to less than 8.3 mg/dL. During clinical studies, at least 1 corrected serum calcium value below 7.0 mg/dL (7.6% vs 3.1%) below 7.5 mg/dL (27% vs 5.5%), and below 8.3 mg/dL (79% vs 19%) occurred; 1% of patients receiving this drug discontinued treatment due low corrected serum calcium (placebo=0).

During clinical trials, 18% of patients receiving this drug had at least 1 measured phosphorus level below the lower normal limit (placebo=8.2%).

See also:

Frequently asked questions

• What is Parsabiv used to treat?

Further information

Parsabiv side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer