Applies to etelcalcetide: intravenous solution.

Serious side effects of Etelcalcetide

Along with its needed effects, etelcalcetide 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:

More common

• Abdominal or stomach cramps
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion
• convulsions
• difficulty with breathing
• irregular heartbeats
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms
• numbness and tingling around the mouth, fingertips, or feet
• tremor

Less common

• Chest pain
• decreased urine output
• difficulty with swallowing
• dilated neck veins
• extreme fatigue
• fever
• hives
• irregular breathing
• nausea
• reddening of the skin, especially around the ears
• swelling of the eyes, face, fingers, feet, lower legs, or inside of the nose
• tightness in the chest
• unusual tiredness or weakness
• weight gain

Incidence not known

• Bloody or black, tarry stools
• constipation
• fainting
• irregular heartbeat recurrent
• seizures
• severe stomach pain
• vomiting of blood or material that looks like coffee grounds

Other side effects of Etelcalcetide

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:

More common

• Diarrhea
• headache
• vomiting

For Healthcare Professionals

Applies to etelcalcetide: intravenous solution.

General

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%).