Pronunciation:

e-tel-KAL-se-tide

Brand Names:

• Parsabiv

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Calcimimetic

Uses of This Medicine:

Etelcalcetide injection is used to used to treat secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH). This hormone controls the concentrations of calcium and phosphorus in your blood. Paricalcitol helps lower the amount of PTH which lowers the calcium and phosphorus concentrations.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of etelcalcetide injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of etelcalcetide injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone disease or
• Heart failure or
• Seizures, or history of—Use with caution. May make these conditions worse.

• Heart rhythm problem (eg, congenital long QT syndrome, QT prolongation), or history of or
• Stomach or other digestive problems (eg, esophagitis, gastritis, ulcers)—May increase risk for more serious side effects.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

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

Some side effects 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.