Description
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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of etelcalcetide injection in the elderly.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
DRG-20406033
