Description
Palopegteriparatide injection is used to treat hypoparathyroidism (low parathyroid hormone). This medicine is a synthetic form of the natural human parathyroid hormone.
This medicine is available only with your doctor's prescription.
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 palopegteriparatide 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 palopegteriparatide 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 cancer, or history of or
- High levels of alkaline phosphatase (enzyme found in the bones) or
- Metabolic bone disease (eg, Paget's disease of the bone) or
- Open epiphyses (bones are still growing)—Use is not recommended. This medicine may increase the risk for bone cancer (osteosarcoma) in patients with these conditions.
- Hypercalcemia (high calcium in the blood) or
- Hypocalcemia (low levels of calcium in the blood)—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach or thigh.
This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Palopegteriparatide may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
You should receive the first few injections of this medicine in a place where you can sit or lie down if needed, until you know how this medicine affects you.
If you use palopegteriparatide at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into skin areas that are red, swollen, or has scars.
Use a new needle each time you inject the medicine. Do not store the prefilled pen with the needle attached.
Check the liquid in the pen. it should be clear and colorless. Do not use it if it is cloudy, colored, or has particles in it. Do not use the pen if it is damaged.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (prefilled pen):
- For hypoparathyroidism:
- Adults—18 micrograms (mcg) injected under the skin once a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For hypoparathyroidism:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose and it is less than 12 hours, take the missed dose as soon as possible. If you missed a dose and it is more than 12 hours, skip the dose and take your next dose at the regular time.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Before first use: Store the pen in the refrigerator and protect it from light. Do not freeze.
After first use: Store the opened pen at room temperature for 14 days. Keep the cap on the prefilled pen to protect it from light. Throw away unused medicine after 14 days.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause hypercalcemia (high levels of calcium in the blood). Contact your doctor right away if you have confusion, constipation, depression, dry mouth, headache, incoherent speech, increased urination, loss of appetite, metallic taste, muscle weakness, nausea, stomach pain, thirst, unusual tiredness, vomiting, or weight loss.
This medicine may cause hypocalcemia (low levels of calcium in the blood). Check with your doctor right away if you have confusion, irregular heartbeat, mood or mental changes, muscle cramps in the hands, arms, feet, legs, or face, numbness and tingling around the moth, fingertips, or feet, seizures, tremor, or trouble breathing.
This medicine may increase your risk of having osteosarcoma (bone cancer). This is more likely to occur if you have a history of radiation treatment involving your bones. Check with your doctor right away if you have bone pain that does not go away or a new soft tissue mass that is tender to palpation.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
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 immediately if any of the following side effects occur:
More common
- Chills
- cold sweats
- confusion
- constipation
- depression
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
- dry mouth
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of constant movement of self or surroundings
- headache
- incoherent speech
- increased urination
- loss of appetite
- metallic taste
- nausea
- sensation of spinning
- spinal pain
- stomach pain
- thirst
- unusual tiredness
- vomiting
- weight loss
Incidence not known
- Chest tightness
- cough
- difficulty swallowing
- hives, itching, skin rash
- irregular heartbeats
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- mood or mental changes
- muscle cramps in the hands, feet, legs, or face
- numbness and tingling around the mouth, fingertips, or feet
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- stomach cramps
- tremor
- trouble breathing
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
- Back pain
- bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- diarrhea
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.
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