Description
Lonapegsomatropin-tcgd injection is used to treat growth failure caused by growth hormone deficiency (inability to produce enough growth hormone). This medicine is a man-made version of the human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lonapegsomatropin-tcgd injection in children 1 year of age and older weighing at least 11.5 kilograms (kg). However, safety and efficacy have not been established in children younger than 1 year of age.
Geriatric
No information is available on the relationship of age to the effects of lonapegsomatropin-tcgd injection in geriatric patients.
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:
- Cancer, active or
- Closed epiphyses (normal bone growth stopped) in children or
- Diabetic retinopathy (eye condition) or
- Prader-Willi syndrome (a genetic disorder), if severely overweight or have severe breathing problems (eg, sleep apnea) or
- Severe illness after surgery or major medical emergency (eg, open heart surgery, stomach surgery, accidental trauma, or respiratory failure)—Should not be used in patients with these conditions.
- Cancer, history of or
- Hypopituitarism (pituitary gland produces low hormone levels) or
- Hypothyroidism (underactive thyroid gland) or
- Scoliosis (abnormally curved spine)—Use with caution. May make these conditions worse.
- Diabetes, or a family history of—Use with caution. May prevent insulin or other drugs for diabetes from working properly.
Proper Use
This medicine is given as a shot under your skin in the stomach, buttock, or thigh area. Somatropin may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.
This medicine comes with a patient instructions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
Use the Skytrofa™ cartridge with the Skytrofa™ autoinjector only. Make sure your doctor, nurse, or pharmacist instructs you on how to prepare and administer this medication. Also, read all instructions carefully to be sure you know how to use your device.
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 from the injections.
Use a new needle and cartridge each time you inject your medicine.
If refrigerated, allow the medicine to warm at room temperature for 15 minutes before use.
This medicine should be clear and colorless. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it.
To use the autoinjector:
- Place the needle straight on the cartridge by turning clockwise until tight. Do not remove the needle cover.
- Press and release the green button to turn on. You will hear a humming sound with the battery icon and 3 other icons above will light up. Then all of the icons will turn off, except the battery icon. The autoinjector is ready to use if you will hear 2 loud beeps and the green top will start flashing.
- Push the cartridge straight down with the needle cover still on into the flashing green top. Once you hear a click sound, the green top will stop flashing and mixing icon will light up. You may remove your finger from the cartridge.
- Wait for 4 to 8 minutes for the autoinjector to mix the medicine. Once finished, you will hear 2 loud beeps.
- Mix the autoinjector up and down by hand, you will hear a tick sound. Turn it 5 to 10 times until you hear 2 loud beeps. Keep it upright until you hear another 2 loud beeps.
- Pull the needle cover, a green eye icon will light up.
- Wash your hands with soap and water. Clean the injection site with an alcohol wipe.
- Press and hold the green top against the injection site for 10 to 15 seconds until you hear 2 loud beeps and green top will flash 2 times. Remove the autoinjector from the skin.
- Press the needle cover back into the flashing green top. Press it down to release the cartridge.
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 (powder for solution):
- For treatment of growth failure caused by growth hormone deficiency:
- Children 1 year of age and older weighing at least 11.5 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.24 milligrams (mg) per kg of body weight injected under the skin once a week.
- Weighing 85 to 100 kg—22 mg (two 11 mg cartridges) injected under the skin once a week. Your doctor may adjust your dose as needed.
- Weighing 70 to 84.9 kg—18.2 mg (two 9.1 mg cartridges) injected under the skin once a week. Your doctor may adjust your dose as needed.
- Weighing 60.5 to 69.9 kg—15.2 mg (two 7.6 mg cartridges) injected under the skin once a week. Your doctor may adjust your dose as needed.
- Weighing 51 to 60.4 kg—13.3 mg injected under the skin once a week. Your doctor may adjust your dose as needed.
- Weighing 42 to 50.9 kg—11.1 mg injected under the skin once a week. Your doctor may adjust your dose as needed.
- Weighing 35 to 41.9 kg—9.1 mg injected under the skin once a week. Your doctor may adjust your dose as needed.
- Weighing 29 to 34.9 kg—7.6 mg injected under the skin once a week. Your doctor may adjust your dose as needed.
- Weighing 24 to 28.9 kg—6.3 mg injected under the skin once a week. Your doctor may adjust your dose as needed.
- Weighing 20 to 23.9 kg—5.2 mg injected under the skin once a week. Your doctor may adjust your dose as needed.
- Weighing 16.5 to 19.9 kg—4.3 mg injected under the skin once a week. Your doctor may adjust your dose as needed.
- Weighing 14 to 16.4 kg—3.6 mg injected under the skin once a week. Your doctor may adjust your dose as needed.
- Weighing 11.5 to 13.9 kg—3 mg injected under the skin once a week. Your doctor may adjust your dose as needed.
- Children younger than 1 year of age—Use and dose must be determined by your doctor.
- Children 1 year of age and older weighing at least 11.5 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.24 milligrams (mg) per kg of body weight injected under the skin once a week.
- For treatment of growth failure caused by growth hormone deficiency:
Missed Dose
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.
If you miss a dose, use it as soon as possible. However, if it is more than 2 days, skip the missed dose and go back to your regular dosing schedule. To avoid missed doses, this medicine can be used 2 days before or 2 days after the scheduled dose. At least 5 days should pass between doses.
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.
Store in the refrigerator. Do not freeze.
Unopened cartridge: You may keep blistered cartridges at room temperature for up to 6 months and store back in the refrigerator within 6 months. Throw away any unused medicine up to expiration date or 6 months after it was first removed from the refrigerator, whichever is earlier.
Mixed medicine: Use it within 4 hours. Throw away any mixed medicine that has not been used after 4 hours.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
If you will be taking this medicine for a long time, it is very important that your doctor check you and your child's progress at regular visits. Blood and urine tests may be needed to check for any problems or unwanted effects that may be caused by this medicine.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which are life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain after receiving this medicine.
Using this medicine may increase your or your child's risk of getting cancer. Talk to your doctor if you have concerns about this risk.
This medicine may affect blood sugar levels. Check with your doctor if you notice a change in the results of your or your child's blood or urine sugar tests or if you have any questions.
Check with your doctor right away if you or your child have decrease in amount of urine, noisy, rattling breathing, swelling of the fingers, hands, feet, or lower legs, or weight gain. These may be symptoms of fluid retention (extra water in the body).
This medicine may cause an increased pressure in the head. Check with your doctor immediately if headache, nausea, vomiting, blurred vision, or any other change in vision occurs during treatment. Your doctor may want you to have your or your child's eyes checked by an ophthalmologist (eye doctor).
Check with your doctor right away if you have darkening of skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of an adrenal gland problem (hypoadrenalism).
Pancreatitis (inflammation of the pancreas) has occurred rarely in some patients receiving lonapegsomatropin-tcgd. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
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
- Bleeding gums
- blood in the eye
- bruise
- coughing up blood
- difficulty in breathing or swallowing
- dizziness
- eye pain
- headache
- increased menstrual flow or vaginal bleeding
- nosebleeds
- paralysis
- prolonged bleeding from cuts
- red or dark brown urine
- red or black, tarry stools
- redness in the whites of the eyes
- small, red, or purple spots on the skin
- trouble breathing
Incidence not known
- Bloating
- chest tightness
- chills
- confusion
- constipation
- cough
- darkening of the skin
- decrease in amount of urine
- depression or indentation of the skin
- diarrhea
- dry skin and hair
- fainting
- fast heartbeat
- feeling cold
- fever
- general feeling of discomfort or illness
- hair loss
- hives, itching, skin rash
- hoarseness or husky voice
- indigestion
- joint pain
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- limp pain in the hip or knee
- loss of appetite
- mental depression
- muscle aches, pains, cramps, and stiffness
- noisy, rattling breathing
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- runny nose
- severe nausea and vomiting
- shivering
- slowed heartbeat
- sore throat
- sweating
- swelling of the fingers, hands, feet, or lower legs
- trouble sleeping
- unusual tiredness or weakness
- vision changes
- weight gain
- yellow eyes or skin
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
- Difficulty in moving
- stomach pain
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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