Lonapegsomatropin-tcgd injection is used to replace growth hormone (a natural hormone produced by your body) in children 1 year of age or older who weigh 26 pounds (11.5 kg) or more with growth hormone deficiency. Lonapegsomatropin-tcgd is a human growth hormone (hGH) analog. It works by replacing growth hormones that are normally produced in the body.

Lonapegsomatropin-tcgd comes as a powder to mixed with the liquid provided in a prefilled cartridge and used in an automatic injection device. Lonapegsomatropin-tcgd is injected subcutaneously (under the skin). It is usually injected once a week, on the same day of the week, and at around the same time of day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use lonapegsomatropin-tcgd injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor may adjust your dose of lonapegsomatropin-tcgd depending on your response to treatment.

You may receive your first dose of lonapegsomatropin-tcgd injection in your doctor’s office. After your first dose, your doctor may allow you or a caregiver to perform the injections at home. Carefully read the manufacturer’s instructions for use that comes with the medication. These instructions describe how to mix and inject a dose of lonapegsomatropin-tcgd. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication. To help you remember to use lonapegsomatropin-tcgd injection, mark a calendar to keep track of when you are to receive a dose.

Continue to use lonapegsomatropin-tcgd injection even if you feel well. Do not stop using lonapegsomatropin-tcgd injection without talking to your doctor.

If you are using a prefilled cartridge that has been refrigerated, before you are ready to inject lonapegsomatropin-tcgd, place the cartridge on a flat surface and allow it to warm to room temperature for around 15 minutes. You should mix the medication right before you plan to inject it. However, you may mix the medication in advance and use within 4 hours.

You can inject lonapegsomatropin-tcgd anywhere on the front of your thighs (upper leg), buttocks, or on your stomach except around your navel (belly button). Choose a different spot each time you inject your medication.

Always look at lonapegsomatropin-tcgd solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless. The liquid should not contain visible particles. Do not use a cartridge if it is expired or if the liquid is cloudy or contains particles.

Do not reuse or share cartridges, automatic injection device, and needles. Dispose of used cartridge and needles in a puncture resistant container that is out of the reach of children. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using lonapegsomatropin-tcgd injection,

• Tell your doctor and pharmacist if you are allergic to lonapegsomatropin-tcgd, other growth hormone products, any other medications, or any of the ingredients in lonapegsomatropin-tcgd injection. Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: corticosteroids such as cortisone acetate, dexamethasone (Hemady), fludrocortisone, hydrocortisone (Alkindi Sprinkle, Cortef,), and prednisone (Rayos); insulin and oral medications for diabetes; and medications that contain estrogen. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with lonapegsomatropin-tcgd, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• Tell your doctor if you have recently had heart or stomach surgery, an accident or trauma, or serious breathing problems, or if you have cancer, diabetic retinopathy (damage to the eyes caused by diabetes), or Prader-Willi syndrome (a genetic condition that can cause physical, mental and behavioral problems). Your doctor may tell you not to use lonapegsomatropin-tcgd injection. Lonapegsomatropin-tcgd should not be used in children whose growth plate has closed and whose bones are no longer growing (usually after puberty).
• Tell your doctor if you have every received radiation therapy in the area of the head or brain and if you have or have ever had diabetes; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions); pancreatitis (swelling of the pancreas); cancer; papilledema (swelling of the optic nerve caused by increased pressure in the brain); scoliosis (curving of the spine); sleep apnea; high blood levels of phosphate; or thyroid, parathyroid, or liver problems.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using lonapegsomatropin-tcgd, call your doctor.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are using lonapegsomatropin-tcgd injection.

Unless your doctor tells you otherwise, continue your normal diet.

Give the missed dose as soon as you remember it. However, if it is more than 2 days after the time you were supposed to use the dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.

You may use a dose of lonapegsomatropin-tcgd 2 days before or 2 days after your scheduled dosing day and then continue your regular dosing schedule; make sure that there are at least 5 days between doses.

Lonapegsomatropin-tcgd may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Fever
• Cough
• Diarrhea
• Joint pain
• Nausea
• Vomiting
• Stomach pain
• Skin thickening at injection site
• Nose bleed
• Tiny red spots directly under the skin

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• Vision changes, headache, nausea, and vomiting
• Hives; rash; itching; difficulty breathing or swallowing; sweating; swelling of the eyes, face, mouth, lips, tongue or throat; hoarseness; lightheadedness; fainting; or chest pain
• Ongoing pain that begins in the stomach area but may spread to the back nausea, vomiting, or loss of appetite
• Numbness, burning, tingling, or tingling in the hands, fingers, arms, legs, or feet
• Swelling of the hands, feet, ankles, or lower legs
• Excessive tiredness, muscle or joint pain, weakness, lightheadedness, darkening of the skin, or weight loss
• Persistent knee or hip pain, limping

Lonapegsomatropin-tcgd may increase the risk of developing certain types of cancer. Your doctor may check your skin during treatment for signs of skin cancer. Call your doctor right away if you have any of the following symptoms: headache; changes in behaviour or vision; or changes in moles, birthmarks, or skin color.

Lonapegsomatropin-tcgd may cause an increase in your blood sugar levels. Your doctor will order tests to monitor your blood sugar levels during your treatment with lonapegsomatropin-tcgd injection. Talk to your doctor about the risks of taking this medication.

Lonapegsomatropin-tcgd may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in to protect from light, tightly closed, and out of reach of children. Store it in the refrigerator, but do not freeze. It also may be stored at room temperature for up to 6 months.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• Swelling of the hands, feet, ankles, or lower legs
• Excessive sweating and body odor
• Enlarged hands, feet, lips, nose, and tongue
• Joint or muscle weakness

Keep all appointments with your doctor and the laboratory. Your doctor will order an eye exam before and during your treatment with lonapegsomatropin-tcgd. Your doctor will also order certain lab tests to check your body’s response to lonapegsomatropin-tcgd.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using lonapegsomatropin-tcgd injection.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.