Lonapegsomatropin is a form of human growth hormone used to treat people 1 year and older who weigh at least 25 lbs (11.5 kg) and have growth problems because of inadequate secretion of growth hormone.

Lonapegsomatropin may also be used for purposes not listed in this medication guide.

Call your doctor at once if you have severe pain in your upper stomach spreading to your back; increased thirst, increased urination; severe headaches, ringing in your ears, dizziness, nausea, vision problems; weight loss, changes in skin color, feeling very weak or tired.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.

Lonapegsomatropin is injected under the skin once a week. A healthcare provider can teach you how to properly use the medication by yourself.

Do not inject into the same place two times in a row.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Never share an injection pen, cartridge, or syringe even if you changed the needle. Sharing these devices can pass infections from person to person.

You may need frequent medical tests.

Store in the refrigerator in the outer carton to protect from light. Do not freeze.

Lonapegsomatropin can also be stored in the outer carton at room temperature for up to 6 months. lonapegsomatropin can be returned to the refrigerator within 6 months.

Do not use lonapegsomatropin beyond 6 months after the date it was first removed from the refrigerator or if this medicine has expired (whichever is earlier).

Ask your pharmacist if you have any questions about proper storage of your medication.

Usual Pediatric Dose for Pediatric Growth Hormone Deficiency:

1 year and older and weighing at least 11.5 kg:
Recommended dose: 0.24 mg/kg subcutaneously once a week

Comments:
-Individualize dose based on response.
-Round dose to closest cartridge dose while considering treatment goals and patient response.
-If no increase in height velocity, particularly during the first year of treatment, assess compliance and evaluate other causes of poor growth such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human growth hormone.
-Discontinue once epiphyseal fusion has occurred.

Use: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)

You should not use lonapegsomatropin if you are allergic to it, or if you have:

• a serious illness due to lung failure, or complications from recent surgery, injury, or medical trauma;

• closed epiphyses;

• active cancer;

• eye problems caused by diabetes (diabetic retinopathy); or

• Prader-Willi syndrome and you are overweight or have severe breathing problems (including sleep apnea).

Tell your doctor if you have ever had:

• cancer (especially during childhood);

• diabetes;

• a head injury or brain tumor;

• childhood brain cancer and radiation treatment;

• a pituitary gland disorder;

• underactive thyroid;

• abnormal curvature of the spine (scoliosis); or

• breathing problems, sleep apnea (breathing stops during sleep).

Tell your doctor if you are pregnant or breastfeeding.

Use the medicine as soon as you can, but skip the missed dose if you are more than 2 days late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Lonapegsomatropin may cause serious side effects. Call your doctor at once if you have:

• pain in your knees or hips, walking with a limp;

• numbness or tingling in your wrist, hand, or fingers;

• severe swelling or puffiness in your hands and feet;

• changes in behavior;

• vision problems, unusual headaches;

• changes in the shape or size of a mole;

• pain or swelling in your joints;

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or

• signs of an adrenal gland problem--extreme weakness, severe dizziness, weight loss, changes in skin color, feeling very weak or tired.

Common side effects of lonapegsomatropin may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• nosebleed, pinpoint purple or red spots under your skin;

• fever;

• cough;

• stomach pain, nausea, vomiting, diarrhea; or

• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• birth control pills or hormone replacement therapy;

• insulin or oral diabetes medicine; or

• a steroid (prednisone, dexamethasone, methylprednisolone, and others).

This list is not complete. Other drugs may affect lonapegsomatropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.