Lonapegsomatropin

Lonapegsomatropin is a type of human growth hormone that is used to treat children who are 1 year old and older, weigh at least 25 lbs (11.5 kg), and have growth issues because their bodies do not produce enough growth hormone.

Lonapegsomatropin is also used to provide growth hormone for adults who have a deficiency.

Lonapegsomatropin may also be used for other reasons that are not mentioned in this medication guide.

You should not use lonapegsomatropin if you have a serious illness after major surgery or trauma, cancer, eye problems caused by diabetes, closed epiphyses, or if you have Prader-Willi syndrome and severe breathing problems.

Get emergency medical help if you have severe upper stomach pain, vision changes, severe headache, pain in your knees or hips, walking with a limp, extreme tiredness, dizziness, weight loss, changes in skin color, or unusual swelling or rapid weight gain.

You should not use lonapegsomatropin if you are allergic to it or any of its ingredients, or if you have:

• a serious illness due to lung failure, or complications from recent surgery, injury, or medical trauma;
• active cancer;
• eye problems caused by diabetes (diabetic retinopathy);
• you are a child with closed bone growth plates (epiphyses); or
• you are a child with Prader-Willi syndrome and you are severely obese or have breathing problems including sleep apnea (breathing that stops during sleep).

Tell your doctor if you have or have ever had:

• diabetes;
• a pituitary gland disorder;
• underactive thyroid;
• breathing problems, sleep apnea (breathing stops during sleep), or lung infections;
• cancer (especially in children); or
• are a child with abnormal curvature of the spine (scoliosis).

If you received radiation to your brain or head for cancer during childhood, using lonapegsomatropin may increase your risk of developing cancer. Ask your doctor about this risk.

It is not known if lonapegsomatropin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using lonapegsomatropin.

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

Lonapegsomatropin may cause serious side effects. Call your doctor right away if you have:

• pain in your knees or hips, walking with a limp;
• numbness, tingling, or burning pain in your hands, arms, wrists, legs, or feet;
• changes in behavior, changes in moles, birthmarks, or skin color;
• pancreatitis--severe pain in your upper stomach that spreads to your back, nausea, and vomiting;
• fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and belly);
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, vision problems, pain behind your eyes; or
• decreased adrenal gland hormones--stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.

Common side effects of lonapegsomatropin may include:

• viral infection, fever, or cough;
• nosebleeds, bleeding gums, unusual vaginal bleeding, any bleeding that will not stop;
• swelling in your hands or lower legs;
• stomach pain, nausea, vomiting, diarrhea; or
• joint pain or stiffness.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Lonapegsomatropin is injected under the skin once a week. A healthcare provider may give you this injection or may teach you how to properly use this medicine by yourself.

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.

Your healthcare provider will show you where to inject lonapegsomatropin. 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 cartridge. 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.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

You may need frequent medical tests before and during your treatment with this medicine.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using lonapegsomatropin.

You may be given other medications to help treat your condition or certain serious side effects. Keep taking these medicines for as long as your doctor has prescribed.

Follow all storage instructions provided with your injectable medication. Your healthcare provider can provide more information about how to store this medicine.

Use the medicine as soon as you can, but skip the missed dose if you are more than 2 days late for the dose, and then go back to your regular schedule. Do not use two doses at one time.

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

Overdose symptoms include hunger, weakness, sweating, confusion, irritability, fast heart rate, or feeling jittery. Long-term overdose may cause excessive growth.

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

Tell your doctor about all the other medicines you are taking, especially:

• birth control pills and other hormones; or
• a steroid (like 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.