Lonapegsomatropin Once-weekly Subcutaneous Injection

What is this medication?

LONAPEGSOMATROPIN (LOE na peg SOE ma TROE pin) is a long-acting growth hormone. It helps children who do not have enough growth hormone to grow taller.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): SKYTROFA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• cancer
• diabetes (high blood sugar)
• loud snoring
• low adrenal gland function
• low thyroid levels
• Prader-Willi syndrome
• recent surgery
• scoliosis
• sleep apnea
• vision problems
• an unusual or allergic reaction to lonapegsomatropin, somatropin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription label. Keep taking it unless your health care provider tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or health care provider to get one.

This medicine comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medicine. Read the information carefully. Talk to your pharmacist or health care provider if you have questions.

Talk to your health care provider about the use of this medicine in children. While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. You can take the dose 2 days before or 2 days after the scheduled dosing day; at least 5 days must elapse between doses. Do not take double or extra doses.

What may interact with this medication?

• certain medicines for diabetes, like glipizide or glyburide
• female hormones, like estrogen or progestins and birth control pills
• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. It may be some time before you see the benefit from this medicine.

You may need blood work while you are taking this medicine.

Talk to your health care provider about your risk of cancer. You may be more at risk for certain types of cancer if you take this medicine.

Your vision may be tested before and during use of this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• change in color of skin
• changes in vision
• edema (sudden weight gain; swelling of the ankles, feet, hands or other unusual swelling; trouble breathing)
• headache
• high blood sugar (increased hunger, thirst, or urination; unusually weak or tired, blurry vision)
• low adrenal gland function (nausea; vomiting; loss of appetite; unusually weak or tired; dizziness; low blood pressure)
• lumpy, thinning skin at site where injected
• pain in hip or knee
• pancreatitis (stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting, fast heartbeat)

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• joint pain
• muscle cramps, pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a refrigerator or at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze.

Refrigeration (preferred): Store it in the refrigerator. Keep it in the original carton until you are ready to take it. Remove the dose from the carton about 15 minutes before it is time for you to take it. Use the medicine within 4 hours of mixing it. If the medicine has been mixed for more than 4 hours before using it, throw it away. Throw away any unused medicine after the expiration date.

Room Temperature: This medicine may be stored at room temperature for up to 6 months. Keep it in the original carton until you are ready to take it. If it is stored at room temperature, throw away any unused medicine 6 months after the date it was first removed from the refrigerator, or after it expires, whichever is first.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, ask your pharmacist or health care provider how to get rid of this medicine safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.