Lonapegsomatropin-tcgd (loe-na-peg-soe-ma-TROE-pin - tcgd)

Treats growth failure in patients who do not make enough growth hormone. This medicine is a human growth hormone.

Brand Name(s):

Skytrofa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It usually injected in the stomach, buttock, or thigh area.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist 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.
• 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 this medicine if the liquid is cloudy, discolored, or has particles in it.
• Use a new needle and cartridge each time you inject your medicine.
• Missed dose: If you miss a dose, use it as soon as possible if it is not more than 2 days. 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.
• If you store this medicine at home, keep it 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.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how lonapegsomatropin-tcgd works. Tell your doctor if you are using birth control pills or hormone replacement treatment (including estrogen), diabetes medicine (including insulin), or steroid medicine (including cortisone acetate, prednisone).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, thyroid problems, pituitary problems, scoliosis (curved spine), or a history of cancer.
• This medicine may cause the following problems:
  • Increased risk for cancer
  • Changes in blood sugar levels
  • Increased pressure in the head
  • Fluid retention (extra water in the body)
  • Adrenal gland problems
  • Thyroid problems
  • Hip bone dislocation
  • Pancreatitis (swelling of the pancreas)
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in skin color, dark freckles, weakness, tiredness, weight loss
• Constipation, depression, feeling cold, muscle cramps and stiffness, weight gain, unusual tiredness or weakness
• Fever, chills, cough, sore throat, body aches
• Headache, vision changes
• Hip or knee pain, limping
• Increased thirst or hunger, change in how much or how often you urinate
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Joint pain
• Pain, redness, burning, swelling, a hard lump, or skin changes where your shot is given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088