Somatrogon-ghla (soe-MA-troe-gon - ghla)

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

Brand Name(s):

Ngenla

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 is usually injected in the stomach, buttock, upper arms, 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.
• 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.
• Do not inject into bony areas, skin areas that are bruised, red, sore or hard, or has scars or skin conditions.
• You may use the pen straight from the refrigerator. You may also allow the medicine to warm at room temperature for 30 minutes before use.
• The medicine should be colorless to slightly light yellow. Do not use the medicine if it is cloudy or dark yellow, or has flakes or particles in it.
• Use a new needle and syringe each time you inject your medicine.
• To use the pen:
  • Wash your hands with soap and water.
  • Place the needle straight on the pen. Prime the pen by removing the air from the needle. Select 0.4 units when turning the dose knob.
  • Hold the pen with the needle pointing up, then gently tap the cartridge holder to collect the air bubbles at the top.
  • Press the injection button until it stops. You should see a "0" in the dose window.
  • You should see the liquid at the needle tip. If you do not see the liquid, repeat the priming steps but not more than 5 times. If there is still no liquid, do not use the pen.
  • Turn the dose selector, be careful not to press the injection button. If the dose is more than 12 milligrams (mg), you will need to split the dose into more than 1 injection.
  • Insert the needle into your skin and press the injection button all the way in for at least 10 seconds. Keep pressing until the needle has been pulled out from the skin. This will make sure that you have received the full dose.
  • Use a new needle each time you inject your medicine. Always remove and throw the needle after each injection. Do not use the pen if it is frozen, exposed to heat, dropped, or looks broken or damaged. Do not shake the pen.
• Missed dose: If you miss a dose, use it as soon as possible within 3 days after the missed dose. However, if it is more than 3 days, skip the missed dose and go back to your regular dosing schedule.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Opened pen: You may keep the pen in the refrigerator for up to 28 days. Throw away opened pen after 28 days.
• 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 somatrogon-ghla 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, 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, bruising, or weakness

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

• 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