Somatrogon

Somatrogon is used to treat growth failure caused by low or no growth hormone levels in children who are at least 3 years old.

Somatrogon may also be used for reasons not mentioned in this medication guide.

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

Somatrogon is given once per week, on the same day each week. Follow your doctor's instructions.

Somatrogon is given under the skin. A healthcare provider will teach you how to properly give somatrogon to a child.

Prepare the injection pen only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it. Ask your doctor or pharmacist if you don't understand how to use the injection pen.

Your child's healthcare provider will show you where to inject somatrogon.

Do not inject into bony areas, areas that are bruised, red, sore or hard, and areas that have scars or any skin condition. Do not inject into the same place two times in a row.

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

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

You will need frequent medical tests before and during treatment. Your child's dose may be delayed based on the results.

Your doctor will need to check your child's progress on a regular basis.

This medicine can affect the results of certain medical tests. Tell any doctor or laboratory staff that your child is using somatrogon.

Store the injection pen in its original carton in the refrigerator, do not freeze or shake. Protect from light. Do not store the injection pen with a needle attached.

Throw away any opened (in use) medicine after 28 days, even if there is still medicine left inside. Place it in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Use only as directed. Inform your doctor if your child is taking other medicines or has other medical conditions or allergies.

Your child should not use somatrogon if they are allergic to it, or if your child has:

• complications after certain types of heart or stomach surgery, trauma;
• closed bone growth plates (epiphyses);
• Prader-Willi syndrome, is severely obese, or has sleep apnea (breathing stops during sleep);
• other serious breathing problems;
• cancer or other tumors; or
• certain types of eye problems caused by diabetes (diabetic retinopathy).

Tell your doctor if your child has or has ever had:

• diabetes;
• history of high pressure inside the skull;
• scoliosis;
• major surgery;
• a breathing disorder; or
• brain cancer or head tumor, especially if it was treated with radiation.

Using somatrogon may increase your risk of developing cancer. Ask your child's doctor about this risk.

Tell your doctor if your child is pregnant or breastfeeding.

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

Call your doctor right away if your child has:

• a mole that has changed in size or color;
• severe headache, nausea, vomiting, vision problems, unusual thoughts or behavior;
• new or unusual pain in your knee, hip, or back, limping;
• fluid retention--swelling in hands and feet, rapid weight gain, numbness, tingling, muscle or joint pain;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods;
• underactive thyroid--tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures; or
• pancreatitis--severe pain in your upper stomach spreading to your back, nausea, and vomiting.

Common side effects of somatrogon may include:

• loss of fat, tissue weakness, pain, itching, swelling, or bleeding where the medicine was injected;
• fever, headache;
• anemia (low red blood cells);
• cold symptoms such as cough, stuffy nose, sneezing, sore throat;
• stomach pain, vomiting, rash; or
• underactive thyroid.

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.

Usual Pediatric Dose for Pediatric Growth Hormone Deficiency:

Recommended dose in patients aged 3 years and older: 0.66 mg/kg based on actual body weight given once a week by subcutaneous injectionComments:-Administer on the same day each week at any time of day.-Subcutaneous injection may be given in abdomen, thighs, buttocks, or upper arms; rotate site weekly. -Perform fundoscopic examination prior to treatment to exclude papilledema.-Dosage should be individualized based on growth response. Use: For the treatment of pediatric patients aged 3 years and older who have growth failuredue to an inadequate secretion of endogenous growth hormone.

Give the medicine as soon as you can, but skip the missed dose if you are more than 3 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.

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

Tell your doctor about all the other medicines your child is taking, especially:

• steroid medicine; or
• oral estrogen.

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