Somatrogon

Generic name: Somatrogon
Brand names: Ngenla
Dosage form: subcutaneous solution (ghla 24 mg/1.2 mL; ghla 60 mg/1.2 mL)
Drug class: Growth hormones

Usage of Somatrogon

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

Somatrogon may also be used for purposes not listed in this medication guide.

Somatrogon side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult 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.

Before taking Somatrogon

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);

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How to use Somatrogon

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.

Warnings

Use only as directed. Tell your doctor if your child uses other medicines or has other medical conditions or allergies.

What other drugs will affect Somatrogon

Tell your doctor about all your child's other medicines, 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.

Disclaimer

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