Somapacitan

Somapacitan is used to treat adults and children who are at least two and a half years (2 1/2 years) old and do not produce enough growth hormone.

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

Follow all instructions on the label and package. Use exactly as instructed.

You should not use somapacitan if you are allergic to it, or if you have:

• cancer;
• a serious illness caused by certain heart or stomach surgeries, injuries, or breathing issues;
• certain eye problems caused by diabetes (diabetic retinopathy);
• you are a child with closed bone growth plates; or
• you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (breathing that stops during sleep).

Tell your doctor if you have or have ever had:

• cancer;
• diabetes;
• adrenal gland problems;
• thyroid gland problems;
• heart or stomach surgery, injuries, or serious breathing issues;
• are a child with worsening curvature of the spine (scoliosis);
• are taking replacement therapy with steroids; or
• liver problems.

Tell your doctor if you are 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.

Somapacitan may cause serious side effects. Call your doctor right away if you have:

• changes in behavior, changes in moles, birthmarks, or skin color;
• headaches, vision problems, nausea, or vomiting;
• fluid retention—shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection);
• 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; or
• pancreatitis—severe pain in your upper stomach spreading to your back, nausea, and vomiting.

Common side effects of somapacitan may include:

• back and joint pain;
• vomiting, heartburn;
• dizziness;
• weight gain;
• sleep problems;
• abnormal blood tests;
• pain in hands and feet;
• difficulty or painful swallowing;
• fever, chills, body aches, flu symptoms;
• severe headache, blurred vision, pounding in your neck or ears;
• pain, bruising, swelling, or irritation where the medicine was injected; or
• pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

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.

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

Your healthcare provider will show you where to inject somapacitan. Do not inject into the same place two times in a row.

Somapacitan is injected under the skin once a week.

Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

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

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests.

Follow all storage instructions provided with your injectable medication. Your healthcare provider can provide more information about how to store somapacitan.

Use the medicine as soon as you can, but skip the missed dose if you are more than 3 days (72 hours) late for the dose. You can start the next dose again on your regularly scheduled dosing day. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include fluid retention, increased thirst, increased urination, dry mouth, fruity breath odor, headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery.

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

Tell your doctor about all your other medicines, especially:

• birth control pills and other hormones.

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