Somapacitan-beco (soe-ma-PAS-i-tan - beco)

Treats conditions in which a person's body does not make enough growth hormone.

Brand Name(s):

Sogroya

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 given in the stomach area or thighs.
• 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.
• 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.
• Use a new needle and syringe each time you inject your medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose, take it as soon as possible within 3 days after the missed dose. If you miss a dose and more than 3 days have passed, skip the missed dose and take your next dose at the regular time.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You might not use all of the medicine in each prefilled pen. After using and there is still medicine left in the pen (in-use pen), you may store it in the refrigerator and use it within 6 weeks. Store the unused and in-use pens with the cap on and keep it in the original carton.
• You may also store the unused and in-use pens at room temperature for up to 3 days and place it back to the refrigerator.
• 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 sompacitan-beco works. Tell your doctor if you are using steroid medicine (including prednisone), birth control pills or hormone replacement medicine (including estrogen), or diabetes medicine (including insulin)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, adrenal problem, thyroid problem, lung or breathing problems, or a history of cancer. Tell your doctor if you have ever had open heart surgery, stomach surgery, or trauma caused by an accident.
• This medicine may cause the following problems:
  • Increased risk for cancer, including skin cancer
  • High blood sugar (hyperglycemia)
  • Increased pressure in the head (intracranial hypertension)
  • Fluid retention (excess fluid build-up in the body)
  • Adrenal gland problems
  • Thyroid problems
  • Pancreatitis (swelling of the pancreas)
• 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 your moles, birthmarks, or color of the skin
• Confusion, headache, or vision changes
• Dark freckles, cold feeling, tiredness, weight loss
• Loss of fat or tissue weakness in the skin area where the shot was given
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling in your hands, ankles, or feet
• Shaking, trembling, sweating, fast or pounding heartbeat, faintness or lightheadedness, hunger
• Sudden and severe stomach pain, nausea, vomiting, fever
• Unusual bleeding, bruising, or weakness

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

• Back, joint, or muscle pain
• Dizziness
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given
• Sore throat
• Stomach upset

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