Sogroya® (somapacitan-beco) injection 5 mg, 10 mg or 15 mg

Please read the Important Safety Information below

Prescribing Information
Novocare_Sogroya_v01

Important Safety Information for Sogroya®

Do not use Sogroya® if:

  • you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems
  • you have cancer or other tumors
  • you are allergic to somapacitan-beco or any of the ingredients in Sogroya®
  • your healthcare provider tells you that you have certain types of eye problems caused by diabetes
  • you are a child with closed bone growth plates
  • you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stopping breathing during sleep)

What is Sogroya®?

  • Sogroya® (somapacitan-beco) injection 5 mg, 10 mg or 15 mg is a prescription medicine that contains human growth hormone, the same growth hormone made by the body. 
  • It is given by injection under the skin (subcutaneous) and is used to treat adults and children 2.5 years and older who do not make enough growth hormone.

Important Safety Information

Before taking Sogroya®, tell your healthcare provider about all of your medical conditions, including if you:

  • have had heart or stomach surgery, trauma, or serious breathing problems
  • have had cancer or any tumor
  • have diabetes
  • have adrenal gland problems
  • are taking replacement therapy with glucocorticoids
  • have thyroid gland problems
  • have liver problems
  • are a child with a history of worsening of curvature of the spine (scoliosis)
  • are pregnant or plan to become pregnant. It is not known if Sogroya® will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if Sogroya® passes into your breast milk. You and your healthcare provider should decide if you will take Sogroya® while you breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sogroya® may affect the way some medicines work, and some medicines may affect how Sogroya® works.

How should I use Sogroya®?

  • Use Sogroya® exactly as your healthcare provider tells you to
  • Use Sogroya® 1 time each week
  • If you miss a dose of Sogroya®, the missed dose can be taken within 3 days (72 hours) after the scheduled dosing day. One-time weekly dosing for the next dose can be started again on the regularly scheduled dosing day
  • If more than 3 days (72 hours) have passed, skip the missed dose, and take your next dose on the regularly scheduled dosing day
  • Sogroya® pens are for use by 1 person only
  • Do not share your Sogroya® pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them

What are the possible side effects of Sogroya®?

Sogroya® may cause serious side effects, including:

  • high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma, or serious breathing problems
  • increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. You or your child’s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or the color of your or your child’s skin
  • new or worsening high blood sugar or diabetes. You or your child’s blood sugar may need to be monitored during treatment with Sogroya®
  • increase in pressure in the skull. If you or your child have headaches, eye problems, nausea or vomiting, contact the healthcare provider
  • serious allergic reactions. Get medical help right away if you or your child have the following symptoms: swelling of your face, lips, mouth, or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness, or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, sweating
  • your or your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your or your child’s joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs, and feet. Tell your or your child’s healthcare provider if you or your child have any of these signs or symptoms of fluid retention
  • decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s healthcare provider if you or your child have darkening of the skin, severe fatigue, dizziness, weakness, or weight loss
  • decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well Sogroya® works. The healthcare provider will do blood tests to check you or your child’s thyroid hormone levels
  • severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain
  • loss of fat and tissue weakness in the area of skin you or your child inject. Talk to your or your child’s healthcare provider about rotating the areas where you or your child inject Sogroya®
  • worsening of curvature of the spine in children (scoliosis)
  • hip and knee pain or a limp in children (slipped capital femoral epiphysis)
  • high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
  • increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood. You or your child’s healthcare provider will do blood tests to check this

The most common side effects of Sogroya® in children include: common cold, headache, fever, pain in extremity, and reaction to injection

The most common side effects of Sogroya® in adults include: back pain, joint pain, indigestion, sleep problems, dizziness, swelling of the tonsils (tonsillitis), vomiting, high blood pressure, increase in the level of an enzyme in your blood called creatine phosphokinase, weight gain, and low red blood cells (anemia)

Please see Prescribing Information for Sogroya®.

Sogroya® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

 

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