What is Sogroya?
- Sogroya is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body.
- Sogroya is given by injection under the skin (subcutaneous) and is used to treat adults who do not make enough growth hormone.
It is not known if Sogroya is safe and effective in children.
Who should not use Sogroya?
Do not use Sogroya if:
- you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems.
- you have cancer or other tumors.
- you are allergic to somapacitan-beco or any of the ingredients in Sogroya. See the end of this Patient Information leaflet for a complete list of ingredients in Sogroya.
- your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy).
Before taking Sogroya
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 (respiratory) 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 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 how other medicines work, and other medicines may affect how Sogroya works.
How should I use Sogroya?
- Read the detailed Instructions for Use that come with Sogroya.
- Sogroya comes in one strength. Your healthcare provider will prescribe the dose that is right for you.
- Your healthcare provider will show you how to inject Sogroya.
- Use Sogroya exactly as your healthcare provider tells you to.
- Use Sogroya one time each week.
- If you miss a dose of Sogroya, take the missed dose as soon as possible within 3 days (72 hours) after the missed dose. If more than 3 days (72 hours) have passed, skip the missed dose and take your next dose on the regularly scheduled day.
- Sogroya pens are for use by one 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.
Sogroya side effects
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 (respiratory) problems.
- increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer. Your healthcare provider will need to monitor you for a return of cancer or a tumor. Contact the healthcare provider if you start to have changes in moles, birthmarks, or the color of your skin.
- new or worsening high blood sugar (hyperglycemia) or diabetes. Your blood sugar may need to be monitored during treatment with Sogroya.
- increase in pressure in the skull (intracranial hypertension). If you have headaches, eye problems, nausea or vomiting, contact the healthcare provider.
- serious allergic reactions. Get medical help right away if you have the following symptoms:
- swelling of your face, lips, mouth, or tongue
- trouble breathing
- skin rashes, redness, or swelling
- dizziness or fainting
- fast heartbeat or pounding in your chest
- severe itching
- your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Tell your healthcare provider if you 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 cortisol levels. Tell your healthcare provider if you 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 your thyroid hormone levels.
- severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your healthcare provider if you have any new abdominal pain.
- loss of fat and tissue weakness in the area of skin you inject. Talk to your healthcare provider about rotating the areas where you inject Sogroya.
- increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your healthcare provider will do blood tests to check this.
The most common side effects of Sogroya include:
- back pain
- joint pain
- sleep problems
- swelling of the tonsils (tonsillitis)
- high blood pressure
- increase in the level of an enzyme in your blood called creatine phosphokinase
- weight gain
- low red blood cells (anemia)
These are not all the possible side effects of Sogroya.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Novo Nordisk at 1-888-668-6444.
How should I store Sogroya?
- Before you use Sogroya pens for the first time:
- Store your new, unused Sogroya pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).
- Store your new, unused Sogroya pen with the cap on and keep it in the original carton.
- Do not freeze Sogroya.
- Keep Sogroya away from direct heat and light.
- Do not use Sogroya that has been frozen or in temperatures warmer than 86ºF (30ºC).
- Do not use Sogroya after the expiration date printed on the carton and the pen.
- After you use Sogroya pens and there is still medicine left:
- Store remaining Sogroya in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 6 weeks.
- Store your in-use Sogroya pen with the cap on and keep it in the original carton.
- If needed, unused and in-use Sogroya pens can be stored out of the refrigerator. Sogroya pens can be stored atroom temperature no warmer than 77ºF (25ºC) for up to 3 days (72 hours) and then returned to the refrigerator.
Keep Sogroya and all medicines out of the reach of children.
General information about the safe and effective use of Sogroya.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Sogroya for a condition for which it was not prescribed. Do not give Sogroya to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Sogroya that is written for health professionals.
What are the ingredients in Sogroya?
Active ingredient: somapacitan-beco
Inactive ingredients: histidine, mannitol, phenol, poloxamer 188, Water for Injection, and hydrochloric acid and sodium hydroxide (as needed)
Instructions for Use
Step 1. Prepare your Sogroya Pen
- Wash your hands with soap and water.
- Check the name, strength, and colored label on your Pen to make sure that it contains Sogroya in the right strength.
- Pull off the Pen cap.
- Turn the Pen upside down 1 or 2 times to check that the Sogroya in your
Pen is clear to almost clear and colorless to slightly yellow. If Sogroya looks cloudy, do not use the Pen.
- When you are ready to give your injection, get a new disposable needle, and remove the paper tab.
- Push the needle straight onto the Pen.
- Turn the needle clockwise until it is on tight.
Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of Sogroya, and blocked needles leading to incorrect dosing.
- Pull off the outer needle cap and throw it away (dispose of)
- Pull off the inner needle cap and throw it away (dispose of)
- A drop of Sogroya may appear at the needle tip. This is normal, but you must still check the Sogroya flow with each new Pen (See Step 2).
- Never use a bent or damaged needle.
Step 2. Check the Sogroya flow with each new Pen
If your Pen is already in use, go to Step 3.
- Before using a new Pen, check the Sogroya flow to make sure the growth hormone can flow through the Pen and needle.
- Turn the dose selector clockwise 1 marking on the dose counter to select 0.05 mg. You may hear a faint “click” when you turn the dose selector.
- 1 marking on the dose counter equals 0.05 mg.
- Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. The “0” must line up with the dose pointer.
- Check that a drop of Sogroya appears at the needle tip.
If no Sogroya appears, repeat Step 2 up to 6 times.
If you still do not see a drop of Sogroya, change the needle:
- Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a
sharps disposal container immediately
- Repeat Step 2 again.
Do not use the Pen if a drop of Sogroya still does not appear after changing the needle and repeating Step 2. Call Novo Nordisk at 1-888-668-6444
Step 3. Select your dose
- To start, check that the dose pointer is set at “0”.
- Turn the dose selector clockwise to select the dose you need. When you have selected your dose, you can go to Step 4.
If there is not enough Sogroya left to select a full dose, see Frequently Asked Questions.
The dose counter shows the dose in “mg”. Always use the dose counter to select the exact dose. Do not use the “click” sounds you hear when you turn the dose selector to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.
If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose.
The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen.
Step 4. Inject your dose
- Select the injection site.
- Sogroya can be injected under the skin (subcutaneously) of your stomach area (abdomen) or upper legs (thighs) as instructed by your healthcare provider. Change the injection site every week.
- Wipe the injection site with an alcohol pad and let the area dry.
- Insert the needle into your skin as your healthcare provider has shown you.
- Make sure you can see the dose counter. Do not cover it with your fingers. This could block the injection.
- Press and hold down the dose button until the dose counter shows “0”. The “0” must line up with the dose pointer. You may then hear or feel a “click”.
- Continue to hold the needle in your skin. If “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged. See Frequently Asked Questions.
- Keep the needle in your skin after the dose counter has returned to “0”. Count slowly to 6 to make sure that the full dose has been delivered.
- Carefully remove the needle from your skin. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.
You may see a drop of Sogroya at the needle tip after injecting. This is normal and does not affect your dose.
Step 5. After your injection
- Carefully remove the needle from the Pen by turning the needle counterclockwise.
- Place the needle in an FDA-cleared sharps disposal container immediately to reduce the risk of a needle stick.
Always throw away (dispose of) the needle after each injection.
For further information about safe sharps disposal, see Frequently Asked Questions.
Do not try to put the needle cap back on. You may stick yourself with the needle.
- Put the Pen cap on your Pen after each use to protect Sogroya from direct light.
See How should I store Sogroya?
Frequently Asked Questions
How do I see how much Sogroya is left in my Pen?
The Pen scale shows you approximately how much Sogroya is left in your Pen. To see how much Sogroya is left in your Pen, use the dose counter:
Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 4.0 mg. If the dose counter stops with the dose pointer lined up with “4.0”, at least 4.0 mg are left in your Pen. If the dose counter stops with the dose
pointer lined up with “2.8”, only 2.8 mg are left in your Pen.
What if I need a larger dose than what is left in my Pen?
It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen. If you need more Sogroya than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. Only split your dose if you have been trained or advised by your healthcare provider on how to do this. You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.
Be very careful to calculate your split dose correctly so that you do not give the wrong dose. If you are not sure how to split your dose using 2 Pens, then select and inject the dose you need with a new Pen.
What if no Sogroya appears when I check the flow?
A. Your needle may be blocked or damaged, if no Sogroya appears at the needle tip. Remove the needle as described in Step 5 and repeat Step 1 and Step 2.
B. Your Pen may be defective, if Sogroya still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444.
What if “0” does not appear after completing my injection?
The needle may be blocked or damaged, and you have not received any Sogroya, even though the dose counter has moved from the dose that you have set. Remove the needle as described in Step 5 and repeat Step 1 to Step 4.
How should I take care of my Pen?
Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light. See How should I store Sogroya? Do not try to refill your Pen, it is prefilled.
What if I drop my Pen?
If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Sogroya flow before you inject (See Step 1 and Step 2). Do not try to repair your Pen or pull it apart.
How do I clean my Pen?
Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth.
How do I throw away (dispose of) used Sogroya needles and Pens?
Put your used needles and Pens in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and Pens in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
- Caregivers must be very careful when handling needles to reduce the risk of needle sticks and infection.
Sogroya is a prefilled growth hormone Pen. It contains 10 mg of somapacitan-beco and delivers doses from 0.05 mg to 4.0 mg, in increments of 0.05 mg. Sogroya is for use under the skin only (subcutaneous) for injection 1 time each week.
Do not share your Sogroya Pen and needles with another person. You may give another person an infection or get an infection from them.
Do not use your Pen without proper training from your healthcare provider. Make sure that you are confident in giving an injection with the Pen before you start your treatment. If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.
More about Sogroya (somapacitan-beco)
- Side effects
- Drug interactions
- Dosage information
- During pregnancy or Breastfeeding
- Drug class: growth hormones
- FDA approval history
Related treatment guides
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.