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Medical Information | Non-US Health Care Professionals
Important Safety Information | Patient Site
Prescribing Information
Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, 15 mg logo

Sogroya® is indicated for pediatric patients aged 2.5 years and older with growth failure due to inadequate secretion of endogenous growth hormone (GH), and for replacement of endogenous GH in adults with growth hormone deficiency (GHD). Please see full indications.

Prescribing Information
Important Safety Information | Patient Site

HOW TO ADMINISTER
A DOSE

The Sogroya® pen is based on the FlexPro® pen, which patients have been using for over 10 years.1

HOW TO ADMINISTER A DOSE

The Sogroya® pen is based on the FlexPro® pen, which patients have been using for over 10 years.1

 

How to inject Sogroya® (somapacitan-beco) injection—

at a glance

Remind your patients to read the Patient Information and Instructions for Use that come with the Sogroya® pen. Do not share the Sogroya® pen and needles with another person. You may give another person an infection or get an infection from them.

Sogroya® is available as prefilled Sogroya® pens.
The injection process includes 5 steps, from preparing the pen to storing or disposing of it afterward.2,a

See Instructions for Use for complete instructions.

aDo not use your Sogroya® pen without proper training from your healthcare provider. Make sure that you are confident in giving an injection with the Sogroya® pen before you start your treatment. If you are blind or have poor eyesight and cannot read the dose counter on the Sogroya® pen, do not use this Sogroya® pen without help. Get help from a person with good eyesight who is trained to use the Sogroya® pen.2

How to inject Sogroya® (somapacitan-beco) injection—at a glance

Remind your patients to read the Patient Information and Instructions for Use that come with the Sogroya® pen. Do not share the Sogroya® pen and needles with another person. You may give another person an infection or get an infection from them.

Sogroya® is available as prefilled Sogroya® pens.
The injection process includes 5 steps, from preparing the pen to storing or disposing of it afterward.2,a

See Instructions for Use for complete instructions.

aDo not use your Sogroya® pen without proper training from your healthcare provider. Make sure that you are confident in giving an injection with the Sogroya® pen before you start your treatment. If you are blind or have poor eyesight and cannot read the dose counter on the Sogroya® pen, do not use this Sogroya® pen without help. Get help from a person with good eyesight who is trained to use the Sogroya® pen.2

Step 1:
Step 1:
Step 2:
Step 2:
Step 3:
Step 3:
Step 4:
Step 4:
Step 5:
Step 5:
Step 1 for using Sogroya® pen

Pen shown is 10 mg/1.5 mL pen. Please see Instructions for Use for complete instructions for each dosage strength.

  • Patients should wash hands with soap and water. They should check the name, strength, and colored label on their pen to make sure that it contains Sogroya® in the right strength.2
  • Pull off the pen cap. Turn the pen upside down 1 or 2 times to check that the Sogroya® in the pen is clear to almost clear and colorless to slightly yellow. If Sogroya® looks cloudy or the patient sees particles, they should not use the pen.
  • Remove the paper tab off of a new disposable needle. Push the needle straight onto the pen and turn the needle clockwise until it is on tight. Patients should make sure the right pen is used and 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 the inner needle cap, and throw them both away.
Step 1 for using Sogroya® pen

Pen shown is 10 mg/1.5 mL pen. Please see Instructions for Use for complete instructions for each dosage strength.

Step 2 for using Sogroya® pen

Pen shown is 10 mg/1.5 mL pen. Please see Instructions for Use for complete instructions for each dosage strength.

  • If the pen is already in use, go to Step 3. 
  • Before patients use a new pen, they must check the medication flow by priming the pen.2
  • Turn the dose selector clockwise to 1 marking on the dose counter to select the smallest amount of medicine for the pen.
  • Hold the pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0” and lines up with the dose pointer. A drop of Sogroya® will appear at the needle tip.
  • If no drop appears, repeat the priming process up to 6 times. If no drop appears, change the needle and prime one more time. If a drop of liquid still does not appear, call 1-888-NOVO-444 (1-888-668-6444) for help.2
Step 2 for using Sogroya® pen

Pen shown is 10 mg/1.5 mL pen. Please see Instructions for Use for complete instructions for each dosage strength.

Step 3 for using Sogroya® pen

Pen shown is 10 mg/1.5 mL pen. Please see Instructions for Use for complete instructions for each dosage strength.

  • The patient should check that the dose pointer is set at “0.” Then turn the dose selector clockwise to select the correct dose. Patients should not rely on pen clicks to select a dose. Only the dose pointer on the dose counter will show the exact dose selected.
  • If there is not enough Sogroya® left to select a full dose, patients may deliver the amount left in the pen. Then, inject the remainder of the dose using a new Sogroya® pen, prepared as described in steps 1 and 2. Patients should only split their dose if they have been trained or advised by their healthcare provider on how to do this.
  • If the patient selects the wrong dose, they can turn the dose selector clockwise or counterclockwise to the correct dose.2
Step 3 for using Sogroya® pen

Pen shown is 10 mg/1.5 mL pen. Please see Instructions for Use for complete instructions for each dosage strength.

Step 4 for using Sogroya® pen

Pen shown is 10 mg/1.5 mL pen. Please see Instructions for Use for complete instructions for each dosage strength.

  • Sogroya® can be injected under the skin of the abdomen, upper arms, thighs, or buttocks. Patient should change the injection site every week. 
  • The injection site should be wiped with an alcohol swab and the area should be dry before injecting. 
  • Insert the needle under the skin.
  • Press and hold the dose button to inject until the “0” appears in the dose counter and lines up with the dose pointer. A click may be heard or felt. 
  • Patients should keep holding down the dose button with the needle in the skin after the dose counter has returned to “0” while counting slowly to 6.
  • Carefully remove the needle from the skin. A drop of Sogroya® may appear at the needle tip. This is normal and does not affect the injected amount.2
Step 4 for using Sogroya® pen

Pen shown is 10 mg/1.5 mL pen. Please see Instructions for Use for complete instructions for each dosage strength.

Step 5 for using Sogroya® pen

Pen shown is 10 mg/1.5 mL pen. Please see Instructions for Use for complete instructions for each dosage strength.

  • Patients should carefully remove the needle from the pen by turning the needle counterclockwise and placing it in an appropriate sharps disposal container immediately.
  • The pen cap should be placed on the pen after each use to protect Sogroya® from light.2


See Prescribing Information for complete storage instructions.

Step 5 for using Sogroya® pen

Pen shown is 10 mg/1.5 mL pen. Please see Instructions for Use for complete instructions for each dosage strength.

Share these educational resources with your patients

Prescribing Information | Important Safety Information
Sogroya® 5 mg/1.5 mL Pen Tutorial
(05:18)
Prescribing Information | Important Safety Information
Sogroya® 10 mg/1.5 mL Pen Tutorial
(05:18)
Prescribing Information | Important Safety Information
Sogroya® 15 mg/1.5 mL Pen Tutorial
(06:10)

See which pen to prescribe

Actor
Portrayal

Enter your patient’s dose information into our tool to find out which pen they should use.

Enter your patient’s dose information into our tool to find out which pen they should use.

Actor Portrayal

A familiar device

The Sogroya® pen is based on the FlexPro® you know.1

The Sogroya® pen is based on the FlexPro® you know.1 
 

Important Safety Information for Sogroya®

Contraindications

Sogroya® is contraindicated in patients with:

  • acute critical illness after open-heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure because of the risk of increased mortality with use of Sogroya®
  • hypersensitivity to Sogroya® or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin
  • pediatric patients with closed epiphyses
  • active malignancy
  • active proliferative or severe non-proliferative diabetic retinopathy
  • pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to risk of sudden death

Warnings & Precautions

  • Increased Mortality in Patients with Acute Critical Illness: Increased mortality has been reported after treatment with somatropin in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery, multiple accidental trauma, and in patients with acute respiratory failure

Indications and Usage

Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg is indicated for the:

  • treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH)
  • replacement of endogenous GH in adults with growth hormone deficiency (GHD)

Important Safety Information

Contraindications

Sogroya® is contraindicated in patients with:

  • acute critical illness after open-heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure because of the risk of increased mortality with use of Sogroya®
  • hypersensitivity to Sogroya® or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin
  • pediatric patients with closed epiphyses
  • active malignancy
  • active proliferative or severe non-proliferative diabetic retinopathy
  • pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to risk of sudden death

Warnings & Precautions

  • Increased Mortality in Patients with Acute Critical Illness: Increased mortality has been reported after treatment with somatropin in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery, multiple accidental trauma, and in patients with acute respiratory failure
  • Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported postmarketing with use of somatropin. Inform patients and/or caregivers that such reactions are possible, and that prompt medical attention should be sought if an allergic reaction occurs
  • Increased Risk of Neoplasms: There is an increased risk of malignancy progression with somatropin in patients with active malignancy. Any preexisting malignancy should be inactive, and its treatment complete prior to instituting Sogroya®. In childhood cancer survivors treated with radiation to the brain/head for their first neoplasm who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Monitor patients with a history of GHD secondary to an intracranial neoplasm for progression or recurrence of the tumor. Children with certain rare genetic causes of short stature have an increased risk of developing malignancies and should be carefully monitored for development of neoplasms. Monitor patients for increased growth or potential malignant changes of preexisting nevi. Advise patients/caregivers to report changes in the appearance of preexisting nevi
  • Glucose Intolerance and Diabetes Mellitus: Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes has been reported. Monitor glucose levels in all patients, especially in those with existing diabetes mellitus or with risk factors for diabetes mellitus, such as obesity, Turner syndrome or a family history of diabetes mellitus. The doses of antidiabetic agents may require adjustment when Sogroya® is initiated
  • Intracranial Hypertension: Has been reported usually within 8 weeks of treatment initiation. Perform fundoscopic examination prior to initiation of treatment and periodically thereafter. If papilledema is identified, evaluate the etiology, and treat the underlying cause before initiating Sogroya®. If papilledema is observed, stop treatment. If intracranial hypertension is confirmed, Sogroya® can be restarted at a lower dose after intracranial hypertension signs and symptoms have resolved
  • Fluid retention: May occur during Sogroya® therapy. Clinical manifestations of fluid retention (e.g. edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent
  • Hypoadrenalism: Patients receiving somatropin therapy who have or are at risk for corticotropin deficiency may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Sogroya®. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases
  • Hypothyroidism: Undiagnosed/untreated hypothyroidism may prevent an optimal response to Sogroya®. Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of Sogroya®
  • Slipped Capital Femoral Epiphysis in Pediatric Patients: Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain
  • Progression of Preexisting Scoliosis in Pediatric Patients: Monitor patients with a history of scoliosis for disease progression
  • Pancreatitis: Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared to adults. Consider pancreatitis in patients with persistent severe abdominal pain
  • Lipohypertrophy/Lipoatrophy: May occur if Sogroya® is administered at the same site over a long period of time. Rotate injection sites to reduce this risk
  • Sudden death in Pediatric Patients with Prader-Willi Syndrome: There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Sogroya® is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome
  • Laboratory Tests: Serum levels of inorganic phosphorus and alkaline phosphatase may increase after Sogroya® therapy. Serum levels of parathyroid hormone may increase with somatropin treatment

Adverse Reactions

  • Pediatric patients with GHD: Adverse reactions reported in ≥5% of patients are nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reaction
  • Adult patients with GHD: Adverse reactions reported in >2% of patients are back pain, arthralgia, dyspepsia, sleep disorder, dizziness, tonsillitis, peripheral edema, vomiting, adrenal insufficiency, hypertension, blood creatine phosphokinase increase, weight increase, and anemia

Drug Interactions

  • Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Sogroya®
  • Cytochrome P450-Metabolized Drugs: Sogroya® may alter the clearance. Monitor carefully if used with Sogroya®
  • Oral Estrogen: Patients receiving oral estrogen replacement may require higher Sogroya® dosages
  • Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin and/or antihyperglycemic agent may be required for patients with diabetes mellitus

Please click here for Sogroya® Prescribing Information.

References:

  1. Data on file. Novo Nordisk, Inc; Plainsboro, NJ.
  2. Sogroya [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2023.