FDA-filed SPL labeling · retrieved through openFDA

Somapacitan-beco Injection

Somapacitan-beco injection (Sogroya) is a once-weekly human growth hormone analog used to treat growth failure in children and to replace growth hormone in adults with growth hormone deficiency.

Brand name Sogroya
Rx Form 1 Route Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveFeb 25, 2026
AvailabilityRx
Earliest approval/marketing year 2023
FDA-listed product records 6
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Somapacitan-beco Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Sogroya (somapacitan-beco) is a once-weekly injectable growth hormone approved for children with several causes of growth failure and for adults with growth hormone deficiency. It is generally well tolerated, but requires careful monitoring — particularly for blood sugar changes, elevated pressure in the skull, and in children, hip and spine problems. Always use it under the supervision of a specialist experienced in growth hormone conditions.

📖 Somapacitan-beco Injection: Patient Information Guide

A plain-language walkthrough of Somapacitan-beco Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Somapacitan-beco injection (Sogroya) is a human growth hormone analog approved for the following conditions:

  • Sogroya (children, aged 2.5 years and older): Growth failure due to the body not making enough growth hormone (growth hormone deficiency, or GHD)
  • Sogroya (children, aged 2.5 years and older): Short stature in children born small for gestational age (SGA) who have not caught up in growth by age 2
  • Sogroya (children, aged 2.5 years and older): Growth failure associated with Noonan syndrome (NS), a genetic condition that can affect growth and development
  • Sogroya (children, aged 2.5 years and older): Idiopathic short stature (ISS) — short stature without an identified medical cause
  • Sogroya (adults): Replacement of growth hormone in adults with growth hormone deficiency (GHD)
⚙️How it works

Somapacitan-beco mimics the body's own growth hormone by binding to growth hormone receptors on the surface of cells, triggering a cascade of signals inside the cell. One key result is that the liver releases more IGF-1 (insulin-like growth factor-1), a protein that drives bone growth, muscle development, and metabolism. Some effects also come directly from the drug itself, independent of IGF-1.

What makes Sogroya different from older daily growth hormone shots is its built-in "slow-release" design: it binds reversibly to albumin, a protein naturally circulating in the blood, which delays its breakdown and stretches its activity across a full week — making once-weekly dosing possible.

💊How it's taken

Sogroya is given as a subcutaneous injection (a small shot just under the skin) once a week. It can be administered at any time of day, regardless of meals, and does not require refrigeration after opening according to the pen instructions. Injection sites should be rotated weekly — recommended areas include the upper arms, thighs, abdomen, and buttocks — to prevent skin changes at the injection site.

  • If a dose is missed, it can be taken within 3 days of the missed day; then resume the regular weekly schedule
  • If more than 3 days have passed since the missed dose, skip it and take the next dose on the usual day
  • Patients switching from daily growth hormone injections should take their last daily dose the day before (or at least 8 hours before) starting Sogroya

Dosing is individualized by a specialist based on weight (in children), clinical response, and IGF-1 blood levels. Always follow your prescriber's specific instructions.

🤒Side effects — in detail

Like all medications, Sogroya can cause side effects. The most commonly reported ones include:

  • Headache
  • Nasopharyngitis (cold-like symptoms — runny nose, sore throat)
  • Respiratory tract infections
  • Pain in the arms or legs
  • Injection site reactions (bruising, pain, swelling, or hematoma at the injection site)
  • Nausea, vomiting, or diarrhea
  • Fever (pyrexia), especially in children
  • Back pain, joint pain (arthralgia), or dizziness in adults

Seek medical attention right away for signs of a serious allergic reaction (trouble breathing, swelling of the face or throat), severe or worsening headache with vision changes, sudden onset of a limp in a child, or severe persistent abdominal pain — these may signal rare but serious complications that need prompt evaluation.

⚠️Warnings & precautions
  • Increased mortality in acute critical illness: Sogroya must not be used in people who are critically ill after major surgery, trauma, or with acute respiratory failure — it has been associated with higher risk of death in these situations.
  • Cancer risk: Sogroya is contraindicated in anyone with an active malignancy (cancer). Childhood cancer survivors treated with brain radiation have a higher risk of developing a second tumor (especially meningiomas) on growth hormone therapy and should be monitored closely.
  • Blood sugar: Sogroya can reduce insulin sensitivity and trigger new-onset type 2 diabetes or worsen existing diabetes. Blood glucose should be monitored regularly, especially in those already at risk.
  • Intracranial hypertension (increased pressure in the skull): Headaches, vision changes, nausea, and vomiting may signal this condition. An eye exam should be done before starting Sogroya and periodically during treatment.
  • Slipped capital femoral epiphysis (a shifted hip growth plate) in children: Watch for a limp or persistent hip or knee pain — this needs prompt evaluation.
  • Prader-Willi syndrome: Children with this condition who are severely obese or have breathing problems must not use Sogroya due to risk of sudden death.
  • Hypothyroidism and hypoadrenalism: Sogroya can unmask or worsen low thyroid function or low cortisol levels; these should be monitored periodically.
🔀What it interacts with

Sogroya can interact with several types of medications — let your doctor and pharmacist know about everything you take:

  • Glucocorticoids (e.g., cortisone, prednisone): Sogroya can lower the body's cortisol levels, meaning steroid replacement doses may need to be increased
  • Insulin and other diabetes medications: Sogroya can lower insulin sensitivity, which may require adjustments to diabetes drug doses to avoid high blood sugar
  • Oral estrogen: Taking estrogen by mouth (not through a patch or cream) can reduce Sogroya's effectiveness, and higher doses of Sogroya may be needed
  • Drugs metabolized by liver enzymes (CYP450 system): Sogroya may change how quickly the liver breaks down certain medications — your doctor may need to monitor or adjust those drugs

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use Sogroya if you have an active cancer (malignancy) or active proliferative or severe non-proliferative diabetic retinopathy (a serious eye complication of diabetes)
  • Do not use Sogroya if you are critically ill following major surgery, a serious accident, or with acute respiratory failure
  • Children with fully closed growth plates (epiphyses) should not use Sogroya for growth promotion
  • Children with Prader-Willi syndrome who are severely obese or have significant breathing problems must not use Sogroya
  • Tell your doctor if you have liver disease — Sogroya is not recommended for children with moderate or severe liver impairment, and adult dosing must be adjusted for moderate liver impairment; it is not recommended at all in severe liver impairment
  • Adults aged 65 and older tend to absorb more of the drug and may be more sensitive to side effects; treatment should start at a lower dose
  • Tell your doctor if you have diabetes, pre-diabetes, thyroid problems, or a history of cancer
  • Tell your doctor if you are pregnant or breastfeeding — there are no well-controlled studies in pregnant women; discuss the benefits and risks with your healthcare provider
🚑If you take too much

Taking too much Sogroya can first cause low blood sugar (hypoglycemia) and then lead to high blood sugar (hyperglycemia). Fluid retention (swelling) is also likely with an overdose. Over a longer period, too much growth hormone can produce signs and symptoms of acromegaly or gigantism — abnormal bone and tissue growth. If you suspect an overdose, contact your healthcare provider or poison control immediately.

📡Pharmacodynamics — effects in the body

Somapacitan-beco raises levels of IGF-1 (insulin-like growth factor-1) in the blood, which is the primary way its growth-promoting effects are measured. In adults with growth hormone deficiency, the drug normalizes IGF-1 levels from below the normal range back into the normal range within 1 to 2 weeks of starting treatment. In children with growth hormone deficiency, approximately 97% achieved a normal average IGF-1 level after 52 weeks of once-weekly treatment. Peak IGF-1 levels in adults are typically seen 2 to 4 days after a dose.

🔬Pharmacokinetics — how your body processes it

After a subcutaneous injection, Sogroya is absorbed relatively slowly, with peak blood levels reached anywhere from 4 to 25 hours after dosing depending on the patient population. The drug binds tightly (over 99%) to albumin in the blood, which slows its elimination and supports once-weekly dosing. The half-life (the time it takes for half the drug to leave the body) is approximately 2 to 3 days in adults with growth hormone deficiency and around 34 to 37 hours in pediatric patients. Sogroya is broken down by the body through protein digestion (proteolytic cleavage) and is eliminated mainly through the urine (about 81%) and feces (about 13%), with no intact drug detected in either — meaning it is fully broken down before being excreted.

📦How to store it

Before and during use: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) with the cap on and in the original carton to protect from light. Do not freeze. for SOGROYA ( Table 14 ).

📄 Written from Somapacitan-beco Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Somapacitan-beco Injection — the kind of thing our pharmacy team would talk through with you at the counter.

Why does my doctor have me inject Sogroya only once a week instead of every day like older growth hormone shots?
Sogroya is specifically designed to last longer in the body. It attaches to a natural blood protein called albumin, which slows its breakdown so one weekly shot provides steady levels all week long. Older growth hormone injections (like somatropin) are cleared more quickly and have to be given daily to stay effective. Once-weekly dosing can make treatment a lot more convenient, especially for kids.
Where exactly do I inject it, and does it matter if I use the same spot every week?
You can inject Sogroya into the upper arm, thigh, abdomen, or buttocks — all are approved injection sites. What really matters is rotating the spot each week. Using the same area repeatedly can cause lipohypertrophy or lipoatrophy — basically, the fatty tissue under the skin can thicken or shrink, forming lumps or indentations. Rotating sites consistently helps prevent that.
What side effects should I just watch for versus which ones mean I need to call someone right away?
Common, usually manageable side effects include headache, cold-like symptoms, injection site bruising or soreness, and limb pain. Those are worth noting but rarely an emergency. Call your doctor right away — or seek emergency care — if you or your child develops a severe headache with vision changes or vomiting, a sudden limp or hip/knee pain, signs of a serious allergic reaction like throat swelling or trouble breathing, or severe persistent stomach pain. These can signal serious complications that need prompt attention.
Can I take Sogroya if I have diabetes or if I'm at risk for it?
You can, but you'll need closer monitoring. Sogroya can lower insulin sensitivity, meaning your body may not respond to insulin as well while you're on it. That can cause blood sugar to rise, and in some people it has triggered new-onset type 2 diabetes or worsened existing diabetes. Your doctor will check your blood sugar regularly, and your diabetes medication doses may need to be adjusted. Make sure your care team knows about your diabetes history before you start.
What if I forget a dose — do I have to wait until next week?
No, you have a little flexibility. If you missed your dose, you can take it any time within 3 days of your scheduled day and then go back to your regular weekly schedule. But if more than 3 days have passed, skip that missed dose and just take your next one on the usual day. Never double up to make up for a missed dose — that could cause side effects like fluid retention or blood sugar changes.
Is Sogroya safe to use during pregnancy or while breastfeeding?
There's limited human data on using Sogroya during pregnancy. Studies with older short-acting growth hormone products over many decades haven't shown major risks to the baby, and animal studies with somapacitan-beco didn't show birth defects at typical doses. For breastfeeding, we don't know if Sogroya passes into human milk. The decision to use it while pregnant or nursing should be made together with your doctor, weighing the benefit to you against any potential risk to your baby.
Is Somapacitan-beco Injection available over the counter?
Somapacitan-beco Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Somapacitan-beco Injection first available?
Somapacitan-beco Injection has been available in the United States since at least 2023, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Somapacitan-beco Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Somapacitan-beco Injection comes

Somapacitan-beco Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Under the skin
Brands Sogroya
How this form is used
What it may be used for
  • Sogroya is used in children aged 2.5 years and older for growth failure due to growth hormone deficiency, short stature from being born small for gestational age (with no catch-up growth by age 2), Noonan syndrome-related growth failure, and idiopathic short stature
  • Sogroya is used in adults to replace growth hormone in growth hormone deficiency
Important instructions
  • Sogroya is injected once weekly under the skin (subcutaneous injection) in the upper arms, thighs, abdomen, or buttocks — rotate the site each week
  • Sogroya can be taken any time of day, with or without food; choose a consistent weekly day that works for you
  • Sogroya comes in a prefilled pen — inspect the solution before use; do not use if it is cloudy or contains particles
  • If you miss a dose, Sogroya can be taken within 3 days of the missed day; if more than 3 days have passed, skip that dose and resume your regular schedule
Available strengths 3 strengths
6 FDA-listed product records

📊 Somapacitan-beco Injection across the U.S. market

How Somapacitan-beco Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
1
Manufacturers
1
Brand names
6
FDA-listed product records
2023
First marketed

📈 How widely Somapacitan-beco Injection is used

A general measure of how commonly Somapacitan-beco Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Somapacitan-beco Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

7,035
Medicaid prescriptions filled (Q1–Q4 2025)
$45.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Somapacitan-beco Injection prescribed? Of the 1,596 medications we measure, Somapacitan-beco Injection ranks #989 by Medicaid prescriptions — more than 38% of them.

Where Somapacitan-beco Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Somapacitan-beco Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1.5 mL / 10 mg/mL pen injector is the most-dispensed Somapacitan-beco Injection product — about 62% of these Medicaid prescriptions.

1.5 ML somapacitan-beco 10 MG/ML Pen Injector Most dispensed

4,347 Medicaid prescriptions (Q1–Q4 2025) 62% of Somapacitan-beco Injection prescriptions shown $33.2M gross reimbursement (before rebates) ≈ $7,642 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2636951

1.5 ML somapacitan-beco 6.7 MG/ML Pen Injector

2,272 Medicaid prescriptions (Q1–Q4 2025) 32% of Somapacitan-beco Injection prescriptions shown $10.8M gross reimbursement (before rebates) ≈ $4,744 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2557398

1.5 ML somapacitan-beco 3.3 MG/ML Pen Injector

416 Medicaid prescriptions (Q1–Q4 2025) 6% of Somapacitan-beco Injection prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $2,809 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2571802

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Somapacitan-beco Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 6 listed Somapacitan-beco Injection NDCs with Medicaid activity.

🔍 Compare Somapacitan-beco Injection products

A representative set of FDA-listed product records for Somapacitan-beco Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Injection
3.3 mg/mL Subcutaneous Novo Nordisk × 2 listings BLA View NDC →
6.7 mg/mL Subcutaneous Novo Nordisk × 2 listings BLA View NDC →
10 mg/mL Subcutaneous Novo Nordisk × 2 listings BLA View NDC →

Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Somapacitan-beco Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Somapacitan-beco Injection RxCUI 2557373 1 dose form · 3 strengths

Look up RxCUI 2557373 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Sogroya

🏭 Manufacturers & labelers

Novo Nordisk 6

RxNorm drug class

Somapacitan-beco Injection belongs to the Somatropin and somatropin agonists class.

Drug family (ATC) Somatropin and somatropin agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 25, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Somapacitan-beco Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Somapacitan-beco Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
6
Distinct labelers/manufacturers represented
1
Linked representative label
Novo Nordisk
Linked label effective
Feb 25, 2026
Composite sections available
24
Linked SPL Set ID
eadd03b4-adc3-4b88-8a24-9d205c5b85aa
Linked SPL Document ID
02935ecf-5395-4b9b-9b2f-75d59ca651f3
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Novo Nordisk is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.