Sogroya
Sogroya (somapacitan or somapacitan-beco) is a long-acting growth hormone injection used to treat low growth hormone in adults and children age 2.5 years and older. It's also FDA approved for children with certain growth-related conditions, like Noonan syndrome and Idiopathic short stature. Sogroya (somapacitan) comes as a pre-filled pen that's injected under the skin once a week. Common side effects include headache, fever, and back pain.
What is Sogroya (somapacitan)?
What is Sogroya (somapacitan) used for?
- Growth problems caused by certain conditions in children age 2.5 years and older (e.g., low growth hormone, small for gestational age, Noonan syndrome, idiopathic short stature)
- Low growth hormone in adults
How Sogroya (somapacitan) works
Sogroya (somapacitan) is a recombinant human growth hormone medication. It works like the natural growth hormone your body makes.
In children, it helps bones and tissues grow. In both adults and children, it helps control important body functions to support overall metabolism.
Drug facts
| Common Brands | Sogroya |
|---|---|
| Drug Class | Recombinant human growth hormone |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Sogroya (somapacitan)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Children (treatment of low growth hormone)
- Common cold symptoms (17%)
- Headache (12%)
- Pain in the arms and legs (10%)
- Fever (9%)
- Injection site reaction (6%)
- Diarrhea (5%)
- Nausea or vomiting (5%)
Adults
- Back pain (10%)
- Joint pain (7%)
- Indigestion (5%)
Less Common Side Effects
- Cough
- Ear infection
- Stomach pain
- Sleep problems
- Dizziness
- Swelling in the arms and legs
- Weight gain
Sogroya (somapacitan) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reactions: skin rash, hives, itching, swelling of face or tongue, trouble breathing, chest tightness
- High pressure in the brain: changes in vision, headache, nausea, vomiting
- Swelling of the pancreas (pancreatitis): nausea, vomiting, severe stomach pain that spreads to your back
The following Sogroya (somapacitan) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Bone or joint pain
- High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
- Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting
- Lipodystrophy—hardening or scarring of tissue at injection site
- Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
- Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
- Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
- Swelling of the ankles, hands, or feet, shortness of breath or trouble breathing, sudden weight gain
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Burning or tingling sensation in hands or feet
- Headache
- Muscle pain
- Pain, redness, or irritation at injection site
- Upset stomach
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Pros and cons of Sogroya (somapacitan)
Pros
- Longer-acting so you only need to inject once a week
- Safe for children and adults
- Comes as a ready-to-use pen
Cons
- Requires regular monitoring
- Can cause swelling and joint pain
- Might raise blood sugar
Pharmacist tips for Sogroya (somapacitan)
- Inject Sogroya (somapacitan) once a week, on the same day each week. This helps keep a steady amount of medication in your body so it works well.
- If you miss a dose of Sogroya (somapacitan), you can take it within 3 days of your scheduled day. If more than 3 days have passed, skip the missed dose and take your next dose on your regular schedule.
- Rotate where you inject Sogroya (somapacitan) each time every week. Using the same spot too often can damage fat tissue.
- You might have mild injection site reactions with Sogroya (somapacitan), like redness, swelling, or pain. These usually go away, but tell your care team if they don’t.
- Sogroya (somapacitan) can cause swelling in your body, such as in your hands, feet, or ankles. Let your care team know if this becomes uncomfortable or doesn’t go away.
- Sogroya (somapacitan) can raise your blood sugar. Tell your care team if you notice symptoms of high blood sugar like feeling more thirsty, urinating more often, or feeling tired.
- Tell your pharmacist and care team about all medications you take before starting Sogroya (somapacitan). It can interact with medications like steroids (e.g., prednisone), insulin, and thyroid medications, which might need dose adjustments.
- If your child is using Sogroya (somapacitan), their growth should be checked regularly. Tell their prescriber if they are limping or have hip or knee pain since it could mean they are growing too fast.
- Storage: Keep Sogroya (somapacitan) in the refrigerator. Unused pens can be kept at room temperature for a total of 3 days, but after that it should be returned to the refrigerator. Used pens can be stored in the refrigerator for up to 6 weeks, or a total of 3 days at room temperature.
How to inject Sogroya (somapacitan):
- Before injecting Sogroya (somapacitan), review the instructions for use and ask your care team or pharmacist if you have questions.
- Wash your hands well with soap and water before injecting. Clean the injection site with an alcohol swab before giving your dose.
- Attach the needle to the pen. Follow instructions to remove any trapped air from the solution before your first dose.
- Inject Sogroya (somapacitan) under the skin of your upper arm, thigh, buttock, or stomach.
- Pinch your skin and inject into the skin. Press the button to inject the full dose.
- After injection, throw away needles and syringes in a sharps container to avoid injury. Check with your local waste removal company or health department to find out where to throw away the sharps container safely.
Risks and warnings for Sogroya (somapacitan)
Sogroya (somapacitan) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Higher risk of death during serious illness
- Risk factors: Open heart or stomach surgery | Serious injuries | Severe breathing problems
Using Sogroya (somapacitan) during a serious illness might increase the risk of death. This includes conditions like recovery after open heart or stomach surgery, serious injuries, or severe breathing problems.
Because of this risk, your care team will decide if it’s safe to continue Sogroya (somapacitan) if you become very sick. They'll weigh the benefits and risks before continuing treatment.
Severe allergic reactions
Severe allergic reactions can happen with Sogroya (somapacitan), including life-threatening reactions like anaphylaxis. Get medical help right away if you have symptoms like dizziness, a choking feeling, trouble breathing, nausea, or swelling of your eyes, lips, or tongue at any point during treatment.
New or returning tumors
- Risk factors: History of cancer | Genetic causes of short stature
If you or your child had cancer in the past, there could be a higher risk of developing a new tumor while using Sogroya (somapacitan). Some tumors can also come back.
Your care team will monitor you closely during treatment. Tell them right away if you notice any symptoms of cancer, like headaches, vision problems, or changes in moles or skin growths.
High blood sugar
- Risk factors: Obesity | Turner syndrome | Family history of diabetes
Sogroya (somapacitan) can raise your blood sugar and make your body less sensitive to insulin. This might lead to new or worsening diabetes, especially if you have risk factors like obesity or a family history of diabetes.
If you have diabetes and take blood sugar-lowering medications, your dose might need to be adjusted. Your care team might also ask you to check your blood sugar regularly during treatment.
High pressure in the brain
Sogroya (somapacitan) might rarely cause high pressure in the brain, also called intracranial hypertension. Symptoms include headache, vision changes, nausea, or vomiting, and they usually happen within the first 2 months of treatment. Your prescriber will probably perform routine exams to watch for this problem before you start the medication and throughout your treatment.
Swelling in the body
- Risk factors: Adults
Sogroya (somapacitan) can cause your body to hold onto fluid, especially in adults. This might lead to swelling, joint or muscle pain, or tingling in your hands (like carpal tunnel symptoms). These side effects usually go away on their own or improve if your dose is lowered. Tell your care team if they bother you or don’t go away.
Low hormone levels
- Risk factors: Taking steroid medications
Sogroya (somapacitan) can lower your cortisol levels, which is a hormone your body uses to handle stress and inflammation. The risk is higher if you're also taking steroid medications, like prednisone or methylprednisolone.
Sogroya (somapacitan) can also lower your thyroid hormone levels. This could make the medication work less well. Your care team will check your thyroid levels before and during treatment and adjust medications if needed.
Bone and growth changes in children
- Risk factors: Growing too fast
Sogroya (somapacitan) can sometimes cause a hip problem in children, especially when they're growing too fast. This can lead to serious bone damage if not treated. Tell your care team right away if your child starts limping or has hip or knee pain so they can be checked quickly.
Sogroya (somapacitan) can also worsen scoliosis in children who already have it and are growing quickly. Although the medication itself doesn't cause scoliosis. Tell your care team if you notice changes in your child's posture or back shape.
Swelling of the pancreas
- Risk factors: Children
It's rare, but Sogroya (somapacitan) can cause a serious problem called pancreatitis (swelling of the pancreas). Symptoms include nausea, vomiting, and severe stomach pain that may spread to your back. Stop using the medication and get help right away if you have these symptoms.
Fat tissue damage
Make sure you rotate where you inject Sogroya (somapacitan) each time. If you inject it in the same spot for a long time, it can damage the fat under your skin. This can cause dents or thinning in that area.
Higher risk of death in children with Prader-Willi syndrome
- Risk factors: Boys | Obesity | Blocked airways | Sleep apnea | Respiratory infection
Sogroya (somapacitan) isn't FDA approved to treat children with Prader-Willi syndrome. Some deaths have been reported after treatment with a similar medication called somatropin, especially in boys with risk factors like severe obesity, breathing problems, or respiratory infections. During treatment, tell your care team right away if your child snores more, has trouble breathing, or shows signs of infection, since they might have to stop the medication.
Sogroya (somapacitan) dosage
Pen| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 1.5ml of 10mg/1.5ml | 1 pen | $2,988.68 | $2,988.68 |
| 1.5ml of 5mg/1.5ml | 1 pen | $1,497.47 | $1,497.47 |
| 1.5ml of 15mg/1.5ml | 2 pens | $8,953.55 | $4,476.78 |
Typical dosage for Sogroya (somapacitan)
Sogroya (somapacitan) is given as an injection under your skin once a week. Your dose depends on your weight and the condition being treated, and your care team might adjust it based on how you respond.
Children
- Low growth hormone: The typical dose is 0.16 mg/kg of body weight once a week.
- Small for gestational age, Noonan syndrome, and idiopathic short stature: The typical dose is 0.24 mg/kg once a week.
Adults
- Low growth hormone: The typical starting dose is 1.5 mg once a week. Your dose might be slowly increased every 2 to 4 weeks based on how you respond.
Your dose might differ if you're 65 years or older, have moderate liver problems, or take an oral estrogen.
How much does Sogroya (somapacitan) cost?
$1,497.47
Sogroya (somapacitan) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Sogroya (somapacitan) will not be safe for you to take.
- Serious illness due to open heart surgery, stomach surgery, injury, or severe breathing problems
- Active cancer
- Allergy to Sogroya (somapacitan)
- Serious diabetic eye problem (diabetic retinopathy)
- Children whose bones have finished growing
- Children with Prader-Willi syndrome with severe obesity, serious breathing problems, or sleep apnea
