How does this medication work? What will it do for me?
Somatrogon belongs to the class of medications called human growth hormone analogues. Growth hormone is made naturally in our bodies by the pituitary gland and is necessary for stimulating growth in children. Somatrogon is used to treat growth hormone deficiency for children between the ages of 3 and 11 years. It works by replacing the growth hormone that they are unable to produce enough of naturally.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
24 mg Prefilled Pen
Each mL of sterile, clear, colourless to slightly yellow solution for injection contains 20 mg of somatrogon. Nonmedicinal ingredients: citric acid monohydrate, L-histidine, m-Cresol, Poloxamer 188, sodium chloride, trisodium citrate dihydrate, and water for injection.
60 mg Prefilled Pen
Each mL of sterile, clear, colourless to slightly yellow solution for injection contains 50 mg of somatrogon. Nonmedicinal ingredients: citric acid monohydrate, L-histidine, m-Cresol, Poloxamer 188, sodium chloride, trisodium citrate dihydrate, and water for injection.
How should I use this medication?
Somatrogon is administered by injection only. The dose is calculated as 0.66 mg per kilogram of body weight injected subcutaneously (under the skin), once a week. Your doctor will determine the appropriate dose for your child.
This medication should be injected on the same day each week. If it is necessary to change the day of the week that you are giving the medication, there must be at least 72 hours (3 days) between injections.
It is injected in the thigh, buttocks, upper arms, or abdomen. It is important to rotate the site of injection in order to minimize the risk of fat wasting at the site of injection. If more than one injection is needed for a full dose, a different injection site should be used for the second injection.
This medication should be clear and colourless to slightly light yellow in colour. If it is cloudy or dark yellow, do not use it. Start a new pen.
If you are using this medication at home, your doctor will ensure that you understand exactly how to use it. Make sure you ask any and all questions necessary to ensure that you use it exactly as prescribed. Please refer to the appropriate package insert for details of proper injection procedures. It is important to visit your doctor regularly during therapy to ensure that the medication is working safely and effectively.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, and it is less than 3 days since the missed dose, inject it as soon as possible and continue with your regular schedule. If more than 3 days have passed, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication in the refrigerator, protect it from light and moisture, and keep it out of the reach of children. The pre-filled pen may be kept at room temperature for up to 2 hours with each use. Return the pen to the refrigerator after injecting a dose. Remove the needle from the pen after each injection. Store the pen with no needle attached and the cap on.
Discard any medication remaining in the pen if more than 28 days have passed since starting to use it, you have used 5 doses from it, or it has been left at room temperature for more than 2 hours.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not give this medication to your child if they:
- are allergic to somatrogon or any ingredients of the medication
- have a critical illness caused by open heart or abdominal surgery, multiple injuries caused by a severe accident, or are in respiratory failure
- have cancer
- have closed or fused epiphysis (growth plates)
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- cold symptoms (e.g., stuffy or runny nose, sore throat)
- joint or muscle pain or stiffness
- pain, redness, swelling, itching, or skin thickening at the injection site
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- symptoms of an ear infection (e.g., ear pain, fever, thick, yellowish or bloody drainage from the ear, loss of appetite, vomiting, grumpy behaviour, trouble sleeping)
- symptoms of intestinal infection (e.g., gas, bloating, diarrhea, abdominal pain or cramping, constipation)
- symptoms of skin infection (e.g., skin redness, rash, itching, pain, tenderness, warmth)
- worsening curvature of the spine (e.g., back pain, one shoulder blade is higher than the other, uneven hips)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Cancer: As with other growth hormone products, there may be an increased risk of tumour growth, both cancerous and non-cancerous when growth hormone is used by survivors of childhood cancer. Discuss any concerns you may have with your doctor.
Diabetes: Other growth hormone treatments can cause increased levels of blood glucose and decreased glucose tolerance. While this has not been seen with somatrogon, if your child has diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Scoliosis: People with scoliosis are at risk of their condition worsening while taking somatrogon. If your child has scoliosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Thyroid function: Other growth hormone treatments may not be as effective if the thyroid gland is not working properly. These treatments can also cause decreased thyroid function. While this has not been seen with somatrogon, if your child has diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if somatrogon passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children younger than 3 years of age or older than 11 years of age.
What other drugs could interact with this medication?
There may be an interaction between somatrogon and any of the following:
- corticosteroids (e.g., budesonide, fluticasone, prednisone)
- diabetes medications (e.g., acarbose, canagliflozin, glyburide, lixisenatide, metformin, insulin, rosiglitazone, sitagliptin)
- estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
- progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
- seizure medications (e.g., carbamazepine, phenobarbital, phenytoin, primidone)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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