Description
Somatrogon-ghla injection is used to treat growth failure caused by growth hormone deficiency (inability to produce enough growth hormone). This medicine is a man-made version of the human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of somatrogon-ghla injection in children 3 years of age and older. However, safety and efficacy have not been established in children younger than 3 years of age.
Geriatric
No information is available on the relationship of age to the effects of somatrogon-ghla injection in geriatric patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acarbose
- Albiglutide
- Alclometasone
- Alogliptin
- Amcinonide
- Beclomethasone
- Betamethasone
- Budesonide
- Canagliflozin
- Chlorotrianisene
- Chlorpropamide
- Ciclesonide
- Clobetasol
- Clobetasone
- Clocortolone
- Cortisone
- Dapagliflozin
- Deflazacort
- Desonide
- Desoximetasone
- Dexamethasone
- Diethylstilbestrol
- Diflorasone
- Diflucortolone
- Difluprednate
- Dulaglutide
- Empagliflozin
- Ertugliflozin
- Esterified Estrogens
- Estradiol
- Estramustine
- Estropipate
- Ethinyl Estradiol
- Exenatide
- Flucloronide
- Flumethasone
- Flunisolide
- Fluocinolone
- Fluocinonide
- Fluocortin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cancer, active or
- Closed epiphyses (normal bone growth stopped) in children or
- Diabetic retinopathy (eye condition) or
- Prader-Willi syndrome (a genetic disorder), if severely overweight or have severe breathing problems (eg, sleep apnea) or
- Severe illness after surgery or major medical emergency (eg, open heart surgery, stomach surgery, accidental trauma, or respiratory failure)—Should not be used in patients with these conditions.
- Cancer, history of or
- Hypopituitarism (pituitary gland produces low hormone levels) or
- Hypothyroidism (underactive thyroid gland) or
- Scoliosis (abnormally curved spine)—Use with caution. May make these conditions worse.
- Diabetes, or a family history of—Use with caution. May prevent insulin or other drugs for diabetes from working properly.
Proper Use
A nurse or other trained health professional may give you this medicine. This medicine is given as a shot under your skin in the stomach, buttock, upper arms, or thigh area. Somatrogon-ghla injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.
This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
Always check the label before use, to make sure you have the correct dose.
This medicine is available in prefilled pens. Read all instructions carefully to be sure you know how to use your device.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.
You may use the pen straight from the refrigerator. You may also allow the medicine to warm at room temperature for 30 minutes before use.
Do not inject into bony areas, skin areas that are bruised, red, sore or hard, or has scars or skin conditions.
The medicine should be colorless to slightly light yellow. Do not use the medicine if it is cloudy or dark yellow, or has flakes or particles in it.
To use the prefilled pen:
- Wash your hands with soap and water.
- Place the needle straight on the pen. Prime the pen by removing the air from the needle. Select 0.4 units when turning the dose knob.
- Hold the pen with the needle pointing up, then gently tap the cartridge holder to collect the air bubbles at the top.
- Press the injection button until it stops. You should see a "0" in the dose window.
- You should see the liquid at the needle tip. If you do not see the liquid, repeat the priming steps but not more than 5 times. If there is still no liquid, do not use the pen.
- Turn the dose selector, be careful not to press the injection button. If the dose is more than 12 milligrams (mg), you will need to split the dose into more than 1 injection.
- Insert the needle into your skin and press the injection button all the way in for at least 10 seconds. Keep pressing until the needle has been pulled out from the skin. This will make sure that you have received the full dose.
- Use a new needle each time you inject your medicine. Always remove and throw the needle after each injection. Do not use the pen if it is frozen, exposed to heat, dropped, or looks broken or damaged. Do not shake the pen.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (solution):
- For treatment of growth failure caused by growth hormone deficiency:
- Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.66 milligrams (mg) per kg of body weight injected under the skin once a week on the same day, at any time of the day.
- Children younger than 3 years of age—Use and dose must be determined by your doctor.
- For treatment of growth failure caused by growth hormone deficiency:
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
If you miss a dose, use it as soon as possible within 3 days after the missed dose. However, if it is more than 3 days, skip the missed dose and go back to your regular dosing schedule.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Store opened pen in the refrigerator for up to 28 days. Throw away opened pen after 28 days.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
If you will be taking this medicine for a long time, it is very important that your doctor check you and your child's progress at regular visits. Blood and urine tests may be needed to check for any problems or unwanted effects that may be caused by this medicine.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which are life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain after receiving this medicine.
Never share pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other bloodborne illnesses.
Using this medicine may increase your or your child's risk of getting cancer. Talk to your doctor if you have concerns about this risk.
This medicine may affect blood sugar levels. Check with your doctor if you notice a change in the results of your or your child's blood or urine sugar tests or if you have any questions.
This medicine may cause an increased pressure in the head. Check with your doctor immediately if headache, nausea, vomiting, blurred vision, or any other change in vision occurs during treatment. Your doctor may want you to have your or your child's eyes checked by an ophthalmologist (eye doctor).
Check with your doctor right away if you or your child have decrease in amount of urine, noisy, rattling breathing, swelling of the fingers, hands, feet, or lower legs, or weight gain. These may be symptoms of fluid retention (extra water in the body).
Check with your doctor right away if you have darkening of skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of an adrenal gland problem (hypoadrenalism).
Pancreatitis (inflammation of the pancreas) has occurred rarely in some patients receiving somatrogon-ghla. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Check with your doctor right away if your child has hip and knee pain or limp. These may be symptoms of slipped capital femoral epiphysis (hip bone dislocation).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Pale skin
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Constipation
- depressed mood
- dry skin and hair
- feeling cold
- hair loss
- hoarseness or husky voice
- muscle cramps and stiffness
- slowed heartbeat
- weight gain
Incidence not known
- Bloating
- blurred vision
- change in ability to see colors, especially blue or yellow
- chest tightness
- chills
- cough
- darkened urine
- darkening of the skin
- decrease amount in urine
- diarrhea
- difficulty swallowing
- dizziness
- dry mouth
- fainting
- fast heartbeat
- flushed, dry skin
- headache
- hives, itching, skin rash
- increased hunger
- increased thirst
- increased urination
- indigestion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- loss of consciousness
- mental depression
- nausea
- noisy, rattling breathing
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomachache
- sweating
- swelling of the fingers, hands, feet, or lower legs
- unexplained weight loss
- vomiting
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- cough producing mucus
- difficulty in moving
- earache
- joint pain
- muscle pain
- redness or swelling in the ear
- sore throat
- stuffy or runny nose
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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