Somatropin
Medically reviewed by A Ras MD.
What is somatropin?
Somatropin is a prescription medicine that is used to treat short bowel syndrome. Somatropin may be given to you for other reasons.
Description
GENOTROPIN lyophilized powder contains somatropin, which is a polypeptide hormone of recombinant DNA origin. It has 191 amino acid residues and a molecular weight of 22,124 daltons. The amino acid sequence of the product is identical to that of human growth hormone of pituitary origin (somatropin). GENOTROPIN is synthesized in a strain of Escherichia coli that has been modified by the addition of the gene for human growth hormone. GENOTROPIN is a sterile white lyophilized powder intended for subcutaneous injection.
GENOTROPIN 5 mg is dispensed in a two-chamber cartridge. The front chamber contains recombinant somatropin 5.8 mg, glycine 2.2 mg, mannitol 1.8 mg, sodium dihydrogen phosphate anhydrous 0.32 mg, and disodium phosphate anhydrous 0.31 mg; the rear chamber contains 0.3% m-Cresol (as a preservative) and mannitol 45 mg in 1.14 mL water for injection. The GENOTROPIN 5 mg two-chambered cartridge contains 5.8 mg of somatropin. The reconstituted concentration is 5 mg/mL. The cartridge contains overfill to allow for delivery of 1ml containing the stated amount of GENOTROPIN – 5 mg.
GENOTROPIN 12 mg is dispensed in a two-chamber cartridge. The front chamber contains recombinant somatropin 13.8 mg, glycine 2.3 mg, mannitol 14.0 mg, sodium dihydrogen phosphate anhydrous 0.47 mg, and disodium phosphate anhydrous 0.46 mg; the rear chamber contains 0.3% m-Cresol (as a preservative) and mannitol 32 mg in 1.13 mL water for injection. The GENOTROPIN 12 mg two-chambered cartridge contains 13.8 mg of somatropin. The reconstituted concentration is 12 mg/ml. The cartridge contains overfill to allow for delivery of 1ml containing the stated amount of GENOTROPIN – 12 mg.
GENOTROPIN MINIQUICK® is dispensed as a single-use syringe device containing a two-chamber cartridge. GENOTROPIN MINIQUICK is available as individual doses of 0.2 mg to 2.0 mg in 0.2 mg increments. The front chamber contains recombinant somatropin 0.22 to 2.2 mg, glycine 0.23 mg, mannitol 1.14 mg, sodium dihydrogen phosphate 0.05 mg, and disodium phosphate anhydrous 0.027 mg; the rear chamber contains mannitol 12.6 mg in water for injection 0.275 mL. The reconstituted GENOTROPIN MINIQUICK two-chamber cartridge contains overfill to allow for delivery of 0.25 ml containing the stated amount of GENOTROPIN.
GENOTROPIN is a highly purified preparation. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7. The concentration of the reconstituted solution varies by strength and presentation.
Mechanism of Action
In vitro, preclinical, and clinical tests have demonstrated that GENOTROPIN lyophilized powder is therapeutically equivalent to human growth hormone of pituitary origin and achieves similar pharmacokinetic profiles in normal adults. In pediatric patients who have growth hormone deficiency (GHD), have Prader-Willi syndrome (PWS), were born small for gestational age (SGA), have Turner syndrome (TS), or have Idiopathic short stature (ISS), treatment with GENOTROPIN stimulates linear growth. In patients with GHD or PWS, treatment with GENOTROPIN also normalizes concentrations of IGF-I (Insulin-like Growth Factor-I/Somatomedin C). In adults with GHD, treatment with GENOTROPIN results in reduced fat mass, increased lean body mass, metabolic alterations that include beneficial changes in lipid metabolism, and normalization of IGF-I concentrations.
In addition, the following actions have been demonstrated for GENOTROPIN and/or somatropin.
Before taking somatropin, tell your doctor:
- If you are allergic to somatropin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have any of these health problems: Breathing problems like sleep apnea; cancer or other tumors like a brain tumor; diabetic eye disease; or illness shortly after open heart surgery, stomach surgery, or accidental injury.
This is not a list of all drugs or health problems that interact with somatropin.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take somatropin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take somatropin?
For all patients taking somatropin:
- Tell all of your health care providers that you take somatropin. This includes your doctors, nurses, pharmacists, and dentists.
- High blood sugar has happened with somatropin. This includes diabetes that is new or worse.
- Check your blood sugar as you have been told by your doctor.
- Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take somatropin.
- Have your eye pressure and eyesight checked as you have been told by the doctor.
- If you have cancer or a tumor or have ever had cancer or a tumor, talk with your doctor. The chance of cancer or tumor growth is raised with somatropin. The chance of new tumors may also be raised in some patients.
- If you have Turner syndrome, talk with your doctor. The chance of ear infections, high blood pressure, and very bad blood vessel problems like stroke and bleeding in the brain may be raised.
- Raised pressure in the head has rarely happened with somatropin. The risk may be greater in patients with Turner syndrome or Prader-Willi syndrome. Signs most often happen within the first 8 weeks of starting somatropin. Call your doctor right away if you have change in eyesight, a very bad headache, upset stomach, or throwing up.
- If you are 65 or older, use somatropin with care. You could have more side effects.
- Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
Children:
- This medicine has benzyl alcohol in it. Benzyl alcohol may cause very bad and sometimes deadly side effects in newborns or infants. This medicine is not approved for use in children. Talk with the doctor.
How is somatropin best taken?
Use somatropin as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as a shot into the fatty part of the skin.
- If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
- If stored in a refrigerator, let somatropin come to room temperature before using it. Be sure you know how long to leave it at room temperature before using. Do not heat somatropin.
- Move the site where you give the shot with each shot.
- Do not give into skin that is irritated, bruised, red, infected, or scarred.
- Do not shake the solution.
- Do not use if the solution is cloudy, leaking, or has particles.
- Do not use if solution changes color.
- Wash your hands before and after use.
- Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
- This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take somatropin.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
What are the side effects of somatropin that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
- Signs of low thyroid levels like constipation; not able to handle cold; memory problems; mood changes; or a burning, numbness, or tingling feeling that is not normal.
- Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Chest pain or pressure or a fast heartbeat.
- Sweating a lot.
- Depression or other mood changes.
- Change in how you act.
- Change in skin color.
- Burning, numbness, pain, or tingling in the hands, arms, legs, or feet.
- Bone pain.
- Change in color or size of a mole.
- Redness or swelling where the shot is given.
- Skin breakdown where somatropin is used.
- Ear pain.
What are some other side effects of somatropin?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Headache.
- Feeling tired or weak.
- Back, muscle, or joint pain.
- Muscle stiffness.
- Trouble sleeping.
- Upset stomach or throwing up.
- Gas.
- Stomach pain or diarrhea.
- Irritation where the shot is given.
- Signs of a common cold.
- Flu-like signs.
- Hair loss.
- Enlarged breasts.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out somatropin?
- Store at room temperature.
- After mixing, store in a refrigerator. Check with the doctor or pharmacist if you have questions about how long somatropin may be used after mixing.
- Protect from light.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
SRC: NLM .