Description
Somatropin injection is used to treat growth hormone deficiency (inability to produce enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained shortness), Turner syndrome, short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years of age. 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.
Somatropin injection is also used together with a proper diet to treat short bowel syndrome (SBS), which is a condition that prevents the intestine or gut from absorbing food properly.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for 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 somatropin injection in children with growth hormone deficiency.
Appropriate studies have not been performed on the relationship of age to the effects of somatropin injection in children with short bowel syndrome. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of somatropin injection in the elderly. However, elderly patients are more sensitive to the effects of somatropin, which may require an adjustment of dosage in patients receiving somatropin injection.
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.
- Insulin Aspart, Recombinant
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:
- Brain tumor or
- 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 or
- Severe illness after surgery or major medical emergency (eg, open heart surgery, abdominal surgery, accidental trauma, or respiratory failure)—Should not be used in patients with these conditions.
- Cancer, history of or
- Fluid retention, history of or
- Hypopituitarism (pituitary gland produces low hormone levels) or
- Hypothyroidism (underactive thyroid gland) or
- Otitis media (ear infection) in children, history of or
- Pancreatitis (inflammation or swelling of the pancreas) 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. .
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Turner syndrome—Use with caution. May increase risk of having serious problems (eg, pancreas, thyroid, or heart and blood vessel problems, ear or hearing disorders, diabetes, increased pressure in the head, and bone problems including dislocation in the hip bone or scoliosis).
Proper Use
This medicine is given as a shot under your skin in the stomach, buttock, upper arm, or thigh area, or into your muscle. Somatropin 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.
If you are using this medicine to treat short bowel syndrome, carefully follow your doctor's instructions about any special diet. Take all other medicines or supplements your doctor has prescribed as part of your combination treatment.
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.
There are many different forms (eg, vial, cartridge, injection device) available for this medicine. Read all instructions carefully to be sure you know how to use your device.
Each time you get your medicine, check to be sure you have received the proper device. Talk to your pharmacist if you have questions about the device that you were given.
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.
Use a new needle, unopened vial, or syringe each time you inject your medicine.
You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial has changed color, or if you see particles in it, do not use it.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
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:
- For treatment of growth hormone deficiency:
- Adults—
- Nutropin® or Nutropin AQ®:
- Non-weight based: At first, the usual dose is 0.15 to 0.3 milligrams (mg) injected under the skin once a day. Your doctor may adjust your dose if needed.
- Weight-based: Dose is based on body weight and must be determined by your doctor. At first, the usual dose is not more than 0.006 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 0.025 to 0.0125 mg per kg of body weight per day.
- Saizen®: Dose is based on body weight and must be determined by your doctor. At first, the usual dose is not more than 0.005 mg per kg of body weight injected under the skin once a day. Your doctor may adjust your dose if needed.
- Zomacton®:
- Non-weight based: At first, the usual dose is 0.15 to 0.3 milligrams (mg) injected under the skin once a day. Your doctor may adjust your dose if needed.
- Weight-based: Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 0.006 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 0.0125 mg per kg of body weight per day.
- Nutropin® or Nutropin AQ®:
- Children—
- Nutropin® or Nutropin AQ®: Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.3 to 0.7 mg per kg of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.
- Saizen®: Dose is based on body weight and must be determined by your doctor. The usual dose is 0.06 mg per kg of body weight, given 3 times per week and injected under the skin or into a muscle. Your doctor may adjust your dose if needed.
- Zomacton®: Dose is based on body weight and must be determined by your doctor. The weekly dose is 0.18 to 0.3 mg per kg of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.
- Adults—
- For treatment of growth failure due to chronic kidney disease:
- Children—Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.35 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.
- For treatment of idiopathic short stature:
- Children—
- Nutropin® or Nutropin AQ®: Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.3 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.
- Zomacton®: Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.37 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.
- Children—
- For treatment of short bowel syndrome:
- Adults—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day for 4 weeks. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor.
- For treatment of short stature born small for gestational age (SGA):
- Children—Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.47 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.
- For treatment of short stature homeobox-containing gene (SHOX) deficiency:
- Children—Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.35 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.
- For treatment of short stature with Turner syndrome:
- Children—
- Nutropin® or Nutropin AQ®: Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.375 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into equal doses 3 to 7 times per week. Your doctor may adjust your dose if needed.
- Zomacton®: Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.375 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.
- Children—
- For treatment of 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.
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 unopened vials, cartridges, and injection devices of Nutropin® and Nutropin AQ® in the refrigerator, away from heat and direct light. Do not freeze.
Store unopened vials of Saizen® and Zorbtive® at room temperature, away from heat and direct light. Do not freeze.
Store the medicine that has been mixed in the refrigerator. The Nutropin® or Saizen® vials and Zorbtive® that has been mixed should be used within 14 days. The Saizen® click.easy® cartridge that has been mixed should be used within 21 days. Nutropin AQ® vial, cartridge, and injection device should be used within 28 days. Make sure you understand how long you can store the medicine after it has been mixed. Throw away any mixed medicine that has not been used within this time.
You may store mixed Zomacton® in the refrigerator for up to 28 days. Do not freeze.
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 your or 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 can be 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 the medicine.
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 cause a dislocation in the hip bone, especially in patients with growth hormone deficiency or Turner syndrome. Check with your doctor right away if you or your child has a limp or pain in the hip or knee.
Pancreatitis (inflammation of the pancreas) has occurred rarely in some patients receiving somatropin. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
This medicine may affect blood sugar levels. Check with your doctor if you or your child notice a change in the results of your 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 or your child to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may cause fluid retention (extra water in the body). Tell your doctor if you or your child have burning, numbness, pain, or tingling in all fingers except smallest finger, swelling of the hands and feet, or pain, swelling, or stiffness of the muscles. Your doctor may adjust your dose to reduce these side effects.
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).
This medicine is usually mixed with Bacteriostatic Water for Injection. You should not use Bacteriostatic Water for Injection if you have had an allergic reaction to benzyl alcohol. If this is a concern, ask your doctor about other ways to mix this medicine.
Before you have any medical tests, tell healthcare providers that you are using this medicine. The results of some tests may be affected by this medicine.
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
- Abnormal or decreased touch sensation
- bleeding after defecation
- bleeding, blistering, burning, coldness, discoloration of the 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
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- changes in skin color
- chest tightness
- cold flu-like symptoms
- cold hands and feet
- confusion
- constipation
- cough or hoarseness
- darkened urine
- decreased urination
- diarrhea
- difficult urination
- dizziness
- dry mouth
- fainting or loss of consciousness
- fast heartbeat
- fast or irregular breathing
- feeling unusually cold
- fever or chills
- full or bloated feeling
- general feeling of discomfort or illness
- headache
- increase in heart rate
- itching or skin rash
- joint pain
- light-colored stools
- lightheadedness
- loss of appetite
- lower back or side pain
- muscle aching or cramping
- muscle pain or stiffness
- nausea
- pain
- pain, redness, or swelling in the arm or leg
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pressure in the stomach
- rapid, shallow breathing
- rapid weight gain
- rectal bleeding
- runny nose
- shivering
- sneezing
- sore mouth or tongue
- sore throat
- stomach bloating, burning, cramping, or pain
- sudden decrease in the amount of urine
- sweating
- swelling of the eyes or eyelids
- swelling of the stomach area
- swelling or puffiness of the face
- swollen joints
- thirst
- tingling of the hands or feet
- trouble breathing
- trouble sleeping
- uncomfortable swelling around the anus
- unpleasant breath odor
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- vomiting of blood
- white patches in the mouth, tongue, or throat
- wrinkled skin
- yellow eyes or skin
Less common
- Bone or skeletal pain
- burning, numbness, pain, or tingling in all fingers except smallest finger
- chest pain
- depressed mood
- dry skin and hair
- feeling cold
- hair loss
- hoarseness or husky voice
- slowed heartbeat
- swelling of the ankles
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Anxiety
- blurred vision
- changes in vision
- cold sweats
- coma
- cool, pale skin
- decrease in the amount of urine
- depression
- excessive sweating
- extreme weakness
- flushed, dry skin
- frequent urination
- fruit-like breath odor
- increase in hands and feet size
- increased hunger
- increased thirst
- increased urination
- increased volume of pale, diluted urine
- nightmares
- noisy, rattling breathing
- pain in the arms or legs
- seizures
- shakiness
- slurred speech
- stop in menstruation
- swelling of the fingers or hands
- trouble breathing
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
- Body aches or pain
- breast pain
- change in the color, amount, or odor of vaginal discharge
- congestion
- discoloration of the fingernails or toenails
- dryness or soreness of the throat
- excess air or gas in the stomach or intestines
- frequent urge to defecate
- increased sweating
- passing gas
- sneezing
- straining while passing stool
- stuffy nose
- tender, swollen glands in neck
- trouble with swallowing
- voice changes
Less common
- Discouragement
- feeling sad or empty
- irritability
- lack of appetite
- loss of interest or pleasure
- tiredness
- trouble concentrating
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.
DRG-20071668
