Health Guide
Drug Guide

Somatropin, E-coli derived (Subcutaneous route, injection route)

Pronunciation:

soe-ma-TROE-pin, E-KOH-lye dee-rived

Brand Names:

Dosage Forms:

Classifications:

Therapeutic

Endocrine-Metabolic Agent

Pharmacologic

Somatropin

Uses of This Medicine:

Somatropin is a man-made version of human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children. Man-made growth hormone may be used in adults or children who have certain conditions that prevent normal growth. These conditions include growth hormone deficiency (inability to produce enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained shortness), Noonan syndrome, 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 available only with your doctor's prescription.

Before Using This Medicine:

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.

Children

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of somatropin in children.

Older adults

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of somatropin in the elderly. However, elderly patients are more sensitive to the effects of somatropin and are more likely to have unwanted effects, which may require a dose adjustment in patients receiving somatropin.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

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.

Other medicines

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

Proper Use of This Medicine:

This medicine is given as a shot under your skin. 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.

This medicine comes with a patient information insert. 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) or prefilled syringe. Use each vial or syringe only one time. Do not save an open vial or syringe. If the medicine in the vial or syringe 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.

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 this medicine in the refrigerator, away from direct light. Do not freeze or shake.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause a serious allergic reaction that requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain after you receive the medicine.

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.

This medicine may affect blood sugar levels. Check with your doctor if you 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 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 have burning, numbness, pain, or tingling in all fingers except the 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.

Pancreatitis has occurred rarely in some patients receiving somatropin. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Using this medicine may increase your risk of getting cancer. Talk to your doctor if you have concerns about this risk.

Before you have any medical tests, tell the medical doctor in charge that you are using this certain brand of somatropin (Humatrope®). 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 of This Medicine:

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
Bleeding gums
bloating or swelling of the face, arms, hands, ankles, lower legs, or feet
burning, numbness, pain, or tingling in all fingers except smallest finger
coughing up blood
difficulty with breathing or swallowing
difficulty with moving
dizziness
increased menstrual flow or vaginal bleeding
muscle pain or stiffness
nosebleeds
not able to move
pain, swelling, or redness in the joints
prolonged bleeding from cuts
rapid weight gain
red or black, tarry stools
red or dark brown urine
tingling of the hands or feet
unusual weight gain or loss
Rare
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
blurred vision
bone pain
change in personality
change in the ability to see colors, especially blue or yellow
changes in vision
chills
confusion
constipation
curved spine
darkened urine
dry mouth
fast heartbeat
fever
flushed, dry skin
fracture
fruit-like breath odor
headache
increased hunger
increased thirst
increased urination
indigestion
limp pain in the hip or knee
loss of appetite
loss of consciousness
nausea
pains in the stomach, side, or abdomen, possibly radiating to the back
problems with walking or talking
seizures
stomachache
sweating
troubled breathing
tumor
unusual tiredness or weakness
vomiting
weakness
yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
Backache
excessive sweating
extreme weakness
increase in hands and feet size
increased volume of pale, diluted urine
pain in extremities
stop in menstruation

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
Large, flat, blue, or purplish patches in the skin
unusually warm skin
Rare
Increased growth of skin lesions
swelling of the breasts or breast soreness in both females and males

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.


Last Updated: 9/15/2016

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