Somatropin, e-coli derived (Subcutaneous, Injection)

Somatropin is an artificial version of human growth hormone. Growth hormone is made naturally by the pituitary gland and is essential for growth in children. The man-made growth hormone can be used in both adults and children with certain conditions that stop normal growth. These conditions include growth hormone deficiency (not making enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained short height), Noonan syndrome, Turner syndrome, Prader-Willi syndrome (PWS), short stature homeobox-containing gene (SHOX) deficiency, and short stature in those who were small for gestational age (SGA) with no catch-up growth by age 2 to 4 years.

This medicine is available only with your doctor's prescription.

If you will be using this medicine for a long time, it is very important for your doctor to regularly check you and your child's progress. Blood and urine tests may be necessary to look for any problems or side effects caused by this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which are life-threatening and need 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 using the medicine.

This medicine may lead to 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 impact 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 increased pressure in the head. Check with your doctor immediately if you experience headache, nausea, vomiting, blurred vision, or any other change in vision during treatment. Your doctor may want you or your child's eyes to be examined by an ophthalmologist (eye doctor).

This medicine may cause fluid retention (extra water in the body). Tell your doctor if you or your child experience 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 the dose to help reduce these side effects.

Pancreatitis (inflammation of the pancreas) has occurred rarely in some patients using somatropin. 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 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 signs of an adrenal gland problem (hypoadrenalism).

Using this medicine may increase your or your child's risk of developing cancer. Talk to your doctor if you have concerns about this risk.

Before you undergo any medical tests, inform the medical doctor in charge that you are using this specific brand of somatropin (Humatrope®, Norditropin®, or Zomacton®). The results of some tests may be influenced by this medicine.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use this medicine, you and your doctor will need to consider the risks and benefits. Here are some important points to think about:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you have, including allergies to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems in children that would limit the use of somatropin.

Geriatric

Studies so far have not shown any specific problems in elderly patients that would limit the use of somatropin. However, older adults may be more sensitive to the effects of somatropin and may experience more side effects, which could require a dose adjustment.

Breast Feeding

There are no adequate studies in breastfeeding women to determine the risk to infants when using this medication. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together despite possible interactions. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or over-the-counter (OTC) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to potential interactions. Drinking alcohol or using tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to benzyl alcohol or
• Allergy to metacresol or
• Brain tumor or
• Active cancer or
• Closed epiphyses (normal bone growth has stopped) in children or
• Diabetic retinopathy (eye condition) or
• Prader-Willi syndrome (a genetic disorder), if severely overweight or have severe breathing issues or
• Severe illness after surgery or a major medical emergency (for example, open heart surgery, abdominal surgery, accidental trauma, or respiratory failure)—This medicine should not be used in these situations.

• History of cancer or
• Hypopituitarism (low hormone production by the pituitary gland) or
• Hypothyroidism (underactive thyroid gland) or
• History of otitis media (ear infection) in children or
• Scoliosis (abnormally curved spine)—Use with caution. This may worsen these conditions.

• Diabetes or a family history of diabetes—Use with caution. It may prevent insulin or other diabetes medications from working properly.

• Turner syndrome—Use with caution. This may increase the risk of serious problems (for example, pancreas, thyroid, or heart and blood vessel issues, ear or hearing disorders, diabetes, increased pressure in the head, and bone problems such as hip dislocation or scoliosis).

Along with its necessary effects, a medicine may also cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if you experience any of the following side effects:

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 the smallest finger
• coughing up blood
• difficulty breathing or swallowing
• difficulty moving
• dizziness
• increased menstrual flow or vaginal bleeding
• muscle pain or stiffness
• nosebleeds
• inability 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 in 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
• pain in the hip or knee
• loss of appetite
• loss of consciousness
• nausea
• pain in the stomach, side, or abdomen, possibly radiating to the back
• problems walking or talking
• seizures
• stomachache
• sweating
• tumor
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Incidence not known

• Cough
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin lesions
• tightness in the chest
• unexplained weight loss

Get emergency help right away if you notice any of these symptoms of overdose:

Symptoms of overdose

• Backache
• excessive sweating
• extreme weakness
• increase in hand and foot size
• increased volume of pale, diluted urine
• pain in the arms or legs
• stop in menstruation

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also have ways to help 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 on the skin
• unusually warm skin

Rare

• 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.

In the U.S.

• Accretropin
• Genotropin
• Genotropin Miniquick
• Humatrope
• Norditropin
• Norditropin Flexpro
• Nutropin
• Nutropin AQ NuSpin 10
• Nutropin AQ NuSpin 5
• Nutropin AQ Pen
• Omnitrope
• Tev-Tropin

In Canada

• Nutropin Aq
• Saizen

Available Dosage Forms:

• Solution
• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Somatropin

Find detailed information on biosimilars for this medication.

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 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, prefilled pen, or syringe each time you inject your medicine.

Check the liquid in the Norditropin® prefilled pen. It should be clear and colorless. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it.

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.

• For injection dosage form:For all indications: Adults—Dose is usually based on body weight (depending on the brand of somatropin you are using) and must be determined by your doctor. Norditropin® may also be given without concern to weight. At first, you may give Norditropin® 0.2 milligram (mg) per day. Your doctor will adjust your dose as needed. Children—Dose is based on body weight and must be determined by your doctor. Your doctor will adjust your child's dose as needed.

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.

Store the unopened Norditropin® FlexPro pen in the refrigerator, away from direct light. Do not freeze. You may also keep the opened Norditropin® FlexPro pen in the refrigerator for up to 4 weeks or at room temperature for up to 3 weeks.

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