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.

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.

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.

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 in children.

Geriatric

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 an adjustment in the dose for patients receiving somatropin.

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.

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.

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.

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:

Allergy to benzyl alcohol or

Allergy to metacresol or

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

Hypopituitarism (pituitary gland produces low hormone levels) or

Hypothyroidism (underactive thyroid gland) or

Otitis media (ear infection) in children, history of 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.

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 such as dislocation in the hip bone or scoliosis).

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 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 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).

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 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 (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.

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).

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.

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

What should I watch for?

Visit your doctor for regular check ups. You will need to have important lab work done while you are taking this medicine.

Common and Rare 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

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 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

ed 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

ncreased 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

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 immediately if any of the following symptoms of overdose occur:

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 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

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.