Norditropin Flexpro (Subcutaneous, Injection)

Somatropin is a man-made version of the human growth hormone. Growth hormone is naturally made by the pituitary gland and is important for growth in children. Man-made growth hormone can be used in adults or children who have specific conditions that affect normal growth. These conditions include growth hormone deficiency (not producing enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained shortness), Noonan syndrome, Turner syndrome, Prader-Willi syndrome (PWS), 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.

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 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.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it provides. Here are some important points to consider:

Allergies

Tell your doctor 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 may have, like those to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

Studies 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 unwanted effects, which could require a dose adjustment for those receiving somatropin.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together with caution. In cases of potential interactions, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Allergy to benzyl alcohol or
• Allergy to metacresol or
• Brain tumor or
• Active cancer 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 (e.g., open heart surgery, abdominal surgery, accidental trauma, or respiratory failure)—Should not be used in patients with these conditions.

• History of cancer or
• Hypopituitarism (low hormone levels from 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. May worsen these conditions.

• Diabetes, or a family history of diabetes—Use with caution. May interfere with insulin or other diabetes medications.

• Turner syndrome—Use with caution. May increase the risk of serious problems (e.g., issues with the pancreas, thyroid, or heart and blood vessels, 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 can also cause some unwanted effects. While not all of these side effects may happen, 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
• Unable 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
• 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 you notice any of the following 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 generally do not need medical attention. These side effects may go away as your body gets used to the medicine. Your healthcare professional may also have ways to help prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, 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, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can 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

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.