Accretropin

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, and short stature born small for gestational age (SGA) with no catch-up growth by age 2-4 years.

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

This product is available in the following dosage forms:

• Solution


• 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 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, which may require an adjustment of dosage in patients receiving somatropin.

Pregnancy

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. 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:

• 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 (e.g., open heart surgery, abdominal surgery, accidental trauma, or respiratory failure)a€”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)a€”Use with caution. May make these conditions worse.

• Diabetes, or a family history ofa€”Use with caution. May prevent insulin from working properly.

• Turner syndromea€”May increase risk of having thyroid problems and ear or hearing disorders .

Proper Use

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.

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.

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 failure caused by growth hormone deficiency (Accretropina„˘):
    
    
    
    • Adultsa€”Use and dose must be determined by your doctor .
    
    
    • Childrena€”Dose is based on body weight and must be determined by your doctor . The usual total weekly dose is 0.18 milligram (mg) per kilogram (kg) of body weight to 0.3 mg per kg of body weight . This is divided into smaller doses that are given 6 or 7 times a week as an injection under the skin .
    
    
    
    
  
  
  • For treatment of growth failure caused by growth hormone deficiency (NorditropinA®):
    
    
    
    • Adultsa€”Dose is based on body weight and must be determined by your doctor . At first, the usual dose is not more than 0.004 milligram (mg) per kilogram (kg) of body weight given once a day as an injection under the skin . Your doctor may adjust your dose as needed.
    
    
    • Childrena€”Dose is based on body weight and must be determined by your doctor . The usual daily dose is 0.024 milligram (mg) per kilogram (kg) of body weight to 0.034 mg per kg of body weight . This is given 6 to 7 times a week as an injection under the skin .
    
    
    
    
  
  
  • For treatment of growth failure caused by growth hormone deficiency (NutropinA®):
    
    
    
    • Adultsa€”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 your skin once a day. Your doctor may adjust your dose as needed.
    
    
    • Childrena€”Dose is based on body weight and must be determined by your doctor . The usual total weekly dose is up to 0.3 milligram (mg) per kilogram (kg) of body weight . This is divided into smaller doses that are given once a day as an injection under the skin .
    
    
    
    
  
  
  • For treatment of growth failure caused by idiopathic short stature:
    
    
    
    • Childrena€”Dose is based on body weight and must be determined by your doctor . The usual total weekly dose is up to 0.3 milligram (mg) per kilogram (kg) of body weight . This is divided into smaller doses that are given once a day as an injection under the skin .
    
    
    
    
  
  
  • For treatment of growth failure caused by chronic kidney disease:
    
    
    
    • Childrena€”Dose is based on body weight and must be determined by your doctor . The usual total weekly dose is up to 0.35 milligram (mg) per kilogram (kg) of body weight . This is divided into smaller doses that are given once a day as an injection under the skin .
    
    
    
    
  
  
  • For treatment of growth failure caused by Noonan syndrome (NorditropinA®):
    
    
    
    • Childrena€”Dose is based on body weight and must be determined by your doctor . The usual dose is up to 0.066 milligram (mg) per kilogram (kg) of body weight given once a day as an injection under the skin .
    
    
    
    
  
  
  • For treatment of growth failure born small for gestational age (SGA) with no catch-up growth by age 2-4 years (NorditropinA®):
    
    
    
    • Childrena€”Dose is based on body weight and must be determined by your doctor . The usual dose is up to 0.067 milligram (mg) per kilogram (kg) of body weight given once a day as an injection under the skin . Your child`s doctor may adjust the dose as needed.
    
    
    
    
  
  
  • For treatment of growth failure caused by Turner syndrome (Accretropina„˘):
    
    
    
    • Childrena€”Dose is based on body weight and must be determined by your doctor . The usual total weekly dose is up to 0.36 milligram (mg) per kilogram (kg) of body weight . This is given 6 or 7 times a week as an injection under the skin .
    
    
    
    
  
  
  • For treatment of growth failure caused by Turner syndrome (NorditropinA®):
    
    
    
    • Childrena€”Dose is based on body weight and must be determined by your doctor . The usual dose is up to 0.067 milligram (mg) per kilogram (kg) of body weight given once a day as an injection under the skin .
    
    
    
    
  
  
  • For treatment of growth failure caused by Turner syndrome (NutropinA®):
    
    
    
    • Childrena€”Dose is based on body weight and must be determined by your doctor . The usual total weekly dose is up to 0.375 milligram (mg) per kilogram (kg) of body weight . This is divided into 3 to 7 equal doses that are given once a day as an injection under the skin .
    
    
    
    
  
  
  
  

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

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 with breathing; or chest pain after you get the injection .

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 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.

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 smallest finger


• Coughing up blood


• Difficulty in breathing or swallowing


• Difficulty in moving


• Dizziness


• Increased menstrual flow or vaginal bleeding


• Muscle pain or stiffness


• Nosebleeds


• Not able to move


• Pain, swelling, or redness in 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 ability to see colors, especially blue or yellow


• Change in personality


• 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.