Nutropin Aq Subcutaneous, Injection

In the U.S.

• Saizen
• Serostim
• Zorbtive

In Canada

• Nutropin
• Nutropin Aq

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Somatropin

Somatropin injection 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 failure caused by growth hormone deficiency (inability to produce enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained shortness), or Turner syndrome.

Somatropin injection is also used together with a proper diet to treat short bowel syndrome (SBS), which is a condition that prevents the intestine or gut from absorbing food properly.

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

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 injection in children with growth hormone deficiency.

Appropriate studies have not been performed on the relationship of age to the effects of somatropin injection in children with short bowel syndrome. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of somatropin injection 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 injection.

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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 (eg, open heart surgery, abdominal surgery, accidental trauma, or respiratory failure)—Should not be used in patients with these conditions.

• Cancer, history of or
• Fluid retention, 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
• Pancreatitis (inflammation or swelling of the pancreas) 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 from working properly. .

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Turner syndrome—May increase risk of having thyroid and hearing problems.

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:

• Abnormal or decreased touch sensation
• bleeding after defecation
• 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
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in skin color
• cold flu-like symptoms
• cold hands and feet
• confusion
• constipation
• cough or hoarseness
• darkened urine
• decreased urination
• diarrhea
• difficult urination
• dizziness
• dry mouth
• fainting or loss of consciousness
• fast heartbeat
• fast or irregular breathing
• feeling unusually cold
• fever or chills
• full or bloated feeling
• general feeling of discomfort or illness
• headache
• increase in heart rate
• itching or skin rash
• joint pain
• light-colored stools
• lightheadedness
• loss of appetite
• lower back or side pain
• muscle aching or cramping
• muscle pain or stiffness
• nausea
• pain
• pain, redness, or swelling in the arm or leg
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pressure in the stomach
• rapid, shallow breathing
• rapid weight gain
• rectal bleeding
• runny nose
• shivering
• sneezing
• sore mouth or tongue
• sore throat
• stomach bloating, burning, cramping, or pain
• sudden decrease in the amount of urine
• sweating
• swelling of the abdominal or stomach area
• swelling of the eyes or eyelids
• swelling or puffiness of the face
• swollen joints
• thirst
• tightness in the chest
• tingling of the hands or feet
• trouble breathing
• trouble sleeping
• uncomfortable swelling around the anus
• unpleasant breath odor
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• vomiting of blood
• white patches in the mouth, tongue, or throat
• wrinkled skin
• yellow eyes or skin

• Bone or skeletal pain
• burning, numbness, pain, or tingling in all fingers except smallest finger
• chest pain
• depressed mood
• dry skin and hair
• feeling cold
• hair loss
• hoarseness or husky voice
• slowed heartbeat
• swelling of the ankles

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

• Anxiety
• blurred vision
• changes in vision
• cold sweats
• coma
• cool, pale skin
• decrease in the amount of urine
• depression
• excessive sweating
• extreme weakness
• flushed, dry skin
• frequent urination
• fruit-like breath odor
• increase in hands and feet size
• increased hunger
• increased thirst
• increased urination
• increased volume of pale, diluted urine
• nightmares
• noisy, rattling breathing
• pain in the arms or legs
• seizures
• shakiness
• slurred speech
• stop in menstruation
• swelling of the fingers or hands
• troubled breathing at rest

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:

• Body aches or pain
• breast pain
• change in the color, amount, or odor of vaginal discharge
• congestion
• discoloration of the fingernails or toenails
• dryness or soreness of the throat
• excess air or gas in the stomach or intestines
• frequent urge to defecate
• increased sweating
• passing gas
• sneezing
• straining while passing stool
• stuffy nose
• tender, swollen glands in neck
• trouble with swallowing
• voice changes

• Discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• tiredness
• trouble concentrating

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.

Applies to somatropin: powder for solution

Other dosage forms:

• powder for solution, solution

Along with its needed effects, somatropin (the active ingredient contained in Nutropin AQ) 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 while taking somatropin:

• Abnormal or decreased touch sensation
• bleeding after defecation
• 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
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in skin color
• cold flu-like symptoms
• cold hands and feet
• confusion
• constipation
• cough or hoarseness
• darkened urine
• decreased urination
• diarrhea
• difficult urination
• dizziness
• dry mouth
• fainting or loss of consciousness
• fast heartbeat
• fast or irregular breathing
• feeling unusually cold
• fever or chills
• full or bloated feeling
• general feeling of discomfort or illness
• headache
• increase in heart rate
• itching or skin rash
• joint pain
• light-colored stools
• lightheadedness
• loss of appetite
• lower back or side pain
• muscle aching or cramping
• muscle pain or stiffness
• nausea
• pain
• pain, redness, or swelling in the arm or leg
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pressure in the stomach
• rapid, shallow breathing
• rapid weight gain
• rectal bleeding
• runny nose
• shivering
• sneezing
• sore mouth or tongue
• sore throat
• stomach bloating, burning, cramping, or pain
• sudden decrease in the amount of urine
• sweating
• swelling of the abdominal or stomach area
• swelling of the eyes or eyelids
• swelling or puffiness of the face
• swollen joints
• thirst
• tightness in the chest
• tingling of the hands or feet
• trouble breathing
• trouble sleeping
• uncomfortable swelling around the anus
• unpleasant breath odor
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• vomiting of blood
• white patches in the mouth, tongue, or throat
• wrinkled skin
• yellow eyes or skin

• Bone or skeletal pain
• burning, numbness, pain, or tingling in all fingers except smallest finger
• chest pain
• depressed mood
• dry skin and hair
• feeling cold
• hair loss
• hoarseness or husky voice
• slowed heartbeat
• swelling of the ankles

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

• Anxiety
• blurred vision
• changes in vision
• cold sweats
• coma
• cool, pale skin
• decrease in the amount of urine
• depression
• excessive sweating
• extreme weakness
• flushed, dry skin
• frequent urination
• fruit-like breath odor
• increase in hands and feet size
• increased hunger
• increased thirst
• increased urination
• increased volume of pale, diluted urine
• nightmares
• noisy, rattling breathing
• pain in the arms or legs
• seizures
• shakiness
• slurred speech
• stop in menstruation
• swelling of the fingers or hands
• troubled breathing at rest

Some side effects of somatropin 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:

• Body aches or pain
• breast pain
• change in the color, amount, or odor of vaginal discharge
• congestion
• discoloration of the fingernails or toenails
• dryness or soreness of the throat
• excess air or gas in the stomach or intestines
• frequent urge to defecate
• increased sweating
• passing gas
• sneezing
• straining while passing stool
• stuffy nose
• tender, swollen glands in neck
• trouble with swallowing
• voice changes

• Discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• tiredness
• trouble concentrating