Accretropin

Name: Accretropin

Before Using Accretropin

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 a dose adjustment in patients receiving somatropin.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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:

  • 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).

Indications

Accretropin™ (somatropin) is indicated for:

  • treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone.
  • treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed.

For the Consumer

Applies to somatropin: powder for solution

Other dosage forms:

  • powder for solution, solution

Along with its needed effects, somatropin (the active ingredient contained in Accretropin) 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:

More common
  • 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
Less common
  • 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:

Symptoms of overdose
  • 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:

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

Usual Adult Dose for Short Bowel Syndrome

Approximately 0.1 mg/kg subcutaneously once a day

Maximum dose: 8 mg once a day

Duration of therapy: 4 weeks

Comments:
-Administration for more than 4 weeks has not been adequately studied.
-Use in conjunction with optimal management of Short Bowel Syndrome (SBS).
-Optimal management of SBS may include dietary adjustments, enteral feedings, parenteral nutrition, fluid, and micronutrient supplements, as needed.
-Specialized nutritional support may consist of a high carbohydrate, low-fat diet, adjusted for patient requirements and preferences.
-Nutritional supplements may be added at the discretion of the treating physician.
-Changes to concomitant medications should be avoided.
-Patients and physicians should monitor for adverse events.

Use: Treatment of Short Bowel Syndrome in patients receiving specialized nutritional support.

Usual Pediatric Dose for Pediatric Growth Hormone Deficiency

Pediatric Growth Hormone Deficiency (GHD):
0.024 to 0.034 mg/kg subcutaneously once a day, 6 to 7 times a week

Prader-Willi syndrome (PWS):
Up to 0.24 mg/kg per week; divided over 6 or 7 days of subcutaneous injections

Comments:
-The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
-GHD: Generally, a dose of 0.16 to 0.3 mg/kg body weight per week is recommended.
-GHD: In pubertal patients, a weekly dosage of up to 0.7 mg/kg divided into daily doses may be used.
-PWS: Generally, a dose of 0.16 to 0.24 mg/kg body weight per week is recommended.
-Individualize dosage and administration schedule based on the growth response.
-Serum insulin-like growth factor I (IGF-I) levels may be useful during dose titration.
-Response to therapy in pediatric patients tends to decrease with time, however, failure to increase height velocity, particularly during the first year of treatment, should prompt close assessment of compliance and evaluation of other causes of poor growth, such as hypothyroidism, under-nutrition, advanced bone age, and antibodies to recombinant human growth hormone.
-Treatment for short stature should be discontinued when the epiphyses are fused.

Uses:
-Treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone (GH).
-Treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing

Liver Dose Adjustments

Data not available

Dialysis

Children with chronic renal disease:
-Hemodialysis: administer at night just prior to going to sleep, or at least 3 to 4 hours after hemodialysis to prevent hematoma formation due to heparin.
-Chronic Cycling Peritoneal Dialysis (CCPD): administer in the morning after dialysis is completed.
-Chronic Ambulatory Peritoneal Dialysis (CAPD): administer in the evening at the time of the overnight exchange.

Somatropin Pregnancy Warnings

Animal studies did not show any teratogenicity or adverse effects on gestation, morphogenesis, parturition, lactation, postnatal development, or reproductive capacity of the offspring; a slight increase in fetal death and increased body weight of pups, and reduced pregnancy rate, increased litter size, irregular estrus cycles, and decreased sperm motility in the parents were seen. There are no controlled data in human pregnancy. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended unless clearly needed. AU TGA pregnancy category: B2 US FDA pregnancy category: C Comments: -Women of childbearing potential should use contraception. -Some formulations are AU TGA pregnancy category B1 or US FDA pregnancy category B: the manufacturer product information should be consulted.

Somatropin Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown

Following subcutaneous administration of radiolabeled medication in animal studies, radioactivity was transferred to milk reaching four times the concentration found in maternal plasma. However, absorption of the intact protein in the gastrointestinal tract of the infant is considered extremely unlikely.

Administrative Information

LactMed Record Number

608

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

(web3)