Humatrope 5mg /15iu vial (somatropin)

Humatrope 5mg /15iu vial (somatropin)

Brand: Eli-Lilly
Product Code: humatrope_5mg_vial
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Price: $210.00$225.00
Description

HUMATROPE 5mg 15iu vial (somatropin)

  • Generic: somatropin
  • Brand: Humatrope

HUMATROPE® [somatropin (rDNA ORIGIN)] for injection, for subcutaneous use

 

INDICATIONS AND USAGE

Humatrope® is a recombinant human growth hormone (somatropin) indicated for:

 

  • Pediatric Patients: Treatment of children with short stature or growth failure associated with growth hormone (GH) deficiency, Turner syndrome, idiopathic short stature, SHOX deficiency, and failure to catch up in height after small for gestational age birth.
  • Adult Patients: Treatment of adults with either childhood-onset or adult-onset GH deficiency

 

1.2 Adult Patients

Humatrope is indicated for the replacement of endogenous GH in adults with GH deficiency who meet either of the following two criteria

 

Adult-Onset (AO): Patients who have GH deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or

 

Childhood-Onset (CO): Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GH deficient adults. According to current standards, confirmation of the diagnosis of adult GH deficiency in both groups involves an appropriate GH provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic GH deficiency.

 

2 DOSAGE AND ADMINISTRATION

 

For subcutaneous injection.

Therapy with Humatrope should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GH deficiency, Turner syndrome, idiopathic short stature, SHOX deficiency, small for gestational age birth, or adult patients with either childhood-onset or adult-onset GH deficiency.

 

2.1 Reconstitution

 

Vial — Each 5-mg vial of Humatrope should be reconstituted with 1.5 to 5 mL of Diluent for Humatrope. The diluent should be injected into the vial of Humatrope by aiming the stream of liquid gently against the vial wall. Following reconstitution, the vial should be swirled with a GENTLE rotary motion until the contents are completely dissolved. DO NOT SHAKE. The resulting solution should be clear. If the solution is cloudy or contains particulate matter, the contents MUST NOT be injected.

If sensitivity to the diluent should occur, the vials may be reconstituted with Bacteriostatic Water for Injection (Benzyl Alcohol preserved), USP or Sterile Water for Injection, USP. When Humatrope is reconstituted with Bacteriostatic Water for Injection, USP, the solution should be kept refrigerated at 36° to 46°F (2° to 8°C) and used within 14 days. It is important to note that benzyl alcohol used as a preservative in Bacteriostatic Water has been associated with toxicity in newborns. Therefore, Bacteriostatic Water for Injection must not be used to reconstitute Humatrope for use in a newborn infant. When Humatrope is to be administered to a newborn infant it should be reconstituted with the diluent provided or, if the infant is sensitive to the diluent, Sterile Water for Injection, USP. When reconstituted with Sterile Water for Injection the solution should be kept refrigerated at 36° to 46°F (2° to 8°C) and used within 24 hours.

 

2.2 General Administration Guidelines

For all indications, the following general principles for administration should be followed:

  • When using the Humatrope vial the septum of the vial should be wiped with an alcoholic antiseptic solution before and after each injection to prevent contamination of the contents by repeated needle insertions. Sterile disposable syringes and needles should be used. The volume of the syringe should be small enough so that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
  • When using the Humatrope cartridge a sterile disposable needle should be used for each injection.
  • Humatrope should be administered by subcutaneous injection with regular rotation of injection sites to avoid lipoatrophy.
  • For pediatric patients the calculated weekly Humatrope dosage should be divided into equal doses given either 6 or 7 days per week.
  • For adult patients the prescribed dose should be administered daily.

 

2.3 Dosing for Pediatric Patients

The Humatrope dosage and administration schedule should be individualized for each patient based on the growth response. 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. Response to somatropin treatment tends to decrease with time. Somatropin treatment for stimulation of linear growth should be discontinued once epiphyseal fusion has occurred.

The recommended weekly dosages in milligrams (mg) per kilogram (kg) of body weight for pediatric patients are:

a Recent literature has recommended initial treatment with larger doses of somatropin (e.g., 0.067 mg/kg/day), especially in very short children (i.e., height SDS <–3), and/or older pubertal children, and that a reduction in dosage (e.g., gradually towards 0.033 mg/kg/day) should be considered if substantial catch-up growth is observed during the first few years of therapy. On the other hand, in younger SGA children (e.g., approximately <4 years) (who respond the best in general) with less severe short stature (i.e., baseline height SDS values between -2 and -3), consideration should be given to initiating treatment at a lower dose (e.g., 0.033 mg/kg/day), and titrating the dose as needed over time. In all children, clinicians should carefully monitor the growth response, and adjust the somatropin dose as necessary.

Growth hormone deficiency 0.026 to 0.043 mg/kg/day (0.18 to 0.30 mg/kg/week)
Turner syndrome up to 0.054 mg/kg/day (0.375 mg/kg/week)
Idiopathic short stature up to 0.053 mg/kg/day (0.37 mg/kg/week)
SHOX deficiency 0.050 mg/kg/day (0.35 mg/kg/week)
Small for gestational age up to 0.067 mg/kg/day (0.47 mg/kg/week)a
 

2.4 Dosing for Patients with Adult Growth Hormone Deficiency

Either of two approaches to Humatrope dosing may be followed: a non-weight-based regimen or a weight-based regimen.

 

Non-weight based — based on published consensus guidelines, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor I (IGF-I) concentrations. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-I concentrations above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person, and between male and female patients

 

Weight-based — based on the dosing regimen used in the original adult GH deficiency registration trials, the recommended dosage at the start of treatment is not more than 0.006 mg/kg (6 μg/kg) daily. The dose may be increased according to individual patient requirements to a maximum of 0.0125 mg/kg (12.5 μg/kg) daily. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-I concentrations should be used as guidance in dose titration.

A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. Estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.

 

Humatrope® (somatropin for injection) is used to treat:
  • Children who do not make enough growth hormone on their own, have short stature associated with Turner syndrome, or have SHOX deficiency; have idiopathic short stature, which means they are shorter than 98.8% of other children ofthe same age and sex, are growing at a rate not likely to allow them to reach normal adult height, and for whom no other cause of short stature can be found; were born smaller than normal for the number of weeks of pregnancy and who do not catch up in height by 2 to 4 years of age
  • Adults who have growth hormone deficiency that began either in adulthood (as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma) or in childhood. Patients treated for growth hormone deficiency in childhood whose bones have stopped growing should be reevaluated to determine if they should continue growth hormone
Important Safety Information for Humatrope
What is the most important information I should know about Humatrope?
  • Do not take Humatrope if you are having serious complications after having open heart surgery, abdominal surgery, or serious injuries involving many body systems, or are having life-threatening breathing problems. Deaths have been reported in such cases.
  • Do not use Humatrope in children with Prader-Willi syndrome who are severely obese or have a history of blocked upper airways or other severe breathing problems, or sleep apnea. Deaths have been reported in such cases. Humatrope is not approved for the treatment of patients with Prader-Willi syndrome.
  • Do not use Humatrope if you have active cancer. Growth hormone deficiency can be an early sign of some tumors in the brain or pituitary gland. The presence of these types of tumors should be ruled out by your doctor before you start Humatrope.
  • Serious allergic reactions have been reported with Humatrope. Humatrope is contraindicated if you know you have allergies to growth hormone or any of its ingredients. Tell your doctor if you have an allergic reaction. Do not mix Humatrope with the supplied diluent if you are allergic to metacresol or glycerin.
  • Your doctor should check your blood sugar regularly while you are taking Humatrope, especially if you have diabetes, pre-diabetes, or risk factors for diabetes. New cases of type 2 diabetes have been reported in patients taking Humatrope.
  • Tell your doctor if you have any visual changes accompanied by headache, nausea, and/or vomiting while taking Humatrope. This may be a sign of increased pressure in the brain.
  • Adults may retain water during Humatrope treatment. This may be brief and may increase with higher doses of Humatrope.
  • If you have hypoadrenalism and are on glucocorticoid replacement therapy, your doctor may increase your dosage when you initiate growth hormone treatment.
  • Your doctor should test your thyroid function periodically during Humatrope therapy. Thyroid hormone treatment may need to be started or adjusted.
  • Fracture in the ball of the hip joint can occur in children who have endocrine problems and in children who have rapid growth. Any child taking Humatrope who develops a limp or complains of hip or knee pain should be seen by a doctor to check for this.
  • Progression of curvature of the spine (scoliosis) can occur in children who have rapid growth. Humatrope has not been shown to increase the occurrence of this condition. If the child has scoliosis, the doctor should carefully monitor the progression of the scoliosis during Humatrope treatment.
  • Cases of pancreatitis (inflammation of the pancreas) have been reported rarely in children and adults receiving growth hormone. Consult a doctor if you develop abdominal pain while taking Humatrope.
  • You should rotate your injection sites to avoid breakdown of skin and fat. Seek prompt medical attention for any allergic reaction you experience to the injection of Humatrope.
Who should not take Humatrope?

Humatrope should not be used by:

  • People with serious complications after having open heart surgery, abdominal surgery, serious injuries involving many body systems, or with life-threatening breathing problems
  • Children with Prader-Willi syndrome who are severely obese or have a history of severe breathing problems
  • People with active cancer
  • People who have had an allergic reaction to growth hormone
  • People with diabetic disease of the retina (the lining in the back of the eyeball)
  • Children who have closed growth plates in their bones
What should I tell my doctor before taking Humatrope?

Tell your doctor about all of your prescription and over the counter drugs, including cyclosporine, hormone replacement therapy, insulin or other diabetes medications, drugs containing steroids, or drugs for seizures. These medications may need to be adjusted while taking Humatrope.

What are the possible side effects of Humatrope?

Common side effects reported in adults and children taking Humatrope include injection site reactions, allergic reactions to the diluent, and hypothyroidism. Additional common side effects in adults include swelling, joint pain, muscle pain, carpal tunnel syndrome, unusual skin sensations, and high blood sugar.

You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

How should I store Humatrope?

Humatrope must be kept refrigerated (36° to 46°F [2° to 8°C]) before and after it is mixed. Do not freeze. Once Humatrope has been mixed and is in liquid form, cartridges must be used within 28 days and vials must be used within 14 days. Throw away any unused Humatrope in a cartridge after 28 days and in a vial after 14 days. Before giving an injection, check the manufacturer’s expiration date on the cartridge or vial. Do not use the cartridge or vial if it has expired.

Humatrope is available by prescription only.

 

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