Accretropin

Name: Accretropin

Description

Accretropin™ (recombinant human growth hormone (r-hGH); somatropin) is a protein produced by recombinant DNA technology. It is produced during fermentation in E. coli yielding a protein containing 192 amino acids. The N-terminal amino acid, methionine, is later removed to yield a protein that is chemically and physicochemically identical to pituitary derived human growth hormone, consisting of 191 amino acids in a single polypeptide chain.

Accretropin™ (somatropin injection) is distributed in a liquid solution containing 1 mL of a 5 mg/mL solution of growth hormone (15 IU/mL). The formulation also contains 0.75% NaCl, 0.34% Phenol (as preservative), 0.2% Pluronic F-68 (a non-ionic surfactant) and is designed for subcutaneous administration. Accretropin™ (somatropin injection) is stabilized to pH 6.0 with 10 mM NaPO4 buffer.

How supplied

NDC Number Contents
60492-0162-1 A single vial carton containing one multidose vial and a package insert.

REFERENCES

Janssen YJ, Frolich M, Roelfsema F. The absorption profile and availability of a physiological subcutaneously administered dose of recombinant human growth hormone (GH) in adults with GH deficiency. Br J Clin Pharmacol 1999 Mar;47(3):273-8.

Zeisel HJ, Lutz A, von Petrykowski W. Immunogenicity of a mammalian cell-derived recombinant human growth hormone preparation during long-term treatment. Horm Res 1992;37 Suppl 2:47-55.

Manufactured by: Cangene Corporation, Winnipeg, Canada R3T 5Y3. March 2007. FDA Rev date: 1/23/2008

FDA Approves Accretropin

The U.S. Food and Drug Administration has approved Accretropin (somatropin (rDNA origin)) Injection, a recombinant human growth hormone indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone. Accretropin is also indicated for the treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed.

Accretropin is identical in sequence to authentic human growth hormone of pituitary origin. Natural human growth hormone is a protein produced by the pituitary gland that acts on the ends of the long bones of the body (epiphyses) until the onset of puberty and promotes growth to normal stature. A deficiency of this hormone during childhood results in abnormally small stature.

Turner Syndrome is an X-chromosome-linked genetic disorder in girls that results in short stature and infertility.

Source: Cangene

What is the most important information I should know about Accretropin?

If you use a steroid or any medicine to treat diabetes, your doses may need to be changed when you start using Accretropin. Do not stop using or change the dose of your steroid or diabetes medication without your doctor's advice.

Call your doctor at once if you have sudden and severe pain or tenderness in your upper stomach, with nausea, vomiting, sweating, fever, fast heartbeat, and yellowing of the skin or eyes. You should also call your doctor promptly if you have vision changes and sudden, severe pain behind your eyes.

Accretropin should be stored in the refrigerator. Avoid freezing and shaking. Do not use after expiration date stated on the vial and carton labels.

Once opened, Accretropin may be stored up to 14 days when refrigerated. Discard 14 days after first use. Protect from light.

What should I discuss with my healthcare provider before using Accretropin?

Before you receive Accretropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine.

Do not use this medication if you are allergic to Accretropin, or if you have:

  • diabetic retinopathy (a serious eye condition caused by diabetes);
  • cancer; or
  • Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.

You should also not use Accretropin if you have a serious medical condition after having:

  • open heart surgery or stomach surgery;
  • trauma or other medical emergency; or
  • breathing problems (such as lung failure).

Before using Accretropin, tell your doctor if you have:

  • liver disease;
  • kidney disease (or if you are on dialysis);
  • diabetes;
  • scoliosis;
  • high blood pressure (hypertension);
  • a pancreas disorder;
  • cancer (past or present);
  • carpal tunnel syndrome;
  • underactive thyroid; or
  • a brain tumor or lesion.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Accretropin.

FDA pregnancy category C. Accretropin may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Accretropin passes into breast milk or if it could harm a nursing baby. Do not use Accretropin without telling your doctor if you are breast-feeding a baby.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Symptoms of long-term overdose may include excessive growth.

Usual Pediatric Dose for Growth Retardation - Chronic Renal Failure

Up to 0.35 mg/kg of body weight per week, divided into daily subcutaneous injections

Duration of therapy: Therapy may be continued up to the time of renal transplantation.

Comments:
-Therapy should be used in conjunction with optimal management of chronic kidney disease.
-Individualize dosage and administration schedule based on the growth response.
-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.
-To optimize therapy for dialysis patients, the following injection schedules are recommended:
-Hemodialysis patients: 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.

Use: Treatment of growth failure secondary to chronic kidney disease (CKD) up to the time of renal transplantation.

Usual Pediatric Dose for Noonan's Syndrome

Up to 0.066 mg/kg subcutaneously once a day

Comments:
-Not all Noonan syndrome patients have short stature; some will achieve a normal adult height without treatment.
-Establish that the patient does have short stature before starting treatment.
-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.

Use: Treatment of pediatric patients with short stature associated with Noonan Syndrome

Usual Pediatric Dose for Cachexia

0.04-0.07 mg/kg subcutaneously once a day

Comments:
-Safety and effectiveness in pediatric patients with HIV have not been established.
-Somatropin clearance appears similar in adults and children, but no pharmacokinetic studies have been conducted in children with HIV.
-Two small studies (total of 16 patients) of up to 26 weeks duration showed therapy was well tolerated with safety observations consistent with the adult studies.

Use: Treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance

Renal Dose Adjustments

The dosage in children with chronic renal disease must be adjusted according to the individual response to therapy.

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