CinnaTropin (Somatropin)

CinnaTropin is the brand name for the recombinant growth hormone (somatropin).

• CinnaTropin is used for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH).

• CinnaTropin is used for the treatment of pediatric patients with short stature associated with Turner syndrome.

• CinnaTropin is used for the treatment of pediatric patients with short stature associated with Noonan syndrome.

• CinnaTropin is used for the treatment of pediatric patients with short stature associated with Parder-Willi syndrome.

• CinnaTropin is used for the treatment of pediatric patients with short stature associated with chronic renal insufficiency.

• CinnaTropin is used for the treatment of pediatric patients who have Idiopathic Short Stature (ISS).

• CinnaTropin is used for the treatment of children born small for gestational age (SGA) who failed to show catch-up growth by 4 years of age or later.

• CinnaTropin is used for the treatment of adults with childhood-onset or adult-onset growth hormone deficiency.

Do not use CinnaTropin if:

• you have a critical illness caused by certain types of stomach or heart surgery, trauma, or breathing problems.

• you are a child with Prader-Willi syndrome who has breathing problems or is severely obese including sleep apnea (briefly stop breathing during sleep).

• you have cancer or other tumors.

• you are allergic to somatropin or any of the ingredients in CinnaTropin.

• your doctor tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy).

• you are a child with closed bone growth plates (epiphyses).

Tell your doctor if you are taking:

• birth control pills or hormone replacement therapy;

• insulin or oral diabetes medicine;

• a steroid (prednisone, dexamethasone, methylprednisolone, and others).

Other drugs may affect somatropin, including prescriptions, over-the-counter medicines, vitamins, and herbal products.

Tell your doctor if you are pregnant or planning to become pregnant during treatment or if you are breastfeeding a baby.

CinnaTropin will be given under the skin and your doctor will prescribe the dose that is right for you.

• Call your doctor at once if you have pain in your knees or hips or limp in walking.

• Call your doctor at once if you have nausea, vomiting, headache, or visual change.

• Use with caution in diabetic patients. These patients may require adjustment of their doses of insulin and/or other hypoglycemic agents.

Edema, hypothyroidism, nausea, vomiting, headache, paresthesia, pain at the injection site, flatulence, abdominal pain, arthralgia, injection site reaction, otitis, and upper respiratory tract infection.

• Fluid retention: fluid retentions are generally transient and dose-dependent. If the symptoms of carpal tunnel syndrome do not get better by decreasing the dose or frequency of somatropin, discontinue therapy.

• Slipped capital femoral epiphyses: Patients undergoing rapid growth or patients with endocrine disorders (including growth hormone deficiency and Turner syndrome) may develop slipped capital femoral epiphyses more frequently. Evaluate any child with pain in their knees, hips or limp in walking.

• Glucose tolerance: CinnaTropin may decrease insulin sensitivity. Diabetic coma and diabetic ketoacidosis have been reported in some patients. Discontinuing CinnaTropin may improve glucose tolerance in some patients.

• Intracranial hypertension: Intracranial hypertension with nausea, papilledema, headache, visual changes, and/or vomiting has been reported. The symptoms usually occur within the first 8 weeks of therapy and symptoms of intracranial hypertension may rapidly resolve after discontinuation or reduction of the dose. Patients with chronic renal impairment and Turner syndrome may be at increased risk for intracranial hypertension.

• Neoplasm: Any pre-existing malignancy should be inactive and treatment complete prior to initiating therapy.

• Scoliosis: Worsening of scoliosis may occur in children experiencing rapid growth. Your doctor will monitor you for any progression in scoliosis.

• Keep CinnaTropin out of the reach of children.

• Do not use it if the solution is leaking, cloudy, or has particles.

• Do not freeze the medicine.

• Keep the medicine away from direct light.