Humatrope for salem
HUMATROPE 72IU is a man-made form of human growth hormone used in the treatment of clinical dwarfism.In addition Humatrope is used in the nanism of children with chronic kidney failure. However, It was first approved in 1987 to treat children who are growing slowly because they do not make enough growth hormone on their own.
Important Safety Information and Indications
What is the most important information I should know about Humatrope?
- Do not take this drug if you are having serious complications like after having open heart surgery, abdominal surgery.
- 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.
- 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.
Indications
Furthermore, Humatrope (somatropin for injection) is used to treat children who are short or growing slowly because they:
- Do not make enough growth hormone on their own
- Are suffering from Turner syndrome
- Have idiopathic short stature, which means they are shorter than 98.8% of other children of the same age and sex, are growing at a rate not likely to allow them to reach normal adult height
- suffer from SHOX deficiency
- Were born smaller than normal for the number of weeks of pregnancy and do not catch up in height by 2 to 4 years of age
Humatrope is used to treat adults who have growth hormone deficiency.
Humatrope Dosage and Administration
Administration and Use Instructions
- Therapy with Humatrope should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which Humatrope is indicated.
- Fundoscopic examination should be performed routinely before initiating treatment with Humatrope to exclude preexisting papilledema, and periodically thereafter.
- Leave Humatrope at room temperature for 10 minutes prior to administration.
- Administer Humatrope by subcutaneous injection to the back of the upper arm, abdomen, buttock, or thigh with regular rotation of injection sites to avoid lipoatrophy.
Pediatric Dosage
- Individualize dosage for each patient based on the growth response.
- Divide the calculated weekly Humatrope dosage into equal doses given either 6 or 7 days per week.
- The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
- Pediatric GH Deficiency: 0.18 mg/kg/week to 0.3 mg/kg/week (0.026 to 0.043 mg/kg/day)
- Turner Syndrome: Up to 0.375 mg/kg/week (up to.054 mg/kg/day)
- Idiopathic Short Stature: Up to 0.37 mg/kg/week (up to 0.053 mg/kg/day)
- SHOX Deficiency: 0.35 mg/kg/week (0.05 mg/kg/day)
- Small for Gestational Age (SGA): Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
- In very short pediatric patients, height SDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of Humatrope (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline height SDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed.
- Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment.
- Discontinue Humatrope for stimulation of linear growth once epiphyseal fusion has occurred [see Contraindications (4)].
Adult Dosage
- Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin for GH deficient adults.
- Consider using a lower starting dose and smaller dose increment increases for geriatric patients as they may be at increased risk for adverse reactions with Humatrope than younger individuals.
- Women may require higher doses and patients receiving oral estrogen may require higher doses.
- Administer the prescribed dose daily.
- Either of two Humatrope dosing regimens may be used:
- Non-weight based:
- Initiate Humatrope with a dose of approximately 0.2 mg/day (range, 0.15 mg/day to 0.3 mg/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg/day to 0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations.
- Use the patient’s clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration.
- Maintenance dosages will vary considerably from person to person, and between male and female patients.
- Weight-based:
- Initiate Humatrope at 0.006 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.0125 mg/kg daily.
- Use the patient’s clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration.
- Maintenance dosages will vary considerably from person to person, and between male and female patients
- Not recommended for obese patients as they are more likely to experience adverse reactions with this regimen.
- Non-weight based:
Dosage Forms and Strengths
Humatrope for injection is a white lyophilized powder available in the following vial and cartridge sizes:
- 5 mg vial and a 5-mL vial of Diluent for Humatrope
- 6 mg cartridge (gold) and a prefilled syringe of Diluent for Humatrope
- 12 mg cartridge (teal) and a prefilled syringe of Diluent for Humatrope
- 24 mg cartridge (purple) and a prefilled syringe of Diluent for Humatrope
4 CONTRAINDICATIONS
Humatrope has contraindications in patients with:
- Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin.
- Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death.
- Active malignancy.
- Known hypersensitivity to somatropin or any of the excipients in Humatrope.
- Active proliferative or severe non-proliferative diabetic retinopathy.
- Pediatric patients with closed epiphyses.
How Should I use Humatrope?
Your dose and brand of somatropin, and how often you use it will depend on the condition you are treating. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Injecting humatrope into a muscle is for effective than under the skin. A healthcare provider can teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Do not use Humatrope if you don’t understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.
Prepare your injection only when you are ready to give it. Do not shake the medicine. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.
If your medicine comes with a syringe, cartridge, or injection pen, use only that device to give your medicine.
You may need frequent medical tests.
Follow any diet plan created for you by your doctor or nutrition counselor to help control your condition.
How to store this drug:
How you store this medicine will depend on the Humatrope brand and the diluent you are using. Ask your pharmacist if you have any questions about proper storage of your medication.
Throw away any Humatrope left over after the expiration date on the label has passed.
Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.
Call your doctor if you miss more than 3 doses in a row.
What happens if I overdose?
Just like every other HGH products, seek emergency medical attention if you overdose.
Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.
What should I avoid while using Humatrope?
Avoid drinking fruit juice and soda beverages
Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.
WARNINGS AND PRECAUTIONS
Acute Critical Illness
Increasing mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic doses of somatropin. Two placebo-controlled clinical studies in non-GH deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3-8.0 mg/day) compared to those receiving placebo.
Sudden Death in Pediatric Patients with Prader-Willi Syndrome
There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females.
Increased Risk of Neoplasms
Active Malignancy
There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with Humatrope. Discontinue Humatrope if there is evidence of recurrent activity.
Risk of Second Neoplasm in Pediatric Patients
Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence. Monitor all patients receiving Humatrope who have a history of GH deficiency secondary to an intracranial neoplasm for progression or recurrence of the tumor.
New Malignancy During Treatment
Because pediatric patients with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting Humatrope in these patients. When initiating humatrope, carefully monitor patients for development of neoplasms.
Monitor all patients receiving Humatrope carefully for increased growth, or potential malignant changes, of preexisting nevi. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of pre-existing nevi.
Glucose Intolerance and Diabetes Mellitus
Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving Humatrope, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus.
Intracranial Hypertension
Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose.
Severe Hypersensitivity
Do not use Humatrope in patients with known hypersensitivity to somatropin or any of the excipients in Humatrope. Do not use Humatrope cartridges or the diluent supplied with Humatrope vials in patients with known hypersensitivity to metacresol or glycerin
Fluid Retention
Fluid retention during somatropin replacement therapy may frequently occur.Moreover, Clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent.
Hypoadrenalism
Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Humatrope treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.
Hypothyroidism
Undiagnosed/untreated hypothyroidism may prevent an optimal response to Humatrope, in particular, the growth response in pediatric patients. Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism. Also, In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment.
Slipped Capital Femoral Epiphysis in Pediatric Patients
Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of hip or knee pain.
Progression of Preexisting Scoliosis in Pediatric Patients
Somatropin increases the growth rate, and progression of existing scoliosis can occur in patients who experience rapid growth. Monitor patients with a history of scoliosis for progression of scoliosis.
Pancreatitis
The risk will be greater risk in pediatric patients than with adults. Published literature indicates that girls who have Turner syndrome are likely to be at greater risk than other pediatric patients receiving somatropin products.
Lipoatrophy
Laboratory Tests
Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone and IGF-I may increase after Humatrope therapy.
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