Lonapegsomatropin-tcgd

Lonapegsomatropin-tcgd
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tejasvi Aryaputra

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Overview

Lonapegsomatropin-tcgd is a human growth hormone that is FDA approved for the treatment of short stature due to inadequate secretion of endogenous growth hormone. Common adverse reactions include pyrexia, vomiting, abdominal pain, viral infection, nausea, arthralgia, hemorrhage, arthritis, and hemorrhage.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• 0.24 mg/kg body weight is the recommended dosage given once weekly for patients switching from daily somatropin therapy and naïve patients.
• Dosage of Lonapegsomatropin-tcgd should be titrated and individualized based on response of patient.
• Patients should be advised to wait at least 8 hours after final dose of somatropin and first dose of Lonapegsomatropin-tcgd if switching to Lonapegsomatropin-tcgd from somatropin therapy.
• During the first year of Lonapegsomatropin-tcgd treatment, monitor causes if patient experiences failure to increase height velocity.
• Patients who experience epiphyseal fusion should stop Lonapegsomatropin-tcgd treatment.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Lonapegsomatropin-tcgd in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Lonapegsomatropin-tcgd in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Lonapegsomatropin-tcgd FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Lonapegsomatropin-tcgd in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Lonapegsomatropin-tcgd in pediatric patients.

Contraindications

• Patients with abdominal surgery, acute critical illness after open heart surgery, or acute respiratory failure due to the risk of increased mortality with use of somatropin.
• Patients with post-marketing use of somatropin products have experienced systemic hypersensitivity reactions.
• Patients with hypersensitivity to somatropin or any of the excipients in Lonapegsomatropin-tcgd.
• Patients with closed epiphyses and active malignancy.
• Patients with active proliferative or severe non-proliferative diabetic retinopathy as a result of somatropin treatment that may worsen these conditions.
• Patients with Prader-Willi syndrome who have a history of upper airway obstruction, are severely obese, have severe respiratory impairment, or have sleep apnea.

Warnings

Increased Mortality in Patients with Acute Critical Illness

• After treatment with pharmacologic doses of somatropin, complications in patients following abdominal surgery, open heart surgery, or multiple accidental trauma have increased mortality risk due to acute critical illness.
• After treatment with pharmacologic doses of somatropin, complications in patients with acute respiratory failure have increased mortality risk due to acute critical illness.
• Data on safety of patients receiving replacement doses with Lonapegsomatropin-tcgd treatment have not been established.

Severe Hypersensitivity

• Post-marketing use of somatropin products have caused angioedema and anaphylactic reactions in patients.
• Advise patients to seek medical attention if they experience severe allergic reactions.
• Advise patients with known hypersensitivity to excipients in Lonapegsomatropin-tcgd or somatropin to not take Lonapegsomatropin-tcgd.

Increased Risk of Neoplasms

Active Malignancy

• Patients with active malignancy that are being treated with somatropin have a high risk of malignancy progression.
• When treated with Lonapegsomatropin-tcgd, there should be no active preexisting malignancy.
• Advise patients that display evidence of recurrent malignancy to stop Lonapegsomatropin-tcgd treatment.

Risk of Second Neoplasm in Pediatric Patients

• There is an increased risk second neoplasm in patients that had childhood cancer which was treated with radiation for their first neoplasm. These patients used somatropin treatment to deal with GHD.
• The most common second neoplasms reported in patients were intracranial tumors.
• Patients with a history of GHD secondary to an intracranial neoplasm that is during somatropin therapy should be monitored.

New Malignancy During Treatment

• Advise patients that have high risk malignancies to monitor the risks of somatropin therapy.
• Monitor patients for neoplasms, potential malignant changes of preexisting nevi, and increased growth of preexisting nevi with somatropin treatment.
• Report any changes in behavior and appearance preexisting nevi during somatropin treatment.

Glucose Intolerance and Diabetes Mellitus

• A decrease in insulin sensitivity may occur in patients taking high doses of somatropin.
• Monitor the glucose levels in patients taking Lonapegsomatropin-tcgd.
• Adjust the doses of antihyperglycemic drugs during Lonapegsomatropin-tcgd treatment in patients with impaired glucose tolerance, preexisting type 1 diabetes mellitus or preexisting type 2 diabetes mellitus.

Intracranial Hypertension

• Small number of patients treated with somatropin have reported intracranial hypertension with headache, papilledema, vomiting, and/or visual changes.
• Reduction or cessation of somatropin resolved IH-associated symptoms and signs.
• Somatropin treatment should be stopped if papilledema is observed.
• When IH-associated symptoms and signs are resolved, Lonapegsomatropin-tcgd treatment may be restarted at low doses.

Fluid Retention

• Somatropin therapy may cause fluid retention.
• Fluid retention are usually dose dependent and transient.

Hypoadrenalism

• Unmasking of central hypoadrenalism and reduced serum cortisol levels may occur in patients at risk for pituitary hormone deficiency when taking somatropin.
• After starting Lonapegsomatropin-tcgd treatment, patients with glucocorticoid replacement for previously diagnosed hypoadrenalism may require stress dose increase.
• Monitor hypoadrenalism patients taking Lonapegsomatropin-tcgd for reduced serum cortisol levels.
• Monitor hypoadrenalism patients taking Lonapegsomatropin-tcgd for an increase in glucocorticoid dose.

Hypothyroidism

• Optimal response by Lonapegsomatropin-tcgd in patients may be prevented by untreated or undiagnosed hypothyroidism.
• Advise patients to take periodic thyroid function tests.
• Monitor thyroid levels and adjust or initiate thyroid hormone replacement therapy if necessary.

Slipped Capital Femoral Epiphysis

• Rapid growth may cause more frequent slipped capital femoral epiphysis in patients.
• Monitor persistent hip or knee pain.

Progression of Preexisting Scoliosis

• Rapid growth may cause progression of existing scoliosis in patients.
• Monitor patients that have a history of scoliosis.

Pancreatitis

• Pediatric patients have experienced pancreatitis when taking somatropin.
• Monitor patients with persistent severe abdominal pain which can be a sign of pancreatitis.

Lipoatrophy

• Lipoatrophy may occur when Lonapegsomatropin-tcgd is given subcutaneously at the same site over a long period of time.
• Reduce the risk of lipoatrophy by rotating Lonapegsomatropin-tcgd injection sites.

Sudden Death in Pediatric Patients with Prader-Willi Syndrome

• Pediatric patients with Prader-Willi syndrome have experienced fatalities when starting somatropin therapy.
• Advise pediatric patients with genetically confirmed Prader-Willi syndrome to not be treated with Lonapegsomatropin-tcgd.

Laboratory Tests

• Somatropin treatment may cause an increase in serum levels of alkaline phosphatase, phosphate, and parathyroid hormone.
• Monitor patients that display abnormal laboratory tests.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Lonapegsomatropin-tcgd Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Lonapegsomatropin-tcgd Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Lonapegsomatropin-tcgd Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Lonapegsomatropin-tcgd in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lonapegsomatropin-tcgd in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Lonapegsomatropin-tcgd during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Lonapegsomatropin-tcgd in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Lonapegsomatropin-tcgd in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Lonapegsomatropin-tcgd in geriatric settings.

Gender

There is no FDA guidance on the use of Lonapegsomatropin-tcgd with respect to specific gender populations.

Race

There is no FDA guidance on the use of Lonapegsomatropin-tcgd with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Lonapegsomatropin-tcgd in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Lonapegsomatropin-tcgd in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Lonapegsomatropin-tcgd in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Lonapegsomatropin-tcgd in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Lonapegsomatropin-tcgd Administration in the drug label.

Monitoring

There is limited information regarding Lonapegsomatropin-tcgd Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Lonapegsomatropin-tcgd and IV administrations.

Overdosage

There is limited information regarding Lonapegsomatropin-tcgd overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Lonapegsomatropin-tcgd Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Lonapegsomatropin-tcgd Mechanism of Action in the drug label.

Structure

There is limited information regarding Lonapegsomatropin-tcgd Structure in the drug label.

Pharmacodynamics

There is limited information regarding Lonapegsomatropin-tcgd Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Lonapegsomatropin-tcgd Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Lonapegsomatropin-tcgd Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Lonapegsomatropin-tcgd Clinical Studies in the drug label.

How Supplied

There is limited information regarding Lonapegsomatropin-tcgd How Supplied in the drug label.

Storage

There is limited information regarding Lonapegsomatropin-tcgd Storage in the drug label.

Images

Drug Images

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Patient Counseling Information

There is limited information regarding Lonapegsomatropin-tcgd Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Lonapegsomatropin-tcgd interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Lonapegsomatropin-tcgd Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Lonapegsomatropin-tcgd Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.