Lonapegsomatropin-tcgd
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
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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Package and Label Display Panel
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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.