Is Lonapegsomatropin approved by the FDA?

Lonapegsomatropin, sold under the brand name Skytrofa, is a form of human growth hormone designed to treat growth hormone deficiencies in pediatric patients. Lonapegsomatropin (Skytrofa) received FDA approval on August 25, 2021. This approval marked a significant advancement in the treatment options available for children with growth hormone deficiencies.

Indications and Usage

Lonapegsomatropin is indicated for use in patients who are at least 1 year old and weigh at least 25 lbs (11.5 kg). It is specifically used to treat pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone. The recommended dosage is 0.24 mg/kg administered subcutaneously once a week.

Administration and Storage

Lonapegsomatropin should be injected under the skin once a week. Patients or caregivers must follow the prescription label directions and medication guides meticulously. The injection site should be rotated to avoid repeated injections in the same location.

Proper storage of the medication is crucial. Lonapegsomatropin should be refrigerated in its outer carton to protect it from light. It must not be frozen. Alternatively, it can be stored at room temperature in the outer carton for up to six months. It should not be used beyond six months after being removed from the refrigerator or if it has expired, whichever comes first.

Side Effects

While lonapegsomatropin is generally safe when used as prescribed, it may cause side effects. Some common side effects include cold symptoms (such as stuffy nose, sneezing, sore throat), nosebleed, fever, cough, stomach pain, nausea, vomiting, diarrhea, and joint pain.

More serious side effects require immediate medical attention. These include severe pain in the knees or hips, numbness or tingling in the wrist or fingers, severe swelling or puffiness in the hands and feet, changes in behavior, vision problems, unusual headaches, changes in mole size or shape, pain or swelling in joints, symptoms of pancreatitis, high blood sugar, increased pressure inside the skull, and signs of adrenal gland problems.

Precautions and Warnings

Patients should avoid using lonapegsomatropin if they have severe illness due to lung failure, complications from recent surgery, active cancer, closed epiphyses, diabetic retinopathy, or if they are overweight with Prader-Willi syndrome and have severe breathing problems.

Drug Interactions

Patients should inform their healthcare provider about all other medications they are taking, including over-the-counter medicines, vitamins, and herbal products. Some drugs, such as birth control pills, hormone replacement therapy, insulin, oral diabetes medicines, and steroids, can interact with lonapegsomatropin.

Conclusion

Lonapegsomatropin (Skytrofa) represents a critical therapeutic option for children with growth hormone deficiencies. Its careful administration and monitoring can help manage and treat growth failure effectively. Patients and caregivers should work closely with healthcare providers to ensure the safe and effective use of this medication.

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