Skytrofa Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Skytrofa Injection (lonapegsomatropin-tcgd) is a once-weekly growth hormone medicine used to treat growth failure in children due to growth hormone deficiency and growth hormone deficiency in adults. It is a long-acting prodrug of somatropin that is injected under the skin using a special auto-injector device. Skytrofa belongs to the growth hormones drug class.

What is Skytrofa Injection

Skytrofa is a once-weekly growth hormone injection used to treat growth hormone deficiency in children and adults. It is a long-acting prodrug of somatropin, a lab-made version of human growth hormone, given under the skin using a special auto-injector device.

Skytrofa Injection uses

• Treatment of growth failure in children 1 year and older who weigh at least 11.5 kg (about 25 lb) due to not enough natural growth hormone
• Treatment of growth hormone deficiency in adults who cannot make enough of their own growth hormone

Benefits of Skytrofa Injection

• Only needs to be injected once a week instead of daily
• In a clinical trial, children treated with Skytrofa grew faster over one year than those on daily growth hormone injections (11.2 cm/year vs 10.3 cm/year)
• In adults, Skytrofa reduced trunk body fat and increased lean body mass compared with placebo
• The auto-injector automatically mixes the medicine and guides you through the injection

How Skytrofa Injection works

Skytrofa attaches growth hormone to a carrier molecule that slowly breaks apart after injection, releasing active growth hormone steadily over the week. The growth hormone then attaches to receptors on cells, which triggers growth effects, including stimulating bone and tissue growth in children with growth hormone deficiency.

Skytrofa Injection dosage

Skytrofa is given once weekly as an injection under the skin, at any time of day. It can be injected into the stomach (abdomen), thigh, or buttocks; change the injection site with every injection to reduce the risk of skin or fat problems. Do not inject through clothing; clean the injection site with an alcohol wipe and inject directly into the skin. Do not touch the cleaned skin area before injecting, and do not fan or blow on it. Wash your hands before preparing and giving the injection.

If a cartridge has been refrigerated, let it sit at room temperature for 15 minutes before use. Use the mixed medicine within a few hours of mixing, as instructed by your healthcare provider. Check that the mixed medicine looks clear and colorless before injecting; do not use it if it looks cloudy or has particles in it.

When switching from a daily growth hormone injection, wait at least 8 hours between the last daily dose and the first Skytrofa dose. When switching from another weekly growth hormone product, wait at least 7 days before starting Skytrofa.

If a dose is missed, give it as soon as possible, but not more than 2 days after the missed dose. If more than 2 days have passed, skip the missed dose and give the next dose on the regular schedule; at least 5 days should pass between doses.

Never share the auto-injector or needles with another person, even if the needle has been changed. The auto-injector should only be used after training from a healthcare provider. Do not use the auto-injector with other medicines or needles, and never reuse needles.

Available forms and strengths

Skytrofa is available as an injection powder in single-dose, dual-chamber, prefilled cartridges, for use with the Skytrofa Auto-Injector.

Side effects of Skytrofa Injection

Common

• Viral infection
• Fever
• Cough
• Nausea and vomiting
• Bleeding, mostly nosebleeds and bruising
• Diarrhea
• Stomach/abdominal pain
• Joint pain and arthritis
• Swelling from fluid build-up (mostly in adults)
• Low thyroid hormone levels (mostly in adults)

Serious

• Serious allergic reactions, including swelling of face, mouth, tongue, or throat, or trouble breathing (anaphylaxis, angioedema)
• Increased risk of death in people with critical illness from heart or stomach surgery, trauma, or serious breathing problems
• Increased risk of tumor growth or return, particularly in people previously treated with radiation to the brain or head
• New or worsening high blood sugar or diabetes
• Increased pressure in the skull (intracranial hypertension) with headaches, eye problems, nausea, or vomiting
• Fluid retention causing swelling, joint or muscle pain, or nerve problems like tingling or burning in hands, arms, legs, feet
• Decrease in cortisol levels (hypoadrenalism)
• Decrease in thyroid hormone levels (hypothyroidism)
• Hip and knee pain or limp in children (slipped capital femoral epiphysis), which may lead to bone tissue death (osteonecrosis)
• Worsening curvature of the spine in children (scoliosis)
• Severe and constant abdominal pain, possibly a sign of pancreatitis
• Loss of fat and tissue weakness at the injection site (lipoatrophy)
• High risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems
• Increases in phosphate, alkaline phosphatase, and parathyroid hormone levels in blood

Warnings and precautions

• Do not use Skytrofa if you have a critical illness from certain heart or stomach surgery, trauma, or breathing problems, due to an increased risk of death.
• Do not use Skytrofa if you are allergic to somatropin or any of its ingredients, have active cancer, certain diabetes-related eye problems, or are a child with closed growth plates.
• Do not use in children with Prader-Willi syndrome who are severely obese or have severe breathing problems, due to a risk of sudden death.
• Do not use the auto-injector for the first time without training from a healthcare provider, as incorrect use may cause the wrong dose, injury, or infection.
• Never share the auto-injector with another person, even if the needle has been changed, because of the risk of spreading or catching serious infection.
• Keep the device and cartridges away from children; small parts are a choking hazard and the cable is a strangulation hazard.
• There isn't enough information to know whether Skytrofa is safe during pregnancy. Tell your healthcare provider if you are pregnant or plan to become pregnant.
• There is no information on whether Skytrofa passes into breast milk, but similar large proteins are expected to pass into milk only in small amounts with limited effects on a nursing infant. Talk to your healthcare provider about the benefits of breastfeeding versus your need for this medicine.
• No specific studies have looked at how Skytrofa works in people with kidney problems or in people with liver problems.
• No major direct interaction with alcohol is established, although excessive alcohol may negatively affect metabolic health.

Storage

• Refrigerate cartridges at 36°F to 46°F (2°C to 8°C) in the outer carton to protect from light until the expiration date
• Do not freeze
• Outer cartons containing blistered cartridges may instead be stored at room temperature, up to 86°F (30°C), for up to 6 months, and can be returned to the refrigerator within those 6 months
• Write down the date the cartridge was first removed from the refrigerator on the outer carton
• Do not use beyond the expiration date or 6 months after first removal from the refrigerator, whichever comes first
• Store the auto-injector itself at room temperature between 59°F to 86°F (15°C to 30°C) between uses, with the protective cover on
• The auto-injector can be stored between 14°F to 104°F (-10°C to 40°C) when not in use
• Keep the auto-injector away from dirt, dust, humid or wet places, direct sunlight, and extreme temperatures
• Put used cartridges and needles in an FDA-cleared sharps disposal container right away after use; do not throw loose needles and cartridges in household trash
• Do not recycle a used sharps disposal container; follow community guidelines or state/local laws for disposing of a full sharps container
• The auto-injector, including its battery, must be returned to the manufacturer for proper disposal as electronic waste; do not throw it away in household trash
• Packaging material (not including cartridges) may be thrown away with household waste

When to see a doctor

• Get medical help right away if you have signs of a serious allergic reaction, such as swelling of the face, mouth, tongue, or throat, or trouble breathing.
• Contact your healthcare provider if you notice sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or skin color.
• Contact your healthcare provider if headaches, eye problems, nausea, or vomiting occur, as these could be signs of increased pressure in the skull.
• Contact your healthcare provider if you notice swelling in the hands and feet, joint or muscle pain, or nerve pain, burning, or tingling, which can be signs of fluid retention.
• Tell your healthcare provider right away if you experience extreme fatigue, dizziness, weakness, weight loss, or darkening of the skin, which may be signs of low cortisol.
• Get medical help right away for a child who develops a limp or hip or knee pain, which may signal a bone problem.
• Tell your healthcare provider about any new, severe, or constant abdominal pain, which could be a sign of pancreatitis.
• If you think you have used too much Skytrofa, contact your healthcare provider or seek emergency care; call your local poison control center if needed.