lonapegsomatropin

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	25 hr	unknown

Contraindicated in:

Hypersensitivity;
Acute critical illness secondary to complications of open heart surgery, abdominal surgery, or trauma; those with acute respiratory failure (↑ risk of mortality);
Closure of epiphyses;
Active malignancy (↑ risk of progression);
Diabetic retinopathy (↑ risk of progression);
Prader-Willi syndrome with severe obesity and have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment (↑ risk of mortality).

Use Cautiously in:

Growth hormone deficiency due to intracranial neoplasm (↑ risk of second neoplasm);
Genetic causes of short stature (↑ risk of malignancy);
Diabetes or risk factors for type 2 diabetes (may cause insulin resistance);
Pituitary hormone deficiency or hypoadrenalism;
Undiagnosed or untreated hypothyroidism;
Scoliosis (may ↑ risk of progression).

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema

Endo: hyperglycemia, hyperparathyroidism, hypothyroidism

F and E: hyperphosphatemia

GI: ↑alkaline phosphatase, nausea, vomiting, abdominal pain, diarrhea, PANCREATITIS

Hemat: bleeding

Local: lipoatrophy

MS: arthralgia

Neuro: intracranial hypertension

Resp: cough

Misc: fever, infection, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

Excessive corticosteroid use (equivalent to 10–15 mg/m²/day) may ↓ response to growth hormone. May also suppress response of corticosteroid replacement therapy for hypoadrenalism (may require higher doses of the corticosteroid).
Oral estrogen may ↓ response to growth hormone; may require higher dose of lonapegsomatropin.
May ↓ effects of insulin and other antihyperglycemic agents.

Route/Dosage ⬆ ⬇

SUBQ (Children ≥1 yr and 85–100 kg): Patients naive to therapy or switching from somatropin therapy: 22 mg once weekly; titrate dose based on clinical response.
SUBQ (Children ≥1 yr and 70–84.9 kg): Patients naive to therapy or switching from somatropin therapy: 18.2 mg once weekly; titrate dose based on clinical response.
SUBQ (Children ≥1 yr and 60.5–69.9 kg): Patients naive to therapy or switching from somatropin therapy: 15.2 mg once weekly; titrate dose based on clinical response.
SUBQ (Children ≥1 yr and 51–60.4 kg): Patients naive to therapy or switching from somatropin therapy: 13.3 mg once weekly; titrate dose based on clinical response.
SUBQ (Children ≥1 yr and 42–50.9 kg): Patients naive to therapy or switching from somatropin therapy: 11 mg once weekly; titrate dose based on clinical response.
SUBQ (Children ≥1 yr and 35–41.9 kg): Patients naive to therapy or switching from somatropin therapy: 9.1 mg once weekly; titrate dose based on clinical response.
SUBQ (Children ≥1 yr and 29–34.9 kg): Patients naive to therapy or switching from somatropin therapy: 7.6 mg once weekly; titrate dose based on clinical response.
SUBQ (Children ≥1 yr and 24–28.9 kg): Patients naive to therapy or switching from somatropin therapy: 6.3 mg once weekly; titrate dose based on clinical response.
SUBQ (Children ≥1 yr and 20–23.9 kg): Patients naive to therapy or switching from somatropin therapy: 5.2 mg once weekly; titrate dose based on clinical response.
SUBQ (Children ≥1 yr and 16.5–19.9 kg): Patients naive to therapy or switching from somatropin therapy: 4.3 mg once weekly; titrate dose based on clinical response.
SUBQ (Children ≥1 yr and 14–16.4 kg): Patients naive to therapy or switching from somatropin therapy: 3.6 mg once weekly; titrate dose based on clinical response.
SUBQ (Children ≥1 yr and 11.5–13.9 kg): Patients naive to therapy or switching from somatropin therapy: 3 mg once weekly; titrate dose based on clinical response.

Availability ⬆ ⬇

Lyophilized powder for injection (prefilled cartridges): 3 mg; 3.6 mg; 4.3 mg; 5.2 mg; 6.3 mg; 7.6 mg; 9.1 mg; 11 mg; 13.3 mg

Assessment ⬆ ⬇

Monitor for hypersensitivity reactions (anaphylaxis, angioedema). If these occur, implement emergency medical support (epinephrine).
Assess for fluid retention (edema, arthralgia, myalgia) and nerve compression syndromes (carpal tunnel, paresthesia).
Assess for onset of a limp or persistent hip/knee pain. May cause slipped capital femoral epiphysis and osteonecrosis.
Assess for intracranial hypertension with papilledema (visual changes, headache, nausea/vomiting). Obtain fundoscopic examination to assess for preexisting papilledema,before starting therapy and periodically thereafter. If papilledema is observed, discontinue therapy. If somatropin-induced intracranial hypertension is confirmed, restart therapy at ↓ dose once signs and symptoms have resolved.
Assess for signs and symptoms of pancreatitis (abdominal pain, bloating, nausea/vomiting).
Monitor patients with preexisting tumors for progressions or recurrence. Discontinue therapy if there is evidence of recurrent malignancy.

Lab Test Considerations:

May ↑ serum phosphate, alkaline phosphatase, and parathyroid hormone. Monitor as appropriate.
May ↓ serum cortisol levels. Patients may require ↑ glucocorticoid dose in known hypoadrenalism.
Monitor glucose levels, especially in type 1 and 2 diabetes. Adjust doses of antihyperglycemic drugs as needed.

Implementation ⬆ ⬇

Therapy should be supervised by a qualified health care professional experienced in the diagnosis and management of pediatric patients with growth failure due to growth hormone deficiency. Discontinue therapy once epiphyseal fusion has occurred.
Use cartridges with manufacturer-supplied autoinjector. It is designed for automatic reconstitution of cartridge. Autoinjector must be fully charged (requires 2 hr and 30 min) before 1st use; ensure sufficient battery life for administration (full charge allows ≥4 injections). Device cannot be used when autoinjector is charging.
The autoinjector device should never be used for >1 person (even if the needle is changed) because the risk of infection.
Store cartridges (before reconstitution) in the refrigerator in the outer carton to protect from light. Do not freeze. Outer carton containing blistered cartridges may be stored at room temperature for up to 6 mo and can be returned to refrigeration within the 6 mo. Write the date 1st removed from the refrigerator in the space provided on the outer carton. Do not use beyond the expiration date or 6 mo after the date it was first removed from refrigeration (whichever is earlier). Store autoinjector device >12 inches from microwaves and/or electronic devices with antennas (mobile phones, Wi-Fi transceivers).
SUBQ: Administer once weekly. If refrigerated, allow to warm for 15 min at room temperature. Connect needle (with cover on) to dose cartridge. Turn autoinjector on; when autoinjector indicates ready for use, insert cartridge until it clicks into device. Ensure cartridge is standing upright on a flat surface and wait for 4–8 min for automatic mixing. Once automated mixing is complete, hand mix by turning the autoinjector straight up and straight down 5–10 times (an audible click should be heard with each turn); two loud beeps will be heard when mixing is complete; if hand mixing is not performed within 2 hr of automatic mixing, the autoinjector will cancel the procedure and that cartridge will be unusable. After hand mixing is complete, keep autoinjector upright for automatic air removal; once complete, autoinjector is ready for administration; administer within 2 hr of final mixing. Use cartridges within 4 hr after reconstitution. Discard reconstituted cartridges after 4 hr if stored at room temperature.
SUBQ: Immediately before administration, pull needle cover off (do not twist) and save for later. View inspection window to ensure medication is mixed; solution should be clear and colorless; some air bubbles may be visible; do not use if particles are visible or solution is discolored. Administer SUBQ into the abdomen (excluding area around navel), thighs, or buttocks; rotate injection site with each dose. Press and hold green top of autoinjector against skin for 10–15 sec; do not remove from skin until autoinjector indicates injection is complete. Following injection, a buzzing sound will occur while autoinjector unlocks cartridge; once unlocked, the needle cover may be replaced; press down on needle cover to release cartridge. Remove cartridge by pulling straight up (do NOT twist) and dispose in appropriate container. If two injections are needed to complete dose, repeat entire process with new cartridge.
Pedi: Failure to ↑ growth rate, during the 1st yr of therapy, indicates need for close assessment of compliance and evaluation for other causes of growth failure (hypothyroidism, undernutrition, advanced bone age, and antibodies to recombinant human growth hormone).

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. To avoid missed doses, administer dose 2 days before or after scheduled dose; resume weekly dosing on the previously scheduled day. Give doses >5 days apart. If ≤2 days since scheduled day, administer dose as soon as possible. If >2 days since scheduled day, skip dose and resume at next scheduled dose. Emphasize the importance of routine blood and diagnostic tests.
Advise patient/caregiver on autoinjector instructions for use (www.Skytrofa.com/IFU). Advise to call the Ascendis Pharma Customer Support toll-free number at 1-844-442-7236 (1-844-44-ASCENDIS) for assistance or additional training, if needed. Instruct on proper needle disposal and caution against any reuse of needles.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
If severe or serious systemic hypersensitivity reactions (anaphylaxis and angioedema) occur, advise patient and/or caregiver to seek immediate medical attention and notify health care professional.
Advise patient and/or caregiver to report changes in behavior, onset of headaches, vision disturbances, or changes in skin pigmentation or in the appearance of preexisting nevi to health care professional.
Instruct patient and/or caregiver that new-onset impaired glucose intolerance/type 2 diabetes mellitus or exacerbation of preexisting diabetes mellitus can occur and to monitor blood glucose during treatment.
Advise patient and/or caregiver to report to health care professional any signs or symptoms of fluid retention, visual changes, headache, abdominal pain, nausea, or vomiting.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or expected or if breastfeeding.

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇