lonapegsomatropin

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.

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

Route/Dosage ⬆ ⬇

SC (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.
SC (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.
SC (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.
SC (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.
SC (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.
SC (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.
SC (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.
SC (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.
SC (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.
SC (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.
SC (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.
SC (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.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to growth hormone receptor, stimulating skeletal growth

Therapeutic effects:

Increased skeletal growth in children with growth hormone deficiency.

Classifications ⬆ ⬇

Therapeutic Classification: hormones

Pharmacologic Classification: growth hormones

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following SUBQ administration.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Broken down into amino acids in the liver and kidney. Methoxypolyethylene glycol carrier cleared by kidneys.

Half-Life: 25 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	25 hr	unknown

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.

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Indications ⬇

Contraind./Precautions ⬆ ⬇