somapacitan

Contraindicated in:

Hypersensitivity;
Acute critical illness secondary to complications of open heart surgery, abdominal surgery or trauma, or those with acute respiratory failure;
Active malignancy;
Diabetic retinopathy;
Closed epiphyses (children only);
Prader-Willi syndrome in children who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment (↑ risk of sudden death);
Severe hepatic impairment (adults and children);
Moderate hepatic impairment (children only).

Use Cautiously in:

Pre-existing skin nevi (↑ risk of becoming malignant);
Diabetes (may cause insulin resistance) or prediabetes;
Hypoadrenalism;
Hypothyroidism;
Scoliosis (may worsen condition; children only);
Moderate hepatic impairment (↓ dose in adults only);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <2.5 yr (safety and effectiveness not established); childhood cancer survivors treated with radiation to the brain/head (↑ risk of cancer);
Geri: Older adults may have ↑ sensitivity to effects and ↑ risk of adverse reactions.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension, peripheral edema

EENT: tonsillitis

Endo: adrenal insufficiency, hyperglycemia, hyperparathyroidism

F and E: hyperphosphatemia

GI: dyspepsia, PANCREATITIS, vomiting

Hemat: anemia

Local: lipohypertrophy/lipoatrophy

Metab: weight gain

MS: back pain, ↑CK, arthralgia, slipped capital femoral epiphysis (children);

Neuro: dizziness, INTRACRANIAL HYPERTENSION, sleep disorders

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

May ↓ effects of cortisone or prednisone; patients being treated with these glucocorticoids for hypoadrenalism may require an ↑ in their stress or replacement doses.
Estrogens (oral) may ↓ effectiveness; may need to ↑ somapacitan dose.
May ↓ effectiveness of hypoglycemic agents; may need to ↑ doses of hypoglycemic agents.

Availability ⬆ ⬇

Solution for injection (prefilled pens): 5 mg/1.5 mL; 10 mg/1.5 mL; 15 mg/1.5 mL

Route/Dosage ⬆ ⬇

SC (Adults ): 1.5 mg once weekly; may ↑ weekly dosage every 2–4 wk by 0.5–1.5 mg until desired clinical response and serum insulin-like growth factor 1 concentrations achieved (max dose = 8 mg once weekly). Concurrent use of estrogens in women: 2 mg once weekly; may ↑ weekly dosage every 2–4 wk by 0.5–1.5 mg until desired clinical response and serum insulin-like growth factor 1 concentrations achieved (max dose = 8 mg once weekly).
SC (Adults ≥65 yr): 1 mg once weekly; may ↑ weekly dosage every 2–4 wk by 0.5 mg until desired clinical response and serum insulin-like growth factor 1 concentrations achieved (max dose = 8 mg once weekly).
SC (Children ≥2.5 yr): 0.16 mg/kg (actual body weight) once weekly.

Hepatic Impairment

SC (Adults ): Moderate hepatic impairment: 1 mg once weekly; may ↑ weekly dosage every 2–4 wk by 0.5 mg until desired clinical response and serum insulin-like growth factor 1 concentrations achieved (max dose = 4 mg once weekly).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a human GH analog and binds to GH receptor in the cell membrane of target cells resulting in multiple effects, some of which are mediated by insulin-like growth factor 1 produced in the liver.

Therapeutic effects:

Reduction in truncal fat percentage.

Classifications ⬆ ⬇

Therapeutic Classification: hormones

Pharmacologic Classification: growth hormones

Pharmacokinetics ⬆ ⬇

Absorption: Unknown.

Distribution: Somewhat distributed to extravascular tissue.

Protein Binding: >99%.

Metabolism/Excretion: Metabolized via proteolytic cleavage. Primarily excreted in urine (81%) as broken down peptides, with 13% excreted in the feces (as broken down peptides).

Half-Life: 2–3 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	4–24 hr	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. If dose is missed ≤3 days, administer as soon as possible; then resume usual schedule. If dose missed >3 days, skip missed dose and administer next dose on the next regular dosing day. Educate on the importance of adhering to routine laboratory testing.
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.
Advise patient/caregiver to seek immediate medical attention if signs/symptoms hypersensitivity reactions (anaphylaxis, angioedema) occur.
Advise childhood cancer survivors/caregivers treated with radiation to the head that they are ↑ risk for secondary neoplasms and to monitor for recurrence. Advise them to report changes in skin pigmentation and appearance of pre-existing nevi.
Advise patient/caregiver that new onset insulin resistance and hyperglycemia may occur. Advise those with glucose intolerance or risk factors for diabetes to closely monitor their blood glucose.
Advise patient/caregiver to report symptoms of intracranial hypertension, including visual changes, headache, and nausea or vomiting.
Advise patient/caregiver to monitor weight for fluid retention and to report signs and symptoms of edema, arthralgia, myalgia, or nerve compression syndromes.
Advise patient/caregiver to notify health care professional if new onset persistent severe abdominal pain develops.
Educate patient/caregiver to monitor injection sites for inflammation, itching, pain, redness, and swelling and to rotate sites to ↓ risk.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇