somapacitan

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

Contraind./Precautions ⬆ ⬇

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.

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).

Availability ⬆ ⬇

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

Assessment ⬆ ⬇

Assess BMI and waist circumference/waist-to-hip ratio.
Monitor patients closely with acute critical illness due to complications after heart surgery, abdominal surgery, multiple accidental trauma, and acute respiratory failure. Treatment may ↑ mortality.
Assess for hypersensitivity reactions (anaphylaxis, angioedema) and implement medical interventions (epinephrine) if indicated.
Monitor patients closely with preexisting tumors for progression or recurrence. May ↑ risk of 2nd neoplasm.
Monitor for intracranial hypertension with papilledema (visual changes, headache, nausea/vomiting). Obtain fundoscopic examination before treatment to exclude pre-existing papilledema. If confirmed, evaluate etiology and treat before starting therapy. If papilledema occurs, permanently discontinue somapacitan.
Monitor weight frequently. Fluid retention (edema, nerve compression syndromes such as carpal tunnel syndrome/paresthesia) may occur; may be dose dependent and require dose ↓.
Monitor for pancreatitis (severe abdominal pain, nausea, vomiting).
Assess injection sites. Rotate site with each injection and monitor for lipoatrophy (localized loss of fat tissue).
Evaluate bone mineral density with dual-engery x-ray absorptiometry scan before starting therapy; if abnormal, repeat scan every 1.5–3 yr.
Pedi: Failure to ↑ growth rate during 1st yr of therapy may require assessment and evaluation of other causes of growth failure (hypothyroidism, undernutrition, advanced bone age, antibodies to recombinant human GH). If epiphyses are closed, re-evaluate before continuing therapy. Assess spine for development or progression of scoliosis. Assess for onset of limp or reports of persistent hip or knee pain. May cause slipped capital femoral epiphysis. Do not administer therapy if confirmed Prader-Willi syndrome; may cause sudden death.

Lab Test Considerations:

Monitor serum insulin-like growth factor-1 for growth response. Obtain samples 3–4 days after 1st dose and every 2–4 wk during dose titration.
Monitor glucose periodically during treatment, especially in patients with risk factors of diabetes (obesity, Turner syndrome, family history). Monitor hemoglobin A1c if patient has pre-existing type 1 or type 2 diabetes or prediabetes. Doses of antidiabetic agents may require adjustment.
Monitor for ↓ cortisol levels. May cause hypoadrenalism. Doses for glucocorticoid may require adjustment in known hypoadrenalism.
Monitor thyroid function tests. May ↑ parathyroid hormone levels. Thyroid hormone replacement therapy may need to be started or adjusted.
Monitor phosphorus and alkaline phosphatase. May ↑ levels.
Monitor lipid profile.

Implementation ⬆ ⬇

Administer on same day each wk; rotate injection site weekly. Store unopened pen in refrigerator with cap on. Once opened, use within 6 wk. Pens (opened or unopened) may be at room temperature for 72 hr.
SC: Allow pen to warm to room temperature 30 min before injection. Inspect solution; use only if colorless to slightly yellow with no visible particles/flakes. Each new pen must be primed before use. After prime, set dose knob to appropriate dose. Insert needle into cleaned skin at the abdomen (do not inject within 2 inches of belly button), front of upper thigh, buttock, or outer area of upper arm. Activate device by pressing injection button down; hold button until dose window reads “0.” Continue to hold needle into skin for 6 sec. Do not rub site. Remove and safety discard needle after each injection.

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

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇