somatrogon

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	11 hr	unknown

Contraindicated in:

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

Use Cautiously in:

History of GH disorder due to previous intracranial neoplasm (↑ risk of secondary neoplasm);
Diabetes (may cause insulin resistance);
Obesity, Turner syndrome, or family history of diabetes mellitus;
Undiagnosed/untreated hypothyroidism;
Scoliosis;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <3 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema

Derm: rash

EENT: nasopharyngitis, oropharyngeal pain, otitis media, tonsilitis

Endo: adrenal insufficiency, hyperglycemia, hypothyroidism

GI: abdominal pain, pancreatitis, vomiting

Hemat: eosinophilia, anemia

Local: injection site reactions, lipoatrophy

MS: arthralgia, slipped capital femoral epiphysis

Neuro: headache, INTRACRANIAL HYPERTENSION

Resp: bronchitis, cough

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

Interactions ⬆ ⬇

Drug-drug:

May ↓ effectiveness of cortisone and prednisone; may need to ↑ cortisone or prednisone doses during therapy.
Excessive corticosteroid use (equivalent to 10–15 mg/m²/day) may ↓ response to GH.
Effectiveness may be ↓ by estrogen; may need to ↑ somatrogon dose.
May ↓ effectiveness of antihyperglycemic drugs; may need to ↑ dose of antihyperglycemic drugs.

Route/Dosage ⬆ ⬇

SC (Children ≥3 yr): 0.66 mg/kg (actual body weight) once weekly.

Availability ⬆ ⬇

Solution for injection (prefilled pens): 20 mg/mL; 50 mg/mL

Assessment ⬆ ⬇

Monitor for intracranial hypertension with papilledema (visual changes, headache, nausea/vomiting). Obtain fundoscopic examination before treatment to exclude preexisting papilledema. If confirmed, evaluate etiology and treat before starting therapy. If papilledema occurs, permanently discontinue somatrogon.
Monitor patients closely with pre-existing tumors for progression or recurrence. May ↑ risk of 2nd neoplasm.
Monitor weight frequently. Fluid retention (edema and nerve compression syndromes such as carpal tunnel syndrome/paresthesia) may occur; may be dose dependent and require dose ↓.
Assess for hypersensitivity reactions (anaphylaxis, angioedema); implement medical interventions (epinephrine) if indicated.
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.
Monitor for development of pancreatitis (severe abdominal pain, nausea, vomiting).
Assess injection sites. Rotate site with each injection and monitor for lipoatrophy (localized loss of fat tissue).
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 growth hormone). If epiphyses are closed, reevaluate before continuing therapy. 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.
Monitor glucose levels periodically during treatment, especially in patients with risk factors of diabetes (obesity, Turner syndrome, family history). Monitor closely if pre-existing type 1 or type 2 diabetes or prediabetes. Doses of antidiabetic agents may require adjustment.
Monitor thyroid function tests. May ↑ parathyroid hormone levels. Thyroid hormone replacement therapy may need to be started or adjusted.
Monitor for ↓ cortisol levels. May cause hypoadrenalism. Doses for glucocorticoids may require adjustment in known hypoadrenalism.
Monitor phosphorus and alkaline phosphatase. May ↑ levels.

Implementation ⬆ ⬇

Administer on same day each week; rotate injection site weekly. If >one injection, administer each in different site using a new sterile 31- or 32-gauge 8-mm needle. Day of weekly administration may be changed as long as time between doses is >72 hr. Discard pen after five uses, 28 days after 1st use, or if left out >2 hr from refrigerator, even if it is not empty. Pens can be stored in refrigerator for 28 days.
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 pen is primed, set dose knob to appropriate dose, and insert needle into clean 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 10 sec. Do not rub site. The 24-mg pen (20 mg/mL) will administer up to 12 mg/injection in 0.2-mg increments, and the 60-mg pen (50 mg/mL) will administer up to 30 mg/injection in 0.5-mg increments. Remove and safety discard needle after each injection.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient/caregiver. Advise to read Patient Information before starting therapy. If dose is missed ≤3 days, administer as soon as possible; then resume regular once-weekly dosing. If dose missed >3 days, skip missed dose and administer next dose on the regularly scheduled 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. Somatrogon may interfere with hCG pregnancy testing (false positives or false negatives); alternative methods are preferred.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇