SOGROYA

SOGROYA- somapacitan injection, solution
Novo Nordisk

1 INDICATIONS AND USAGE

SOGROYA is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (GHD).

2 DOSAGE AND ADMINISTRATION

2.1 Administration and Use Instructions

Therapy with SOGROYA should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which SOGROYA is indicated [see Indications and Usage (1)].
Perform fundoscopic examination before initiating treatment with SOGROYA to exclude preexisting papilledema, and periodically thereafter. If papilledema is identified, evaluate the etiology and treat the underlying cause before initiating therapy with SOGROYA [see Warnings and Precautions (5.4)].
Administer SOGROYA by subcutaneous injection to the abdomen or thigh with regular rotation of injection sites to avoid lipohypertrophy.
Inspect visually for particulate matter and discoloration. SOGROYA should be a clear to slightly opalescent and colorless to slightly yellow solution. If the solution is cloudy or contains particulate matter do not use.
The SOGROYA prefilled pen dials in 0.05 mg increments and delivers doses from 0.05 mg to 4 mg.
Instructions for delivering the dosage are provided in the PATIENT INFORMATION and INSTRUCTIONS FOR USE leaflets enclosed with the SOGROYA prefilled pen.

2.2 Recommended Dosage, Titration, and Monitoring

Administer the prescribed dose subcutaneously one time each week (weekly).
Initiate SOGROYA with a dosage of 1.5 mg once weekly for treatment naïve patients and patients switching from daily growth hormone (somatropin).
Increase the weekly dosage every 2 to 4 weeks by approximately 0.5 mg to 1.5 mg until the desired response is achieved.
Titrate the dosage based on clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations. Draw IGF-1 samples 3 to 4 days after the prior dose.
Decrease the dosage as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and sex-specific normal range.
The maximum recommended dosage is 8 mg once weekly.

2.3 Recommended Dosage and Titration for Specific Populations

Patients Aged 65 Years and Older

Initiate SOGROYA with a dosage of 1 mg once weekly and use smaller dose increment increases when titrating the dosage [see Use in Specific Populations (8.5)]. See above for monitoring recommendations and the maximum recommended dosage of SOGROYA [see Dosage and Administration (2.2)].

Patients with Hepatic Impairment

SOGROYA is not recommended in patients with severe hepatic impairment.
For patients with moderate hepatic impairment, initiate SOGROYA with a dosage of 1 mg once weekly and use smaller dose increment increases when titrating the dosage. See above for monitoring recommendations [see Dosage and Administration (2.2)]. The maximum recommended dosage is 4 mg once weekly.
No dosage adjustment is recommended for patients with mild hepatic impairment.

Women Receiving Oral Estrogen

Initiate SOGROYA with a dosage of 2 mg once weekly [see Drug Interactions (7)]. See above for titration and monitoring recommendations and the maximum recommended dosage of SOGROYA [see Dosage and Administration (2.2)].

2.4 Missed Doses

Administer a missed dose as soon as possible and not more than 3 days after the missed dose (72 hours).
If more than 3 days have passed since the missed dose, skip the dose and administer the next dose on the regular dosing day.

3 DOSAGE FORMS AND STRENGTHS

Injection: 10 mg/1.5 mL (6.7 mg/mL) of somapacitan-beco as a clear to slightly opalescent and colorless to slightly yellow solution in a single-patient-use prefilled pen

4 CONTRAINDICATIONS

SOGROYA is contraindicated in patients with:

Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure because of the risk of increased mortality with use of pharmacologic doses of SOGROYA [see Warnings and Precautions (5.1)].
Active malignancy [see Warnings and Precautions (5.2)].
Hypersensitivity to SOGROYA or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with other growth hormone products [see Warnings and Precautions (5.5)].
Active proliferative or severe non-proliferative diabetic retinopathy.

5 WARNINGS AND PRECAUTIONS

5.1 Increased Mortality in Patients with Acute Critical Illness

Increased mortality has been reported after treatment with pharmacologic amounts of growth hormone products in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery and multiple accidental trauma, as well as patients with acute respiratory failure [see Contraindications (4)]. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo. The safety of continuing SOGROYA treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. SOGROYA is not indicated for the treatment of non-GH deficient adults.

5.2 Increased Risk of Neoplasms

Active Malignancy

There is an increased risk of malignancy progression with growth hormone treatment in patients with active malignancy [See Contraindications (4)]. Any preexisting malignancy should be inactive, and its treatment complete prior to instituting therapy with SOGROYA. Discontinue SOGROYA if there is evidence of recurrent activity.

New Skin Malignancy during Treatment

There is a potential risk of malignant changes of preexisting nevi. Monitor all patients receiving SOGROYA carefully for increased growth, or potential malignant changes, of preexisting nevi. Advise patients to report changes in skin pigmentation or changes in the appearance of pre-existing nevi.

5.3 Glucose Intolerance and Diabetes Mellitus

Treatment with growth hormone products may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes mellitus has been reported in patients taking growth hormone products. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic. Monitor glucose levels periodically in all patients receiving SOGROYA, especially in those with risk factors for diabetes mellitus, such as obesity, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or pre-diabetes should be monitored closely. The doses of antidiabetic agents may require adjustment when SOGROYA is initiated.

5.4 Intracranial Hypertension

Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in patients treated with growth hormone products. Symptoms usually occurred within the first eight (8) weeks after the initiation of growth hormone therapy. In all reported cases, intracranial hypertension-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the growth hormone dose.

Perform fundoscopic examination before initiating treatment with SOGROYA to exclude preexisting papilledema and periodically thereafter. If papilledema is identified prior to initiation, evaluate the etiology and treat the underlying cause before initiating SOGROYA. If papilledema is observed by fundoscopy during SOGROYA treatment, treatment should be stopped. If intracranial hypertension is diagnosed, treatment with SOGROYA can be restarted at a lower dose after intracranial hypertension-associated signs and symptoms have resolved.

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