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Somapacitan-Beco) Injection, for Subcutaneous Use X Hypersensitivity: Serious Hypersensitivity Reactions May Occur

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Somapacitan-Beco) Injection, for Subcutaneous Use X Hypersensitivity: Serious Hypersensitivity Reactions May Occur HIGHLIGHTS OF PRESCRIBING INFORMATION x Intracranial Hypertension (IH): Has been reported usually within 8 These highlights do not include all the information needed to use weeks of initiation. Perform fundoscopic examinations prior to initiation SOGROYA safely and effectively. See full prescribing information for and periodically thereafter. If papilledema is identified prior to initiation, SOGROYA. evaluate the etiology and treat the underlying cause before initiating. If papilledema occurs with SOGROYA, stop treatment (5.4). SOGROYA® (somapacitan-beco) injection, for subcutaneous use x Hypersensitivity: Serious hypersensitivity reactions may occur. In the Initial U.S. Approval: 2020 event of an allergic reaction, seek prompt medical attention (5.5). x Fluid Retention: May occur in adults and may be dose dependent (5.6). --------------------------INDICATIONS AND USAGE--------------------------- x Hypoadrenalism: Monitor patients for reduced serum cortisol levels SOGROYA is a human growth hormone analog indicated for replacement of and/or need for glucocorticoid dose increases in those with known endogenous growth hormone in adults with growth hormone deficiency(1). hypoadrenalism (5.7). ----------------------DOSAGE AND ADMINISTRATION----------------------- x Hypothyroidism: Monitor thyroid function periodically as x Administer by subcutaneous injection to the abdomen or thigh with hypothyroidism may occur or worsen after initiation of SOGROYA. regular rotation of injection sites to avoid lipohypertrophy/lipoatrophy (5.8). (2.1). x Pancreatitis: Has been reported; consider pancreatitis in patients with x Administer the prescribed dose subcutaneously one time each week persistent severe abdominal pain (5.9). (2.2). x Lipohypertrophy/lipoatrophy: May occur if SOGROYA administered in x Initiate SOGROYA with a dosage of 1.5 mg once weekly for treatment the same location over a long period of time. Rotate injection sites on a naïve patients and patients switching from daily growth hormone (2.2). regular basis (5.10). x Increase the weekly dosage every 2 to 4 weeks by approximately 0.5 mg ------------------------------ADVERSE REACTIONS------------------------------- to 1.5 mg until the desired response has been achieved (2.2). Adverse reactions UHSRUWHGLQ2% of patients treated with SOGROYA are: x Titrate the dosage based on clinical response and serum insulin-like back pain, arthralgia, dyspepsia, sleep disorder, dizziness, tonsillitis, growth factor 1 (IGF-1) concentrations (2.2). peripheral edema, vomiting, adrenal insufficiency, hypertension, blood x The maximum recommended dosage is 8 mg once weekly. creatine phosphokinase increase, weight increase, anemia (6.1). x See the Full Prescribing Information for dosage recommendations in patients aged 65 years and older, patients with hepatic impairment, and To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk women receiving oral estrogen (2.3). Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or ---------------------DOSAGE FORMS AND STRENGTHS---------------------- www.fda.gov/medwatch. Injection: 10 mg/1.5 mL (6.7 mg/mL) somapacitan-beco single-patient-use -----------------------DRUG INTERACTIONS------------------------ prefilled pen (3) x Replacement Glucocorticoid Treatment: Patients treated with -------------------------------CONTRAINDICATIONS------------------------------ glucocorticoid for hypoadrenalism may require an increase in their x Acute critical illness (4) maintenance or stress doses following initiation of SOGROYA (7). x Active malignancy (4) x Cytochrome P450-Metabolized Drugs: SOGROYA may alter the clearance. Monitor carefully if used with SOGROYA (7). x Hypersensitivity to somapacitan-beco or excipients (4) x Oral Estrogen: Larger doses of SOGROYA may be required (7). x Active proliferative or severe non-proliferative diabetic retinopathy (4) x Insulin and/or Other Hypoglycemic Agents: Dose adjustment of insulin -----------------------WARNINGS AND PRECAUTIONS------------------------ or hypoglycemic agent may be required (5.3, 7). x Increased Risk of Neoplasm: There are risks of malignancy progression in patients with active malignancy and of malignant changes of See 17 for PATIENT COUNSELING INFORMATION and FDA- preexisting nevi. Monitor patients with preexisting tumors for approved patient labeling. progression or recurrence (5.2). x Glucose Intolerance and Diabetes Mellitus:SOGROYA may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels Revised: 8/2020 periodically in all patients receiving SOGROYA, especially in patients with existing diabetes mellitus or at risk for its development (5.3). _______________________________________________________________________________________________________________________________________ FULL PRESCRIBING INFORMATION: CONTENTS* 8 USE INSPECIFIC POPULATIONS 8.1 Pregnancy 1 INDICATIONS AND USAGE 8.2 Lactation 2 DOSAGE AND ADMINISTRATION 8.4 Pediatric Use 2.1 Administration and Use Instructions 8.5 Geriatric Use 2.2 Recommended Dosage, Titration, and Monitoring 8.6 Hepatic Impairment 2.3 Recommended Dosage and Titration for Specific Populations 9 DRUG ABUSE AND DEPENDENCE 2.4 Missed Doses 9.1 Controlled Substance 3 DOSAGE FORMS AND STRENGTHS 9.2 Abuse 4 CONTRAINDICATIONS 9.3 Dependence 5 WARNINGS AND PRECAUTIONS 10 OVERDOSAGE 5.1 Increased Mortality in Patients with Acute Critical Illness 11 DESCRIPTION 5.2 Increased Risk of Neoplasms 12 CLINICAL PHARMACOLOGY 5.3 Glucose Intolerance and Diabetes Mellitus 12.1 Mechanism of Action 5.4 Intracranial Hypertension 12.2 Pharmacodynamics 5.5 Severe Hypersensitivity 12.3 Pharmacokinetics 5.6 Fluid Retention 13 NONCLINICAL TOXICOLOGY 5.7 Hypoadrenalism 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.8 Hypothyroidism 14 CLINICAL STUDIES 5.9 Pancreatitis 16 HOW SUPPLIED/STORAGE AND HANDLING 5.10 Lipohypertrophy/Lipoatrophy 17 PATIENT COUNSELING INFORMATION 5.11 Laboratory Tests *Sections or subsections omitted from the full prescribing information 6 ADVERSE REACTIONS are not listed. 6.1 Clinical Trials Experience 6.2 Immunogenicity 7 DRUG INTERACTIONS _______________________________________________________________________________________________________________________________________ Reference ID: 4663035 FULL PRESCRIBING INFORMATION 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 x 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)]. x 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)]. x Administer SOGROYA by subcutaneous injection to the abdomen or thigh with regular rotation of injection sites to avoid lipohypertrophy. x 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. x The SOGROYA prefilled pen dials in 0.05 mg increments and delivers doses from 0.05 mg to 4 mg. x 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 x Administer the prescribed dose subcutaneously one time each week (weekly). x Initiate SOGROYA with a dosage of 1.5 mg once weekly for treatment naïve patients and patients switching from daily growth hormone (somatropin). x Increase the weekly dosage every 2 to 4 weeks by approximately 0.5 mg to 1.5 mg until the desired response is achieved. x 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. x 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. x 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 x SOGROYA is not recommended in patients with severe hepatic impairment. x 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. x 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 x Administer a missed dose as soon
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