SOGROYA- somapacitan-beco injection, solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

SOMAPACITAN (UNII: 8FOJ430U94) (SOMAPACITAN - UNII:8FOJ430U94)

Mevcut itibaren:

Novo Nordisk

Uygulama yolu:

SUBCUTANEOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

 SOGROYA is indicated for the: SOGROYA is contraindicated in patients with:   Risk Summary There are no available data on the use of SOGROYA during pregnancy; however, published studies describing the use of short-acting recombinant growth hormone (rhGH) during pregnancy over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneously administered somapacitan-beco was not teratogenic in rats or rabbits during organogenesis at doses approximately 12 times the clinical exposure at the maximum recommended human dose (MRHD) of 8 mg/week. No adverse developmental outcomes were observed in a pre- and post-natal development study with administration of somapacitan-beco to pregnant rats from organogenesis through lactation at approximately 275 times the clinical exposure at the MRHD (see Data) . The background risk of birth defects and miscarriage for the indicated population is unknown. In the

Ürün özeti:

How Supplied SOGROYA ( somapacitan-beco) injection is a clear to slightly opalescent and colorless to slightly yellow solution available as one 1.5 mL single-patient-use prefilled pen per carton: Storage and Handling Before and during use: Store in a refrigerator at 36°F to 46°F (2°C to 8°C) with the cap on and in the original carton to protect from light. Do not freeze. Do not use SOGROYA if it has been frozen. Discard prefilled pen if kept above 86°F (30°C). Avoid direct or excessive heat. Avoid sunlight. Refer to storage conditions for SOGROYA (Table 8). Write the date of first use in the space provided on the carton. Always remove and safely discard the needle after each injection and store the SOGROYA prefilled pen without an injection needle attached. Always use a new needle for each injection to prevent contamination. Table 8. Storage conditions for SOGROYA Before first use (unopened) After first use (opened) Refrigerated 36°F to 46°F (2°C to 8°C) Room Temperature up to 77°F (25°C) Refrigerated 36°F to 46°F (2°C to 8°C) Room Temperature up to 77°F (25°C) SOGROYA Until expiration date Maximum 72 hours (3 days)* up to 6 weeks Maximum 72 hours (3 days)*

Yetkilendirme durumu:

Biologic Licensing Application

Ürün özellikleri

SOGROYA- SOMAPACITAN-BECO INJECTION, SOLUTION
NOVO NORDISK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOGROYA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SOGROYA.
SOGROYA (SOMAPACITAN-BECO) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2020
RECENT MAJOR CHANGES
Indications and Usage (1)
----------------------------------------------- 04/2023
Dosage and Administration (2.1, 2.3, 2.5) ----------------------------
04/2023
Contraindications (4)
----------------------------------------------------- 04/2023
Warnings and Precautions (5.3, 5.9, 5.10, 5.11, 5.13) ---------------
04/2023
INDICATIONS AND USAGE
SOGROYA is a human growth hormone analog indicated for:
Pediatric Patients: Treatment of pediatric patients aged 2.5 years and
older who have growth failure due to
inadequate secretion of endogenous growth hormone (GH) (1).
Adults: Replacement of endogenous growth hormone in adults with growth
hormone deficiency (1).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
SOGROYA is a liquid solution available in a ready-to-use prefilled
pen.
Injection: 5 mg/1.5 mL (3.3 mg/mL) or 10 mg/1.5 mL (6.7 mg/mL) or 15
mg/1.5 mL (10 mg/mL) in a single-
patient-use prefilled pen (3).
CONTRAINDICATIONS
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SOGROYA treatment should be supervised by a healthcare provider who is
experienced in the
diagnosis and management of patients with growth hormone deficiency
(2.1).
SOGROYA should be administered by subcutaneous injection once weekly,
any time of the day, in the
upper arms, thigh, abdomen or buttocks with regular rotation of
injection site to avoid
lipohypertrophy/lipoatrophy (2.1).
See Full Prescribing Information for complete dosage, titration, and
monitoring recommendations for
pediatric and adult patients, including those aged 65 years and older,
patients with hepatic
impairment, and women receiving oral estrogen (2.1, 2.2, 2.3, 2.4,
2.5).
For pediatric patients with