somapacitan
Regulatory sources consulted
Approved indications
- Growth-hormone replacement in children aged 3 years or older and adolescents with growth failure due to GH deficiency, and in adults with GH deficiency.
Contraindications
Absolute
- Active tumor; closed epiphyses for growth promotion; acute critical illness after major surgery, multiple trauma, or respiratory failure; hypersensitivity.
Clinical warnings
- Major warning · Monitor IGF-I, glucose, thyroid, and adrenal function; it may reduce insulin sensitivity and unmask diabetes or adrenal insufficiency. — CIMA/AEMPS, ficha técnica 1201501001
- Major warning · Do not use with active tumor. Monitor recurrence, intracranial hypertension, edema, pancreatitis, and slipped capital femoral epiphysis in pediatric patients. — CIMA/AEMPS, ficha técnica 1201501001
Drug interactions
- ModerateInsulin or antidiabetic medicines
Mechanism: Somapacitan may reduce insulin sensitivity.
Recommendation: Monitor glucose and adjust antidiabetic medicines.
CIMA/AEMPS, ficha técnica 1201501001https://cima.aemps.es/cima/dochtml/ft/1201501001/FT_1201501001.html
- ModerateGlucocorticoids, oral estrogens, or CYP450 substrates
Mechanism: They may require adjustments because of changes in cortisol, GH exposure, or substrate clearance.
Recommendation: Individualize doses and monitor response.
CIMA/AEMPS, ficha técnica 1201501001https://cima.aemps.es/cima/dochtml/ft/1201501001/FT_1201501001.html
Adverse events
Common (≥1%)
Headache · Pain in extremity · Hypothyroidism · Injection-site reaction · Peripheral edema · Arthralgia · Hyperglycemia · Fatigue
Rare but serious
Tumor progression · Intracranial hypertension · Pancreatitis · Adrenal insufficiency
Pregnancy and lactation
Not recommended during pregnancy or in women of childbearing potential without contraception. Decide whether to stop breastfeeding or treatment based on benefits and risks.
Recent literature (PubMed)
Somapacitan, a once-weekly reversible albumin-binding GH derivative, is evaluated in children with GH deficiency (GHD). To demonstrate efficacy and safety of somapacitan vs daily GH. REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535). Eighty-six sites across 20 countries. 200 treatment-naïve patients were randomized and exposed. Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously. The primary endpoint was annualized height velocity (HV; cm/y) at week 52. Additional assessments included HV SD score (SDS), height SDS, bone age, IGF-I SDS, patient-reported outcomes, and safety measures. Estimated mean HV at week 52 was 11.2 and 11.7 cm/y for somapacitan and daily GH, respectively. Noninferiority was confirmed. Changes in HV SDS, height SDS, bone age, and IGF-I SDS from baseline to week 52 were similar between treatment groups. At week 52, mean IGF-I SDS values were similar between treatment groups and within normal range (-2 to +2). Safety of somapacitan was consistent with the well-known daily GH profile. Low proportions of injection-site reactions were reported for somapacitan (5.3%) and daily GH (5.9%). Both treatments similarly reduced disease burden from baseline to week 52, whereas a greater treatment burden reduction was observed for somapacitan. Similar efficacy for somapacitan compared to daily GH was demonstrated over 52 weeks of treatment with comparable safety and mean IGF-I SDS levels in treatment-naïve children with GHD. Somapacitan is a long acting, recombinant growth hormone analog that is used to treat adults and children two years of age or older with growth hormone deficiency. Somapacitan has not been linked to elevations in serum aminotransferase levels or bilirubin levels during therapy or to instances of clinically apparent liver injury with symptoms or jau
The purpose of this study is to compare the relative efficacy and safety of long-acting growth hormone (LAGH) as a growth hormone replacement therapy in prepubertal children with growth hormone deficiency (GHD). We searched the PubMed, Embase, CNKI, and Wanfang databases from inception to July 2023 and identified eleven relevant studies. PEG-LAGH showed better effect on height velocity (mean difference [MD]: - 0.031, 95% credibility interval [CrI]: - 0.278, 0.215) than somatrogon (MD: 0.105, 95% CrI: - 0.419, 0.636), somapacitan (MD: 0.802, 95% CrI: - 0.451, 2.068) and lonapegsomatropin (MD: 1.335, 95% CrI: - 0.3, 2.989) when compared with daily growth hormone (DGH). Furthermore, in terms of height standard deviation score, PEG-LAGH demonstrated better improvement (MD: - 0.15, 95% CrI: - 1.1, 0.66) than somatrogon (MD: - 0.055, 95% CrI: - 1.3, 0.51) and somapacitan (MD: 0.22, 95% CrI: - 0.91, 1.3). PEG-LAGH (risk ratio [RR]: 1.00, 95% CrI: 0.82, 1.2) reduced the risk of adverse events compared with other LAGH (somatrogon, RR: 1.1, 95% CrI: 0.98, 1.2; somapacitan, RR: 1.1, 95% CrI: 0.96, 1.4; lonapegsomatropin, RR, 1.1, 95% CrI: 0.91, 1.3) and was comparable with DGH. This is the first study to indirectly compare the LAGH thorough a network meta-analysis and provide evidence of the optimal efficacy of various LAGH specifically PEG-LAGH and acceptable safety profile in prepubertal children with GHD.
Somapacitan is a long-acting GH approved for once-weekly treatment of GH deficiency (GHD). This study aims to evaluate the efficacy and tolerability of somapacitan after 3 years of treatment and 2 years after switch from daily GH in children with GHD. Randomized, multi-national, open-labelled, active-controlled parallel-group phase 3 trial, with a 52-week main phase and 3-year safety extension (NCT03811535). Treatment-naïve children with GHD were randomized (2:1) to continuous somapacitan (0.16 mg/kg/week; "soma/soma" group) or daily GH (Norditropin®; 0.034 mg/kg/day) followed by somapacitan (0.16 mg/kg/week; "switch" group). Of 200 participants, 188 completed 3 years of treatment. Sustained growth was observed in both groups. At week 156, mean (SD) height velocity (HV) between weeks 104 and 156 was 7.4 (1.5) cm/year in the soma/soma group and 7.8 (1.4) cm/year in the switch group. At week 156, the soma/soma and switch groups had reached a mean (SD) height SD score (HSDS) of -0.95 (0.98) and -1.08 (0.93), respectively, and were approaching the mean mid-parental HSDS of -0.74 (for both groups). Mean total insulin-like growth factor I (IGF-I) SDS during year 3 was similar between groups and within normal range (-2.0 to +2.0). Bioactive IGF-I and bioactive IGF-I to IGF-I ratio were similar between groups. Somapacitan was well tolerated, with low proportions reporting injection-site reactions. Sustained efficacy and tolerability were observed for continuous somapacitan treatment for 3 years, and for 2 years after the switching from daily GH treatment. HSDS in both groups was approaching mean mid-parental HSDS. NCT03811535.