Precautions

Therapy with Pegpesen^® should be supervised by a physician for pediatric patients with confirmed growth failure due to GHD.

Pegpesen^® has the expected growth-promoting effect in pediatric patients only before epiphyseal closure.

Pegpesen^® is a human growth hormone analogue. Referencing adverse reactions reported with other growth hormone products, some GH class effects might correlate mechanistically even if not observed in Pegpesen^® trials—summarized in the subsections below.

Treatment may cause injection site swelling, erythema, atrophy, pain, reaction, pruritus, and induration. Avoid repeating injections at the same site within 30 days; sites should be >2 cm apart. Long-term SC injection at the same site may cause lipohypertrophy, lipoatrophy, or acquired lipodystrophy—rotate sites.

Manifestations (oedema, arthralgia, myalgia, nerve compression including carpal tunnel syndrome / paraesthesia) are usually transient and dose-dependent.

Treatment-emergent hypothyroidism may occur. Monitor thyroid function periodically; initiate or adjust thyroid hormone replacement when indicated to avoid compromising GH response.

Oral estrogen influences the IGF-1 response to GH. Consider changing the route of estrogen (e.g., transdermal). Patients starting Pegpesen^® while on oral estrogen may need a higher starting dose; if oral estrogen is started during Pegpesen^®, dose may need increasing to keep age-appropriate serum IGF-1.

Severe hypersensitivity is rare but may have serious consequences if poorly managed. Seek prompt care for allergic reactions. First dose should be observed in hospital/clinic for at least 1 hour, especially with allergy history. Contraindicated if known hypersensitivity to inpegsomatropin or excipients.

GH may inhibit 11βHSD-1 and lower serum cortisol. Patients with ACTH deficiency may have reduced cortisol and/or central hypoadrenalism—monitor cortisol during therapy. Patients on glucocorticoid replacement may need higher maintenance or stress doses after GH starts.

GH may reduce insulin sensitivity, especially at higher doses; hyperglycaemia may occur if insulin secretory capacity is inadequate. Impaired glucose tolerance or diabetes may be unmasked. Monitor glucose in all GH-treated patients, especially with risk factors; adjust antihyperglycaemic therapy as needed when Pegpesen^® starts.

Isolated cases reported with GH; often within first 8 weeks; may resolve after stopping GH. With severe/recurrent headache, visual symptoms, nausea/vomiting—funduscopy for papilloedema. If confirmed, consider BIH and discontinue GH. If restarting GH, monitor closely for recurrence.

Rapid growth can worsen existing scoliosis. GH increases growth velocity; GH has not been shown to increase scoliosis incidence. Monitor for new or progressive scoliosis during Pegpesen^®.

May occur in endocrine disorders including GHD. Evaluate promptly if limp or hip/knee pain emerges after starting GH.

Rare in GH-treated children. Persistent severe abdominal pain warrants evaluation to exclude pancreatitis.

Inorganic phosphorus, alkaline phosphatase, PTH, and IGF-1 may rise during GH therapy. Monitor patients with abnormalities as appropriate.

No evidence for increased risk of new malignancies in pediatric GH recipients, or increased relapse in patients with fully cured tumors.

Active malignancy: GH may increase progression risk. Preexisting malignancy should be inactive and treatment completed before Pegpesen^®. Discontinue if recurrent malignancy is evident.

Secondary malignancy: Increased risk reported in childhood cancer survivors who received cranial/brain radiation, later developed GHD, and received GH—intracranial tumors (especially meningiomas) were most common. Monitor patients with GHD secondary to intracranial neoplasm for progression/recurrence.

New malignancy during therapy: Certain rare genetic short stature syndromes carry higher malignancy risk—balance risks and benefits; if treating, monitor closely including tumor markers; if new nevi, birthmarks, or pigmentation appear, stop GH, inform physician, and investigate.

Leukaemia: Reported in individual GHD patients, some treated with GH; no evidence GH increases leukaemia incidence in patients without susceptibility factors.

Increased mortality reported after GH in acute critical illness complications (open heart surgery, abdominal surgery, multiple trauma, acute respiratory failure). Safety of continuing approved GH doses in these concurrent illnesses is not established—evaluate benefit/risk.

Few patients may develop anti-GH antibodies (low binding activity; no observed effect on growth velocity in available data). Test for antibodies if therapy fails.

Use with caution in athletes.

No clinical study data in pregnant or lactating women.

Pediatric GHD aged ≥3 years: use per medical advice (see dosing page).

No geriatric data.