Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Growth hormone-secreting tumours

As growth hormone-secreting pituitary tumours may sometimes expand, causing serious complications (e.g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable.

Serum IGF-1 monitoring

Pegvisomant is a potent antagonist of growth hormone action. A growth hormone deficient state may result from administration of this medicinal product, despite the presence of elevated serum growth hormone levels. Serum IGF-I concentrations should be monitored and maintained within the age-adjusted normal range by adjustment of the pegvisomant dose.

ALT or AST elevations

Serum concentrations of alanine aminotransferase (ALT) and aspartate transaminase (AST) should be monitored at four to six week intervals for the first six months of treatment with pegvisomant, or at any time in patients exhibiting symptoms suggestive of hepatitis.
Evidence of obstructive biliary tract disease should be ruled out in patients with elevations of ALT and AST or in patients with a prior history of treatment with any somatostatin analogue. Administration of pegvisomant should be discontinued if signs of liver disease persist.

Hypoglycaemia

The study conducted with pegvisomant in diabetic patients treated either by insulin or by oral hypoglycaemic medicinal products revealed the risk of hypoglycaemia in this population. Therefore, in acromegalic patients with diabetes mellitus, doses of insulin or hypoglycaemic medicinal products may need to be decreased (see section 4.5).

Improved fertility

The therapeutic benefits of a reduction in IGF-I concentration which results in improvement of the patient’s clinical condition could potentially also improve fertility in female patients (see section 4.6).

Pregnancy

Acromegaly control may improve during pregnancy. Pegvisomant is not recommended during pregnancy (see section 4.6). If pegvisomant is used during pregnancy, IGF-I levels should be closely monitored and pegvisomant doses may need to be adjusted (see section 4.2) based on IGF-I values.



Sodium content

This medicinal product contains less than 1 mmol sodium (23 mg) per dose. Patients on low sodium diets can be informed that this medicinal product is essentially ‘sodium-free’.

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