SOMAVERT ® - Pegvisomant

SOMAVERT ® is a pegvisomant based drug

THERAPEUTIC GROUP: Receptor antagonists of the somatotropic hormone

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications SOMAVERT ® - Pegvisomant

SOMAVERT ® is used for the treatment of acromegaly in patients who do not respond adequately to surgery, radiotherapy and treatment with somatostatin.

Mechanism of action SOMAVERT ® - Pegvisomant

The Pegvisomant, active ingredient of SOMAVERT ® is the result of the innovative genetic engineering able to act selectively on the amino acid structure of the growth hormone, producing a structurally similar but functionally opposite molecule.

In fact, this active ingredient, administered parenterally, is able to bind cell receptors for GH with high affinity, inhibiting them, thus preventing the aforementioned hormone from activating all that series of molecular mechanisms that translate macroscopically into the intense anabolic stimulus.

The administration of Pegvisomant, which inevitably accompanies a reduction in blood concentrations of IGF 1-2, therefore becomes valuable in the treatment of acromegaly not responsive to other therapeutic approaches.

The medical intervention in these pathologies assumes a fundamental therapeutic value, useful both to lengthen the average life and the quality of life of these patients, seriously compromised by the anomalous growth of flat and short bones and by visceromegaly, often the cause of collateral pathologies.

Studies carried out and clinical efficacy

1. EFFECTIVENESS AND SAFETY OF PEGVISOMANT THERAPY

Important German observational study that demonstrates how drug therapy with Pegvisomant is a highly effective and safe treatment during acromegaly, resulting in a significant improvement in symptoms with limited side effects.

2. THE PEGVISOMANT IN CLINICAL AREA

Results taken from the very important ACROSTUDY study which show that treatment with Pegvisomant was effective even in cases of particularly severe disease, where the somatostatin analogues had not produced any appreciable results.

3. PEGVISOMANT AND TUMORS

Very interesting experimental study that demonstrates how pegvisomant is able to block the proliferation of carcinomatous cells that are positive for the estrogen receptor, such as mammary ones.

Method of use and dosage

SOMAVERT ®

Powder and solvent for solution for injection containing 10 mg - 15 mg - 20 mg of Ppegvisomant:

the dosage must be defined by a specialist doctor in the treatment of endocrine disorders, taking into account the patient's state of health, his clinical picture and serum IGF 1 concentrations (an important marker of the disease).

Warnings SOMAVERT ® - Pegvisomant

The high specialist nature of SOMAVERT ® therapy requires the supervision of a doctor who is competent in the treatment of endocrine disorders both during the definition of the therapeutic scheme and throughout the therapeutic intervention.

Periodic monitoring of the patient's health status and continuous monitoring of liver function and serum IGF 1 concentrations are fundamental in assessing the safety and therapeutic efficacy of SOMAVERT ®

Administration of Pegvisomant in diabetic patients may reduce the need for insulin or oral hypoglycemic agents.

It is useful to remember that this drug acts by blocking the molecular signal of the growth hormone and its biological effects, but it has absolutely no impact on the evolution of the tumor.

PREGNANCY AND BREASTFEEDING

The absence of clinical studies concerning the safety of Pegvisomant when taken during pregnancy on fetal health extend the contraindications to the whole gestational period.

Similarly, the use of SOMAVERT ® is also contraindicated during the subsequent breastfeeding phase.

Interactions

A scientific literature concerning the possible pharmacokinetic interactions between Pegvisomant and other active ingredients is lacking.

The biological role of the drug and the chemical-physical structure identical to that of the growth hormone, suggest a possible overlap of the possible interactions.

Contraindications SOMAVERT ® - Pegvisomant

SOMAVERT ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients.

Undesirable effects - Side effects

Significant literature and modest post-marketing monitoring support the relative safety of SOMAVERT ® therapy when performed within therapeutic limits, despite numerous and worrying side effects.

More precisely increased sweating, asthenia, headache, drowsiness, diarrhea and gastrointestinal disorders, skin rash, itching at the injection site, weight gain, hypertension, hypercholesterolemia, changes in hepatocellular function, sleep disturbances and decreased immune defenses were the events most frequently seen adverse events during therapy, without clinical exacerbations.

Note

SOMAVERT ® sold only under medical prescription.

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