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Saizen HGH

1vial x 8mg 24IU (automatically reconstituted)

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Saizen HGH
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Saizen HGH

Saizen is a human growth hormone produced by recombinant DNA technology: it has 191 amino acid residues, a molecular weight of 22KD and an identical amino acid sequence and structure, to the dominant fform of human pituitary growth hormone. Saizen is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone gene.

Saizen is a sterile, non-pyrogenic, white, lyophilized powder intended for subcutaneous injection after reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The reconstituted solution has a pH of 6.5 to 8.5. It comes in 1vial x 8mg 24IU (automatically reconstituted), and contains 8.8 mg somatropin, 60.2 mg sucrose and 2.05 mg O-phosphoric acid. The pH is adjusted with sodium hydroxide or O-phosphoric acid.

Mechanism of Action

Somatropin binds to dimeric growth hormone receptors located within the cell membranes of target tissue cells resulting in intracellular signal transduction and pharmacodynamic effects: skeletal, cell and organ growth, protein synthesis (increased uptake of amino acids and nitrogen retention), carbohydrate metabolism, lipolysis, mineral metabolism (retention of total body potassium, phosphorus, and sodium), connective tissue and bone metabolism (increased synthesis of chondroitin sulphate, collagen and increased excretion of hydroxyproline).   

Indications

Saizen is indicated for the treatment of paediatric patients with growth failure due to inadequate secretion of endogenous growth hormone.

In adults, Saizen is indicated for GH replacement in either:

  • The Adult Onset GHD: growth hormone deficiency alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma
  • The Childhood Onset GHD resulting from congenital, genetic, acquired, or idiopathic causes.

Patients with closed epiphyses should be re-evaluated before continuation of somatropin therapy.

Safety information

Before prescribing Saizen, doctor should look out for the following:

  • Signs of upper airway obstruction and sleep apnoea in children with Prader-Willi Syndrome; if any symptoms arise – treatment should be discontinued. Male patients with one or more of the known risk factors are at greater risk;
  • Neoplasms: patients with pre-existing tumours should be monitored for progression or recurrence, as well as for potential malignant transformation of skin lesions, i.e. increased growth of pre-existing nevi. Childhood cancer survivors if treated with somatropin, hold the increased risk of a second neoplasm, especially meningiomas in those treated with radiation to the head for their first neoplasm;
  • Treatment with somatropin may reduce sensitivity to insulin, especially at high doses in susceptible patients (obese, with Turner syndrome, or with family history of Diabetes mellitus) thus glucose levels should be monitored in all patients; especially in diabetic patients – dosage of concurrent anti-hyperglycaemic drugs (like insulin, oral agents) may require adjustment.
  • Intracranial Hypertension with papilledema, visual changes, headache, nausea, and/or vomiting have been reported in a few cases; such symptoms normally present at 8 weeks after the initiation of somatropin therapy, and can be reversed by reducing the dose or terminating the treatment; those with Turner syndrome and Prader-Willi Syndrome may be at higher risk to develop IH;
  • Fluid retention - frequent in adults, like oedema, arthralgia or carpal tunnel syndrome. Dose reduction is required in such cases;
  • Other hormone replacement therapies should be monitored closely due to an increased risk for hypopituitarism;
  • Hypothyroidism can become evident or get worse in patients with GHD ;
  • Patients with Turner syndrome are at risk of autoimmune thyroid disease and primary hypothyroidism
  • Children with the onset of a limp or hip/knee pain should be evaluated for slipped capital femoral epiphysis
  • Pre-existing scoliosis may worsen in rapidly growing paediatric patients
  • Those with Turner syndrome are at higher risk of ear and hearing disorders, e.g. otitis media and also cardiovascular disorders such as stroke, aortic aneurysm/dissection or hypertension;
  • Injection site rotation is necessary to avoid tissue atrophy;
  • Local or systemic allergic reactions are possible;
  • Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH) and IGF-I may increase;
  • Pancreatitis should be considered in patients with persistent severe abdominal pain.

 

Moreover, benzyl alcohol has been previously associated with serious adverse effects and death in paediatric patients. The ‘gasping syndrome’ has been associated with BA administration at over 99 mg/kg body weight/day in neonates and low-birth weight neonates. In addition, seizures, intracranial haemorrhage, gradual neurological deterioration, hematologic abnormalities or skin breakdown, liver or kidney failure, bradycardia, hypotension and cardiovascular collapse may also occur.

Physicians before prescribing Saizen or any alternative drugs containing BA should consider the total daily metabolic load of benzyl alcohol.

Once the treatment is started, risks of continuing Saizen HGH should be evaluated if the child has any of the following: scoliosis, diabetes, cancer, hormone deficiencies, trauma, complains about hip or knee pains, limping, or difficulty breathing. Tests for child’s blood glucose and funduscopic examination (an eye test for intracranial hypertension) must be performed before starting the treatment and periodically afterwards. Parents of children, who are treated for Prader-Willi syndrome and start having difficulty breathing, start snoring or their snoring increases, should seek medical advice.

Side effects that may arise after the treatment with Saizen include headaches, loss of fatty tissue under the skin (lipoatrophy) or rash at the injection sites.

Side effects

Rare side effects include: pain, numbness, redness, or swelling at the delivery site, hypothyroidism, hypoglycaemia, seizures or convulsions, water retention, and worsening of psoriasis symptoms that existed before therapy began. In adults arthralgia, myalgia, peripheral oedema, other types of oedema, carpal tunnel syndrome, paraesthesia and hypaesthesia have been previously reported.

Contraindications

Saizen is contraindicated in following patients:

  • Formulation with benzyl alcohol must not be used in premature babies or neonates;
  • With acute critical illnesses: due to the complications following multiple accidental trauma, acute  respiratory failure, open heart surgery or abdominal surgery;
  • With cancer/ active malignancy; in case of recurrent activity, somatropin should be discontinued; must not be used in presence with evidence of progression or recurrence of an  intracranial tumour or in presence of pituitary tumour;
  • With active proliferative or severe non-proliferative diabetic retinopathy;
  • With known hypersensitivity to somatropin or any of its excipients, localised reactions in such cases are the most common;
  • With closed epiphyseal plates,
  • Severely obese, with history of upper airway obstruction, sleep apnoea, or with respiratory impairment with Prader-Willi Syndrome.

 

Dosage and Administration

Saizen should be administered subcutaneously. Dosage and administration schedule should be individualized for each patient:

  • In paediatric GHD, the recommended weekly dosage is 0.18 mg/kg of body weight, and should be divided into equal doses given either on 3 alternate days, 6 times per week or daily
  • In adult GHD two approaches may be followed: a weight-based regimen (starting with no more than 0.005 mg/kg daily, which may be increased by 0.01 mg/kg/day after 4 weeks) or a non-weight-based regimen (starting with 0.2 mg/day (range, 0.15-0.30 mg/day) which can be increased gradually every 1 to 2 months by 0.1 to 0.2 mg/day, according to clinical response and serum IGF-1 concentrations)

Older patients prone to adverse side effects should start with a lower dose and smaller dose increments, whereas oestrogen-replete women or those using oral oestrogen may need higher doses. In addition, obese individuals should not be treated with a weight-based regimen as that may cause adverse side effects.

Overdose

Short-term over dosage could lead to hypoglycaemiaor even to hyperclycaemia, and fluid retention. Long-term over dosage can cause signs and symptoms of gigantism and acromegaly.

Storage

Keep refrigerated (36°-46° F/2°-8° C). Do not freeze or use after the expiration date.



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