SAIZEN Infusion

Somatropin

4 IU/ml

LABORATOIRES SERONO SA

Pack size	1 Vial (Dry) + 1 Solvent Ampoule (1ml)
Dispensing mode	POM-R (Hospital only)
Source	SWITZERLAND
Agent	ARABIAN ETHICALS CO.
Retail Price	112.00 AED

Indications

SAIZEN Infusion is used for: Growth hormone deficiency, HIV-associated wasting or cachexia, Short bowel syndrome

Adult Dose

Growth Hormone Deficiency Weight-based dosing Not to exceed 0.004 mg/kg/day SC initially for 6 weeks; may increase up to 0.016 mg/kg/day maximum Nonweight-based dosing 0.2 mg/day (0.15-0.3 mg/day range) SC initially; may increase every 1-2 months by 0.1-0.2 mg/day based on clinical response and/or serum IGF-I levels Short-bowel Syndrome 0.1 mg/kg/day SC (rotating injection sites to avoid lipodystrophy) for 4 weeks; may increase up to 8 mg/day maximum; treatment exceeding 4 weeks not studied HIV-associated Wasting or Cachexia 0.1 mg/kg/day SC at bedtime (rotating injection sites to avoid lipodystrophy) up to 6 mg/day; Alternatively: >55 kg: 6 mg/day SC 45-55 kg: 5 mg/day SC 35-45 kg: 4 mg/day SC <35 kg: 0.1 mg/kg/day SC Elderly: Lower doses may be required.

Child Dose

Growth Hormone Deficiency 0.024-0.034 mg/kg/day SC 6-7 days/week Small for Gestational Age Not to exceed 0.067 mg/kg/day SC Nooman Syndrome With Growth Hormone Deficiency Not to exceed 0.066 mg/kg/week SC Turner Syndrome With Growth Hormone Deficiency Not to exceed 0.067 mg/kg/day SC

Renal Dose

Administration

Contra Indications

Acute critical illness due to heart or abdominal surgery, multiple accidental trauma or respiratory failure; active neoplasms, proliferative or preproliferative diabetic retinopathy; lactation; patients with closed epiphyses. Intracranial lesions. Patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment.

Precautions

Monitor thyroid function; benign intracranial hypertension. DM; may require dose reduction in insulin. Pregnancy. Discontinue treatment if there is evidence of tumour growth. Monitoring in patients with scoliosis is recommended due to risk of progression of scoliosis.

Pregnancy-Lactation

Pregnancy Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes In animal reproduction studies, there was no evidence of fetal or neonatal harm when pregnant rats were administered SC somatotropin during organogenesis or during lactation at doses ~10-times higher than the maximal clinical dose of 0.016 mg/kg, based on body surface area Diluent contains benzyl alcohol, which has been associated with gasping syndrome in neonates; the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants; if therapy needed during pregnancy, reconstitute with normal saline, use only one dose per vial, and discard reconstituted product after use, or use a benzyl alcohol-free formulation Lactation There are no data on presence of somatropin in human milk; limited published literature reports no adverse effects on breastfed infants with maternal administration of somatropin; no decrease in milk production or change in milk content during treatment with somatropin reported; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for somatotropin and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition Diluent contains benzyl alcohol; if therapy needed during lactation, reconstitute with normal saline, use only one dose per vial, and discard after use or use a benzyl alcohol-free formulation

Interactions

High doses of corticosteroid may inhibit growth-promoting effects of somatropin.

Adverse Effects

Side effects of Somatropin : Hypothyroidism, peripheral oedema; headache; muscle and joint pain; benign intracranial hypertension. Loss of glycaemic control in diabetics, New onset type 2 diabetes mellitus, Scoliosis, Hypoglycemia, Seizures, Pancreatitis, Exacerbation of psoriasis, Hematuria, Hematoma, Leukemia, Papilledema, Arthralgia, Hyperlipidemia, Otitis media, Ear disorders, Respiratory Illness, Urinary tract infection.

Mechanism of Action

Somatropin is a synthetic human growth hormone of recombinant DNA origin. It stimulates skeletal and soft tissue growth by promoting cell division, amino acid uptake and protein synthesis. It also possesses both insulin-like and diabetogenic effects.

Note

SAIZEN 4 IU/ml Infusion manufactured by LABORATOIRES SERONO SA. Its generic name is Somatropin. SAIZEN is availble in United Arab Emirates. Farmaco UAE drug index information on SAIZEN Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Somatropin :

GENOTROPIN ^{12mg (36 IU)/Cartridge}

PFIZER MANUFACTURING BELGIUM N.V.

GENOTROPIN ^{5.3mg (16 IU)/Cartridge}

PFIZER MANUFACTURING BELGIUM N.V.

Injection

NORDITROPIN NordiFlex ^{10mg (30 units)/1.5ml}

Novo Nordisk A/S