Drugs List

Therapeutic Indications

Uses

Growth hormone deficiency - assessment of pituitary function

For the evaluation of the functional capacity and response of the somatotrophs of the anterior pituitary in cases of suspected growth hormone deficiency.

It is not suitable as a screening test for growth hormone deficiencies.

Dosage

The recommended dosage for patients of standard weight is 50 micrograms of somatorelin in the morning following an overnight fast. In cases of highly overweight patients, a dosage of 1 microgram per kg body weight is indicated.

GHRH Test
Withdraw approximately 2 ml of venous blood from the fasted patient to use as a measure of basal growth hormone levels in plasma or serum after the single intravenous injection of somatorelin.

Administer the reconstituted injection to the fasted patient as an intravenous bolus injection within 30 seconds.

To evaluate the growth hormone increment in plasma or serum take a second blood sample 30 minutes after the injection. Peak growth hormone values may occasionally occur sooner or later and so additional blood samples may be taken 15, 45, 60 and 90 minutes after the injection, for better assessment of growth hormone release.

Administration

For intravenous injection

Contraindications

Breastfeeding
Pregnancy

Precautions and Warnings

Elevated plasma fatty acids
High levels of somatostatin
Obesity
Epileptic disorder
Hyperglycaemia
Uncontrolled hyperthyroidism

Resuscitation facilities must be immediately available
Discontinue growth hormone therapy at least 1 week prior to test

Pregnancy and Lactation

Pregnancy

Somatorelin is not indicated during pregnancy.

Schaefer suggests inadvertent use is not grounds for either termination of the pregnancy or invasive diagnostic procedures.

Somatorelin reduces blood flow to the uterus and inhibits endometrial proliferation. Schaefer suggests in case of inadvertent use during pregnancy miscarriage and foetal growth restriction are conceivable but have not been reported.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Somatorelin is not indicated in breastfeeding.

There are no data, at the time of writing, on the use of somatorelin during breastfeeding.

Schaefer suggests, due to the limited oral bioavailability of somatorelin, no toxic effect on the infant is expected and usage for appropriate indications during breastfeeding is allowed.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Blood pressure changes
Hot flushes
Local pain (injection site)
Sensation of warmth
Smelling disturbances
Taste disturbances
Variation in heart rate

Presentation

Injections of somatorelin (as somatorelin acetate)

Drugs List

Therapeutic Indications

Uses

Growth hormone deficiency - assessment of pituitary function

For the evaluation of the functional capacity and response of the somatotrophs of the anterior pituitary in cases of suspected growth hormone deficiency.

It is not suitable as a screening test for growth hormone deficiencies.

Dosage

The recommended dosage for patients of standard weight is 50 micrograms of somatorelin in the morning following an overnight fast. In cases of highly overweight patients, a dosage of 1 microgram per kg body weight is indicated.

GHRH Test
Withdraw approximately 2 ml of venous blood from the fasted patient to use as a measure of basal growth hormone levels in plasma or serum after the single intravenous injection of somatorelin.

Administer the reconstituted injection to the fasted patient as an intravenous bolus injection within 30 seconds.

To evaluate the growth hormone increment in plasma or serum take a second blood sample 30 minutes after the injection. Peak growth hormone values may occasionally occur sooner or later and so additional blood samples may be taken 15, 45, 60 and 90 minutes after the injection, for better assessment of growth hormone release.

Administration

For intravenous injection

Contraindications

Breastfeeding
Pregnancy

Precautions and Warnings

Elevated plasma fatty acids
High levels of somatostatin
Obesity
Epileptic disorder
Hyperglycaemia
Uncontrolled hyperthyroidism

Resuscitation facilities must be immediately available
Discontinue growth hormone therapy at least 1 week prior to test

Pregnancy and Lactation

Pregnancy

Somatorelin is not indicated during pregnancy.

Schaefer suggests inadvertent use is not grounds for either termination of the pregnancy or invasive diagnostic procedures.

Somatorelin reduces blood flow to the uterus and inhibits endometrial proliferation. Schaefer suggests in case of inadvertent use during pregnancy miscarriage and foetal growth restriction are conceivable but have not been reported.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Somatorelin is not indicated in breastfeeding.

There are no data, at the time of writing, on the use of somatorelin during breastfeeding.

Schaefer suggests, due to the limited oral bioavailability of somatorelin, no toxic effect on the infant is expected and usage for appropriate indications during breastfeeding is allowed.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Blood pressure changes
Hot flushes
Local pain (injection site)
Sensation of warmth
Smelling disturbances
Taste disturbances
Variation in heart rate

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: August 2013

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: GHRH Ferring. Ferring Pharmaceuticals Ltd. Revised June 2011.