Drugs List

Therapeutic Indications

Uses

Growth hormone deficiency - assessment of pituitary function

Diagnosis of growth hormone deficiency (GHD) in adults.

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
Long QT syndrome
Pregnancy
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Obese patients with a BMI greater than 40kg/m2
Cardiac failure
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of myocardial infarction
History of torsade de pointes
Lactose intolerance
Renal impairment

Correct electrolyte disorders before treatment
Treatment to be initiated and supervised by a specialist
Contains lactose
Advise patient to avoid strenuous exercise 24 hours prior to administration
Limit fluid intake 1 hour before and 1 hour after administration
Patient to fast for at least 8hrs prior to dose until end of blood sampling
Perform ECG before and during treatment
Monitor serum electrolytes
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Advise patient not to take St John's wort concurrently

Interpretation of test results
The maximally stimulated serum GH level of less than 2.8 nanogram/mL following administration confirms a diagnosis of adult growth hormone deficiency. Interpretation of macimorelin test results should always include the outcome of all examinations within the diagnostic work-up for the patient.

Patients with Cushing's disease or on supra-physiologic glucocorticoid therapy (systemic doses of hydrocortisone (or equivalent) in excess of 15 mg/square meter/day) may lead to false positive results.

Growth hormone deficiency caused by hypothalamic lesion may cause a false negative result.

Discontinue treatment with replacement therapy with growth hormone (somatotropin) or treatment that can affect pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) at least 1 month before treatment.

Ensure other deficiency affecting hormones (e.g. adrenal, thyroidal, gonadal and diabetes insipidus) are adequately replaced to exclude stimulation failure from a secondary growth hormone deficiency.

The cut-off point for macimorelin has not been determined during the transition period of late puberty to adult maturation. Macimorelin test results were comparable to insulin tolerance test (ITT) results for patients aged 18 to 25 years.

Pregnancy and Lactation

Pregnancy

Macimorelin is contraindicated during pregnancy.

The manufacturer advises that macimorelin is not recommended during pregnancy and the risk for humans is unknown.

Lactation

Macimorelin is contraindicated during breastfeeding.

The manufacturer advises that a decision must be made on whether to discontinued breastfeeding for the child or abstain the use of macimorelin for the woman, taking into account the benefits and risks. It is unknown whether macimorelin is excreted in human milk.

Side Effects

Abdominal pain
Diarrhoea
Dizziness
Dysgeusia
Fatigue
Feeling hot
Headache
Hunger
Nausea
Palpitations
Prolongation of QT interval
Sensation of cold
Sinus bradycardia
Somnolence
T-wave changes
Thirst
Tremor
Vertigo

Presentation

Oral formulation of macimorelin.

Drugs List

Therapeutic Indications

Uses

Growth hormone deficiency - assessment of pituitary function

Diagnosis of growth hormone deficiency (GHD) in adults.

Dosage

Adults

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
Long QT syndrome
Pregnancy
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Obese patients with a BMI greater than 40kg/m2
Cardiac failure
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of myocardial infarction
History of torsade de pointes
Lactose intolerance
Renal impairment

Correct electrolyte disorders before treatment
Treatment to be initiated and supervised by a specialist
Contains lactose
Advise patient to avoid strenuous exercise 24 hours prior to administration
Limit fluid intake 1 hour before and 1 hour after administration
Patient to fast for at least 8hrs prior to dose until end of blood sampling
Perform ECG before and during treatment
Monitor serum electrolytes
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Advise patient not to take St John's wort concurrently

Interpretation of test results
The maximally stimulated serum GH level of less than 2.8 nanogram/mL following administration confirms a diagnosis of adult growth hormone deficiency. Interpretation of macimorelin test results should always include the outcome of all examinations within the diagnostic work-up for the patient.

Patients with Cushing's disease or on supra-physiologic glucocorticoid therapy (systemic doses of hydrocortisone (or equivalent) in excess of 15 mg/square meter/day) may lead to false positive results.

Growth hormone deficiency caused by hypothalamic lesion may cause a false negative result.

Discontinue treatment with replacement therapy with growth hormone (somatotropin) or treatment that can affect pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) at least 1 month before treatment.

Ensure other deficiency affecting hormones (e.g. adrenal, thyroidal, gonadal and diabetes insipidus) are adequately replaced to exclude stimulation failure from a secondary growth hormone deficiency.

The cut-off point for macimorelin has not been determined during the transition period of late puberty to adult maturation. Macimorelin test results were comparable to insulin tolerance test (ITT) results for patients aged 18 to 25 years.

Pregnancy and Lactation

Pregnancy

Macimorelin is contraindicated during pregnancy.

The manufacturer advises that macimorelin is not recommended during pregnancy and the risk for humans is unknown.

Lactation

Macimorelin is contraindicated during breastfeeding.

The manufacturer advises that a decision must be made on whether to discontinued breastfeeding for the child or abstain the use of macimorelin for the woman, taking into account the benefits and risks. It is unknown whether macimorelin is excreted in human milk.

Side Effects

Abdominal pain
Diarrhoea
Dizziness
Dysgeusia
Fatigue
Feeling hot
Headache
Hunger
Nausea
Palpitations
Prolongation of QT interval
Sensation of cold
Sinus bradycardia
Somnolence
T-wave changes
Thirst
Tremor
Vertigo

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: September 2022

Reference Sources

Summary of Product Characteristics: Ghryvelin 60mg granules for oral suspension in sachet. Consilient Health Limited. Revised January 2019.