The use of all preparations in this section requires detailed prior investigation and should be reserved for specialist centres.

Anti-oestrogen

Clomifene

• Tablets 50mg (£9.47 = 28 tablets)

Indications

• Clomifene is only indicated for patients in whom ovulatory dysfunction has been demonstrated and other causes of infertility have been excluded or adequately treated.

Notes

1. To be initiated by a consultant only
2. It is envisaged that certain aspects of fertility treatment, once initiated and stabilised by a specialist, may be appropriate for on-going maintenance within primary care e.g. clomifene.

Anterior pituitary hormones

Corticorelin

• Injection 100 micrograms (unlicensed preparation)

Tetracosactide

• Injection 250 micrograms in 1ml, 1mg in 1ml (depot)

Notes

1. Tetracosactide test – measure plasma cortisol immediately before and at exactly 30 and 60 minutes after an IM/IV dose of 250 micrograms. Plasma cortisol should be measured immediately before the injection, after exactly 30 minutes and then at 1, 2, 3, 4 and 5 hours.

Gonadotrophins

Safety concerns around risks of Ovarian Hyper Stimulation Syndrome (OHSS) mean that drugs used in the IVF treatment option are not considered appropriate for routine prescribing in the primary care setting. Patients who present in primary care who, after initial assessment by the GP, qualify for further investigation of fertility problems should be referred to and managed within specialist teams.

Choriogonadotropin alfa

• Ovitrelle prefilled syringe 6500 unit/0.5ml (250 micrograms/0.5ml)

Human Chorionic Gonadotrophin (HCG)

• Pregnyl injection with solvent 1500 units, 5000 units

Follitropin alfa

• Gonal-F 600 unit per 1ml
• Bemfola 600 unit per 1ml

Notes

1. Prescribe by brand. Follitropin alfa is available as Gonal-F and the biosimilar product Bemfola. A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in terms of quality, safety, and efficacy) to an existing biological medicine however they cannot be considered generic equivalents of the originator biological medicine. Because they are not identical, biological medicines must be prescribed by brand. The decision which brand to prescribe rests with the responsible clinician in consultation with the patient. Automatic substitution of brands at the point of dispensing is not appropriate for biological medicines.

Follitropin beta

• Puregon 50 unit, 300 unit, 600 unit vials

Human Menopausal Gonadotrophins (FSH/LH)

(Menotrophin)

• Menopur Injection powder for reconstitution 75 units FSH / luteinising hormone

To be used in the context of the NICE Guidance CG11: Fertility (Feb 2013)

Growth hormone

Somatropin

• See BNF for preparations

Notes

1. West Devon:
   1. Adults: refer to individual shared care guidelines for use in Endocrine conditions
   2. Children: prescribing remains hospital only
2. South Devon: all prescribing remains hospital only
3. To be initiated by a consultant only
4. Prescribe by brand. A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in terms of quality, safety, and efficacy) to an existing biological medicine however they cannot be considered generic equivalents of the originator biological medicine. Because they are not identical, biological medicines must be prescribed by brand. The decision which brand to prescribe rests with the responsible clinician in consultation with the patient. Automatic substitution of brands at the point of dispensing is not appropriate for biological medicines.
5. NICE TA64: Recombinant human growth hormone (somatropin) treatment is recommended for the treatment of adults with growth hormone (GH) deficiency (August 2003), only if:
   1. they have severe GH deficiency, defined as a peak GH response of less than 9 mU/litre (3ng/ml) during an insulin tolerance test or a cross-validated GH threshold in an equivalent test, and
   2. they have perceived impairment of quality of life (QoL), as demonstrated by a reported score of at least 11 in the disease-specific 'Quality of life assessment of growth hormone deficiency in adults' (QoL-AGHDA) questionnaire, and
   3. they are already receiving treatment for any other pituitary hormone deficiencies as required.
6. NICE TA188: Somatropin (recombinant human growth hormone) is recommended as a treatment option for children with growth failure (May 2010), when associated with any of the following conditions:
   1. growth hormone deficiency
   2. Turner syndrome
   3. Prader-Willi syndrome
   4. chronic renal insufficiency
   5. born small for gestational age with subsequent growth failure at 4 years of age or later
   6. short stature homeobox-containing gene (SHOX) deficiency.
7. Recombinant human growth hormone is a licensed therapy for adults with hypopituitarism and biochemically confirmed growth hormone deficiency. It should be used in conjunction with NICE guidelines and should only be initiated on the advice of an endocrinologist experienced in its use. On-going monitoring in secondary care is required for patients on this therapy

Somatrogon

• Solution for injection pre-filled pens 24mg in 1.2ml, 60mg in 1.2ml

Notes

1. NICE TA863: Somatrogon (Ngenla) is recommended, within its marketing authorisation, as an option for treating growth disturbance cause by growth hormone deficiency in children and young people aged 3 years and over (February 2023)

Growth hormone antagonist

Pegvisomant

• Powder and solvent for injection 10mg/ml, 15mg/ml, 20mg/ml, 25mg/ml, 30mg/ml

Indications

• Acromegaly

Notes

1. For the treatment of Acromegaly (Adults) in line with the NHS England Commissioning Policy

Hypothalamic hormones

Gonadorelin

• Injection 100 microgram vial with diluent