Greater Glasgow and Clyde Medicines

Restrictions:

The use in combination with other antiretroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age is restricted to use by HIV specialists.

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Restrictions:

Restricted for use in asthma patients according to the BTS/SIGN asthma guidelines.

Prescribing Notes:

Preferred brands and devices:

• DuoResp^® Spiromax (dry powder inhaler)
• Fobumix^® Easyhaler (dry powder inhaler
• Symbicort^® Turbohaler (dry powder inhaler)

To prevent confusion, prescribe inhaler devices by brand name.

Non-Formulary indication:

Treatment of patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) 50% to 70% predicted normal (post bronchodilator) and an exacerbation history despite regular bronchodilator therapy.

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Restrictions:

Desmopressin tablets are restricted to use in patients unable to use intramuscular preparations. Intravenous desmopressin is restricted to use in specialist haemophilia centres.

Prescribing Notes:

• Used for treatment of diabetes insipidus, primary nocturnal enuresis and postoperative polyuria or polydipsia. Due to the high level of adverse reactions, desmopressin nasal spray is no longer indicated for primary nocturnal enuresis. Oral formulations should be considered as an alternative.
• For use in the symtomatic treatment of nocturia due to idiopathic nocturnal polyuria see section 7.4.2

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Restrictions:

Restricted to specialist use in accordance with local guidelines in patients with the following indications:

Psoriasis

Patients with moderate to severe psoriasis who have failed to respond to standard systemic therapies, are intolerant to, or have a contra-indication to these treatments.

Hidradenitis suppurativa (HS)

Adult patients with active moderate to severe HS for whom adalimumab is contraindicated or otherwise unsuitable, including those who have failed to respond or have lost response to prior adalimumab treatment.

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Restrictions:

Restricted to use under the advice of the national paroxysmal nocturnal haemoglobinuria (PNH) service as add-on to ravulizumab or eculizumab for the treatment of adult patients with PNH who have residual haemolytic anaemia.

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Restrictions:

Chronic Kidney Disease:

Restricted to initiation by clinicians, either in primary or secondary care, experienced in the treatment of chronic kidney disease (CKD) for use in patients having individually optimised standard care (including angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, unless these are contraindicated or not tolerated), and either, at the start of treatment:

• an estimated glomerular filtration rate (eGFR) of 20 mL/min/1.73m² up to 45 mL/min/1.73m², or
• an eGFR of 45 mL/min/1.73m² up to 90 mL/min/1.73m² and either:
  • A urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more, or
  • Type 2 Diabetes Mellitus (T2DM). 

For use in chronic heart failure, see section 2.5.6

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Restrictions:

Restricted to specialist use in the treatment of:

• Moderate to severe plaque psoriasis in accordance with local guidelines in patients who have failed to respond to conventional systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have contra-indications to these treatments.
• Moderate to severely active Crohn's disease in patients 16 year of age and older, who have an inadequate response to, lost response to, or where intolerant to conventional therapy, or if such therapies are not advisable. 

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Restrictions:

Restricted to specialist use in accordance with the prescribing notes below.

Prescribing Notes:

Psoriasis in adults:

• The treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA) is restricted to specialist use. Continued treatment should be restricted to patients who achieve a PASI 75% response within 16 weeks.

Psoriasis in adolescents:

• The treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies is restricted to specialist use.  Continued treatment should be restricted to patients who achieve at least 75% improvement in their Psoriasis Area and Severity Index (PASI 75) within 16 weeks.

For use in psoriatic arthritis see section 10.1.3 and for use in Crohn's disease see section 1.5.3

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Restrictions:

Restricted to specialist use for moderate to severe atopic dermatitis in patients who have had an
inadequate response to at least one conventional systemic immunosuppressant such as ciclosporin, or
in whom such treatment is considered unsuitable.

Prescribing Notes:

Following a MHRA review in April 2023, the risk of increased incidence of malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality, when compared to those treated with tumour necrosis factor (TNF)-alpha inhibitors, were are considered a class effects across JAK inhibitors used for chronic inflammatory disorders and therefore it is advised to avoid prescribing these medicines unless there are no suitable alternatives in patients with the following risk factors:
- age 65 years or older
- current or past long-time smoking
- other risk factors for cardiovascular disease or malignancy

Please see further details of the review here.

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