Greater Glasgow and Clyde Medicines

Restrictions:

Restricted to use on the advice of a consultant microbiologist or consultant infectious disease physician for patients with acute bacterial skin and skin structure infections (ABSSSI) who have suspected or confirmed polymicrobial infection following treatment failure or when standard antibacterial therapies are not suitable.

Please note: this is a PROTECTED ANTIBIOTIC (see policy here) and relevant paper work should be completed.

Prescribing Notes:

Due to the risk of severe, disabling and potentially permanent adverse events, new restrictions apply to the prescribing of fluoroquinolones.

Please see new MHRA advice (January 2024) and NHSGGC statement (March 2024) for more details.

BNF Link

Restrictions:

Restricted to specialist use in accordance with regional protocols [NHS network access required] for the following indications:

• Lung cancer:
  • As monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 (programmed cell death ligand 1) on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.
  • In combination with etoposide and either carboplatin or cisplatin for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). 
  • As monotherapy for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
• Biliary tract cancer: In combination with gemcitabine and cisplatin for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer. 
• Endometrial cancer: In combination with carboplatin and paclitaxel for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with:
  • durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
  • durvalumab in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).
• Liver cancer: In combination with tremelimumab for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
• Bladder cancer: In combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by durvalumab as monotherapy adjuvant treatment after radical cystectomy, for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).

BNF Link

Restrictions:

Restricted to specialist use as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control, and who have had one or more prior surgery for chronic rhinosinusitis with nasal polyps and have a SNOT-22 score of 50 or higher.

BNF Link

Restrictions:

Restricted to specialist use in accordance with regional protocols [NHS network access required] for the following indications:

Breast cancer

• As monotherapy for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received one or more prior anti-HER2-based regimens.
• As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Prescribing Notes:

Trastuzumab deruxtecan is currently non-formulary for the following indications:

• Gastric or gastroesophageal junction adenocarcinoma: As monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
• Non-small cell lung cancer: As monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
• Breast cancer: Treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultra low breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.
• Treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.

BNF Link

Restrictions:

Restricted to specialist use for the treatment of the following indication:

• Treatment of cystic fibrosis (CF) in people aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

BNF Link