Greater Glasgow and Clyde Medicines

Restrictions:

Monotherapy, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations, is restricted to specialist use only in accordance with regional protocol [NHS network access required].

BNF Link

Restrictions:

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

Multiple Myeloma: 

• Use as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma is restricted to use as a fourth-line treatment option. 
• In combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received one prior therapy only. 
• Use in combination with bortezomib, thalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
• In combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

Amyloidosis:

• Use in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of newly-diagnosed systemic light chain (AL) amyloidosis.

Prescribing Notes:

The following indications for the infusion preparation are not recommended by SMC and are non-Formulary:

• In combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
• Combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy.

The following indication for the solution for injection preparation is not recommended by SMC and is non-Formulary:

• Monotherapy for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma.

BNF Link

Restrictions:

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

• Non-metastatic castration-resistant prostate cancer (nmCRPC) in men who are at high risk of developing metastatic disease.
• Treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.

BNF Link

Restrictions:

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

• Treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
• Treatment of adult patients with chronic, accelerated or blast phase chronic myelogenous leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate.
• Treatment of adult patients with Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy (as approved by NCMAG). 
• Treatment of adult patients with newly diagnosed Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukaemia (ALL) integrated with chemotherapy (as approved by NCMAG). 

Prescribing Notes:

The following indications are not recommended by the SMC and are non-Formulary:

• ALL: Treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy (non-submission to SMC).

BNF Link

Restrictions:

Restricted to specialist use only. Use for adjuvant and metastatic breast cancer, metastatic prostate cancer, non-small cell lung cancer and cancer of the head and neck is restricted to use in accordance with regional protocols [NHS network access required]. 

Prescribing Notes:

The use of docetaxel in metastatic gastric adenocarcinoma has not been accepted by SMC and remains non-Formulary.

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

Prescribing Notes:

In April 2014, the MHRA issued advice to healthcare professionals relating to the use of domperidone, restricting its use to relief or nausea and vomiting, advising that it should be used at the lowest effective dose for the shortest possible time, and highlighting changes to the contraindications, dosing and duration of treatment of the medicine.

Domperidone is no longer licensed in patients weighing less than 35 kg because of a lack of evidence for benefit. See this MHRA alert for further information and a reminder of contraindications.

BNF Link

Restrictions:

Restricted to use by consultant anaesthetists for use as a third line antiemetic for post-operative nausea and vomiting (PONV) in patients with previous failure of other formulary agents. This preparation should only be routinely held in theatre recovery areas for this indication. The use of droperidol for addition to a PCA containing opiates remains non-Formulary.

BNF Link

Restrictions:

Excludes DF118 Forte®, Remedeine®, and Remedeine Forte® and their generic equivalents.

Prescribing Notes:

Dihydrocodeine is generally not an effective analgesic for post-operative pain except in neurosurgical procedures where NSAIDs are contraindicated when it avoids undue sedation and confusion which might interfere with neurological appraisal.

BNF Link

Restrictions:

Restricted to specialist use only for the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.

BNF Link