Medicines advice

Add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.

As monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with or without an anti-vascular endothelial growth factor (VEGF) therapy and, if rat sarcomas virus (RAS) wildtype and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy.

As monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations who have previously received at least one line of therapy containing a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-(L)1) inhibitor in the unresectable or metastatic treatment setting.

For the prevention of ototoxicity caused by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (APOE4) heterozygotes on non-carriers.

Treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper.

Treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir in paediatric patients aged from 2 years and with body weight at least 14 kg to less than 25 kg.

For the treatment of transfusion-dependent β-thalassaemia in patients 12 years of age and older for whom haematopoietic stem cell transplantation is appropriate and a human leukocyte antigen (HLA)-matched related haematopoietic stem cell (HSC) donor is not available.

Treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19.

Treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness.

In adults for the treatment of chronic kidney disease (CKD).

For treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

For treatment of adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis (ATTRv).

Monotherapy as adjuvant treatment for adult patients with Stage IB (tumours ≥ 4cm) to IIIA (7th edition of the UICC/AJCC-staging system) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following complete tumour resection.

Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

For the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.

Treatment of HLA-A*02:01-positive adult patients with advanced (unresectable or metastatic) uveal melanoma.

In combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.

For the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.

Treatment of patients aged 12 years and older with acute graft versus host disease who have inadequate response to corticosteroids.

In combination with tremelimumab for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma.

In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19
deletions or exon 21 (L858R) substitution mutations.

Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease as defined by clinical or imaging features.

As monotherapy for the treatment of adults and adolescents 12 years and older with advanced rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC).

For treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients that are apolipoprotein E ɛ 4 (ApoEɛ4) heterozygotes or non-carriers.

ANTICIPATED: As monotherapy for the treatment of adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer (TC) who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Treatment of adult patients with previously untreated cell membrane receptor 30-positive (CD30+) Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).

As an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive (AChR-Ab+).

For treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.

In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon20 insertion mutations.

Treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Treatment of osteoporosis in postmenopausal women at increased risk of fracture.

In combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults.

In combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence.s

In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

Treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.

Indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.

Treatment of adult patients with Philadelphia chromosome (Ph)-negative, CD19-positive, B-cell precursor acute lymphoblastic leukaemia (ALL) in the consolidation phase.

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 ismismatch repair proficient (pMMR).