Medicines advice

For treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age

In combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, for the treatment of resectable non‑small cell lung carcinoma at high risk of recurrence in adults.

Treatment of adult patients with diffuse large B‑cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

In combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive.

Treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.

In combination with omeprazole, for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with active or a history of H. pylori associated ulcers.

In adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.

As monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy.

For the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents.

In combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

- For the treatment of adult patients with advanced hormone-sensitive prostate cancer.
- For the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
- As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

As monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy.

For the treatment of adult patients with visual impairment due to macular oedema secondary to branched and central retinal vein occlusion (BRVO and CRVO).

In combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have:
- locally advanced NSCLC who are not candidates for definitive chemoradiation, or
- metastatic NSCLC

Contraception

In combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

As monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R 132 mutation who were previously treated by at least one prior line of systemic therapy.

• In combination with trametinib for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600 mutation who require systemic therapy.
  
  
• In combination with trametinib for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600 mutation who have received at least one prior radiation and/or chemotherapy treatment.

Symptomatic treatment of adult patients with overactive bladder (OAB) syndrome.

For treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results

In combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy after surgery, is indicated for the treatment of adults with resectable (tumours ≥ 4 cm and/or node-positive) NSCLC and no known EGFR mutations or ALK rearrangements.

As monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.

Treatment of moderate-to-severe Dry Eye Disease (keratoconjunctivitis sicca) in adult patients who have not responded adequately to artificial tears.

Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

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

As monotherapy for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH):

• In patients with haemolysis with clinical symptom(s) indicative of high disease activity.
• In patients who are clinically stable after having been treated with a complement component 5 (C5) inhibitor for at least the past 6 months.

For the treatment of adult and paediatric patients aged 6 and above with facial angiofibroma (facial AF) associated with tuberous sclerosis complex (TSC).

For the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older.

Paroxysmal nocturnal hemoglobinuria (PNH), who have haemolytic anaemia.

In adult women of reproductive age for symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

As an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia.

Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

As monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

In combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired human immunodeficiency-1 (HIV-1) infection in high-risk adults and adolescents, weighing at least 35 kg.

as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma

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

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