Medicines advice

For treatment of adults with neuromyelitis optica spectrum disorder in patients who are anti-aquaporin-4 antibody-positive with a relapsing course of the disease.

Adjunctive therapy to preparations of levodopa / DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Induction of remission in patients with active microscopic colitis (MC)

As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

For treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (HER2+) breast cancer who have received two or more prior anti-HER2-based regimens.

In combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens

In combination with ipilimumab and 2 cycles of platinum-based doublet chemotherapy (PDC) is indicated for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have no sensitising epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocations.

nivolumab with ipilimumab (NIVO+IPI) is indicated for the treatment of adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-based combination chemotherapy.

In combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

Treatment of adult patients with alkaptonuria (AKU).

Treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate.

Substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.

Field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.

Treatment of wild type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

As a single agent for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

In adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis

Treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.

Durvalumab in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of adults with extensive-stage small cell lung cancer.

As monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments.

For treatment of adult patients with relapsing remitting multiple sclerosis (RRMS)

In combination with ipilimumab for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

As adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older.

As monotherapy for the treatment of adults with locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) gene fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

For treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.

For the treatment of 5q spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA type 1, type 2 or type 3 or with one to four SMN2 copies.

For the adjunctive treatment of focal onset seizures (FOS) with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite treatment with at least two anti-epileptic products.

Monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum‑containing regimen.

Routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.

For treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults

As monotherapy for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have progressed on, or are intolerant to, platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotheray

Treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior lines of systemic therapies, at least one of them given for unresectable locally advanced or metastatic disease.

To improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

For treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older

In combination with a hypomethylating agent (HMA) for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy (IC).

For treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older

For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.