Ibrutinib as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
·Ibrutinib as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least prior therapy.
·Ibrutinib as a single agent is indicated for the treatment of adult patients with Waldenström"s macroglobulinaemia (WM) who have received at least prior therapy, or in first line treatment for patients unsuitable for chemoimmunotherapy.
·Ibrutinib in combination with rituximab is indicated for the treatment of adult patients with WM.
Ravulizumab is indicated for:
The treatment of adult and pediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal hemoglobinuria (PNH).
The treatment of adults and pediatric patients with a body weight of 10 kg or above with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
Ibrutinib as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
·Ibrutinib as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least prior therapy.
·Ibrutinib as a single agent is indicated for the treatment of adult patients with Waldenström"s macroglobulinaemia (WM) who have received at least prior therapy, or in first line treatment for patients unsuitable for chemoimmunotherapy.
·Ibrutinib in combination with rituximab is indicated for the treatment of adult patients with WM.
Hypercholesterolaemia and mixed dyslipidaemia
Ezetimibe/Bempedoic Acid is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
·in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe
·alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDLC goals with ezetimibe alone,
·in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.
Cardiovascular disease
Ezetimibe/Bempedoic Acid is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
·in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment or,
·in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or,
·in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.
For adult patients with type 2 diabetes mellitus, is indicated to improve glycaemic control:
as monotherapy:
• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
• metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control
as triple oral therapy in combination with:
• a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Sitagliptin is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
For adult patients with type 2 diabetes mellitus, Sitaglu is indicated to improve glycaemic control:
as monotherapy:
• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
• metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
as triple oral therapy in combination with:
• a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Sitagliptin is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
For adult patients with type 2 diabetes mellitus, Sitaglu is indicated to improve glycaemic control:
as monotherapy:
• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
• metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control
as triple oral therapy in combination with:
• a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Sitagliptin is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Spironolactone is an antagonist of aldosterone indicated for:
·Heart Failure: Initiate treatment at 20 mg daily
·Hypertension: Initiate treatment at 20 to 75 mg daily in either single or divided doses
·Edema associated with Hepatic Cirrhosis: Initiate therapy in a hospital setting and titrate slowly. The initial recommended daily dose is 75 mg in either single or divided doses
Heart Failure
Spironolactone is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction in adult patients to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. Spironolactone oral suspension is usually administered in conjunction with other heart failure therapies
Hypertension
Spironolactone is indicated as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Edema caused by Cirrhosis
Spironolactone is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction.
Spironolactone is an aldosterone antagonist acting primarily through competitive binding of receptors at the aldosterone-dependent sodium- potassium exchange site in the distal convoluted renal tubule, increasing sodium and water excretion, while retaining potassium. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism.
Malignant pleural mesothelioma
-Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
-Pemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
-Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
-Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non small cell lung cancer other than predominantly squamous cell histology.
-Pemetrexed is indicated in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous
NSCLC (non-small cell lung cancer), with no EGFR (Epidermal growth factor receptor) or ALK (anaplastic lymphoma kinase) genomic tumor aberrations
For the treatment of adult patients with immune (idiopathic) thrombocytopenic purpura (ITP) lasting at least 6 months from diagnosis who have not responded sufficiently to other treatment options (e.g.Corticosteroids, immunoglobulins or splenectomy) when there is an increased risk of bleeding due to pronounced thrombocytopenia.
For the treatment of paediatric patients (aged 1 year and older) with immune (idiopathic) thrombocytopenic purpura (ITP) lasting at least 6 months from diagnosis and a significant tendency to bleed who have not responded to an established treatment (e.g. IVIG, corticosteroids) and for whom splenectomy is not a treatment option.
For the treatment of thrombocytopenia in adult patients aged 18 years and older with chronic hepatitis C virus (HCV) infection, where the degree of thrombocytopenia prevents the initiation of interferon-based therapy and/or the ability to optimally maintain it. Ropirage has not been tested in combination with HCV protease inhibitors (boceprevir, telaprevir).
For the treatment of cytopenias in adult patients with acquired severe aplastic anaemia (SAA) who are either treatment-refractory or who have undergone considerable prior therapy and who are not eligible for a haematopoietic stem cell transplant at the time of indication.
For the first-line treatment of acquired severe aplastic anaemia (SAA) in combination with standard immunosuppressive therapy in adult and paediatric patients aged 2 years and over who are unsuitable for haematopoietic stem cell transplantation at the time of diagnosis.
Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.
For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.
