July 2022

New Products

• Amifampridine (Ruzurgi) is a broad-spectrum potassium channel blocker. The mechanism by which amifampridine exerts its therapeutic effect in Lambert-Eaton myasthenic syndrome (LEMS) patients has not been fully elucidated. Ruzurgi is indicated for the treatment of LEMS in adults and children aged 6 years and above. Ruzurgi is contraindicated in patients with a history of seizures, hypersensitivity to another aminopyridine, or who are taking other forms of amifampridine or other aminopyridines. Ruzurgi tablets contain amifampridine 10 mg and are available in a pack size of 100.
   
• Chlormethine (hydrochloride) (Ledaga) is a bifunctional alkylating agent that reacts with DNA to form cross-links, inducing the death of rapidly proliferating cells. Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients. Ledaga gel contains 160 mcg/g chlormethine and is available in a pack size of one 60 g tube.
   
• Estetrol (monohydrate) and drospirenone (Nextstellis) is a combined oral contraceptive that prevents pregnancy primarily by suppressing ovulation. Estetrol (E4) displays a high selectivity for estrogen receptors (ERs) and binds to both ERα and ERβ, with a 4 to 6 times higher affinity for ERα compared to ERβ. Estrogen agonist activity by E4 was demonstrated in various cell-based assays in vitro and animal models in vivo. The progestin drospirenone possesses antigonadotropic, antiandrogenic and mild antimineralocorticoid properties and has no estrogenic, glucocorticoid or antiglucocorticoid activity. Nextstellis is indicated for use by women of reproductive potential to prevent pregnancy. Nextstellis is contraindicated in the presence or risk of venous thromboembolism (VTE) (current VTE (on anticoagulants) or history of deep venous thrombosis or pulmonary embolism; known hereditary or acquired predisposition for VTE such as APC-resistance (including factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency; major surgery with prolonged immobilization; a high risk of VTE due to the presence of multiple risk factors); in the presence or risk of arterial thromboembolism (ATE) (current ATE or history of ATE (e.g. myocardial infarction or stroke) or prodromal condition (e.g. angina pectoris or transient ischaemic attack (TIA)); known hereditary or acquired predisposition for ATE, such as hyperhomocysteinaemia and antiphospholipid-antibodies (e.g. anticardiolipin antibodies, lupus anticoagulant); history of migraine with focal neurological symptoms; a high risk of ATE due to the presence of multiple combined risk factors such as heavy cigarette smoking (around 15 or more per day), positive family history (ATE in a sibling or parent especially at relatively early age e.g. below 50) and over 35 years of age; a high risk of ATE due to the presence of one serious risk factor such as diabetes with vascular symptoms, severe hypertension and severe dyslipoproteinaemia); pancreatitis, or a history thereof if associated with severe hypertriglyceridemia; presence or history of severe hepatic disease as long as liver function values have not returned to normal; severe renal insufficiency or acute renal failure; presence or history of liver tumours (benign or malignant); adrenal insufficiency; known or suspected sex steroid-influenced malignancies (e.g. of the genital organs or the breasts); undiagnosed vaginal bleeding; and known or suspected pregnancy. Nextstellis tablets contain estetrol 14.2 mg and drospirenone 3 mg in each active tablet and are available in 1, 3 or 6 packs of 28 tablets (24 pink active tablets + 4 white inactive tablets).
   
• Gilteritinib (fumarate) (Xospata) is an FMS-like tyrosine kinase 3 (FLT3) and AXL (as well as other kinases) inhibitor. Gilteritinib inhibits FLT3 receptor signalling and proliferation in cells expressing FLT3 including FLT3- ITD, FLT3-D835Y, and FLT3-ITD-D835Y, and it induces apoptosis in leukaemic cells expressing FLT3- ITD. Xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with an FLT3 mutation. Xospata tablets contain gilteritinib 40 mg and are available in a pack size of 84.
   
• Meningococcal polysaccharide conjugate A, C, Y and W-135 vaccine (MenQuadfi) induces the production of bactericidal antibodies specific to the capsular polysaccharides of N. meningitidis serogroups A, C, W, and Y. The presence of bactericidal anti-capsular meningococcal antibodies has been associated with protection from invasive meningococcal disease. MenQuadfi is indicated for active immunisation for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y. Primary vaccination: individuals 12 months of age and older receive a single dose. Booster vaccination: MenQuadfi may be given as a single booster dose to adolescents and adults who have previously been primed with meningococcal vaccine at least 4 years prior. MenQuadi contains 40 mcg/0.5 mL meningococcal (groups A, C, Y, W) polysaccharide tetanus toxoid conjugate vaccine and is available in a pack size of 1 vial.
   
• Rabies immunoglobulin (KamRAB) is infiltrated into the inoculation site (i.e., at the beginning of anti-rabies post-exposure prophylaxis (PEP)) to previously unvaccinated persons, to provide immediate passive rabies virus neutralising antibody protection until the patient’s immune system responds to vaccination by actively producing antibodies. KamRAB is indicated for passive, transient PEP of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. It should be administered concurrently with a full course of rabies vaccine. Do not administer additional (repeat) doses of KamRAB once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine. Do not administer to patients with a history of a complete pre-exposure or post-exposure vaccination regimen and confirmed adequate rabies antibody titre. KamRab solution for injection contains rabies immunoglobulin 300 IU/2 mL and is available in a pack of 1 vial.
   

New Presentation

• Bortezomib (Bortezomib Ever Pharma) is the first brand of bortezomib available as a solution for injection. It contains bortezomib 2.5 mg/1 mL or 3.5 mg/1.4 mL and is available in packs of 1 vial.

New Indications

• Abemaciclib (Verzenio), in combination with endocrine therapy, is now indicated for the adjuvant treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative, node-positive early breast cancer at high risk of recurrence. In pre- or peri-menopausal women, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. 
   
• Agomelatine (Valdoxan) is now indicated for treatment of generalised anxiety disorder in adults.
   
• Beclometasone dipropionate and formoterol (eformoterol) fumarate dihydrate and glycopyrronium (bromide) (Trimbow) is now indicated for the maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta₂-agonist and medium (Trimbow 100/6/10) or high (Trimbow 200/6/10) dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.
   
• Pembrolizumab (Keytruda) in combination with lenvatinib is now indicated for the first-line treatment of adult patients with advanced renal cell carcinoma.

New Contraindications

• Chlorpromazine hydrochloride (Largactil) is now contraindicated in children younger than 1 year; and with concomitant dopaminergics except in patients with Parkinson’s disease.
   
• Dexchlorpheniramine maleate (Polaramine) is now contraindicated in children under 2 years.
   
• Periciazine (Neulactil) is now contraindicated with concomitant dopaminergics except in patients with Parkinson’s disease.
   
• Propantheline bromide (Pro-Banthine) is now contraindicated in prostatic enlargement.
   
• Riociguat (Adempas) coadministration with other soluble guanylate cyclase stimulators is now contraindicated.
   
• Teriparatide (Forteo) is now contraindicated in pre-existing hypercalcaemia, severe renal impairment, metabolic bone diseases (including hyperparathyroidism) other than primary osteoporosis or glucocorticoid-induced osteoporosis, unexplained elevations of alkaline phosphatase, prior external beam or implant radiation therapy to the skeleton, patients with skeletal malignancies or bone metastases, pregnancy and breast-feeding.
   
• Tranexamic acid (Cyklokapron). Intrathecal and epidural administration is now contraindicated.
   

Safety Related Changes

• Pembrolizumab (Keytruda) is no longer indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing therapy and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥ 10] as determined by a validated test, regardless of PD-L1 status.

This list is a summary of only some of the changes that have occurred over the last month.
Before prescribing, always refer to the full product information.