May 2025

New Products

• Dexrazoxane (Dexrazoxane-Reach) is an analogue of ethylene diamine tetra-acetic acid. The dose-dependent cardiotoxicity observed during anthracycline administration is due to anthracycline-induced iron-dependent free radical oxidative stress on the relatively unprotected cardiac muscle. Dexrazoxane is hydrolysed in cardiac cells to the ring-opened product ICRF‑198. ICRF‑198 is capable of chelating metal ions. It is generally thought that it can provide cardioprotection by scavenging metal ions, thus preventing the Fe³⁺‑anthracycline complex from redox cycling and forming reactive radicals. Dexrazoxane also inhibits topoisomerase IIb, which may also contribute to protection of anthracycline-induced cardiotoxicity. Dexrazoxane-Reach is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m² and who will continue to receive doxorubicin therapy to maintain tumour control. Dexrazoxane-Reach is contraindicated in children aged 0 to 18 years; in breastfeeding; and during vaccination with yellow fever vaccine. Dexrazoxane-Reach powder for infusion contains dexrazoxane 500 mg and is available in packs of 1 vial.
   
• Edaravone (Radicava) is a free radical scavenger to reduce oxidative stress. Radicava is indicated in adults with a diagnosis of amyotrophic lateral sclerosis who are independent in activities of daily living with normal respiratory function and where treatment is initiated within two years of disease onset. Radicava concentrate for infusion contains edaravone 30 mg per 20 mL and is available in packs of 10 ampoules.
   
• Epcoritamab (rch) (Epkinly) is a humanised IgG1-bispecific antibody that binds to a specific extracellular epitope of CD20 on B cells and to CD3 on T cells. CD20 is expressed on most human B cell lymphomas and leukaemias and on B cells in peripheral blood, but not haematopoietic stem cells or plasma cells. The activity of epcoritamab is dependent upon simultaneous engagement of CD20‑expressing cancer cells and CD3‑expressing endogenous T cells by epcoritamab that induces specific T cell activation and T cell-mediated killing of CD20‑expressing cells, as epcoritamab does not have direct immune effector mechanisms. The Fc region of epcoritamab is silenced for direct immune effector mechanisms, such as antibody-dependent cellular cytotoxicity, complement-dependent cellular cytotoxicity, and antibody-dependent cellular phagocytosis. Epkinly has provisional approval for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma after two or more lines of systemic therapy. Epkinly concentrate for injection (dilute to use) contains epcoritamab 4 mg per 0.8 mL and is available in packs of 1 vial. Epkinly solution for injection (ready to use) contains epcoritamab 48 mg per 0.8 mL and is available in packs of 1 vial.
   
• Iptacopan (Fabhalta) is a proximal complement inhibitor that targets Factor B (FB) to selectively inhibit the alternative pathway while leaving the direct signalling from the lectin and classical pathways intact. Inhibition of FB prevents the activity of alternative pathway related C3 convertase and the subsequent formation of C5 convertase. In paroxysmal nocturnal haemoglobinuria (PNH), intravascular haemolysis (IVH) is mediated by the downstream membrane attack complex, while extravascular haemolysis (EVH) is facilitated by opsonisation with C3 fragments. Iptacopan acts proximally in the alternative pathway of the complement cascade to control both C3‑mediated EVH and terminal complement-mediated IVH. Fabhalta is indicated for the treatment of adult patients with PNH. Fabhalta is contraindicated in patients who are not currently vaccinated against Neisseria meningitidis and Streptococcus pneumoniae unless the risk of delaying Fabhalta treatment outweighs the risk of developing an infection from these encapsulated bacteria; for initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B; and for use in combination with other complement inhibitor therapies for PNH, unless medically justified. Fabhalta capsules contain iptacopan 200 mg and are available in packs of 56.
   
• Lutetium (¹⁷⁷Lu) vipivotide tetraxetan (Pluvicto) is a radionuclide which is linked to a targeting moiety that binds to prostate-specific membrane antigen (PSMA), a transmembrane protein that is highly expressed in prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC). Upon the binding of Pluvicto to PSMA-expressing cancer cells, the beta‑minus emission from lutetium-177 delivers therapeutic radiation to the targeted cell, as well as to surrounding cells, and induces DNA damage which can lead to cell death. Pluvicto is indicated for the treatment of adult patients with PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. Pluvicto solution for injection contains lutetium (¹⁷⁷Lu) vipivotide tetraxetan 1000 MBq per 1 mL and is available in packs of 1 vial.
   
• Rozanolixizumab (rch) (Rystiggo) is a humanised IgG4 monoclonal antibody which decreases serum IgG concentration by inhibiting the binding of IgG to neonatal Fc receptor, a receptor that normally protects IgG from intracellular degradation and recycles IgG back to the cell surface. By the same mechanism, rozanolixizumab is expected to decrease the concentration of pathogenic IgG autoantibodies associated with generalised myasthenia gravis (gMG). Rystiggo is indicated as an add-on to standard therapy for the treatment of gMG in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. Rystiggo solution for infusion contains rozanolixizumab 280 mg per 2 mL and is available in packs of 1 vial.

New Presentations

• Macitentan and tadalafil (Opsynvi) is a single tablet combination therapy containing two oral components with synergistic mechanisms of action to improve pulmonary arterial hypertension (PAH): macitentan, an endothelin receptor antagonist, and tadalafil, a phosphodiesterase 5 inhibitor. Opsynvi is indicated for the maintenance treatment of PAH (World Health Organization (WHO) Group 1) in adult patients of WHO functional class II and III whose PAH is idiopathic, heritable or associated with connective tissue disease or congenital heart disease with repaired shunts. Opsynvi is intended as substitution treatment only for patients currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg as separate tablets. Opsynvi is contraindicated in women who are or may become pregnant; in women of child-bearing potential who are not using reliable contraception (women must not become pregnant for at least 3 months after stopping treatment with macitentan); in patients with severe hepatic impairment (with or without cirrhosis); in patients with baseline values of hepatic aminotransferases (AST and/or ALT) greater than 3 times the upper limit of normal; for concomitant use with nitric oxide donors, organic nitrates or organic nitrites (e.g. glyceryl trinitrate (injection, tablets, sprays or patches), isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil) in any form either regularly or intermittently (where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours in most patients and 4-5 days in the elderly (approximately 4-5 half-lives) should have elapsed after the last dose of Opsynvi before nitrate administration is considered); for concomitant use with guanylate cyclase stimulators such as riociguat; in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy, regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure; in patients who had acute myocardial infarction within the last 90 days; in patients with severe hypotension (< 90/50 mmHg), unstable angina, uncontrolled arrhythmias, uncontrolled hypertension; and in patients with a stroke within the last 6 months. Opsynvi tablets contain macitentan 10 mg and tadalafil 40 mg and are available in packs of 30.
   
• Pegcetacoplan (Syfovre) binds to complement protein C3 and its activation fragment C3b with high affinity thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation. Overactivation of the complement system is strongly associated with the progression of geographic atrophy (GA). Increased levels of complement activity have been found in patients with GA, specifically in lesions and surrounding areas including photoreceptors. The complement C3 protein plays a role in driving the downstream damaging effects of complement overactivation in the progression of GA, which include uncontrolled inflammation, opsonisation, and retinal cell death. Pegcetacoplan acts centrally in the complement cascade by regulating C3, thereby exerting broad control of complement activation, and of the complement effectors that are involved in the pathogenesis of GA. Syfovre is indicated for the treatment of adult patients with GA secondary to age-related macular degeneration with an intact fovea and when central vision is threatened by GA lesion growth. Syfovre is contraindicated in patients with ocular or periocular infections and active intraocular inflammation. Syfovre solution for injection contains pegcetacoplan 15 mg per 0.1 mL and is available in packs of 1 vial.

New Indications

• Benralizumab (Fasenra) is now indicated as an add-on treatment for relapsing or refractory eosinophilic granulomatosis with polyangiitis in adult patients aged 18 years and over.
   
• Isavuconazole (sulfate) (Cresemba) is now indicated in paediatric patients from 1 year of age for the treatment of invasive aspergillosis and mucormycosis in patients for whom amphotericin B is inappropriate. 
   
• Ribociclib (succinate) (Kisqali), in combination with an aromatase inhibitor, is now indicated for the adjuvant treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative stage II and III early breast cancer at high risk of recurrence.
   
• Trastuzumab deruxtecan (Enhertu) is now indicated (with provisional approval) for the treatment of adult patients with locally advanced or metastatic HER2‑positive gastric or gastroesophageal junction adenocarcinoma who have received a prior anti‑HER2‑based regimen.
   
• Venetoclax (Venclexta), in combination with ibrutinib, is now indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/ small lymphocytic lymphoma.
   

New Contraindications

• Nirmatrelvir and ritonavir (Paxlovid) is now contraindicated for concomitant use with cariprazine.
   
• Ribociclib (succinate) (Kisqali) is now contraindicated in patients who are at significant risk of developing Torsades de Pointes (including uncontrolled hypertension, high degree atrioventricular block, severe aortic stenosis, uncontrolled hypothyroidism).

Safety Related Changes

• Ganirelix (acetate) (Orgalutran) is no longer contraindicated in patients with hypersensitivity to dry natural rubber/ latex.

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.