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New Products
- Asciminib (hydrochloride) (Scemblix) is an oral and potent inhibitor of ABL/BCR::ABL1 tyrosine kinases. Asciminib inhibits the ABL1 kinase activity of the BCR::ABL1 fusion protein, by specifically targeting the ABL myristoyl pocket. Scemblix is indicated for the treatment of patients 18 years of age and above with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors; and in Ph+ CML in CP with the T315I mutation. Scemblix tablets contain asciminib 20 mg or 40 mg and are available in packs of 20 or 60.
- Estradiol (hemihydrate) and progesterone (Bijuva 1/100) is a combined hormone replacement therapy (HRT). Bijuva 1/100 is indicated for use during continuous combined HRT for estrogen deficiency symptoms in postmenopausal women with an intact uterus and with at least 12 months since last menses. Bijuva 1/100 is contraindicated in patients with known, past or suspected breast cancer; known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer); undiagnosed genital bleeding; untreated endometrial hyperplasia; previous or current venous thromboembolism (deep vein thrombosis, pulmonary embolism); known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency); active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction); acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal; and porphyria. Bijuva 1/100 capsules contain estradiol 1 mg and progesterone 100 mg and are available in a pack size of 28.
- Selinexor (Xpovio) is a reversible covalent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1). XPO1 is a major nuclear export protein that transports cargo proteins and several classes of mRNA from the nucleus to the cytoplasm. XPO1 cargoes include many tumour suppressor proteins (TSPs), growth regulator proteins (GRPs) and mRNAs of growth promoting (oncogenic) proteins. XPO1 inhibition by selinexor leads to marked accumulation of TSPs and GRPs (such as p53, p21, FOXO and IκB) in the nucleus (their site of action), and reduced expression of several oncoproteins (such as c-Myc, Bcl2 and cyclin D1) and translation/chaperon proteins (Hsp70), resulting in cell cycle arrest and apoptosis of cancer cells. Xpovio is indicated, in combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and, in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory medicinal product, and an anti-CD38 monoclonal antibody. Xpovio tablets contain selinexor 20 mg and are available in packs of 16, 20 or 32.
- Somapacitan (Sogroya) is a long-acting recombinant human growth hormone (GH) derivative. The mechanism of action of somapacitan is either directly via the GH-receptor and/or indirectly via insulin-like growth factor-1 (IGF-1) produced in tissues throughout the body, but predominantly by the liver. When GH deficiency is treated with somapacitan, a normalisation of body composition (i.e. decreased body fat mass, increased lean body mass) and of metabolic action is achieved. Sogroya is indicated for the replacement of endogenous GH in adults with GH deficiency. Sogroya is contraindicated in patients with any evidence of activity of a tumour and anti-tumour therapy must be completed prior to starting Sogroya therapy; and in patients with acute critical illness suffering from complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions. Sogroya solution for injection contains somapacitan 10 mg/1.5 mL and is available in a pack of 1 prefilled pen.
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New Presentation
- Elasomeran (Spikevax) is now also available as a suspension for injection containing elasomeran 100 mcg/mL in packs containing ten 2.5 mL multidose vials or ten 0.5 mL prefilled syringes.
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New Indications
- Atezolizumab (Tecentriq), as monotherapy, is now indicated as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage II to IIIA (as per 7th edition of the UICC/AJCC staging system) NSCLC whose tumours have PD-L1 expression on ≥ 50% of tumour cells.
- Dupilumab (rch) (Dupixent) is now indicated as add on maintenance treatment in patients aged 6 years and older with moderate to severe asthma with type 2 inflammation (elevated eosinophils or elevated fractional exhaled nitric oxide) that is inadequately controlled despite therapy with other medicinal products for maintenance treatment.
- Elasomeran (Spikevax) now has provisional approval for the active immunization of individuals 6 months of age and older to prevent coronavirus disease 2019 (COVID‑19) caused by SARS‑CoV‑2.
- Leuprorelin acetate (Eligard) is now indicated for the treatment of children 2 years of age and older with central precocious puberty. This indication is for the 45 mg 6-month presentation only.
- Nivolumab (Opdivo), as monotherapy, is now indicated for the adjuvant treatment of patients with muscle invasive urothelial carcinoma (MIUC) who are at high risk of recurrence after undergoing radical resection of MUIC.
- SARS-CoV-2 rS (NVX-CoV2373) (Nuvaxovid) now has provisional approval for the active immunization of individuals 12 years of age and older to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
- Trastuzumab deruxtecan (Enhertu) is now indicated, as monotherapy, for the treatment of adult patients with unresectable or metastatic HER2‑positive breast cancer who previously received trastuzumab and a taxane for metastatic disease, or one prior anti‑HER2‑based regimen and developed disease recurrence during or within six months of completing neo‑adjuvant or adjuvant therapy.
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New Contraindications
- Dobutamine hydrochloride (DBL Dobutamine Hydrochloride Injection) is now contraindicated in patients with mechanical obstruction affecting left ventricular filling or outflow, especially in the case of obstructive cardiomyopathy or constrictive pericarditis.
- Gemeprost (Cervagem) is now contraindicated in patients at risk of hemorrhage due to procedures for placenta previa, ectopic pregnancy, etc; and in patients with fever due to pelvic infection.
- Midostaurin (Rydapt) is now contraindicated with concomitant administration of potent CYP3A4 inducers (e.g. rifampicin, St. John’s Wort (Hypericum perforatum), carbamazepine, enzalutamide, phenytoin).
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Safety Related Changes
- Neratinib (Nerlynx) is no longer contraindicated with concomitant moderate CYP3A4/P‑gp inhibitors (e.g. fluconazole, diltiazem, verapamil, erythromycin).
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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.
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