October 2026

New Products

• Dengue vaccine tetravalent (live, attenuated) (Qdenga) contains 4 serotypes of live attenuated dengue virus. The primary mechanism of action of Qdenga is to replicate locally and elicit neutralising antibodies to confer protection against dengue disease caused by any of the four dengue virus serotypes. Qdenga activates multiple arms of the immune system, including binding antibodies, complement fixing antibodies, functional antibodies to dengue non-structural protein 1 (NS1), and cell-mediated immune responses (CD4+, CD8+, and natural killer cells). Qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age. Qdenga is contraindicated in individuals with congenital or acquired immune deficiency, including those receiving immunosuppressive therapies such as high doses of systemic corticosteroids (e.g. 20 mg/day or 2 mg/kg/day of prednisone for 2 weeks or more) within 4 weeks prior to vaccination, or any other medicinal product with known immunosuppressive properties including chemotherapy; individuals with symptomatic human immunodeficiency virus (HIV) infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function; and in women who are pregnant or breastfeeding. After reconstitution, Qdenga powder for injection contains ≥ 3.3 log10 plaque-forming units (PFU) (serotype 1), ≥ 2.7 log10 PFU (serotype 2), ≥ 4.0 log10 PFU (serotype 3), and ≥ 4.5 log10 PFU (serotype 4) of dengue virus (live attenuated) per 0.5 mL. It is available in packs of 1 vial of powder plus 1 prefilled solvent syringe.
   
• Sodium oxybate (Sodium Oxybate-Reach) is a central nervous system depressant. The precise mechanism by which sodium oxybate produces an effect is unknown, however sodium oxybate is thought to act by promoting slow (delta) wave sleep and consolidating night-time sleep. Sodium oxybate administered before nocturnal sleep increases Stages 3 and 4 sleep and increases sleep latency, whilst reducing the frequency of sleep onset REM periods (SOREMPs). Sodium Oxybate-Reach is indicated for the treatment of narcolepsy in adult patients, adolescents and children from the age of 7 years. Sodium Oxybate-Reach is contraindicated in patients with major depression; with succinic semialdehyde dehydrogenase deficiency; and in those being treated with opiates or barbiturates. Sodium Oxybate-Reach oral solution contains sodium oxybate 500 mg per 1 mL and is available in bottle containing 180 mL.
   
• Tofersen (Qalsody) is an antisense oligonucleotide that is complementary to a portion of the 3′ untranslated region (3′UTR) of the mRNA for human superoxide dismutase 1 (SOD1) and binds to the mRNA by Watson-Crick base pairing (hybridisation). The human SOD1 gene encodes an abundant dimeric enzyme, copper/zinc superoxide dismutase (Cu/ZnSOD), which catalyses the transmutation of superoxide (O₂^-) into oxygen (O₂) and hydrogen peroxide (H₂O₂). In SOD1-associated amyotrophic lateral sclerosis (SOD1-ALS) patients, mutations in the SOD1 gene lead to accumulation of a toxic form of SOD1 protein, resulting in axonal injury and neurodegeneration. Hybridisation of tofersen to the cognate mRNA results in RNase-H-mediated degradation of the mRNA for SOD1, which reduces the amount of SOD1 protein synthesis. Qalsody has provisional approval for the treatment of adults with amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene. Qalsody solution for injection contains tofersen 100 mg per 15 mL and is available in packs of 1 vial.

New Presentation

• Perindopril arginine and amlodipine (besilate) (Coveram LD) are now available in a low dose combination tablet containing 3.5 mg of perindopril arginine and 2.5 mg of amlodipine. Coveram LD is the only combination Coveram tablet indicated for initiation therapy of hypertension. In addition to the existing contraindications for Coveram, it is also contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/minute).

New Indications

• Capivasertib (Truqap) in combination with fulvestrant is now indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
   
• Deucravacitinib (Sotyktu) is now also indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response to, or who have been intolerant to, a prior disease modifying therapy (DMARD). Sotyktu may be used as monotherapy or in combination with conventional synthetic DMARDs (csDMARDs).
   
• Estradiol (hemihydrate) (Sandrena) is now also indicated for the prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. The experience of treating women older than 65 years is limited.
   
• Goserelin (acetate) (Zoladex 10.8 mg Implant) is now also indicated for the management of oestrogen-receptor (ER) positive early and advanced breast cancer in pre- and perimenopausal women.
   
• Pembrolizumab (rch) (Keytruda) is now indicated in combination with paclitaxel, with or without bevacizumab, for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express programmed cell death-ligand 1 (PD-L1) (CPS ≥ 1) as determined by a validated test, and who have received one or two prior systemic treatment regimens.

New Contraindications

• Goserelin (acetate) (Zoladex 10.8 mg Implant) is contraindicated in pregnancy and lactation.

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.