May 2023

New Products

• LetibotulinumtoxinA (Letybo) blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve terminals. This inhibition occurs according to the following sequence: heavy chain of toxin binding to cholinergic nerve terminals, internalisation of the toxin within vesicles into the nerve terminal, translocation of the light‑chain of the toxin molecule into the cytosol of the nerve terminal and enzymatic cleavage of SNAP25, the presynaptic target protein essential for the release of acetylcholine. Complete recovery of endplate function/impulse transmission after intramuscular injection normally occurs within 3‑4 months as nerve terminals sprout and reconnect with the muscle endplate and the presynaptic neurotransmitter release mechanism becomes functional again. Letybo is indicated for the temporary improvement in the appearance of moderate to severe glabellar frown lines in adults. Letybo is contraindicated in generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert‑Eaton syndrome, amyotrophic lateral sclerosis) and in infection or inflammation at the proposed injection sites. Letybo powder for injection contains letibotulinumtoxinA 100 units and is available in packs of 1 vial.
   
• Pneumococcal 20‑valent polysaccharide conjugate vaccine (Prevenar 20) contains 20 pneumococcal capsular polysaccharides all conjugated to a CRM₁₉₇ carrier protein, which modifies the immune response to the polysaccharide from a T‑cell independent response to a T‑cell dependent response. The T‑cell dependent response leads to both an enhanced antibody response and generation of memory B‑cells, allowing for an anamnestic (booster) response on re‑exposure to the bacteria. Vaccination with Prevenar 20 induces serum antibody production and immunologic memory against the serotypes contained within the vaccine. Protection against pneumococcal disease is conferred mainly by opsonophagocytic killing of Streptococcus pneumoniae. Prevenar 20 is indicated for active immunisation for the prevention of pneumococcal disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F in adults 18 years of age and older. Prevenar 20 is contraindicated in individuals with hypersensitivity to diphtheria toxoid. Prevenar 20 suspension for injection contains 2.2 micrograms each of serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, and 4.4 micrograms of serotype 6B, conjugated to 51 micrograms of diphtheria CRM₁₉₇ protein and adsorbed on aluminium phosphate (0.125 mg aluminium per dose). It is available as a 0.5 mL prefilled syringe in packs of 1.

New Indications

• Darolutamide (Nubeqa) is now indicated, in combination with docetaxel, for the treatment of metastatic hormone‑sensitive prostate cancer.
   
• Ipilimumab (Yervoy) is now indicated, in combination with nivolumab, for the first‑line treatment of patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma with tumour cell PD‑L1 expression ≥ 1% as determined by a validated test.
   
• Nivolumab (Opdivo) is now indicated, in combination with ipilimumab or fluoropyrimidine- and platinum‑based combination chemotherapy, for the first‑line treatment of patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma with tumour cell PD‑L1 expression ≥ 1% as determined by a validated test.
   
• Pneumococcal 15‑valent polysaccharide conjugate vaccine (Vaxneuvance) is now indicated for children from 6 weeks of age.
   
• Zanubrutinib (Brukinsa) is now indicated as monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma, including patients with deletion 17p and/or TP53 mutation.

New Contraindications

• Lanthanum (carbonate hydrate) (Fosrenol) is now contraindicated in bowel obstruction, ileus, and faecal impaction.
   
• Nevirapine (Viramune XR) is now contraindicated in total lactase deficiency.

Safety Related Changes

• Atezolizumab (Tecentriq) is no longer indicated for triple negative breast cancer.

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.