March 2023

New Products

• Avalglucosidase alfa (Nexviazyme) is a recombinant human acid α-glucosidase (rhGAA) that provides an exogenous source of acid α‑glucosidase (GAA). Avalglucosidase alfa is a modification of alglucosidase alfa in which approximately 7 hexamannose structures each containing 2 terminal mannose‑6‑phosphate (bis‑M6P) moieties are conjugated to oxidised sialic acid residues on alglucosidase alfa. Avalglucosidase alfa has a 15‑fold increase in mannose‑6‑phosphate (M6P) moieties compared with alglucosidase alfa. Increasing the level of bis‑M6P on rhGAA provides a mechanism to drive uptake into the diaphragm and other skeletal muscle via the cation-independent M6P receptor, where it can degrade glycogen and ameliorate tissue damage. Nexviazyme is indicated for long-term enzyme replacement therapy for the treatment of patients one year of age and older with Pompe disease (GAA deficiency). Nexviazyme powder for infusion contains avalglucosidase alfa 100 mg and is available in packs of 1 vial.
   
• Pneumococcal 15‑valent polysaccharide conjugate vaccine (Vaxneuvance) contains serotype-specific pneumococcal capsular polysaccharides each of which is conjugated to a carrier protein (CRM₁₉₇), and elicits antibodies that enhance opsonisation, phagocytosis, and killing of pneumococci to protect against pneumococcal disease. Vaxneuvance is also expected to elicit a T‑cell dependent immune response. Carrier protein-specific helper T‑cells support specificity, functionality and maturation of serotype-specific B cells. Vaxneuvance is indicated for active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F) in adults 18 years of age and older. Vaxneuvance is contraindicated in individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any diphtheria toxoid-containing vaccine. Vaxneuvance suspension for injection contains 32 micrograms of total pneumococcal purified capsular polysaccharide (2.0 micrograms each of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4.0 micrograms of serotype 6B) conjugated to 30 micrograms of non-toxic diphtheria CRM₁₉₇ protein, adsorbed on 125 micrograms of aluminium (as aluminium phosphate adjuvant). It  is available as a 0.5 mL prefilled syringe in packs of 1 or 10.
   
• Sotorasib (Lumakras) is a KRAS G12C inhibitor, which covalently and irreversibly binds to the unique cysteine of KRAS G12C. Inactivation of KRAS G12C by sotorasib blocks tumour cell signalling and survival, inhibits cell growth, and promotes apoptosis selectively in tumours harbouring KRAS G12C, an oncogenic driver of tumourigenesis across multiple cancer types. The potency and selectivity of sotorasib is enhanced through the unique binding to both the P2 pocket and the His95 surface groove, locking the protein in an inactive state that prevents downstream signalling without affecting wild-type KRAS. Lumakras has provisional approval for the treatment of adult patients with KRAS G12C‑mutated locally advanced or metastatic non-small cell lung cancer who have received at least one prior systemic therapy for advanced disease. Lumakras tablets contain sotorasib 120 mg and are available in packs of 240.
   
• Tozinameran and famtozinameran (Comirnaty Original/Omicron BA.4‑5) is a nucleoside modified messenger RNA vaccine. It is formulated in lipid nanoparticles, which enable delivery of the non-replicating RNA into host cells to direct transient expression of the SARS‑CoV‑2 spike (S) antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralising antibody and cellular immune responses to the antigen, which may contribute to protection against coronavirus disease 2019 (COVID‑19). Comirnaty Original/Omicron BA.4‑5 has provisional approval as a booster dose for active immunisation to prevent COVID‑19 caused by SARS‑CoV‑2, in individuals 12 years of age and older. Comirnaty Original/Omicron BA.4‑5 ready to use suspension for injection contains tozinameran 15 mcg and famtozinameran 15 mcg per 0.3 mL dose and is available in packs of 10 or 195 six dose vials with a grey cap.

New Indications

• Tofacitinib (citrate) (Xeljanz) is now indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy; and for the treatment of active polyarticular course juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF‑] polyarthritis, extended oligoarthritis and systemic juvenile arthritis without systemic features for six months) and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs.
   
• Trastuzumab deruxtecan (Enhertu) is now indicated for the treatment of adult patients with unresectable or metastatic HER2‑low (IHC 1+ or IHC 2+/ISH‑negative) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR+) breast cancer should additionally have received and no longer be considered eligible for endocrine therapy.
   
• Upadacitinib (hemihydrate) (Rinvoq) is now indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C‑reactive protein and/or magnetic resonance imaging change, who have responded inadequately to, or are intolerant to nonsteroidal anti‑inflammatory drugs. 

New Contraindications

• Estradiol (Sandrena) is now contraindicated in acute liver disease; history of liver disease where liver function has failed to return to normal; and known, past or suspected malignancy of the genitals or breasts.
   
• Nirmatrelvir and ritonavir (Paxlovid) is now contraindicated with concomitant eletriptan, silodosin, eplerenone, ivabradine, finerenone, naloxegol, oral midazolam, tolvaptan, primidone and lumacaftor/ivacaftor. 
   
• Quinine sulfate dihydrate (Quinate) is now contraindicated in patients with mefloquine or quinidine hypersensitivity; haemolysis or haemoglobinuria; and prolongation of QT interval.
   
• Trimethoprim (Triprim) is now contraindicated in premature infants or children under 4 months of age; pregnant and breastfeeding women.

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.