March 2022

New Products

• Alpelisib (Piqray) is a class I phosphatidylinositol3kinase (PI3K) inhibitor with higher activity against PI3Kα than other members of class I PI3K. Class I PI3K lipid kinases are key components of the PI3K/AKT/mTOR (mammalian target of rapamycin) signaling pathway. PI3K inhibition by alpelisib treatment has been shown to induce an increase in ER transcription in breast cancer cells, therefore, sensitizing these cells to estrogen receptor (ER) inhibition by fulvestrant treatment. Piqray in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, HER2-negative, advanced or metastatic breast cancer with a PIK3CA mutation as detected by a validated test following progression on or after an endocrine-based regimen. Piqray tablets contain alpelisib 50 mg, 150 mg or 200 mg and are available in packs of 56 (150 mg), 28 (200 mg) and a composite pack containing 56 (28 of each 200 mg and 50 mg) tablets.
   
• Cemiplimab (Libtayo) is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and PD-L2. Engagement of PD-1 with its ligands PD-L1 and PD-L2, which are expressed by antigen presenting cells and may be expressed by tumour cells and/or other cells in the tumour microenvironment, results in inhibition of T cell function such as proliferation, cytokine secretion, and cytotoxic activity. Cemiplimab potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate; and for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 tumour proportion score (TPS) ≥ 50% as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC and who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC. Libtayo as monotherapy has provisional approval for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation and for the treatment of adult patients with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. Libtayo concentrate for solution for infusion contains cemiplimab 350 mg/7 mL and is available in a pack of 1 vial.
   
• Molnupiravir (Lagevrio) is a prodrug that is metabolized to the ribonucleoside analogue NHC. NHC distributes into cells where it is phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC-TP). NHC-TP incorporation into viral RNA by the viral RNA polymerase, results in an accumulation of errors in the viral genome leading to inhibition of replication. This mechanism of action is known as viral error catastrophe. Lagevrio has provisional approval for the treatment of adults with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death. Lagevrio capsules contain molnupiravir 200 mg and are available a pack size of 40 capsules.
  
  Molnupiravir (Lagevrio) has received last minute approval for inclusion on the Pharmaceutical Benefits Scheme commencing 1st March 2022. It will be Authority Required (Streamlined) on the s85 General Schedule. Not all prescribing software may have been updated to allow for ePrescribing and prescriptions may be unable to be uploaded to the Prescription Exchange Service. A standard paper-based Authority prescription may be supplied.
  
  Adults who have mild to moderate COVID-19 confirmed by a PCR or medically verified RAT and who can start treatment within 5 days of symptom onset, can be prescribed PBS-subsidised Lagevrio (PBS Code 12910L in a quantity of 40 capsules with no repeats) by their doctor if:
  
  they are immunocompromised, regardless of vaccination status (streamlined authority code 12583); or
  
  they are 75 years of age or older, with one other risk factor for severe disease (streamlined authority code 12582) or; 
  
  they are 65 years of age or older, with two other risk factors for severe disease (streamlined authority code 12582) or; 
  
  they are of Aboriginal or Torres Strait Islander origin, 50 years of age or older, with two other risk factors for severe disease (streamlined authority code 12584). 
  
  Further information from the Department of Health may be accessed using the following link: COVID-19 Treatment FAQ
   
• Nirmatrelvir and ritonavir (Paxlovid). Nirmatrelvir is a peptidomimetic inhibitor of the SARS-CoV-2 main protease (Mpro), also referred to as 3C-like protease (3CLpro) or nsp5 protease. Inhibition of SARS-CoV-2 Mpro renders the protein incapable of processing polyprotein precursors which leads to the prevention of viral replication. Ritonavir inhibits the CYP3A-mediated metabolism of nirmatrelvir, thereby providing increased plasma concentrations of nirmatrelvir. Paxlovid has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death. Paxlovid is contraindicated in patients with severe renal impairment; severe hepatic impairment; and with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions. Paxlovid is also contraindicated with drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. Paxlovid also cannot be started immediately after discontinuation of apalutamide, carbamazepine, phenobarbital, phenytoin, rifampicin or St. John’s wort. Paxlovid tablets are available in a composite pack containing nirmatrelvir 150 mg 20 tablets and ritonavir 100 mg 10 tablets.
  
   
• Ravulizumab (rch) (Ultomiris) is a humanised monoclonal antibody (mAb). It is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a (the pro-inflammatory anaphylatoxin) and C5b (the initiating subunit of the terminal complement complex [C5b-9, also known as the membrane attack complex (MAC)]) and preventing the generation of the C5b-9 or MAC. By binding specifically to C5, ravulizumab (rch) antagonises terminal complement-mediated inflammation, cell activation, and cell lysis while preserving the early components of complement activation that are essential for opsonisation of microorganisms and clearance of immune complexes. In patients with PNH, complement-mediated intravascular haemolysis is blocked with Ultomiris treatment. Ultomiris is indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria. It is contraindicated in patients with unresolved Neisseria meningitidis infection. Ultomiris concentrated solution for infusion contains ravulizumab 300 mg/3 mL or 1.1 g/11 mL and is available in packs of 1 vial.
  
   
• SARS-CoV-2 rS (NVX-CoV2373) COVID-19 vaccine (Nuvaxovid) is composed of purified full-length SARS-CoV-2 recombinant spike (S) protein that is stabilised in its prefusion conformation. The addition of the saponin-based Matrix-M adjuvant facilitates activation of the cells of the innate immune system, which enhances the magnitude of the S protein-specific immune response. The 2 vaccine components elicit B- and T-cell immune responses to the S protein, including neutralising antibodies, which protect against COVID-19. Nuvaxovid has provisional approval for the active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older. Nuvaxovid suspension for injection contains SARS-CoV-2 rS (NVX-CoV2373) 5 mcg/0.5 mL and is available in a pack of 10 multidose 5 mL vials, each containing 10 doses per vial.

New Indications

• Influenza virus vaccine, surface antigen, quadrivalent (inactivated) (Flucelvax Quad) is now indicated for use in adults and children 2 years of age and older for the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine.
   
• Mepolizumab (Nucala) is now indicated as add-on treatment in adult patients (18 years and above) with severe chronic rhinosinusitis with nasal polyps (CRSwNP) with an inadequate response to intranasal corticosteroids.
   
• Nivolumab (Opdivo), in combination with fluoropyrimidine- and platinum-based combination chemotherapy, is now indicated for the first-line treatment of patients with HER2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma.
   
• Olopatadine and mometasone furoate (Ryaltris) is now indicated for the treatment of symptoms associated with allergic rhinitis and rhinoconjunctivitis in patients 6 years of age and older.
   
• Ruxolitinib (Jakavi) is now indicated for the treatment of patients aged 12 years and older with acute or chronic graft-versus-host disease who have inadequate response to corticosteroids.

New Contraindications

• Glyceryl trinitrate (DBL Glyceryl Trinitrate Concentrate Injection) is now contraindicated in patients with angina caused hypertrophic obstructive cardiomyopathy; acute circulatory failure (shock, circulatory collapse); cardiogenic shock, in so far as sufficiently high left ventricular end-diastolic pressure is not ensured by intra-aortal counterpulsation or positive inotropic medicines; and concomitant phosphodiesterase inhibitors used for the treatment of erectile dysfunction or pulmonary arterial hypertension.

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.