April 2022

New Products

• Cabotegravir (Vocabria) inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. Vocabria is indicated in combination with rilpivirine tablets for the short‑term treatment of Human Immunodeficiency Virus type 1 (HIV‑1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) and have no known or suspected resistance to either cabotegravir or rilpivirine for: oral lead in to assess tolerability of cabotegravir prior to administration of cabotegravir prolonged-release suspension for injection plus rilpivirine prolonged-release suspension for injection and oral therapy for adults who will miss planned dosing with cabotegravir prolonged-release suspension for injection. Vocabria is contraindicated in patients receiving rifampicin, rifapentine, phenytoin, phenobarbital, carbamazepine and oxcarbazepine. Vocabria tablets contain cabotegravir 30 mg and are available in a pack size of 30.
   
• Cabotegravir and rilpivirine (Cabenuva). Cabotegavir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. Rilpivirine is a diarylpyrimidine non‑nucleoside reverse transcriptase inhibitor (NNRTI) of HIV‑1. Rilpivirine activity is mediated by non-competitive inhibition of HIV‑1 reverse transcriptase (RT). Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ. Cabenuva is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV‑1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) and have no known or suspected resistance to either cabotegravir or rilpivirine. Cabenuva is contraindicated in combination with anticonvulsants: phenytoin, phenobarbital, carbamazepine and oxcarbazepine; antimycobacterials: rifabutin, rifampicin, rifapentine; glucocorticoids: systemic dexamethasone (except as a single dose treatment); St John’s wort (Hypericum perforatum). Cabenuva prolonged release suspension for injection contains cabotegravir 600 mg/3 mL and rilpivirine 900 mg/3 mL in separate vials and is available in a pack size of 1 + 1 single-dose vials with 2 syringes, vial adaptors and needles.
   
• Tixagevimab and cilgavimab (Evusheld) are two recombinant human IgG1k monoclonal antibodies, with amino acid substitutions to extend antibody half‑life (YTE) and to reduce antibody effector function and potential risk of antibody-dependent enhancement of disease (TM). Tixagevimab and cilgavimab can simultaneously bind to non-overlapping regions of the spike protein receptor binding domain (RBD) of SARS‑CoV‑2. Evusheld has provisional approval for the pre‑exposure prophylaxis of COVID‑19 in adults and adolescents aged 12 years and older weighing at least 40 kg, who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID‐19 vaccination or, for whom vaccination with any approved COVID‑19 vaccine is not recommended due to a history of severe adverse reaction (e.g. severe allergic reaction) to a COVID‑19 vaccine(s) and/or COVID‑19 vaccine component(s). Evusheld solution for injection contains tixagevimab 150 mg/1.5 mL and cilgavimab 150 mg/1.5 mL in separate vials and is available in a pack size of 1 + 1 vials.

New Indications

• American (D. farinae) and European (D. pteronyssinus) house dust mite allergen extracts (Actair) is now indicated for the treatment of house dust mite allergic rhinitis with or without conjunctivitis in adults, adolescents and children 5 years and over diagnosed with house dust mite allergy.
   
• Elasomeran (Spikevax) now has provisional approval for the active immunisation to prevent coronavirus disease 2019 (COVID‑19) caused by SARS‑CoV‑2 in individuals 6 years of age and older.
   
• Progesterone (Utrogestan 200) is now indicated for the treatment of unexplained threatened miscarriage in women with bleeding in the current pregnancy and a history of at least three or more previous miscarriages.

New Contraindications

• Trimethoprim/sulfamethoxazole (Septrin Forte) is now contraindicated in blood dyscrasias, megaloblastic bone marrow, severe renal insufficiency characterised by creatinine clearance < 15 mL/min; premature babies or during the first six weeks of life, because of the risk of producing kernicterus (it should probably not be given to infants less than 3 months of age); and in combination with dofetilide.

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.