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New Products
- Decitabine and cedazuridine (Inqovi 35/100) is a combination of a nucleoside metabolic inhibitor and a cytidine deaminase (CDA) inhibitor. Decitabine is believed to exert its antineoplastic effects after phosphorylation and direct incorporation into DNA and inhibition of DNA methyltransferase, causing hypomethylation of DNA and cellular differentiation and/or apoptosis. In rapidly dividing cells, the cytotoxicity of decitabine may also be attributed to the formation of covalent adducts between DNA methyltransferase and decitabine incorporated into DNA. Non-proliferating cells are relatively insensitive to decitabine. Cedazuridine inhibits CDA. CDA is an enzyme that is responsible for the degradation of nucleosides, including decitabine. High levels of CDA in the gastrointestinal tract and liver rapidly degrade these nucleosides and prohibit or limit their oral bioavailability. Oral administration of cedazuridine with decitabine enhances the oral bioavailability of decitabine via inhibition of first pass metabolism of decitabine in the gut and liver by CDA. Inqovi 35/100 is indicated for the treatment of adult patients with myelodysplastic syndromes intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups, and patients with chronic myelomonocytic leukaemia. Inqovi is contraindicated in pregnancy. Inqovi tablets contain decitabine 35 mg and cedazuridine 100 mg and are available in packs of 5.
- Elasomeran and imelasomeran (Spikevax Bivalent Original/Omicron) contain messenger RNA (mRNA) encapsulated in lipid nanoparticles. The mRNA encodes for the full-length SARS‑CoV‑2 spike protein modified with 2 proline substitutions within the heptad repeat 1 domain (S‑2P) to stabilise the spike protein into a prefusion conformation. After intramuscular injection, cells at the injection site and the draining lymph nodes take up the lipid nanoparticle, effectively delivering the mRNA sequence into cells for translation into viral spike protein. The delivered mRNA does not enter the cellular nucleus or interact with the genome, is nonreplicating, and is expressed transiently mainly by dendritic cells and subcapsular sinus macrophages. The expressed, membrane-bound spike protein of SARS‑CoV‑2 is then recognised by immune cells as a foreign antigen. This elicits both T-cell and B-cell responses to generate neutralising antibodies, which may contribute to protection against coronavirus disease 2019 (COVID‑19). Spikevax Bivalent Original/Omicron has provisional approval as a booster dose for active immunization to prevent COVID‑19 caused by SARS‑CoV‑2 in individuals 18 years of age and older in accordance with official recommendations. Spikevax Bivalent Original/Omicron is contraindicated in individuals with known severe allergic reactions (e.g. anaphylaxis) to a previous dose of Spikevax (original). Spikevax Bivalent Original/Omicron suspension for injection contains elasomeran 25 mcg and imelasomeran 25 mcg per 0.5 mL dose and is available in packs of ten 2.5 mL or 5 mL multidose vials.
- Fluorouracil and salicylic acid (Actikerall) is a combination of a cytostatic antimetabolite and a keratolytic and corneolytic agent. Actikerall is indicated for the topical treatment of mild to moderate solar (actinic) keratosis on the face, forehead or bald scalp. Actikerall is contraindicated in patients with aspirin hypersensitivity; renal insufficiency; in conjunction with potent inhibitors of the fluorouracil-degrading enzyme dihydropyrimidine dehydrogenase (DPD); with known DPD deficiency; during lactation; in existing pregnancy or by women for whom pregnancy cannot be excluded with certainty; and it must not be allowed to come into contact with the eyes or mucous membranes. Actikerall topical solution contains fluorouracil 0.5% and salicylic acid 10% and is available in a bottle containing 25 mL.
- Kit for Galium-68 Glu-urea-Lys(ahx)-hbed-CC radiopharmaceutical preparation (Illuccix) is a radioactive diagnostic agent after radiolabelling with Ga-68. Illuccix is indicated for use with positron emission tomography imaging combined with computerised tomography in patients with prostate cancer who are at risk of metastasis and who are suitable for initial definitive therapy or who have suspected recurrence based on elevated serum prostate specific antigen level. Illuccix kit for solution for injection is available in two different configurations, A and B, each intended for use with Ga-68 produced by different generators. Each kit contains 1 vial of Glu-urea-Lys(ahx)-hbed-CC 25 mcg and mannose 10 mcg lyophilized powder, 1 vial of acetate buffer solution and 1 empty sterile vacuum vial.
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New Indications
- Pembrolizumab (Keytruda) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is now indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.
- Ravulizumab (rch) (Ultomiris) is now indicated for the treatment of atypical haemolytic uraemic syndrome.
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New Contraindications
- Mifepristone (Mifepristone Linepharma) is now contraindicated in pregnancy not confirmed by an ultrasound or biological test such as urine or serum HCG.
- Mifepristone and misoprostol (MS-2 Step) is now contraindicated in asthma uncontrolled by therapy; and in pregnancy not confirmed by an ultrasound or biological test such as urine or serum HCG.
- Sodium valproate (Epilim) is now contraindicated in known systemic primary carnitine deficiency with uncorrected hypocarnitinaemia.
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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.
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