September 2021

New Products

• Brexucabtagene autoleucel (Tecartus) is a CD19-directed genetically modified autologous T‑cell immunotherapy. To prepare Tecartus, a patient’s own T-cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (scFv) linked to CD28 and CD3‑zeta co-stimulatory domains. The anti-CD19 CAR-positive viable T-cells are expanded and infused back into the patient. Tecartus binds to CD19-expressing cancer cells and normal B‑cells, which activate downstream signalling cascades that lead to T-cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells. Tecartus is indicated for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL), who have received two or more lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor (unless ineligible or intolerant to treatment with a BTK inhibitor). Contraindications for lymphodepleting chemotherapy must be considered. Each patient specific bag of Tecartus suspension for infusion contains a dispersion of anti-CD19 CAR T-cells in approximately 68 mL for a target dose of 2 x 10⁶ CAR T-cells/kg bodyweight (range: 1 to 2 × 10⁶ cells/kg; maximum: 2 x 10⁸ cells).
   
• Budesonide/glycopyrronium/formoterol (eformoterol) fumarate dihydrate (Breztri Aerosphere) contains budesonide, a glucocorticosteroid, and two bronchodilators: glycopyrronium, a long-acting muscarinic antagonist (LAMA) (anticholinergic) and formoterol, a long-acting β₂-agonist (LABA). Breztri Aerosphere is indicated for maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD) who require treatment with a combination of an inhaled corticosteroid, a LABA, and a LAMA. It is not indicated for the initiation of therapy in COPD. Brezti Aerosphere pressurised inhalation contains budesonide 160 mcg, glycopyrronium 7.2 mcg (as glycopyrronium bromide (glycopyrrolate) 9 mcg), and 5 mcg formoterol fumarate dihydrate per delivered dose and is available in pack size of 1 metered dose inhaler with 120 actuations.
   
• Cariprazine (HCl) (Reagila) is an orally active and potent dopamine D₃/D₂ receptor partial agonist, with preferential binding to D₃ receptors, and partial agonist at serotonin 5-HT_1A receptors. The therapeutic effect of cariprazine may be mediated through a combination of partial agonist activity at dopamine D₃, D_2L and D_2S receptors and serotonin 5-HT_1A receptors, and antagonist activity at serotonin 5-HT_2B, 5-HT_2A and histamine H₁ receptors. Reagila is indicated for the treatment of schizophrenia in adults. It is contraindicated with concomitant administration of strong or moderate CYP3A4 inhibitors or inducers. Reagila capsules contain cariprazine 1.5 mg, 3 mg, 4 mg or 6 mg and is available in a pack size of 30.
   
• Ciclosporin (Ikervis) is a calcineurin inhibitor immunosuppressant agent when administered systemically. Ciclosporin has been shown to have an anti-inflammatory effect whereby it inhibits the production and/or release of pro-inflammatory cytokines and has been shown to upregulate the release of anti-inflammatory cytokines. In patients with dry eye disease, topical administration of ciclosporin is believed to exert an immunomodulatory effect, although its exact mechanism of action in dry eye disease is not known. Ikervis is indicated for the treatment of severe keratitis in adults with dry eye disease which has not improved despite treatment with tear substitutes. It is contraindicated with ocular or peri-ocular malignancies or premalignant conditions and active or suspected ocular or peri-ocular infection. Treatment with Ikervis should not be initiated or continued until all signs of infection have cleared. Ikervis eye drops contain ciclosporin 1 mg/mL and is available in pack size of 30 x 0.3 mL single use ampoules.
   
• Elasomeran (Spikevax COVID-19 Vaccine) contains 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 COVID-19 Vaccine has provisional approval for the active immunisation of individuals ≥ 18 years to prevent COVID-19 caused by SARS-CoV-2. Spikevax suspension for injection contains elasomeran 100 mcg/0.5 mL dose and is available in multidose vials containing 10 doses/vial.
   
• Obeticholic acid (Ocaliva), a 6-ethyl derivative of the human bile acid, chenodeoxycholic acid, is a selective and potent agonist for the farnesoid X receptor (FXR), a nuclear receptor expressed at high levels in the liver and intestine. FXR is thought to be a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol, as well as by increasing transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids. Ocaliva is indicated for the treatment of primary biliary cholangitis (or primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Ocaliva is contraindicated with complete biliary obstruction. Ocaliva tablets contain obeticholic acid 5 mg or 10 mg and is available in a pack size of 30.

New Presentation

• Daratumumab (rch) (Darzalex SC) is now available as a solution for subcutaneous injection containing daratumumab (rch) 1800 mg/15 mL in a pack size of 1 vial.

New Indications

• BNT162b2 [mRNA] (Comirnaty COVID-19 Vaccine) now has provisional approval for the active immunisation of individuals ≥ 12 years to prevent COVID-19 caused by SARS-CoV-2.
   
• Normal immunoglobulin (human) (Kiovig) is now indicated for immunomodulation in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in adults.
   
• Pembrolizumab (rch) (Keytruda) now has provisional approval for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

New Contraindications

• Bethanechol chloride (Urocarb) is now contraindicated in bronchial asthma (latent or active); pronounced bradycardia; coronary artery disease (especially occlusion); vasomotor instability; conditions in which increased muscular activity of the gastrointestinal tract or urinary bladder might be harmful, e.g. anastomosis, recent bladder surgery, gastrointestinal resection, gastrointestinal or urinary tract obstruction; and with conditions in which strength or integrity of the gastrointestinal (e.g. acute inflammation) or bladder wall is questionable.
   
• ChAdOx1-S (Vaxzevria (previously COVID-19 Vaccine AstraZeneca)) is now contraindicated in individuals who have previously experienced episodes of capillary leak syndrome.
   
• Dopamine HCl (DBL Sterile Dopamine Concentrate) is now contraindicated in ventricular fibrillation.
   
• Fexofenadine HCl/pseudoephedrine HCl (Telfast Decongestant) is now contraindicated in patients with urinary retention related to urethroprostatic disorders; a history of seizures; and in patients using other vasoconstrictor agents used as nasal decongestants, whether administered orally or nasally.
   
• Ioversol (Optiray) is now contraindicated in manifest hyperthyroidism.
   
• Tobramycin (DBL Tobramycin Injection BP) is now contraindicated with intrathecal administration.
   
• Vancomycin HCl (DBL Vancomycin) is now contraindicated in patients with known hypersensitivity to other glycopeptides.

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.