May 2022

New Products

• Elotuzumab (Empliciti) is an immunostimulatory humanised, IgG1 monoclonal antibody that specifically targets the SLAMF7 (signaling lymphocyte activation molecule family member 7) protein. SLAMF7 is highly expressed on multiple myeloma cells independent of cytogenetic abnormalities. Elotuzumab targets SLAMF7 on myeloma cells and facilitates the interaction with natural killer cells (via Fc receptors) to mediate the killing of myeloma cells through antibody-dependent cellular cytotoxicity (ADCC). Elotuzumab also directly activates natural killer cells through the SLAMF7 pathway to enhance anti-myeloma activity in vitro. Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Empliciti is used in combination with other medicinal products; therefore, the contraindications applicable to those medicinal products also apply to Empliciti combination therapy. Empliciti powder for infusion contains elotuzumab 300 mg or 400 mg and is available in pack sizes of 1 single use vial.

• Paliperidone (as palmitate) (Invega Hafyera) is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives (atypical neuroleptic antipsychotic). Paliperidone is a centrally active dopamine Type 2 (D) receptor antagonist and a serotonin Type 2 (5HT_2A) receptor antagonist. Paliperidone is also active as an antagonist at α1 and α2 adrenergic receptors and H₁‑histaminergic receptors, which may explain some of the other effects of the drug. Invega Hafyera, a 6-month injection, is indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months or the 3-month paliperidone palmitate injectable product following at least one 3-month injection cycle. Invega Hafyera is contraindicated in patients with a known hypersensitivity to risperidone. Invega Hafyera modified release injection contains paliperidone 700 mg/3.5 mL or 1000 mg/5 mL and is available in pack sizes of 1 pre-filled syringe.
   
• Sacituzumab govitecan (Trodelvy) is a Trop-2-directed antibody-drug conjugate. Sacituzumab is a humanised antibody that recognises Trop-2. The small molecule, SN-38, is a topoisomerase I inhibitor, which is covalently attached to the antibody by a linker. Sacituzumab govitecan binds to Trop-2-expressing cancer cells and is internalised with the subsequent release of SN-38 via hydrolysis of the linker. SN-38 interacts with topoisomerase I and prevents re-ligation of topoisomerase I-induced single strand breaks. The resulting DNA damage leads to apoptosis and cell death. Sacituzumab govitecan decreased tumour growth in mouse xenograft models of triple-negative breast cancer. Trodelvy is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies, including at least one prior therapy for locally advanced or metastatic disease. Trodelvy powder for injection contains sacituzumab govitecan 180 mg and is available in a pack size of 1 single use vial.
   
• Trastuzumab deruxtecan (Enhertu) is a HER2-targeted antibody-drug conjugate (ADC). The antibody is a humanized anti-HER2 IgG1 attached to deruxtecan, a topoisomerase I inhibitor bound by a tetrapeptide-based cleavable linker. Following binding to HER2 on tumour cells, trastuzumab deruxtecan undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Upon release, the membrane-permeable topoisomerase I inhibitor causes DNA damage and apoptotic cell death. Enhertu has provisional approval for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens. Enhertu powder for injection contains trastuzumab deruxtecan 100 mg and is available in a pack size of 1 vial.
   
• Voretigene neparvovec (Luxturna) is a gene transfer vector designed to deliver a normal copy of the gene encoding the human retinal pigment epithelial 65 kDa protein (RPE65) to cells of the retina in persons with reduced or absent levels of biologically active RPE65. Injection of Luxturna into the subretinal space results in transduction of some retinal pigment epithelial cells with a cDNA encoding normal human RPE65 protein, thus providing the potential to restore the visual cycle. Luxturna is indicated for the treatment of patients with inherited retinal dystrophy caused by pathological biallelic RPE65 mutations and who have sufficient viable retinal cells. Luxturna is contraindicated in patients with ocular or periocular infection; and active intraocular inflammation. Luxturna concentrate for subretinal injection contains voretigene neparvovec 5 trillion vector genomes/mL and is available in a pack size of 1 foil pouch containing 1 vial (0.5 mL) of concentrate and 2 vials (each 1.7 mL) of solvent.
   
• Zolpidem tartrate (ZolpiMist) selectively binds the omega-1 receptor subtype (also known as the benzodiazepine-1 subtype) which is the alpha unit of the GABA-A receptor complex. The modulation of the chloride anion channel via this receptor leads to the specific sedative effects demonstrated by zolpidem i.e. the preservation of deep sleep (stage 3 and 4 slow wave sleep). ZolpiMist is indicated for the short-term treatment of insomnia in adults. ZolpiMist is contraindicated in patients with sleep apnoea; myasthenia gravis; severe hepatic insufficiency; acute and/or severe pulmonary insufficiency; prior or concomitant intake with alcohol; and who have previously experienced complex sleep behaviours after taking zolpidem. ZolpiMist should not be prescribed for children. ZolpiMist oromucosal spray contains zolpidem tartrate 5 mg/actuation and is available in a pack size of 1 oromucosal spray with 28 metered actuations.

New Indications

• Tafenoquine (as succinate) (Kozenis) is now indicated, in combination with chloroquine, for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in adults, adolescents and children weighing greater than 35 kg.
   
• Ozanimod (Zeposia) is now indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.

New Contraindications

• Glecaprevir and pibrentasvir (Maviret) is now contraindicated in patients with moderate hepatic impairment (Child-Pugh B).
   
• Saxagliptin (as hydrochloride)/dapagliflozin propanediol monohydrate (Qtern 5/10) is now contraindicated in patients with history of any serious hypersensitivity reaction to any sodium glucose cotransporter 2 (SGLT2) inhibitor; and patients with eGFR persistently < 45 mL/min/1.73 m² or patients on dialysis.

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.