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New Products
- Faecal microbiota (Biomictra) works via restoration of gut microbial diversity. Biomictra is indicated for the restoration of the gut microbiota in the management of gastrointestinal disorders, specifically Cl. difficile infection. The product must not be released for use in conditions other than C. difficile infection, unless as part of a registered clinical trial or via the Special Access Scheme or via Authorised Prescriber Scheme. Biomictra is contraindicated in patients with suspected bowel perforation and anaphylactic food allergy. Biomictra transplant contains faecal microbiota 12.5 g per 50 mL and is available in packs of 1 or 4 prefilled syringes.
- Odevixibat (sesquihydrate) (Bylvay) is a reversible and selective inhibitor of the ileal bile acid transporter. Odevixibat acts locally in the distal ileum to decrease the reuptake of bile acids and increase the clearance of bile acids through the colon, reducing the concentration of bile acids in the serum. The extent of reduction of serum bile acids does not correlate with systemic pharmacokinetics. Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis in patients aged 6 months or older. Bylvay capsules contain odevixibat 200 mcg, 400 mcg, 600 mcg or 1200 mcg and are available in packs of 30.
- Olipudase alfa (Xenpozyme) is a recombinant human acid sphingomyelinase that reduces sphingomyelin accumulation in organs of patients with acid sphingomyelinase deficiency (ASMD). Xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-central nervous system manifestations of ASMD in paediatric and adult patients with type A/B (Niemann-Pick type A/B) or type B (Niemann-Pick type B). Xenpozyme powder for infusion contains olipudase alfa 4 mg or 20 mg and is available in packs of 1 vial.
- Tucatinib (Tukysa) is a tyrosine kinase inhibitor of human epidermal growth receptor 2 (HER2). In vitro, tucatinib inhibits phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK (mitogen-activated protein kinase) and AKT (protein kinase B) signalling and cell proliferation, and shows anti-tumour activity in HER2-expressing tumour cells. In vivo, tucatinib inhibited the growth of HER2-expressing tumours. The combination of tucatinib and trastuzumab showed increased anti-tumour activity in vitro and in vivo compared to either drug alone. Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. Tukysa, in combination with trastuzumab, has provisional approval for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy. Tukysa tablets contain tucatinib 50 mg or 150 mg and are available in packs of 88 (50 mg) or 84 (150 mg).
- Ublituximab (Briumvi) is a chimeric monoclonal antibody that selectively targets CD20-expressing cells. CD20 is a cell surface antigen found on pre-B cells, mature and memory B cells but not expressed on lymphoid stem cells and plasma cells. The precise mechanism by which ublituximab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20 inducing lysis of CD20+ B cells primarily through antibody-dependent cell-mediated cytotoxicity and, to a lesser extent through complement-dependent cytotoxicity. Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features. Briumvi is contraindicated in severe active infection, in patients in a severely immunocompromised state, and in known active malignancies. Briumvi concentrate for infusion contains ublituximab 150 mg per 6 mL and is available in packs of 1 vial.
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New Indications
- Tisagenlecleucel (Kymriah) is now indicated for adult patients with relapsed or refractory follicular lymphoma after two or more lines of therapy.
- Trastuzumab deruxtecan (Enhertu) is now also indicated as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Patients with hormone receptor positive breast cancer should additionally have received and no longer be considered eligible for endocrine therapy.
It is also indicated as monotherapy for the treatment of adult patients with unresectable or metastatic HR+ and either HER2-low (IHC 1+ or IHC 2+/ISH-negative) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.
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New Contraindications
- Live varicella vaccine (Varilrix HSA-Free) is now contraindicated in patients on recent immunosuppressive therapy (including high doses of corticosteroids but not topical or inhaled corticosteroids).
- Measles virus, mumps virus and rubella virus vaccine (Priorix Albumin Free) and Measles virus, mumps virus, rubella virus and live varicella vaccine (Priorix-Tetra) are now contraindicated in patients on current or recent immunosuppressive therapy (including high doses of corticosteroids but not topical or inhaled corticosteroids).
- Neostigmine methylsulfate (Neostigmine Juno) is now contraindicated in patients with doubtful bowel viability; in bronchial asthma; and for concomitant use with depolarising muscle relaxants.
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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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