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Important New Products
- Ferric derisomaltose (Monofer) contains iron in a complex with isomaltoside 1000, releasing bioavailable iron to iron binding proteins. Monofer is indicated for the treatment of iron deficiency in adults, under the following conditions: when oral iron preparations are ineffective or cannot be used; where there is a clinical need to deliver iron rapidly. The diagnosis must be based on laboratory tests. Monofer is contraindicated with non-iron deficiency anaemia (e.g. haemolytic anaemia); iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis). Monofer solution for injection contains ferric derisomaltose 500 mg/5 mL in a pack size of 1 vial.
- Guselkumab (Tremfya) is a human monoclonal antibody that binds selectively to the interleukin 23 (IL‑23) protein with picomolar affinity. Selective blockade of the regulatory cytokine IL-23 normalises production of effector cytokines including IL-17A, IL-17F and IL-22 that drive inflammatory disease. Levels of IL-23 are elevated in the skin of patients with plaque psoriasis. Tremfya is indicated for the treatment of adults ≥ 18 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya solution for injection (prefilled syringe) contains guselkumab 100 mg/1 mL in a pack size of 1.
- Letermovir (Prevymis) inhibits the cytomegalovirus (CMV) DNA terminase complex, which is required for viral replication and virion maturation. Prevymis is indicated for the prophylaxis of CMV infection or disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). Prevymis is contraindicated with concomitant administration of pimozide; ergot alkaloids (ergotamine and dihydroergotamine); ciclosporin with pitavastatin or simvastatin. Prevymis tablets contain letermovir 240 mg in a pack size of 28.
- Naltrexone hydrochloride/bupropion hydrochloride (Contrave 8/90) contains two components: naltrexone, a mu-opioid antagonist, and bupropion, a moderately weak inhibitor of neuronal reuptake of dopamine and norepinephrine. The exact neurochemical appetite suppressant effects of naltrexone/bupropion are not fully understood. Contrave 8/90 is indicated, as an adjunct to a reduced calorie diet and increased physical activity, for the management of weight in adults ≥ 18 years with an initial body mass index of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight related co-morbidities (e.g. type 2 diabetes, dyslipidaemia, or controlled hypertension). Treatment with Contrave 8/90 should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight. Contrave 8/90 is contraindicated with uncontrolled hypertension; seizure disorder or history of seizures; known central nervous system tumour; acute alcohol or benzodiazepine withdrawal; history of bipolar disorder; concomitant treatment containing bupropion or naltrexone; current or previous diagnosis of bulimia or anorexia nervosa; current dependence on chronic opioids or opiate agonists (e.g. methadone); acute opiate withdrawal; concomitant monoamine oxidase inhibitors (or within 14 days of MAOI discontinuation) or reversible MAOIs; pregnancy; severe hepatic impairment; end-stage renal failure. Contrave 8/90 tablets contain naltrexone hydrochloride 8 mg/bupropion hydrochloride 90 mg and are available in a pack size of 112.
- Plitidepsin (Aplidin) interacts with eukaryotic Elongation Factor 1A2 (eEF1A2), a protein that forms part of the cell’s translation machinery, is described to have oncogenic properties and is overexpressed in various tumour cells. Aplidin, in combination with dexamethasone, is indicated for the treatment of relapsed and refractory multiple myeloma after at least three prior treatment regimens, including both a proteosome inhibitor and an immunomodulator. Aplidin may be used after two prior lines of therapy if refractory and/or intolerant to both a proteasome inhibitor and an immunomodulator. Treatment must be initiated and administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents. Aplidin is contraindicated with hypersensitivity to excipients PEG-35 castor oil or ethanol. Aplidin powder for solution for infusion contains plitidepsin 2 mg and is available in a pack size of 1 vial.
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New Indications
- Pembrolizumab (rch) (Keytruda) is now indicated as monotherapy for the adjuvant treatment of melanoma with lymph node involvement in patients who have undergone complete resection.
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New Contraindications
- Dextromethorphan hydrobromide monohydrate (Bisolvon Dry) is now contraindicated with bronchial asthma, chronic obstructive pulmonary disease, pneumonia, respiratory insufficiency, respiratory depression, and breastfeeding.
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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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Active Ingredient Naming Changes
In this release, MIMS Australia will be including the following INNs (International Non-proprietary Names) as well as Australian Approved Names (AANs) as part of our push to support the Therapeutic Goods Administration (TGA) active ingredient name changes project.
MIMS will begin referring to these ingredients by their new names, however, users may continue to search by the old AANs if preferred. ...(more)
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