MIMS Monthly Update
Kanuma (sebelipase alfa rce) is a recombinant human lysosomal acid lipase (rhLAL). Lysosomal acid lipase deficiency (LAL-D) is a rare disease associated with significant morbidity and mortality affecting individuals from infancy through to adulthood. Treatment with sebelipase alfa rce restores LAL enzyme activity in LAL-D cells, enabling hydrolysis of cholesteryl esters and triglycerides in the lysosome. Kanuma (sebelipase alfa rce) is indicated for long-term enzyme replacement therapy in patients of all ages with LAL-D. Kanuma is contraindicated in patients with a life-threatening hypersensitivity (anaphylactic reaction) to egg. Kanuma solution for infusion 20 mg in 10 mL is supplied as a single use vial, pack of 1.
Lonsurf (trifluridine/ tipiracil (hydrochloride)) is comprised of an antineoplastic thymidine based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride, at a molar ratio 1:0.5. Trifluridine/ tipiracil hydrochloride demonstrated antitumor activity against both 5-fluorouracil (5-FU) sensitive and resistant colorectal cancer cell lines in nonclinical studies. Lonsurf is indicated for the treatment of adults with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for fluoropyrimidine, oxaliplatin and irinotecan based chemotherapies, anti-VEGF agents, and anti-EGFR agents. Lonsurf 15/6.14 (trifluridine 15 mg and tipiracil (hydrochloride) 6.14 mg)) and Lonsurf 20/8.19 (trifluridine 20 mg and tipiracil (hydrochloride) 8.19 mg) tablets are available in a pack of 20.
Ocrevus (ocrelizumab) is a recombinant humanised anti-CD20 monoclonal antibody that selectively targets CD20-expressing B-cells. The precise mechanisms through which ocrelizumab exerts its therapeutic clinical effects in multiple sclerosis (MS) are not fully elucidated but is presumed to involve immunomodulation through the reduction in the number and function of CD20-expressing B-cells. Ocrevus is indicated for the treatment of relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and to reduce the frequency of relapse; treatment of primary progressive multiple sclerosis (PPMS) to delay the progression of physical disability. Ocrevus concentrate for solution for infusion 300 mg in 10 mL is supplied in a 15 mL vial, pack of 1.
Pheburane (sodium phenylbutyrate) is an ammonia scavenger. Pheburane is indicated for the management of hyperammonaemia associated with urea cycle disorders. Pheburane should be used with dietary protein restriction and, in some cases, dietary supplements. Pheburane is contraindicated with pregnancy and breastfeeding. Pheburane is available in a bottle containing sodium phenylbutyrate 84 g in 174 g of granules (sodium phenylbutyrate 483 mg/gram of granules).
Urorec (silodosin) is a selective antagonist of α1A-adrenoreceptors primarily located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra. Smooth muscle relaxation causes an improvement of both storage (irritative) and voiding (obstructive) symptoms (lower urinary tract symptoms (LUTS)) associated with benign prostatic hyperplasia. Urorec is indicated for the relief of LUTS associated with benign prostatic hyperplasia in adult men. Urorec 8 mg capsules are available in a pack of 30.
Opdivo (nivolumab) is now indicated as monotherapy for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy.
Ozurdex (dexamethasone) intravitreal implant is now indicated for the treatment of macular oedema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO); noninfectious uveitis affecting the posterior segment of the eye.
Daktarin Oral Gel (miconazole) is now contraindicated in combination with CYP2C9 substrate coumarin anticoagulants such as warfarin.
Eltroxin (levothyroxine sodium) is now contraindicated with acute myocarditis and acute pancarditis.
Neotigason (acitretin) is highly teratogenic and must not be used by patients who intend to become pregnant within 3 years after cessation of therapy.
Trileptal (oxcarbazepine) is now contraindicated with known hypersensitivity to eslicarbazepine.
Victrelis (boceprevir) is now contraindicated in combination with lurasidone.
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.