April 2019

Important New Products

  • Telotristat ethyl (as telotristat etiprate) (Xermelo) and its active metabolite (telotristat) are inhibitors of L-tryptophan hydroxylases (TPH1 and TPH2), the rate limiting steps in serotonin biosynthesis. Serotonin regulates secretion, motility, inflammation and sensation of the gastrointestinal tract, and is over secreted in patients with carcinoid syndrome. Through inhibition of peripheral TPH1, telotristat reduces the production of serotonin, thus alleviating symptoms associated with carcinoid syndrome. Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Xermelo tablets contain telotristat ethyl (as telotristat etiprate) 250 mg in a pack size of 90.

New Indications

  • Mepolizumab (rch) (Nucala) is now indicated as an add-on treatment for relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA) in adults aged ≥ 18 years.
     
  • Morphine sulfate pentahydrate (Kapanol 10 mg, 20 mg) is now indicated for the symptomatic reduction of chronic breathlessness in the palliative care of patients with distressing breathlessness due to severe chronic obstructive pulmonary disease (COPD), cardiac failure, malignancy or other cause.  Kapanol should only be used after treatments for the underlying cause(s) of the breathlessness have been optimised and non-pharmacological treatments are not effective. Treatment with Kapanol in this setting should only be initiated by a specialist knowledgeable in its use.
     
  • Tofacitinib (Xeljanz) is now indicated for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy. Therapy with Xeljanz should be initiated and monitored by a specialist physician with expertise in the management of conditions for which Xeljanz is indicated (e.g. gastroenterologist).

New Contraindications

  • Amoxicillin (trihydrate)/clarithromycin/esomeprazole (magnesium trihydrate) (Nexium Hp7) contains clarithromycin, which is contraindicated with concurrent domperidone, hypokalaemia (risk of QT-time prolongation), severe hepatic failure in combination with renal impairment.
     
  • Hylan G-F 20 (Synvisc, Synvisc-One) should not be used in patients with known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations.
     
  • Saxagliptin (hydrochloride)/metformin hydrochloride (Kombiglyze XR) is now contraindicated with acute or chronic metabolic acidosis, including lactic acidosis, with or without coma.

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.

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. 
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