Important New Products

• Avanafil (Spedra) is a reversible inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by avanafil produces increased levels of cGMP in the corpus cavernosum of the penis. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Avanafil has no effect in the absence of sexual stimulation. Spedra is indicated for treatment of erectile dysfunction in adult males. Spedra is contraindicated with the following: coadministration with nitrates, nitric oxide donors or organic nitrites in any form (either regularly or intermittently), guanylate cyclase stimulators (eg riociguat), potent CYP3A4 inhibitors; patients in whom sexual intercourse is inadvisable due to cardiovascular risk factors; cardiac conditions (unstable angina, angina with sexual intercourse, congestive heart failure (New York Heart Association ≥ class 2); MI, stroke, life-threatening arrhythmia, coronary revascularisation in last 6 months; resting hypotension (BP < 90/50 mmHg), hypertension (BP > 170/100 mmHg)); severe hepatic impairment (Child-Pugh C); severe renal impairment (creatinine clearance < 30 mL/min) - CKD stage 4 or end stage renal failure (CKD Stage 5); loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection with previous PDE5 inhibitor exposure; known hereditary degenerative retinal disorders. Spedra tablets contain avanafil 50 mg, 100 mg or 200 mg in a pack size of 4.
   
• Cerliponase alfa (rch) (Brineura) is a recombinant form of human tripeptidyl peptidase-1 (rhTPP1). The activated proteolytic enzyme (rhTPP1) cleaves tripeptides from the N-terminus of the target protein with no known substrate specificity. Inadequate levels of TPP1 cause neuronal ceroid lipofuscinosis type 2 (CLN2) disease, resulting in neurodegeneration, loss of neurological function and death during childhood. Brineura is indicated for the treatment of CLN2 disease, also known as TPP1 deficiency. Brineura must only be administered by a trained healthcare professional knowledgeable in intracerebroventricular administration in a healthcare setting. Brineura is contraindicated in CLN2 patients with ventriculo-peritoneal shunts; Brineura must not be administered as long as there are signs of acute intracerebroventricular access device leakage, device failure, or device related infection. Brineura solution for injection contains cerliponase alfa 150 mg/5 mL in a pack size of 2 vials plus flushing solution 5 mL 1 vial.
   
• Durvalumab (rch) (Imfinzi) is a fully human, high affinity, monoclonal antibody immune checkpoint inhibitor that blocks the interaction of programmed cell death ligand-1 (PD-L1) with PD‑1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances anti-tumour immune responses, including tumour elimination. Imfinzi is indicated for the treatment of locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum containing chemotherapy, or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. This indication is approved based on objective response rate and duration of response in a single arm study. An improvement in survival or disease related symptoms has not been established. Imfinzi is also indicated for the treatment of locally advanced, unresectable NSCLC in disease that has not progressed following platinum based chemoradiation therapy. Imfinzi concentrated solution for infusion contains durvalumab 120 mg (2.4 mL) or 500 mg (10 mL) in a pack size of 1 vial.
   
• Safinamide (mesilate) (Xadago) is a highly selective and reversible α-aminoamide derivative monoamine oxidase B (MAO-B) inhibitor that causes an increase in extracellular levels of dopamine in the striatum. MAO-B is inhibited with more than 1000-fold selectivity over MAO-A. Safinamide is also associated with state and use dependent inhibition of voltage gated sodium (Na⁺) channels, calcium (Ca²⁺) channel modulation and inhibition of glutamate release. Xadago is indicated for the treatment of adults with fluctuating idiopathic Parkinson’s disease (PD) as add-on therapy to a regimen that includes levodopa. Xadago is contraindicated with concomitant treatment with other MAO inhibitors (at least 7 days must elapse between treatments), pethidine (at least 7 days must elapse between treatments); severe hepatic impairment; albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy. Xadago tablets contain safinamide 50 mg or 100 mg in a pack size of 30.
   
• Tafenoquine (succinate) (Kodatef) is an antimalarial that kills the developing asexual, developing exoerythrocytic, and latent hypnozoites of malaria parasites. The mechanism of action is unknown, but is hypothesised to involve redox reactions. Kodatef is indicated for the prevention of malaria in adults ≥ 18 years of age for up to 6 months of continuous dosing. Kodatef is contraindicated in G6PD deficiency or unknown G6PD status due to the risk of haemolytic anaemia; pregnancy and lactation; current or history of psychosis; known hypersensitivity to other 8-aminoquinolines. Kodatef is not intended for treatment of acute malaria. Relevant clinical guidelines should be used for management of acute malaria, including subjects who develop acute malaria while taking Kodatef for prophylaxis or in instances of relapse of malaria following cessation of prophylaxis with Kodatef. Kodatef tablets contain tafenoquine 100 mg in a pack size of 8 and 16.

• Daratumumab (rch) (Darzalex) is now indicated for treatment in combination with bortezomib, melphalan and prednisone of newly diagnosed multiple myeloma in patients ineligible for autologous stem cell transplant.
   
• Emicizumab (rch) (Hemlibra) is now indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors.
   
• Ipilimumab (rch) (Yervoy), in combination with nivolumab (rch) (Opdivo), is now indicated for the treatment of unresectable or metastatic melanoma. The approval of this indication is based on a prespecified comparison to ipilimumab monotherapy. All analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive. Ipilimumab (rch) (Yervoy), in combination with nivolumab (rch) (Opdivo), is now also indicated for the treatment of intermediate/poor risk, previously untreated advanced renal cell carcinoma.
   
• Tofacitinib (citrate) (Xeljanz) in combination with conventional synthetic disease modifying antirheumatic drugs (DMARDs) is now indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response to a prior DMARD therapy.

• Atazanavir (sulfate)/cobicistat (Evotaz) should not be used in combination with glecaprevir/pibrentasvir because of the increased risk of ALT elevations due to an increase in glecaprevir and pibrentasvir plasma concentrations. Coadministration of Evotaz with the antipsychotic lurasidone is contraindicated due to the potential for serious and/or life-threatening events or loss of virologic response and possible resistance.
   
• For doxycycline hyclate (hydrochloride) (Doryx), the concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.
   
• Fosamprenavir (calcium) (Telzir)/ritonavir must not be administered concomitantly with the antipsychotic medicinal product lurasidone.
   
• Human normal immunoglobulin (Privigen) is contraindicated with hyperprolinaemia type I or II.
   
• Imipramine hydrochloride (Tofranil) is now contraindicated in children under 18 years of age for the treatment of depression or other psychiatric disorders.

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. ...(more)