MIMS April prescribing update - 17 April 2012

MIMS

New Products

Eviplera (tenofovir disoproxil fumarate, emtricitabine and rilpivirine) is a combination of an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate, a synthetic nucleoside analog of cytidine and a non-nucleoside reverse transcriptase inhibitor respectively. 

The triple combination of tenofovir, emtricitabine and rilpivirine demonstrated synergistic antiviral activity in cell culture. 

Eviplera is indicated for the treatment of HIV infection in treatment-naive adult patients with plasma HIV-1 RNA ≤ 100,000 copies/mL at the start of therapy. 

Eviplera is contraindicated in concurrent administration with lamivudine, adefovir, other products containing tenofovir (Viread), emtricitabine (Emtriva), tenofovir/ emtricitabine (Truvada, Atripla), rilpivirine (Edurant); concurrent anticonvulsants (carbamazepine, oxcarbazepine, phenobarbitone, phenytoin), antimycobacterials (rifabutin, rifampicin, rifapentine), PPIs (e.g. omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole), St John’s wort, systemic dexamethasone (excluding single dose treatment) and in children < 18 years.

Jevtana (cabazitaxel) is a taxane. Cabazitaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells. 

Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel containing regimen. 

Jevtana is contraindicated with neutrophil counts ≤ 1500/mm3; hepatic impairment (bilirubin ≥ 1 x ULN, or AST/SGOT and/or ALT/SGPT ≥ 1.5 × ULN); pregnancy and breastfeeding; concomitant vaccination with yellow fever vaccine or with a history of severe hypersensitivity reactions to other drugs formulated with polysorbate 80.  

Omnaris (ciclesonide) is a non-halogenated glucocorticoid. The precise mechanism through which ciclesonide affects allergic rhinitis symptoms is not known. 

Omnaris is indicated for the treatment of seasonal allergic rhinitis in adults and children six years of age or older and the treatment of perennial allergic rhinitis in adults and adolescents 12 years of age or older.The recommended dose of Omnaris is 200µg per day administered as two actuations (50µg/actuation) in each nostril once daily. 

New Indications

Enbrel (etanercept (rch)) is now indicated in treatment of chronic, severe plaque psoriasis in children and adolescents from four to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Sandostatin LAR (octreotide) is now indicated in the treatment of patients with progression of well differentiated, advanced neuroendocrine tumours of the midgut or suspected midgut origin.

New Presentations

Humulin (neutral, isophane insulin (rbe)) is now available as Humulin NPH KwikPen (isophane human insulin (rbe) suspension) and Humulin 30/70 KwikPen (30% regular (neutral) human insulin (rbe) injection and 70% isophane human insulin (rbe) suspension). Humulin KwikPen 3mL is a multiple dose, disposable pen device containing 100 units/mL in packs of five.

Safety-Related Changes

Aethoxysklerol (laureth-9) is now contraindicated in hormone replacement therapy, known hypercoagulability, neuropathy and spider veins: arterial occlusive disease (Fontaine stage II).

Exjade (deferasirox) is contraindicated with platelet counts < 50 x 109/L.

If a diagnosis of ulcerative keratitis is confirmed, treatment with Iressa (gefitinib) should be interrupted, and if symptoms do not resolve, or recur on reintroduction of Iressa, permanent discontinuation should be considered.

The potential risk with the combination of azathioprine or 6-mercaptopurine and Humira (adalimumab (rch)) should be carefully considered.

Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with MabThera (rituximab).

Events of neutropenia associated with MabThera (rituximab) treatment, the majority of which were transient and mild or moderate in severity, were observed in clinical trials in RA patients after the first course of treatment. Neutropenia can occur several months after the administration of MabThera.

This list is a summary of changes over the past month. Before prescribing, refer to the full PI.