August 2019

New Products

• Binimetinib (Mektovi) is an ATP-uncompetitive reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. Binimetinib has shown significant anti-tumour activity in BRAF-mutant xenograft models, including melanoma. Binimetinib in combination with encorafenib is indicated for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Treatment should only be initiated and supervised by a physician experienced in the use of anti-cancer medicines. Mektovi tablets contain binimetinib 15 mg in a pack size of 84.
   
• Buprenorphine (Buvidal Weekly, Buvidal Monthly) is a high-affinity partial agonist at the human μ (mu) opioid receptor and is a high affinity antagonist at the δ (delta) and κ (kappa) opioid receptors, as well as being a moderate affinity partial agonist for nociception opioid receptors. Its activity in opioid maintenance treatment is attributed to its slowly reversible properties with the μ-opioid receptors which, over a prolonged period, might minimise the need of illicit opioids for patients with opioid dependence. Buvidal is indicated for the maintenance treatment of opioid dependence in patients who have been stabilised on treatment for opioid dependence, within a framework of medical, social and psychological support. Buvidal is contraindicated in children < 16 years; severe hepatic or respiratory insufficiency; acute alcoholism or delirium tremens; pregnancy and lactation. Buvidal Weekly modified release solution for subcutaneous injection contains buprenorphine 8 mg (0.16 mL), 16 mg (0.32 mL), 24 mg (0.48 mL) or 32 mg (0.64 mL) in a pack size of 1 prefilled syringe. Buvidal Monthly modified release solution for subcutaneous injection contains buprenorphine 64 mg (0.18 mL), 96 mg (0.27 mL) or 128 mg (0.36 mL) in a pack size of 1 prefilled syringe. Buvidal Weekly and Buvidal Monthly are available via an early access scheme.
   
• Encorafenib (Braftovi) is an ATP-competitive small molecule RAF kinase inhibitor. Encorafenib suppresses the RAF/MEK/ERK pathway in tumour cells expressing several mutated forms of BRAF kinase (V600E, V600D and V600K). It does not inhibit RAF/MEK/ERK signalling in cells expressing wildtype BRAF. Encorafenib in combination with binimetinib is indicated for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Treatment should only be initiated and supervised by a physician experienced in the use of anti-cancer medicines. Braftovi capsules contain encorafenib 50 mg or 75 mg in a pack size of 28 or 42, respectively.
   
• Estradiol (as hemihydrate) (Estrogel) is chemically and biologically identical to endogenous human estradiol, the major and most potent estrogenic hormone secreted by the ovary from menarche to menopause. Estrogens are important for the development and maintenance of the female reproductive system and secondary sexual characteristics, and modulate various physiological processes, including bone resorption. Exogenous estradiol substitutes for the loss of endogenous estrogen production in menopausal women to alleviate menopausal symptoms, and prevents bone loss following menopause or ovariectomy. Estrogel is indicated as hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women; prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. Estrogel is contraindicated in known, past or suspected breast cancer; known or suspected estrogen-dependent malignant tumours; undiagnosed genital bleeding; untreated endometrial hyperplasia; previous or current venous thromboembolism; thrombophilic disorders; active or recent arterial thromboembolic disease; porphyria; acute liver disease, or a history of liver disease while liver function tests remain abnormal; known or suspected pregnancy; and lactation. Estrogel contains estradiol 0.6 mg/g (≡ 0.75 mg/actuation) as an 80 g pump in a pack size of 1.

New Presentation

• Dupilumab (rch) (Dupixent) is now available as a 200 mg/1.14 mL solution for injection in a pack size of 2.

New Indications

• Afatinib (as dimaleate) (Giotrif) is now indicated for the treatment of locally advanced or metastatic squamous non-small cell lung carcinoma (NSCLC) with progression on or after platinum-based chemotherapy.
   
• Dupilumab (rch) (Dupixent) is now indicated as add on maintenance treatment in patients aged 12 years and older with moderate to severe asthma with type 2 inflammation (elevated eosinophils or elevated FeNO), and as maintenance therapy for oral corticosteroid dependent asthma.
   
• Ivacaftor (Kalydeco) is now indicated for the treatment of cystic fibrosis in patients aged 12 months and older who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
   
• Olaparib (Lynparza) tablets are now indicated for the maintenance treatment of adults with advanced BRCA-mutated (germline or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. 

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.