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Drug Info New Product Focus Boniva®: the new quarterly intravenous osteoporosis treatment Approved indication Precautions A Boniva® 3 mg/3 ml injection contains the bisphosphonate, ibandronate, and is indicated for the treatment of osteoporosis in postmenopausal women, in order to reduce the risk of vertebral fractures.1 General Ibandronate is contraindicated in patients with hypocalcaemia; hypersensitivity to the active ingredient, or to any excipients of the product; as well as in patients with severe renal impairment.1 Mode of action Ibandronate, administered intravenously, may cause a transient decrease in serum calcium values. Hypocalcaemia and other disturbances of bone and mineral metabolism must be corrected before starting therapy.1 Ibandronate is a bisphosphonate belonging to the potent, nitrogen-containing group of bisphosphonates which are considered to be the treatment of choice for postmenopausal osteoporosis.2 Ibandronate acts selectively on bone tissue and specifically inhibits osteoclast activity (the cells that break down bone), without directly affecting bone formation.1 Pregnancy and lactation Ibandronate should not be used during pregnancy or lactation.1 Dosage Major adverse effects Oral bisphosphonates are poorly absorbed from the gastrointestinal tract. To maximise absorption after oral administration, it is recommended that the oral agents are taken on an empty stomach with plain water, and that the patient fasts and does not lie down for 30-60 minutes after taking the medicine.2 Poor patient adherence to these requirements with daily and weekly oral dosing prompted the development of formulations with more convenient, extended, between-dose intervals.3 In a pivotal two-year study and a five-year, long-term extension thereof, ibandronate 3 mg, administered intravenously, was generally well tolerated.3,4 The most frequent adverse events included nasopharyngitis, influenza-like illness, back pain, arthralgia and hypertension. The most common adverse events considered to relate to treatment pertained to the gastrointestinal system, and included upper abdominal pain, dyspepsia, constipation, nausea and gastritis.3 Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates, including ibandronate.1 Most cases were patients with cancer, undergoing dental procedures.1 Known risk factors for osteonecrosis of the jaw include a diagnosis of cancer, concomitant therapies (e.g. chemotherapy, radiotherapy and corticosteroids) and co-morbid disorders (e.g. anaemia, coagulopathy, infection and pre-existing dental disease).1 Boniva® 3 mg/3 ml is administered as an intravenous injection over 15-30 seconds every three months. Strict adherence to the intravenous route is required.1 Patients must receive supplemental calcium and vitamin D.1 A dosage adjustment is not necessary for patients with mild to moderate renal impairment, hepatic impairment or in the elderly.1 Evidence of efficacy Drug interactions The quarterly intravenous administration of ibandronate was shown to significantly increase bone mineral density (BMD) at both the spine and the hip.3 The sustained lumbar spine dual energy X-ray absorptiometry BMD increase, observed over 60 months in this pivotal long-term extension clinical trial, resulted in a prediction that with continued treatment, sustained anti- Metabolic interactions are not considered to be likely since ibandronate does not inhibit the major hepatic cytochrome (CY) P450 isoenzymes, and has not been shown to induce the hepatic CYP450 system. Ibandronate plasma protein binding is 85-87%, and has a low potential for medicine-medicine interaction owing to displacement.1 fracture efficacy would result.3 S Afr Pharm J 34 2014 Vol 81 No 9 Drug Info Cost: SEP, including VAT References Boniva® 3 mg/3 ml injection in a pre-filled syringe: R798.00. 1. Boniva® 3 mg/3 ml injection package insert. 2009. Marketed by Roche and Adcock Ingram. 2. Rizzoli R. Bisphosphonates for postmenopausal osteoporosis: are they all the same? QJM. 2011;104(4):281-300. Patient information 3. Bianchi G, Czerwinski E, Kenwright A, et al. Long-term administration of quarterly ibandronate is effective and well-tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension. Osteoporos Int. 2012;23(6):1769-1778. Patients need to take supplemental calcium and vitamin D during therapy with ibandronate.1 Ibandronate 3 mg/3 ml intravenously is administered every three months. If a dose is missed, the injection should be administered as soon as it is convenient.1 4. Eisman JA, Civitelli R, Adami S, et al. Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-year results from the DIVA study. J Rheumatol. 2008;35:488-497. Conclusion An ibandronate quarterly intravenous injection is an attractive option for patients who are unable to tolerate oral bisphosphonates and/or who may better adhere to an extended dosing interval.3 Noticeboard Classified advertisements may be faxed to 086 607 2744, for attention SAPJ Notice Board, or e-mailed to [email protected]. The placement of classified advertisements is offered as a free service to members and subscribers. Advertisements will be placed for three consecutive months, if space is available. Advertisements longer than 30 words will be edited. Pharmacies for sale Centurion: Well established business next to doctors. Lots of passing trade. Premises can be part of the deal. For serious buyers, please contact 082 872 4214 Vereeniging / Vaal: Pharmacy in Business 37 years. Well established in busy shopping centre. Owner retiring. Please contact: 016-556 1225 / 083 753 6842 Positions offered Managing Pharmacist position available at Namaqualand Pharmacy in Springbok. Contact Hermien Prinsloo on 0829096609 for further information. NAMIBIA: TSUMEB & OSHAKATI - Soek energieke aptekers vir belowende geleentheid. Kandidate moet begeerte he om na Namibia te verhuis, ‘n apteek te bestuur, aandele op te neem in ‘n maatsappy MET 5 klein handelsapteke. Namibia bied nog veilige lewensomstandighede. Kontak [email protected] Locum pharmacist needed for after hours in a pharmacy in Faerie Glen (Pretoria East). One night per week and one weekend per month. Please contact Wynand by email at [email protected] We seek pharmacists from the Eastern Cape and Western Cape Regions for our Correctional Services Programme: apply online at www.tbhivcare.org or email CV directly to [email protected] Luderitz, Namibia – Full-time pharmacist required for 2014/2015. Competitive salary, free housing, annual bonus & profit sharing. Country side pharmacy ideal for single, innovative persons who love change and the great outdoors with the option of taking over the business. For details please contact or fax CV to Mr EJH van Zyl, +264 63 202852 Northern part of KZN - Dynamic pharmacy manager wanted – Excellent package with relocation bonus and monthly incentive bonuses. The right candidate will also have the chance for future profit sharing and buying of shares. Experience in retail pharmacy and Unisolv is an advantage. Please send cv to [email protected] Natal – Midlands: Pharmacist required for a busy retail pharmacy. 30 minute drive from the central Drakensberg. Offering long-term prospects. Submit CV to estpharm@ futurenet.co.za or fax 086 683 5089. Registered Pharmacist warehouse environment Northriding, Computer literate, Pharmaceutical Logistics/Distribution experience, knowledge of finance/ economics, work in a team, GCP training an advantage. E-mail 2 page CV to [email protected] Pharmacist Assistant PB warehouse environment Northriding, registered with SAPC, Computer literate, Pharmaceutical Logistics/Distribution experience, work in a team, GCP training an advantage. E-mail 2 page CV to [email protected] Namibia: Pharmacist – Namibian will receive preference, but work permit for South African applicant available. Work entails industrial as well as retail pharmacy. Salary negotiable. Please contact fanie@fabupharmproducts. com or +264 67 302069. S Afr Pharm J 35 2014 Vol 81 No 9 King Williams Town: Xhosa pharmacist required. R35 000 – R40 000 per month CTC. Contact Julie-Anne Mittermaier: Cell: 082 568 3793 or e-mail: julie.anne@ hotmail.co.za Positions wanted RSA & Namibië – Apteker beskikbaar – locum en permanent – Tel: 083 752 4828 Locum/Contract/Consulting position needed in the Pharmaceutical, Nutriceuticals, Veterinary & Cosmetic Indsutries Gauteng Industrial Pharmacist available, with 37 years practical and management experience in the Pharmaceutical Manufacturing Industry. Specialist fields include tablet manufacture, coating, capsule, powder, liquids, creams, ointment, manufacturing and packing. Warehousing and distribution. QA /QC. Contact : Bernard 083 288 2476 Miscellaneous Thinking of selling your pharmacy but not sure on an exit strategy? Our company has an extensive acquisitions plan. Contact Paul Smit at 015-307 1000 or 083 290 9990 for an equitable solution.