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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
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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
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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
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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.