SPC changes
Arimidex
The summary of product characteristics for Arimidex (anastrozole; AstraZeneca)
has been updated to include a new indication for adjuvant treatment of
early breast cancer in hormone receptor positive postmenopausal women
who have received two to three years of adjuvant tamoxifen. The pharmacodynamic
properties section has been updated accordingly. See SPC.
Efexor and Efexor XL
The summaries of product characteristics for Efexor and Efexor XL (venlafaxine;
Wyeth) have been updated. The indication for major depressive disorder
now reads: “the treatment of major depressive disorder including
depression accompanied by anxiety”. The SPCs now say that specialist
supervision (including shared care arrangements) is only necessary
for patients who require daily doses of 300mg or more. Electrolyte
imbalance as a contraindication, and the requirement for baseline electrocardiogram
have been removed from the SPCs. Further advice on the use of Efexor
and Efexor XL for patients with established cardiac disease and those
at increased risk of suicide is now included in the SPCs. See SPCs.
MabThera
The summaries of product characteristics for MabThera (rituximab; Roche)
have been updated to include the following new indications: maintenance
therapy for patients with relapsed/refractory follicular lymphoma responding
to induction therapy with chemotherapy with or without MabThera; and
treatment, in combination with methotrexate, of adult patients with
severe active rheumatoid arthritis who have had an inadequate response
or intolerance to other disease-modifying antirheumatic drugs including
one or more tumour necrosis factor inhibitor therapies. The dosage
of MabThera for maintenance treatment of follicular lymphoma is 375mg/m2 once every three months until disease progression or for up to two
years. A course of MabThera for rheumatoid arthritis is two 1,000mg
intravenous infusions given two weeks apart. The SPCs state that there
are limited data on the safety and efficacy of subsequent courses of
MabThera for rheumatoid arthritis; if a repeat course of treatment
is considered it should not be given at an interval less than 16 weeks.
The contraindications, special warnings, undesirable effects and pharmacological
properties sections of the SPCs have been updated accordingly. See
SPCs.
Rebif
The summaries of product characteristics for Rebif (interferon beta-1a;
Serono) have been updated. The therapeutic indications sections have
been reworded and now read: “for the treatment of relapsing multiple
sclerosis. In clinical trials, this was characterised by two or more
acute exacerbations in the previous two years.” See SPCs.
Vfend
The summary of product characteristics for Vfend (voriconazole; Pfizer)
has been updated to include information on an interaction with an oral
contraceptive containing norethisterone 1mg and ethinylestradiol 0.035mg.
See SPC.
Zometa
The summary of product characteristics for Zometa (zoledronic acid; Novartis)
has been updated to include a special warning about reports of osteonecrosis
of the jaw, predominantly in patients with cancer receiving treatment
regimens including bisphosphonates. Further details are included in
the undesirable effects section of the SPC. See SPC.
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