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SPC changes: September 2013

28 September 2013

Aclasta

Renal impairment has been observed in patients after a single administration of Aclasta (zoledronic acid monohydrate; Novartis), according to the updated summary of product characteristics. To minimise the risk of renal adverse reactions, creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each Aclasta dose. Additionally, the incidence of post-dose symptoms occurring within the first three days after administration can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta administration.

Ilaris

Ilaris (canakinumab; Novartis) is now indicated for the treatment of systemic juvenile idiopathic arthritis in patients aged two years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs and systemic corticosteroids. Extensive changes to the summary of product characteristics reflect this addition.

Paliperidone

Intraoperative floppy iris syndrome has been observed during cataract surgery in patients treated with medicines with alpha1a-adrenergic antagonist effect, including Invega (paliperidone; Janssen-Cilag) and Xeplion (paliperidone palmitate; Janssen-Cilag) according to their updated summaries of product characteristics.

21 September

Botox

Botox (botulinum toxin type a; Allergan) is now indicated for the management of bladder dysfunctions in adult patients who are not adequately managed with anticholinergics, including those with an overactive bladder with symptoms of urinary incontinence, urgency and frequency and those with neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord injury.

Estraderm

Cases of anaphylactic and anaphylactoid reactions have been recorded using Estraderm (estradiol hemihydrate; Novartis), but the frequency of such reactions is unknown, according to the updated summary of product characteristics.

Eylea

Eylea (aflibercept; Bayer) is now indicated for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion. Extensive changes to the summary of product characteristics reflect this addition.

Isentress

Co-administration of Isentress (raltegravir potassium; Merck, Sharpe & Dohme) with aluminium and magnesium antacids resulted in reduced raltegravir plasma levels and is therefore not recommended, according to the updated summary of product characteristics.

Neupogen

Capillary leak syndrome, which is potentially life-threatening, has been reported as an uncommon undesirable effect in cancer patients undergoing chemotherapy and healthy donors undergoing peripheral blood progenitor cell mobilisation following administration of granulocyte colony-stimulating factors, according to the updated summary of product characteristics for Neupogen (filgrastim; Amgen). Hypotension, hypoalbuminaemia, oedema and haemoconcentration characterise capillary leak syndrome. Patients who develop symptoms should be closely monitored and receive standard symptomatic treatment, which may include intensive care.

Rasilez

The summary of product characteristics for Rasilez (aliskiren; Novartis) now advises caution in patients with heart failure treated with torasemide. Further changes to the SPC reflect this addition.

Tobi

According to the updated summary of product characteristics for Tobi (tobramycin; Novartis), serum tobramycin concentrations should be monitored in patients with known or suspected auditory or renal dysfunction and in patients receiving concomitant medicines that can affect renal excretion. If oto- or nephrotoxicity occurs, tobramycin therapy should be discontinued until serum concentration falls below 2µg/ml.

Dysphonia, lung disorder, rhinitis, discoloured sputum and decreased pulmonary function test results are now listed as very common adverse effects of using Tobi. Laryngitis and tinnitus have also been changed from rare to common adverse effects, malaise has changed from very rare to common, and myalgia has been added as a common side effect. 

14 September 2013

Emflex

Antiplatelet agents and selective serotonin reuptake inhibitors have been added to the list of drug interactions for Emflex (acemetacin; Merck Serono) on the summary of product characteristics, because of an increased risk of gastrointestinal bleeding. Additionally, non-steroidal anti-inflammatory drugs may reduce the effect of SSRIs.

Gliclizade

Almus Gliclazide tablets 80mg now contain lactose as an excipient, following a change of marketing authorisation holder from Actavis UK to Bristol Laboratories.

Invirase

Autoimmune disorders such as Graves disease have been reported to occur in the setting of immune reactivation and can happen many months after initiation of treatment with Invirase (saquinavir; Roche), according to the updated summary of product characteristics. Furthermore, it is not recommended to use Invirase in HIV-infected patients under two years of age.

Lioresal

Discontinuation of Lioresal (baclofen; Novartis) should be by successively reducing the dosage over a period of approximately one to two weeks, except in overdose-related emergencies, or where serious adverse effects have occurred, according to the updated summary of product characteristics. Other changes state that Lioresal should also be prescribed with caution in patients with hepatic impairment, and caution should be exercised when Lioresal is used concomitantly with lithium. A cautious dosing schedule for Lioresal should also be adopted in elderly patients and patients with spasticity of cerebral origin.

Vfend

Squamous cell carcinoma has been reported in patients taking Vfend (voriconazole; Pfizer). Some of some of these patients had reported prior phototoxic reactions. If phototoxic reactions occur, the patient should be referred to a dermatologist, according to the updated summary of product characteristics.

7 September 2013

Aprovel and Exforge

Both Aprovel (irbesartan; Sanofi, Bristol-Myers Squibb) and Exforge (amlodipine, varsartan; Novartis) should not be co-administered with aliskiren- containing medicines in patients with diabetes or with moderate to severe renal impairment (glomerular filtration rate <60ml/min/1.73m2), according to their updated summaries of product characteristics.

Aranesp

The summary of product characteristics for Aranesp (darbepoetin alfa; Amgen) contains a new dosing schedule, which states that patients can receive treatment once monthly.

Onglyza

Onglyza (saxagliptin; Bristol-Myers Squibb) is now indicated as monotherapy for adult patients with type 2 diabetes mellitus to improve glycaemic control in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate owing to contraindications or intolerance, according to the updated summary of product characteristics.

Risperdal

Hyperprolactinaemia has been added to the summary of product characteristics as a common side effect of Risperdal (risperidone; Janssen). Additionally, increased appetite and decreased appetite, decreased libido and injection site reaction have all changed from uncommon to common adverse reactions on the updated SPC.

Victrelis

Calcium channel blockers have been added to the list of medicinal interactions in the summary of product characteristics for Victrelis (boceprevir; Merck Sharp & Dohme).

 

 

 

Citation: The Pharmaceutical Journal URI: 20065402

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