18 May 2013
Viread (tenofovir disoproxil fumarate; Gilead Sciences) film-coated tablets 245mg and granules 33mg/g are now indicated for the treatment of patients with chronic, lamivudine-resistant hepatitis B infection.
11 May 2013
Acute generalised exanthematous pustulosis is an undesirable effect of Atarax (hydroxyzine hydrochloride; Alliance) tablets 10mg and 25mg, according to the updated summary of product characteristics.
Severe, potentially life-threatening and fatal skin reactions have been reported with Incivo (telaprevir; Janssen) combination treatment, according to the updated summary of product characteristics. Toxic epidermal necrolysis including fatal outcome has been observed in post-marketing experience. Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive Incivo combination treatment after a serious reaction was identified. Guidance on management of severe rash recommends immediate and permanent discontinuation of Incivo and now also recommends that peginterferon and ribavirin should be immediately discontinued.
Severe skin reactions such as toxic epidermal necrolysis (Lyell’s syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported following MabThera (rituximab; Roche) treatment. The summary of product characteristics states that in case of such an event, treatment should be permanently discontinued.
The summary of product characteristics for Ondemet (ondansetron hydrochloride dehydrate; Alliance) injection 2mg/ml, now specifies that during highly emetogenic chemotherapy, a single dose should not exceed 16mg due to a dose-dependent increase of QT-prolongation risk. Further information is contained in the SPC.
The summary of product characteristics for Thalidomide Celgene (thalidomide; Celgene) now states that acute myeloid leukaemia and myelodysplastic syndromes have been reported in an ongoing clinical study in patients with previously untreated multiple myeloma (MM) receiving the combination of melphalan, prednisone and thalidomide. The risk increases over time and was about 2 per cent after two years and about 4 per cent after three years. An increased incidence of second primary malignancies has also been observed in patients with newly diagnosed MM receiving lenalidomide. In addition, post-marketing observations of hepatic disorders and gastrointestinal haemorrhage associated with thalidomide have also been added. Further information in the SPC.
The shelf life of Zebinix (eslicarbazepine acetate; Eisai) tablets 800mg has been extended from 48 months to 60 months in the updated summary of product characteristics.
04 May 2013
During dose titration, patients can be instructed to use multiples of 100µg tablets and 200µg tablets for any single dose of Abstral sublingual tablets (fentanyl citrate; ProStraken). No more than four tablets should be used at any one time. During titration or the maintenance period, patients should wait at least two hours before treating another episode of breakthrough pain with Abstral.
Daxas (roflumilast; Takeda) is not recommended for patients receiving strong cytochrome P450 enzyme inducers (eg. phenobarbital, carbamazepine, phenytoin), according to the updated summary of product characteristics.
Diovan (valsartan; Novartis) should be immediately stopped in patients who experience angioedema, and it should not be readministered, according to the updated summary of product characteristics. In addition, in vitro data indicate valsartan is a substrate of the hepatic uptake transporter OATP1B1/OATP1B3 and hepatic efflux transporter MRP2. Co-adminstration of inhibitors of the uptake transporter (eg, rifampin, ciclosporin) or efflux transporter (eg, ritonavir) may increase systemic exposure to valsartan. Appropriate care should be exercised when initiating or ending concomitant treatment with such drugs.
Lescol (fluvastatin sodium; Novartis) capsules 20mg and 40mg no longer contain soya lecithin or dimethyl polysiloxane excipients. Advice for patients with a soya or peanut allergy not to take Lescol has been removed from the updated summary of product characteristics. Propylene glycol and potassium hydroxide have been added to the list of excipients.
The summary of product characteristics now states that, as with other renin-angiotensin-aldosterone system blockers, headache is a common side effect of Rasilez (aliskiren; Novartis) in children. Also, in patients aged over 65 taking Rasilez, the area under the curve (AUC) is 50 per cent higher than in young people.
Serious, acute hypersensitivity reactions (eg, urticaria, angioedema) have been observed during combination therapy with Victrelis (boceprevir; Merck Sharp & Dohme), peginterferon alfa, and ribavirin. If such reaction occurs, combination therapy should be discontinued and appropriate medical therapy immediately instituted. In addition, for patients taking atorvastatin, a daily dose of 20mg should not be exceeded when in combination with Victrelis.
27 April 2013
The summary of product characteristics of Pariet (rabeprazole sodium; Eisai) 10mg and 20mg has been updated to include information about the risks associated with proton pump inhibitors, including risk of hip, wrist and spine fracture and severe hypomagnesaemia.
20 April 2013
Studies in animals have shown adverse effects on male fertility following treatment with Camcolit (lithium; Norgine).
The shelf life of Prialt (ziconotide acetate; Eisai) has been extended from three years to four years, according to the updated summary of product characteristics.
Angioedema has been added to the list of serious hypersensitivity reactions reported in patients receiving Sycrest (asenapine; Lundbeck), according to the updated summary of product changes.
Tegretol and Lioresal
The shelf life of Tegretol tablets (carbamazepine; Novartis) 100mg, 200mg and 400mg has been decreased from 36 months to 24 months. The shelf life of Lioresal tablets (baclofen; Novartis ) 10mg has been decreased from four to three years, according to the updated summary of product characteristics.
13 April 2013
Komboglyze (metformin hydrochloride, saxagliptin hydrochloride; Bristol-Myers Squibb) is now also indicated in combination with a sulfonylurea (ie, triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when the maximally tolerated dose of both metformin and the sulfonylurea does not provide adequate glycaemic control. For patients inadequately controlled on dual therapy with a sulfonylurea and metformin, or for patients switching from triple therapy of saxagliptin, metformin and a sulfonylurea taken as separate tablets, the dose of Komboglyze should provide saxagliptin 2.5mg twice daily and a dose of metformin similar to the dose already being taken. When Komboglyze is used in combination with a sulfonylurea, a lower dose of the sulfonylurea may be required to reduce the risk of hypoglycaemia.
It is now advised that pregnancy be avoided for one month, not three months, following vaccination with M-M-RvaxPro (measles, mumps and rubella vaccine [live]; Sanofi Pasteur). In addition, vaccination may be considered for patients with selected immune deficiencies where the benefits outweigh the risks.
Corticosteroid tapering in patients taking Nulojix (belatacept; Bristol-Myers Squibb) should be implemented cautiously, particularly in
patients at high immunological risk, such as those with four to six human leukocyte antigen mismatches.
Onglyza (saxagliptin; Bristol-Myers Squibb) is indicated as triple therapy in combination with metformin plus a sulfonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control, or, as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control. Onglyza tablets must not be split or cut. When Onglyza is used in combination with insulin or a sulfonylurea, a lower dose of the insulin or sulfonylurea may be required to reduce the risk of hypoglycaemia.
In most patients, it is expected that co-administration of voriconazole and Reyataz (atazanavir; Bristol-Myers Squibb), will result in a reduction in both voriconazole and Reyataz exposures. In a small number of patients without a functional CYP2C19 allele, significantly increased voriconazole exposures are expected. Table 2 has been updated with additional safety information
All patients treated with Stelara (ustekinumab; Janssen) should be monitored for the appearance of non-melanoma skin cancer, in particular those over 60 years of age, those with a history of prolonged immunosuppressant therapy or those who have had PUVA (psoralen combined with UVA light) treatment.
If Sustiva (efavirenz; Bristol-Myers Squibb) and telaprevir are co-administered, telaprevir 1,125mg every eight hours should be used. In addition, the daily dose of rifabutin should be increased by 50 per cent when administered with Sustiva. Consider doubling the rifabutin dose in regimens where rifabutin is given two or three times a week in combination with Sustiva. The updated summary of product characteristics for Sustiva contains further information on dose adjustment.
The summary of product characteristics for Videx (didanosine; Bristol-Myers Squibb) capsules has been updated to include a new dosing schedule for the paediatric population (ie, a body weight adjusted dosing scheme), to expand the age range to include infants from two weeks to three months of age. Further information is available in the SPC of Videx.
It is now advised that pregnancy be avoided for one month, not three months, following vaccination with Zostavax (varicella-zoster virus [live]; Sanofi Pasteur).
06 April 2013
According to the updated summary of product characteristics of Avastin (bevacizumab; Roche), in order to improve the traceability of biological medicinal products the trade name of the product should be clearly recorded (or stated) in the patient’s file. In addition, serious wound healing complications, including anastomatic complications, some of which had a fatal outcome, have been reported following treatment with
Very rare cases of fatal progressive multifocal leukoencephalopathy have been reported following the use of MabThera (rituximab; Roche). Furthermore hypogammaglobulinaemia has been observed in paediatric patients, in some cases severe and requiring long-term immunoglobulin substitution therapy. Patients also have an increased risk of infection following MabThera therapy,
23 march 2013
Humira (adalimumab; AbbVie), indicated for treatment of
active polyarticular juvenile idiopathic arthritis, can now be administered to children and adolescents aged two to 17 years of age, rather than the previous four to 17 years of age. Furthermore, there is no longer the option to include latex-containing syringes in the paediatric vial packs and so the latex warnings have been removed from the summary of product characteristics.
The combination of Prozac (fluoxetine; Eli Lilly & Co) with a reversible monoamine oxidase inhibitor such as linezolid is not recommended. However in exceptional circumstances linezolid can be given in combination with fluoxetine provided there are facilities for close observation of symptoms of serotonin syndrome and monitoring of blood pressure, according to the updated summary of product characteristics.
There is now the option to take an oral analgesic before application of Qutenza cutaneous patch (capsaicin; Astellas pharma), in addition to the option of a topical analegsic, according to the updated summary of product characteristics.
16 March 2013
Norditropin SimpleXx solution for injection 15mg/1.5ml, 10mg/1.5ml and 5mg/1.5ml and Norditropin NordiFlex solution for injection 15mg/1.5ml (somatropin; Novo Nordisk) can be stored below 25C for up to 21 days after opening.
Xalatan (latanoprost; Pfizer) eye drops solution 0.005% can now be stored at up to 25C. The shelf life of the product has been reduced from three to two years. The product must be used within four weeks of being opened. Further information on 0845 608 8866.
09 March 2013
When the concurrent use of a histamine-2 blocker is necessary during treatment with Tasigna (nilotinib; Novartis), it may be administered approximately 10 hours before and two hours after the dose of Tasigna If necessary, an antacid may be administered approximately two hours before or approximately two hours after the dose of Tasigna. Additionally, taking Tasigna with food has been found to alter the bioavailability, more information is available in the updated summary of product characteristics.
In patients with unrecognised dihydropyrimidine dehydrogenase (DPD) deficiency treated with Xeloda (capecitabine; Roche) life-threatening toxicities manifesting as acute overdose may occur. In the event of grade 2–4 acute toxicity, treatment must be discontinued immediately until observed toxicity resolves. Permanent discontinuation should be considered based on clinical assessment of the onset, duration and severity of the observed toxicities. In addition, an effective method of contraception should be used during treatment with Xeloda by both men and women.
Zelboraf (vemurafenib; Roche) may be taken with or without food, but consistent intake of both daily doses on an empty stomach should be avoided, according to the updated summary of product characteristics.
02 March 2013
Abilify (aripiprazole; Bristol-Myers Squibb) is now indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar I disorder in adolescents aged 13 years and older. There have been extensive changes to the summary of product characteristics to reflect this extended indication.
Atripla (tenofovir disoproxil fumarate, efavirenz, emtricitabine; Gilead) should not be co-administered with products containing efavirenz unless needed for dose adjustment, eg, with rifampicin, according to the updated summary of product characteristics. Also, hypertriglyceridaemia, elevated aspartate aminotransferase, elevated alanine aminotransferase and elevated gamma-glutamyltransferase are listed as common adverse reactions.
Available evidence suggests long-term neurodevelopmental adverse events after early dexamethasone (Hameln) treatment (<96 hours) of premature infants with chronic lung disease at starting doses of 0.25mg/kg twice daily.
Patients with underlying neuromuscular disorders, including swallowing disorders, treated with NeuroBloc (botulinum toxin type b; Eisai), are at increased risk of adverse reactions such as dysphagia, aspiration pneumonia and/or potentially fatal respiratory disease, according to the updated summary of product characteristics.
Parmid XL prolonged release tablets (felodipine; Sandoz) should be used with caution in patients with severe left ventricular dysfunction or a propensity for tachycardia. Severe renal impairment is no longer a precaution for use. Furthermore, although felodipine has been detected in breast milk, at therapeutic doses it is unlikely to affect the infant, according to the updated summary of product characteristics.
23 February 2013
The summary of product characteristics for Lamisil AT 1% Gel and Lamisil Cream have been updated to say that the products may cause local skin reactions such as contact dermatitis, due to the presence of butylhydroxytoluene, and cetyl and stearyl alcohols, respectively.
16 February 2013
Disseminated cutaneous hypersensitivity reactions of unknown frequency have been added to the list of adverse reactions associated with Exelon (rivastigmine; Novartis). Decreased appetite and urinary incontinence have been added as common adverse reactions. In addition, depression has been removed as an adverse reaction experienced by patients with dementia associated with Parkinson’s disease using Exelon patches. There have also been changes to the dose recommendations with Exelon patches in the summary of product characteristics and dizziness has been added as a common adverse reaction reported in a study of patients with Alzheimer’s dementia treated with Exelon patches.
09 February 2013
The summary of product characteristics for Aricept and Aricept Evess (donepezil hydrochloride; Eisai) has been updated to include neuroleptic malignant syndrome as a possible very rare side effect, particularly in patients receiving concomitant antipsychotics.
Exjade (deferasirox; Novartis) is indicated for treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.
Allele HLA-A*3101 has been shown to increase the risk of developing carbamazepine induced cutaneous adverse reactions in patients of European descent and Japanese populations, according to the updated summary of product characteristics for Zebinix (eslicarbazepine acetate; Eisai).
02 February 2013
Camcolit (lithium carbonate; Norgine) is contraindicated in patients with Brugada syndrome or a family history of Brugada syndrome. Lithium should be avoided in patients with a prolonged QT-interval or taking medicines that prolong the QT interval. Concomitant administration of Camcolit with antipsychotics should also be avoided. The risk of convulsions may be increased when lithium is co-administered with drugs that lower the epileptic threshold or in those who have epilepsy. The side effects in the updated summary of product characteristics now also includes benign intracranial hypertension.
The summary of product characteristics for Orencia (abatacept; Bristol-Myers Squibb) now includes the following information: The
entire, fully diluted Orencia solution should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile,
non-pyrogenic, low-protein-binding filter (pore size of 0.2 to 1.2 μm).
Salivary hypersecretion has
been added to list of undesirable effects in the updated summary of product characteristics of Sycrest (asenapine maleate; Lundbeck).
26 January 2013
Fostair (formoterol fumarate dihydrate, beclometasone dipropionate; Chiesi) can be taken as a regular maintenance treatment for asthma and now also as needed in response to asthma symptoms, according to the updated summary of product characteristics.
A liver function test should be carried out before prescribing Lamisil (terbinafine hydrochloride; Novartis) and after four to six weeks of treatment. Treatment should
be discontinued if liver
function is elevated. Also, Lamisil should be used with caution in patients with lupus or psoriasis, according to the updated summary of product characteristics.
Post marketing reports of fatal and non-fatal hepatic failures have been reported in patients taking statins, including Lescol (fluvastatin sodium; Novartis). Patients should be advised to report any signs of hepatic failure and treatment discontinuation should be considered in these cases. Also, Lescol should not be given to patients with allergy to soya or peanuts, according to the updated summary of product characteristics.
Pregnant partners of men treated with Siklos (hydroxycarbamide; Nordic) should have careful follow up with clinical, biological and ultrasonographic examinations considered. The shelf life of Siklos 100mg tablets has also been extended from two to three years, according to the updated summary of product characteristics.
19 January 2013
Actos and Competact
Hypersensitivity and allergic reactions have been added to the list of undeseriable effects in the summary of product characteristics for Actos (pioglitazone hydrochloride; Takeda) and Competact (metformin hydrochloride, pioglitazone hydrochloride; Takeda).
Exjade (deferasirox; Novartis) is now indicated for the treatment of chronic iron overload requiring chelation therapy when desferrioxamine therapy is contraindicated or inadequate in patients with non-transfusion dependent thalassaemia syndromes aged 10 years and older. Other changes to the summary of product characteristics have been made in accordance with the additional indication.
Intravascular administration of TachoSil (human fibrinogen and human thrombin; Takeda) medicated sponge is contraindicated, according to the updated summary of product characteristics.
05-12 January 2013
Pathological gambling has been added to the list of undesirable effects observed during post-marketing surveillance of patients prescribed Abilify (aripiprazole; Bristol-Myers Squibb), according to the updated summary of product characteristics.
Serious adverse events including fatal outcomes have been reported in patients who had received Botox (botulinum toxin type a; Allergan) injected directly into salivary glands, the oro-lingual-pharyngeal region, oesophagus and stomach. Some patients had pre-existing dysphagia or significant debility. Furthermore, pneumothorax associated with injection procedure has been reported following the administration of Botox near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices. Botox should not be used in women of child bearing potential not using contraception, unless clearly necessary. Denervation/muscle atrophy, respiratory depression and/or failure, aspiration pneumonia, strabismus and peripheral neuropathy were added to the list of adverse events reported since the drug has been marketed.
The shelf life of Bydureon (exenatide; Eli Lilly) has been extended from two to three years, according to the updated summary of product characteristics.
Salagen (pilocarpine; Novartis) is not recommended during pregnancy or in women of child bearing potential not using contraception. Additionally, Salagen should only be administered to men attempting to father children if the expected benefit justifies potential impairment of fertility, according to the updated summary of product characteristics.
22-29 December 2012
The dosage of Distamine (penicillamine; Alliance) for children with cystinuria should be 20 to 30mg/kg per day in two or three divided doses, given one hour before meals. For lead poisoning in children Distamine is only recommended when blood lead levels are <45µg/dL and the recommended dose is now 15 to 20mg/kg per day in two or three doses, according to the updated summary of product characteristics.
Eliquis (apixaban; Bristol-Myers Squibb) is now also indicated for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, with one or more risk factors, such as prior stroke or transient ischaemic attack, age ≥75 years, hypertension, diabetes mellitus or symptomatic heart failure (NYHA Class ≥ II), according to the updated summary of product characteristics.
The following hypersensitivity reactions in association with Inovelon (rufinamide; Eisai) therapy have been added to the summary of product characteristics: serious antiepileptic medicinal product hypersensitivity syndrome, including drug reaction with eosinophilia and systemic symptoms and Stevens-Johnson syndrome.
The list of adverse reactions has been extensively updated in the summary of product characteristics for Proleukin (aldesleukin; Novartis). Other changes have also been made.
Anaphylatic reactions have been observed during treatment with Rasilez (aliskiren; Novartis) from post-marketing experience and patients should be told to report any signs suggestive of allergy. Furthermore, cases of angioedema or angioedema-like reactions have been reported when aliskiren was co-administered with angiotensin-converting enzyme inhibitors and or angiotensin receptor blockers. Special caution is advised in patients with a hypersensitivity predisposition, according to the updated summary of product characteristics.
Transiderm Nitro (nitroglycerin; Novartis) is contraindicated in severe hypotension (systolic blood pressure less than 90mmHg) and severe hypovolaemia, according to the updated summary of product characteristics.
Voltarol (diclofenac; Novartis) is contraindicated in patients with severe renal impairment or severe hepatic impairment, according the updated summary of product characteristics.
Votubia (everolimus; Novartis) is now indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex who are at risk of complications but who do not require immediate surgery, according to the updated summary of product characteristics. Furthermore haemorrhage, in some cases fatal, has been observed in patients treated with everolimus in an oncology setting. Other changes to the SPC have been made.
Xarelto (rivaroxaban; Bayer) is now indicated for the treatment of pulmonary embolism and the prevention of recurrent deep vein thrombosis and pulmonary embolism, according to the updated summary of product characteristics.
08-15 December 2012
Exforge (valsartan and amlodipine; Novartis) is contraindicated with the following conditions; severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis) and haemodynamically unstable heart failure after acute myocardial infarction, according to the updated summary of product characteristics. Furthermore, somnolence, dizziness, palpitations, abdominal pain, nausea and ankle swelling have been added to the list of common side effects. It also notes that there are no established amlodipine dosing recommendations in patients with mild to moderate hepatic impairment. Other revisions to the SPC have been made.
The shelf life of Fycompa (perampanel; Eisai) tablets 6mg, 8mg, 10mg and 12mg is three years, according to the updated summary of product characteristics.
Caution is advised when administering Glivec (imatinib: Novartis) with protease inhibitors, azole antifungals, certain macrolides and CYP3A4 substrates with a narrow therapeutic index, according to the updated summary of product characteristics.
Cases of severe hypocalcaemia requiring hospital admission have been reported. In some instances life-threatening hypocalcaemia may be encountered, according to the updated summary of product characteristics. The risk factors for developing osteonecrosis of the jaw have also been updated.
01 December 2012
The shelf life of AmBisome (amphotericin B; Gilead) has been extended from 36 to 48 months, according to the updated summary of product characteristics.
Ashton and Parsons Infants’ Powders
Ashton and Parsons Infants’ Powders (tincture of matricaria; Alliance) is no longer recommended for use in babies under three months of age and the maximum dose has been stated as six doses in 24 hours, in the updated summary of product characteristics.
Mothers are advised not to use Eurax cream (crotamiton; Novartis) while breastfeeding, unless directed by a physician, according to the updated summary of product characteristics.
Exjade (deferasirox; Novartis) may decrease the efficacy of hormonal contraceptives, according to the updated summary of product characteristics.
The indication for Galvus (vildagliptin; Novartis) has been extended to include triple oral therapy in combination with a sulfonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. It is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control, according to the updated summary of product characteristics. The recommended dose is 50mg in the morning and 50mg in the evening when in combination with metformin and a sulfonylurea, or in combination with insulin. The SPC for Eucreas (vildagliptin and metformin hydrochloride; Novartis) has been updated accordingly.
Voltarol Pain-eze Emulgel
Use of Voltarol Pain-eze Emulgel (diclofenac diethylammonium; Novartis) is contraindicated for women in the third trimester of pregnancy.
24 November 2012
The shelf life of Atripla (tenofovir disoproxil fumarate, efavirenz, emtricitabine; Gilead) has been changed from 36 to 48 months.
Renal function should be carefully evaluated before and during Baraclude (entecavir; Bristol-Myers Squibb) therapy in liver transplant patients who are also receiving ciclosporin or tacrolimus.
Co-administration of Cipramil (citalopram; Lundbeck) with medicines that prolong the QT interval is contraindicated, because an additive effect cannot be ruled out.
In rare instances, treatment with Daxas (roflumilast; Takeda) has been associated with suicidal behaviour, including suicide itself. Daxas is therefore not recommended in patients with a history of depression associated with suicidal ideation or behaviour. If any of these psychiatric symptoms occur, it is recommended that Daxas treatment be discontinued.
Caution should be taken when using Exocin 3mg/ml eye drops (ofloxacin; Allergan) in elderly or female patients because they are more sensitive to medicines that prolong the QTc interval, such as Exocin.
Trajenta (linagliptin; Boehringer Ingelheim and Eli Lilly & Co) is now indicated for the treatment of type II diabetes in combination with insulin with or without metformin, when this regimen alone, with healthy diet and exercise, does not provide adequate glycaemic control.
17 November 2012
The shelf life of Fosrenol (lanthanum carbonate; Shire Pharmaceuticals) oral powder has been changed from two to three years, according to the updated summary of product characteristics.
Recent evidence suggests that evening dosing of Ganfort (bimatoprost 0.3mg, timolol 5mg; Allergan) may be more effective than morning dosing, according to the updated summary of product characteristics. In addition, periocular skin hyperpigmentation has been added as a common adverse reaction, and iris hyperpigmentation and deepening of eyelid sulcus have been added as uncommon adverse reactions.
It is recommended that patients undergo a neuropsychiatric evaluation before and after starting Prialt (ziconotide acetate; Eisai), according to the updated summary of product characteristics.
Some patients treated with Strattera (atomoxetine; Eli
Lilly and Company) experienced growth retardation (weight
and height) early in therapy. On average, these patients recovered to mean weight and height over long-term treatment.
Sinus tachycardia has been added as an uncommon side effect of Sycrest (asenapine; Lundbeck Ltd) in the summary of product characteristics.
10 November 2012
Avastin (bevacizumab; Roche)
is now indicated for the treatment of adult patients with a first recurrence of platinum-sensitive epithelian ovarian, fallopian tube or primary peritoneal cancer and who have not previously received therapy with a vascular endothelial growth factor inhibitor, as detailed in the updated summary of product characteristics.
Cialis (tadalafil; Lilly UK) tablets, at a dose of 5mg once daily, have received a licence for the treatment of benign prostatic hyperplasia, in addition to its current indication for erectile dysfunction.
Rabies Vaccine BP
Changes have been made to the vaccination series recommendations in the “Posology and method of administration” section of the Rabies Vaccine BP summary of product characteristics, including the recommended timing of booster doses.
03 November 2012
Foradil (formoterol fumarate dihydrate; Novartis) inhalation powder in capsules is now not recommended for children under the age of six years rather than five years, according to the updated summary of product characteristics.
Apnoea has been included as an adverse event with unknown frequency in the Pediacel (diphtheria, tetanus, five component acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b conjugate vaccine [adsorbed]; Sanofi Pasteur) summary of product characteristics.
The minimum age for administration of Varivax (Varicella vaccine [live]; Sanofi Pasteur) has been lowered and under special circumstances it can now be administered to infants from nine months of age.
27 October 2012
Intravenous amiodarone hydrochloride 50mg/ml concentrate for solution for injection (Hameln) may induce hyperthyroidism that can be fatal. Particularly at risk are patients with a history of thyroid disorders, those who are iodine-deficient and those who have previously taken amiodarone.
Administration of dexamethasone 3.3mg/ml solution for injection (Hameln) may increase the clearance of antiretroviral protease inhibitors that are metabolised by CYP3A. This may result in lower plasma concentrations. Furthermore, dexamethasone co-administered with thalidomide and lenalidomide in multiple myeloma patients may increase the risk of thromboembolic events.
20 October 2012
Voltarol Emugel P
Mild localised skin irritation caused by the excipient propylene glycol has been added to the special warnings and precautions for use for diclofenac diethylammonium (Voltarol Emugel P; Novartis). It is also recommended that treatment be discontinued if a skin rash develops after application of the product.
Rosuvastatin has been added to the list of drug interactions in the summary of product characteristics for eslicarbazepine acetate (Zebinix; Eisai Ltd).
Sexually active males are strongly recommended to use condoms throughout treatment with mycophenolic acid (Myfortic; Novartis) and for 13 weeks after treatment ends. Female partners of males taking mycophenolic acid are also recommended to use highly effective birth control during treatment and for 13 weeks after.
Repevax (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, adjuvanted) may be administered concomitantly with a dose of inactivated influenza vaccine based on the results of a clinical trial conducted in persons 60 years of age and older.
Concomitant administration of valsartan and amlodipine (Exforge; Novartis) with grapefruit juice is not recommended due to increased bioavailability. It is recommended that patients also prescribed simvastatin be limited to doses of 20mg daily, due to increased bioavailability when administered with amlodipine. Furthermore, amlodipine should be used with caution in those prescribed CYP3A4 inhibitors and co-administration of amlodipine with verapamil and intravenous dantrolene is to be avoided in those at risk of malignant hyperthermia.
13 October 2012
has been added as an uncommon adverse reaction in the summary of product characteristics of aliskiren (Rasilez; Novartis).
Bortezomib (Velcade; Janssen) is now licensed for subcutaneous administration, which can be used as an alternative to intravenous administration.
Diazepam injection BP
The effects of diazepam
injection BP (Hameln) and its toxicity may be increased if given concurrently with azole antifungals voriconazole, fluconazole or itraconazole.
Severe hypocalcaemia leading to fatalities has been added to the list of adverse drug reactions in the summary of product characteristics for denosumab (XGEVA; Amgen). Hypocalcaemia can occur at any time during therapy with denosumab. Mostly it occurs within the first six months of dosing.
06 October 2012
Afinitor (everolimus; Novartis) is now indicated for use in hormone receptor-positive HER2/neu-negative advanced breast cancer in combination with exemestane in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Botox (botulinum toxin type A; Allergan) has now been licensed for treatment of urinary leakage in patients with multiple sclerosis or spinal cord injury and who are not adequately managed with anticholinergics.
Malarone (atovaquone/proguanil; GSK) is no longer restricted by its licensing to use for stays of 28 days or fewer. Duration of prophylactic use of malarone is now a clinical decision. Safety and effectiveness of malarone has been demonstrated in semi-immune subjects up to 12 weeks and non-immune subjects up to 27 days.
Somnolence and dizziness have been changed from rare to very common side effects and eyelid irritation has been changed from an occasional to a common side effect in the summary of product characteristics of Scopoderm (hyoscine; Novartis). Furthermore, in patients whose case history indicates there might be raised intraocular pressure, an ophthalmological examination should be performed before Scopoderm TTS is used. Due to the presence of aluminium in the patch, it should be removed before medical scans.
Risk of intestinal bleeding may be increased with concomitant administration of Voltarol preparations (diclofenac; Novartis) and selective serotonin reuptake inhibitors, according to the updated summaries of product characteristics.
15 September 2012
Febrile neutropenia has been added as a common undesirable effect to the summary of product characteristics for mifamurtide (Mepact; Takeda).
Treatment with nystatin (Nystan; Bristol-Myers Squibb) oral suspension should be discontinued if irritation or sensitisation develops, according to Nystan’s updated summary of product characteristics.
Syncope has been added as a common adverse reaction to the undesirable effects section of tadalafil’s (Adcirca; Eli Lilly) summary of product characteristics. Angioedema has also been added as an adverse reaction (estimated frequency unknown).
8 September 2012
Ambrisentan (Volibris; GSK) must not be used in patients with idiopathic pulmonary fibrosis (IPF), a new contraindication in the summary of product characteristics states. IPF patients who have already been treated with ambrisentan should be assessed and alternative therapies considered.
Cayston (aztreonam; Gilead) powder for nebuliser solution is now indicated for use by patients aged six years and older. Dosing for this paediatric population is the same as for adults. Other changes to Cayston’s summary of product characteristics include inclusion of information about the recommended order and method of administration of multiple inhaled therapies, and information about resistance.
The shelf-lives of Instanyl (fentanyl; Nycomed) nasal sprays have been increased as follows: multi-dose 50mg/dose, 3 years; 100mg/dose, 42 months and 200mg/dose, 4 years; single-dose 100mg/dose, 42 months and 200mg/dose, 42 months. The shelf-life of the single-dose 50mg/dose spray remains unchanged (23 months).
Panitumumab (Vectibix; Amgen) should be withheld or discontinued in the event of skin toxicity with severe or life-threatening inflammatory or infectious complications, according to an updated summary of product characteristics. Severe skin reactions (grade 3) have been reported very commonly in patients treated with Vectibix and cases of necrotising fasciitis, in rare cases leading to death, have been reported. Patients who have severe skin reactions or who develop worsening skin reactions should be monitored.
Alopecia has been added as a common undesirable effect in the summary of product characteristics for Zonegran (zonisamide).
18-25 August 2012
The shelf life of all Humulin (insulin; Eli Lilly) products has increased from two to three years, according to the updated summaries of product characteristics.
4/11 August 2012
The shelf life of unopened LMX4 lidocaine (Ferndale Pharmaceuticals) cream 4% has increased from two to three years for the 5g pack size only, according to the updated summary of product characteristics.
28 July 2012
Nausea has been listed as a common (≥1/100 to <1/10) side effect of Cimzia (certolizumab pegol; UCB Pharma Ltd) solution for injection, according to the updated summary of product characteristics.
21 July 2012
The maximum dose for Formoterol Easyhaler (Orion Pharma) for children aged six years and older has been reduced to 24μg per day (one metered dose, twice daily), according to the updated summary of product characteristics.
The shelf life for NiQuitin (nicotine; GlaxoSmithKline) lozenges has decreased from 36 to 18 months.
Protelos (strontium ranelate; Servier Laboratories) is now indicated for the treatment of osteoporosis in men at increased risk of fracture.
Erectile dysfunction in men and decreased libido in men and women are now listed as common (≥1/100 to <1/10) side effects of Zyprexa (olanzapine; Eli Lilly).
14 July 2012
The shelf-life of Levonelle (levonorgestrel; Bayer) has been increased from four to five years, according to the updated summary of product characteristics.
If Sustiva (efavirenz; Bristol-Myers Squibb) is co-administered with rifampicin to patients weighing 50kg or more, an increase in the dose of Sustiva to 800mg/day may be considered.
7 July 2012
The shelf life of Primacine (erythromycin; Pinewood Healthcare) has increased from two to three years, according to the updated summary of product characteristics.
Sevikar HCT (amlodipine besilate, hydrochlorothiazide, olmesartan medoxomil; Daiichi-Sankyo) is now indicated as an add-on therapy in adults whose blood pressure is not adequately controlled by a combination of olmesartan medoxomil and amlodipine taken as dual-component formulation.
30 June 2012
The shelf life for amoxicillin (Kent Pharmaceuticals) sachets 3g, has been reduced from 48 months to 36 months, according to the updated summary of product characteristics.
23 June 2012
Initiation of Sebivo (telbivudine; Novartis) treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
16 June 2012
The shelf life of quetiapine (Actavis) has been increased from 30 to 36 months, according to the updated summary of product characteristics.
The shelf-life of Zebinix (eslicarbazepine; Eisai) has been increased from three to four years.
2/5 June 2012
Carace 20 Plus
Carace 20 Plus (hydrochlorothiazide, lisinopril; Merck Sharp & Dohme) tablets are now contraindicated for use during the second and third trimester of pregnancy, according to the updated summary of product characteristics.
Elevated liver function tests and balance disorders are now listed as common (≥1/100 to <1/10) side effects of Ebixa (memantine; Lundbeck).
Estradot (estradiol; Novartis) is contraindicated for use in patients with known thrombophilic disorders such as protein C, protein S or antithrombin deficiency.
26 May 2012
Soya bean oil has been removed from Calcichew D3 (calcium carbonate, colecalciferol) chewable tablets, and hypersensitivity to soya or peanuts has been removed as a contraindication, according to the updated summary of product characteristics.
The shelf life of unopened vials of Humalog (insulin lispro; Eli Lilly) has increased from two to three years.
Rasilez (aliskiren; Novartis) is contraindicated for use in combination with angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers in patients with diabetes mellitus or renal impairment (glomerular filtration rate [GFR] <60ml/min/1.73m2). No adjustment of the initial dose is required for patients with moderate renal impairment. Rasilez is not recommended in patients with severe renal impairment (GFR <30ml/min/1.73m2).
5 May 2012
Young children (12–59 months) who are completely immunised after receiving Prevenar (7 valent), discontinued in January 2011, should receive one dose of 0.5ml of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine; Pfizer) to elicit immune response to the additional six serotypes. Prevenar 13 should be administered at least eight weeks after the final dose of Prevenar 7, according to the updated summary of product characteristics.
28 April 2012
Inspra (eplerenone; Pfizer) is now indicated for use to reduce the risk of cardiovascular mortality and morbidity in adults with chronic heart failure (New York Heart Association functional classification class II) and left ventricular systolic dysfunction (≤30%) in addition to standard optimal therapy, according to the updated summary of product characteristics.
Xolair (omalizumab; Novartis) may be kept for a total of four hours at 25C. The product may be returned to the refrigerator for later use, but this must not be done more than once.
Pruritis is now listed as a very common (≥1/10) and pain in extremities and induration as common (≥1/100 to <1/10) side effects of Zostavax (varicella-zoster virus; Sanofi Pasteur MD) shingles vaccine.
21 April 2012
Avastin (bevacizumab; Roche Products) should not be used in those aged 3–17 years who have recurrent or progressive high-grade glioma because of concerns about efficacy, according to the updated summary of product characteristics.
7/14 April 2012
The shelf-life of Cayston (aztreonam lysine; Gilead Sciences) powder and solvent for nebuliser solution 75mg has increased from three to four years, according to the updated summary of product characteristics.
31 March 2012
Remicade (infliximab; Merck Sharp & Dohme) is now indicated for the treatment of severely active ulcerative colitis in those aged six to 17 years, who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to such therapies, according to the updated summary of product characteristics. A dose of 5mg/kg should be given as an intravenous infusion over a two-hour period followed by additional 5mg/kg infusion doses at two and six weeks after the first infusion, then every eight weeks thereafter.
10 March 2012
The shelf-life of Jevtana (cabazitaxel; Sanofi Aventis) concentrate and solvent for solution for infusion has increased from two to three years, according to the updated summary of product characteristics.
The shelf-life of Pradaxa (dabigatran; Boehringer Ingelheim) hard capsules has increased from two to three years. The use by date once the bottle has been opened has been changed from within 30 days to four months. The frequencies of the side effects of abnormal kidney or liver function has changed from uncommon (≥1/1,000, <1/100) to common (≥1/100, <1/10).
3 March 2012
Aclasta (zoledronic acid; Novartis) is now contraindicated for patients with severe renal impairment with creatinine clearance <35ml/min, according to the updated summary of product characteristics.
Galvus (vildagliptin; Novartis) is now indicated as monotherapy for type 2 diabetes for patients whose disease is inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
Repevax (diphtheria, tetanus, pertussis and poliomyelitis; Sanofi Pasteur MSD) can be used in the management of tetanus prone injuries with or without concomitant administration of tetanus immunoglobulin. Repevax should not be used for children under three years of age. Children over three years of age should receive the same dosage as adults.
25 February 2012
The shelf-life of repaglinide (Actavis) tablets has been increased from two to three years, according to the updated summary of product characteristics.
4 February 2012
Cardioxane (dexrazoxane; Novartis) is now indicated for use in adults with advanced and metastatic breast cancer who have received a prior cumulative dose of 300mg/m2 of doxorubicin or a prior cumulative dose of 540mg/m2 of epirubicin when further anthracycline treatment is required. It is recommended that Cardioxane is given at a dose of 500mg/m2 when the commonly used dosage schedule for doxorubicin of 50mg/m2 is used, and at 600mg/m2 when the commonly used dosage schedule for epirubicin of 60mg/m2 is used. Cardioxane is contraindicated in those under 18 years of age.
Rebif (interferon beta-1a; Merck Serono) is now indicated for use in patients who have experienced clinically isolated syndrome, a potential early sign of multiple sclerosis. Rebif 44μg/0.5ml is approved for use three times weekly following a single demyelination event in people who are at high risk of developing multiple sclerosis.
28 January 2012
Herceptin (trastuzumab; Roche) is now indicated in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced disease or tumours greater than 2cm in diameter in early breast cancer. Patients with metastatic or early breast cancer should be treated with Herceptin until progression of the disease. Patients with early breast cancer should be treated with Herceptin for one year or until the disease reoccurs, whichever is first. Hot flush is now listed as a very common (≥1/10) side effect.
21 January 2012
Avastin (bevacizumab; Roche) is now indicated in combination with carboplatin and paclitaxel for the first-line treatment of advanced epithelial ovarian, fallopian tube and primary peritoneal cancer, according to the updated summary of product characteristics. Treatment should be continued until unacceptable toxicity. For epithelial ovarian, fallopian tube and primary peritoneal cancer Avastin should be administered in addition to carboplatin and paclitaxel for up to six cycles of treatment followed by use as a single agent until progression of the disease or for a maximum of 15 months or until unacceptable toxicity, whichever occurs earlier. The recommended dose of Avastin is 15mg/kg of body weight given once every three weeks as an intravenous infusion.
Nasal dryness is now listed as a common (≥1/100 to <1/10) side effect of Emselex (darifenacin; Novartis) prolonged-release tablets
14 January 2012
ViATIM (hepatitis A and typhoid) vaccine can be used to provide one or both doses of hepatitis A vaccine according to updated summary of product characteristics. For patients who have received one dose of ViATIM, either a dose of monovalent hepatitis A vaccine should be given within 36 months and preferably with six to 12 months, or if continued protection against typhoid is also required, a second dose of ViATIM should be given after 36 months. For patients who have received one dose of monovalent hepatitis A vaccine, ViATIM may be used to provide a booster dose of hepatitis A vaccine if protection against typhoid fever is also desired. It should be given within 36 months of the hepatitis A vaccine and preferably within six to 12 months.
7 January 2012
BeneFIX (nonacog alfa; Pfizer) injection can be stored between 2C and 30C for up to two years, according to the updated summary of product characteristics.