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A regimen including ® — Powerful prevention of chemotherapy induced nausea and vomiting (CINV) For 5 days of CINV prevention prescribe EMEND as part of combination therapy from Day 1, Cycle 1 ® ® EMEND ® 80 mg and 125 mg hard capsules (aprepitant) IVEMEND ® ▼ 115 mg powder for solution for infusion (fosaprepitant dimeglumine) ABRIDGED PRESCRIBING INFORMATION Refer to Summary of Product Characteristics before prescribing Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to MSD Ltd (01992-467272). PRESENTATION: EMEND Capsules: 80 and 125 mg capsules containing 80 mg and 125 mg aprepitant respectively IVEMEND Powder for solution for infusion. Each vial contains fosaprepitant dimeglumine equivalent to 115 mg fosaprepitant. USES: Acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy in adults. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. EMEND and IVEMEND are given as part of combination therapy (see ‘Dosage and Administration’). DOSAGE AND ADMINISTRATION: EMEND is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The recommended dose of EMEND is 125 mg orally Day 1 and 80 mg once daily Days 2 and 3. In clinical studies, the following regimen was used: Highly Emetogenic Chemotherapy Regimen: Day 1 Day 2 Day 3 Day 4 EMEND 125 mg PO 80 mg PO 80 mg PO None Dexamethasone 12 mg PO 8 mg PO 8 mg PO 8 mg PO Ondansetron 32 mg IV none none none EMEND was administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4. The dose of dexamethasone was chosen to account for active substance interactions. Ondansetron was administered intravenously 30 minutes prior to chemotherapy treatment on Day 1 only. Moderately Emetogenic Chemotherapy Regimen: Day 1 Day 2 Day 3 EMEND 125 mg PO 80 mg PO 80 mg PO Dexamethasone 12 mg PO none none Ondansetron 2 x 8 mg PO none none EMEND was administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone was chosen to account for active substance interactions. One 8 mg capsule of Ondansetron was administered 30 to 60 minutes prior to chemotherapy treatment and one 8 mg capsule was administered 8 hours after fi rst dose on Day 1. EMEND may be taken with or without food and swallowed whole. IVEMEND (115 mg) may be substituted for aprepitant (125 mg) prior to chemotherapy, on Day 1 only of the chemotherapy induced nausea and vomiting (CINV) regimen as an infusion administered over 15 minutes. The 3-day CINV regimen includes IVEMEND (115 mg) 30 minutes prior to chemotherapy treatment or aprepitant (125 mg) one hour prior to chemotherapy treatment on Day 1; aprepitant (80 mg) on Days 2 and 3; in addition to a corticosteroid and a 5-HT3 antagonist. The following regimen is recommended, based on clinical studies with aprepitant, for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy. Highly Emetogenic Chemotherapy Regimen: Day 1 Day 2 Day 3 Day 4 IVEMEND 115 mg intravenously none none none Aprepitant none 80 mg PO 80 mg PO none Dexamethasone 12 mg PO 8 mg PO 8 mg PO 8 mg PO Ondansetron 32 mg intravenously none none none In clinical studies: Aprepitant was administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4. The dose of dexamethasone was chosen to account for medicinal product interactions. Ondansetron was administered intravenously 30 minutes prior to chemotherapy treatment on Day 1. Moderately Emetogenic Chemotherapy Regimen: Day 1 Day 2 Day 3 IVEMEND 115 mg intravenously none none Aprepitant none 80 mg PO 80 mg PO Dexamethasone 12 mg PO none none Ondansetron 2 x 8 mg PO none none In clinical studies: Aprepitant was administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone was chosen to account for medicinal product interactions. One 8 mg capsule of ondansetron was administered 30 to 60 minutes prior to chemotherapy treatment and one 8 mg capsule was administered 8 hours after fi rst dose on Day 1. EMEND and IVEMEND: Refer to the Summary of Product Characteristics for co-administered antiemetic agents. Use in elderly: no adjustment is necessary. Use in renal impairment: no adjustment is necessary. Hepatic impairment: no adjustment is necessary in mild hepatic impairment. Data in moderate or severe hepatic insuffi ciency are limited. Under 18 years: not recommended. CONTRAINDICATIONS: Hypersensitivity to active ingredient or to any of the excipients. Co-administration with pimozide, terfenadine, astemizole or cisapride. PRECAUTIONS: Use with caution in patients with moderate or severe hepatic impairment. Use with caution in patients receiving active substances metabolised primarily through CYP3A4 and with a narrow therapeutic range (e.g ciclosporin, tacrolimus, diergotamine). Also use with caution in patients receiving dexamethasone, ergot alkaloid derivatives, irinotectan, midazolam, chemotherapeutic agents e.g. etoposide, vinorelbine, docetaxel and paclitaxel. The effi cacy of hormonal contraceptives may be reduced during and for 28 days after administration. Alternative or back-up methods of contraception should be used during treatment and for 2 months following the last dose. Avoid concomitant administration with medicines that strongly induce CYP3A4 (e.g rifampicin, phenytoin, carbamazepine, phenobarbital). Concomitant use with herbal preparations containing St Johns Wort is not recommended. Concomitant administration with active substances that inhibit CYP3A4 (e.g. ketoconazole, clarithromycin, protease inhibitors) should be approached cautiously. Isolated reports of immediate hypersensitivity reactions including fl ushing, erythema and dyspnoea have occurred during infusion of fosaprepitant. These reactions have generally responded to discontinuation of the infusion. Re-initiation of the infusion in these patients is not recommended. Use with caution in patients receiving concomitant medicinal products that are CYP2C9 substrates (e.g. warfarin, tolbutamide, phenytoin). Monitor closely patients on chronic warfarin therapy. Immunosuppressants: Dose reduction during the 3 days of co-administration with EMEND is not recommended. Do not use the capsules in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insuffi ciency, because EMEND contains sucrose. Pregnancy and lactation: Not be used during pregnancy unless clearly necessary. Breast-feeding is not recommended. IVEMEND: This should not be given as a bolus injection, but should always be diluted and given as a slow intravenous infusion. It should not be administered intramuscularly or subcutaneously. Mild injection site thrombosis has been observed at higher doses. If local irritation occurs, terminate the injection or infusion and restart in another vein. SIDE EFFECTS: Refer to SPC for complete information on side effects. As fosaprepitant is converted to aprepitant, those adverse reactions associated with EMEND (aprepitant) are expected to occur with IVEMEND (fosaprepitant). The most common adverse reactions reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving highly emetogenic chemotherapy were: hiccups (4.6% versus 2.9%), asthenia/fatigue (2.9% versus 1.6%), ALT increased (2.8% versus 1.5%), constipation (2.2% versus 2.0%), headache (2.2% versus 1.8%), and anorexia (2.0% versus 0.5%). The most common adverse reaction reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving moderately emetogenic chemotherapy was fatigue (1.4% versus 0.9%). The following adverse reactions were observed in either HEC or MEC studies in patients treated with the aprepitant regimen and at a greater incidence than with standard therapy: Frequencies are defi ned as: very common (≥1/10); common (≥1/100,
Meetings Personal perspectives from ASCO Advances in treating malignant melanoma Over the last 30 years or so, in the UK and in many other countries, the incidence of malignant melanoma has increased more than for any other common cancer. There was therefore huge excitement when the results of a phase III study indicated that ipilumumab improved survival rates in patients with metastatic melanoma. The double-blind study randomly assigned patients to receive ipilimumab (137 patients), ipilimumab and gp100 (403 patients), or gp100 alone (136 patients). Both agents were given once every three weeks for four cycles, ipilimumab at 3mg/kg and gp100 at 1mg. Overall survival (OS) was the primary endpoint and, after 12 months, 46% of patients receiving ipilimumab alone, 44% of those receiving ipilimumab plus gp100, and 25% of those receiving gp100 alone were still alive. For those receiving the combination of both agents, or ipilimumab alone, this was estimated to result in a modest median OS improvement of around 10 months, compared with just over six months for those receiving gp100 alone. Interestingly, the addition of gp100 appeared to show a trend towards reducing the effect of ipilimumab. Indeed a number of studies presented seemed to show poorer than expected results for vaccine therapy in melanoma 2,3 . Finally, data from several phase I and/ or II studies was presented which showed some promise for drugs that target specific pathways involved in melanoma, particularly mutant RAF kinase inhibitors 4,5 . Such pathways promise to be an area of focus for drug development, although the plennary address (see below) reminds us that optimism must always be accompanied by caution. Even so, I do wonder if in five years time there will be a similar number of treatments available for malignant melanoma as there currently are for renal cell carcinoma and whether the funding issues such advances bring will, by then, have been solved. References 1. O’Day et al Abstract 4. 2. Eggermont et al Abstract 8505. 3. Slingluff et al Abstract 8508. 4. Kefford et al Abstract 8503. 5. McArthur et al Abstract 8529. Contributed by David Thomson A marathon meeting I would like to draw upon some similarities between the ASCO meeting and the London Marathon, as I have attended both of these great events. Advances in oncology practice often proceed at a slow pace, one step at a time being achieved with great pain and dedication. Several examples of these were presented at this year’s conference, with ‘negative’ results from the COIN (cetuximab in colorectal cancer), 1 BR19 (gefitinib in NSCLC), 2 AVAGAST (bevacizumab in advanced gastric cancer) 3 and SPEAR (picoplatin in SCLC) 4 studies indicating that we clearly need to learn more about how, and in which patients, some of the newer targeted drugs should be used. Indeed, the award winning and mind blowing plenary address, delivered by Dr Frank McCormick (of sorafanib fame), about the success and failure of agents specifically targeting the RAS pathway was an illustration of how complex and multi faceted such therapies are, and why many are not as successful as hoped. Shown to be moving at a faster pace towards use in routine clinical practice were PARP inhibitors in ovarian 5 and breast cancer, 6,7 ALK inhibitors in lung cancer 8 and mTOR inhibitors, in combination with other targeted agents, 9,10 to exert a double pronged attack on tumours. Significant strides reported included a reduced ‘risk of progression’ for maintenance therapy with rituximab in first line follicular lymphoma, reported in the PRIMA study, 11 and confirmation that zoledronic acid significantly increases survival in multiple myeloma. 12 My final thought is that, as with the London Marathon, it is a privilege to have been a spectator at ASCO and to have been given the opportunity to appreciate the immense amount of effort and fortitude shown by the multidisciplinary teams and patients involved in the clinical studies presented. References 1. Maughan et al Abstract 3502. 2. Goss et al Abstract LBA7005. 3. Kang et al Abstract LBA2007. 4. Ciuleanu et al Abstract 700. 5. Gelmon et al Abstract 3002. 6. Dent et al Abstract 1018. 7. Isakoff et al Abstract 1019. 8. Bang et al Abstract 3. 9. Dalenc et al Abstract 1012. 10. Morrow et al Abstract 1014. 11. Salles et al Abstract 8004. 12. Morgan et al Abstract 8021. Contributed by Jacky Turner, Macmillan pharmacist, South East London Cancer Network with input from Libby Hardy, lead pharmacist, Penninsula Cancer Network Latest news about sentinal node biopsy Sentinel node biopsy continues to grab headlines from previous years. One large (n=991) phase III study showed that axilliary lymph node clearance is not always necessary, even in women with ‘sentinel node spread’, provided that the spread is limited. Research such as this will continue to reduce the morbidity associated with surgery for early breast cancer. Contributed by Libby Hardy BOPA Bulletin Issue 1 Summer 2010 17
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