NHS Direct Medicines Fact Sheet Relenza® (zanamivir) Inhaler Fact sheets are intended as supplements to the NHS Direct approved electronic medicines information sources offering practical advice and selected facts that the call handler may find difficult to locate elsewhere. The core NHS Direct electronic medicines information sources must be consulted for detailed information on indications, warnings, contraindications, doses, adverse effects and interactions in accordance with the National Policy on Handling Medicines Calls (NP005). General Information Relenza® blocks the entry and release of influenza virions (individual viruses) from cells in the respiratory tract. Unlike a vaccine which prepares the immune system to quickly deal with exposure in the future, Relenza® aims to slow the spread of the virus throughout the body. It does this by stopping virions penetrating cells (in order to reproduce) and preventing the release of new virions from cells that have been infected (1). Note that Relenza® does not stop the virus from reproducing itself once a cell has been infected. Indications Relenza® is indicated for adults and children 5 years of age and over. It is not a cure, but it aims to: Prevent influenza from spreading by reducing the chance of close contacts of confirmed or probable cases becoming infected. Ameliorate (reduce and shorten) the symptoms once infected. Produced by NHS Direct UKMI Working Group Despite the manufacturer’s statement in the Summary of Product Characteristics (SPC), NICE has approved Relenza® for use in Residential Nursing Homes and in adults over the age of 65 years (2,3). Contraindications and restrictions on use Contraindicated: People allergic to zanamivir or any of Relenza’s® excipients including lactose (1). Flu Prevention: At the time of writing Relenza® is indicated only for those who had close contact during the period when the case was symptomatic AND if the most recent exposure to the case occurred within the past 7 days. The Health Protection Agency provides information on who are “close contacts” and the criteria for “confirmed infection” (4). Warnings, Precautions and Important Interactions Most people should be able to take Relenza® however the manufacturer cautions its use in patients with severe asthma because of the risk of bronchospasm (1). Such patients should have a fast acting bronchodilator (e.g. salbutamol) available. No clinically important drug or food interactions have been identified (1). Patients can take it with their usual medicines. Dose For the treatment of symptoms in adults and children from the age of 5 years: two inhalations (2 x 5 mg) twice daily for five days. To be effective it needs to be started within 48hrs of symptoms appearing in adults and 36hrs in children (1). For preventing influenza in adults and children from the age of 5 years who are deemed close contacts of confirmed or probable symptomatic cases: two inhalations (2 x 5 mg) once daily for 10 days. Therapy should Date last updated: 7 May 09 Review due: 7 May 11 Version: 2.0 begin as soon as possible and within 36 hours of exposure to an infected person (1). Dosage Forms and Supply Restrictions Relenza® is a prescription only medicine (POM) available on the NHS for those who have confirmed or probable infection and the close contacts of symptomatic cases. In order for close contacts to be eligible they must have been in close contact with the infected person while they had symptoms and within the last seven days (4,5). People who do not meet the NHS criteria may have obtained supplies by private prescription. Relenza® is a dry powder, diskhaler device. Each blister contains the equivalent of 5mg of zanamivir (1). See the SPC for further details. Common Side-effects No common side-effects are expected. Bronchospasm is mentioned in the SPC as a rare complication in patients with severe asthma (1). Time to effect Relenza® reduces the duration of influenza symptoms by one and a half days on average (1). Driving, Machinery and Alcohol Taking Relenza® should not further impair people’s ability to drive or operate machinery. Relenza® is not expected to enhance the sedative effects of alcohol (1). Produced by NHS Direct UKMI Working Group Timing with other inhaled medicines Patients who use other inhaled medicines are advised to take them before using Relenza® (1). Pregnancy and Breastfeeding Pregnancy: Although there is very little information about the safety of Relenza® in human pregnancy, animal studies do not suggest there is a risk to the foetus. Influenza during pregnancy can lead to pneumonia in the mother and infection might pose a risk to the unborn baby. Overall the benefits of Relenza® are likely to outweigh the risks (6,7). Breastfeeding: Taking Relenza® is not a reason to stop breastfeeding. Very small amounts pass into the breast milk but not enough to cause concern. Breastfeeding can continue as normal while taking Relenza® (7). References 1) Summary of Product Characteristics – Relenza 5mg/dose inhalation powder. (zanamivir) GlaxoSmithKline. Last revision of text 1 October 2008 Accessed via http://emc.medicines.org.uk on 30 April 2009. 2) The National Institute for Health and Clinical Excellence (NICE) Technology Appraisal Guidance 168. Amantadine, oseltamivir and zanamivir for the treatment of influenza (review of NICE technology appraisal guidance 58). February 2009. Accessed via http://guidance.nice.org.uk on 29 April 2009. 3) The National Institute for Health and Clinical Excellence (NICE) Technology Appraisal Guidance 158. Amantadine, oseltamivir and zanamivir for the prophylaxis of influenza (review of NICE technology appraisal guidance 67). September 2008. Accessed via http://guidance.nice.org.uk on 29 April 2009. Date last updated: 7 May 09 Review due: 7 May 11 Version: 2.0 4) Health Protection Agency. WHO Pandemic Alert Phase 5: Actions and post exposure prophylaxis for close contacts of probable or confirmed human case(s) of swine influenza A/H1. Accessed via http://www.hpa.org.uk/ on 5 May 2009. 5) Martin J, editor. British National Formulary No 57. London: BMJ Group and RPS Publishing; March 2009. 6) Anon. Zanamivir in Pregnancy. National Poisons Information Service and the UK Teratology Information Service. Updated 06/05/09. Accessed via www.toxbase.org on 7 May 2009. 7) Anon. Management of pregnant women during an influenza A (H1N1) (Swine Flu) pandemic. National Poisons Information Service and the UK Teratology Information Service. National Poisons Information Service and the UK Teratology Information Service. Updated 06/05/09. Accessed via www.toxbase.org on 7 May 2009. 8) Oseltamivir or zanamivir - Can mothers breastfeed after treatment for influenza? Trent Medicines Information Service. Accessed via http://www.nelm.nhs.uk/en/NeLM-Area/Evidence/Medicines-Q-A/Oseltamivir-or-zanamivir---Can-mothers-breastfeed-aftertreatment-for-influenza/ on 01 May 2009. Quality Assurance Search strategy Standard in-house resources. Prepared by Wynn Pevreal Principal Pharmacist London Medicines Information Service Contact Med.info@nwlh.nhs.uk Checked by Alexandra Denby Regional MI Manager London Medicines Information Service Date of check April 30th 2009. Updated May 7th 2009 (NeLM weblinks, phrasing, updated references 4,6,7) Wynn Pevreal Produced by NHS Direct UKMI Working Group Date last updated: 7 May 09 Review due: 7 May 11 Version: 2.0