Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
Drug updates
Diamorphine nasal spray launched in UK
A diamorphine nasal spray (Ayendi; Wockhardt) indicated for the treatment of acute severe nociceptive pain in children and adolescents 2–15years old in a hospital setting, is now available as an authorized (licensed) product in the UK. The nasal spray is available as 720microgram/metered spray and 1600microgram/metered spray and is provided with 0.5% saline for reconstitution and 9 disposable nasal tips to allow multiple patients to use the producwithin its 14 day expiry. The NHS list price is currently £113 and £124 for the 720microgram and 1600microgram bottle (containing 160metered dose sprays), however we understand that significant discount is available until a smaller pack size is launched later in the year. For the SPC, click here.
Fentanyl buccal film launched in UK
A fentanyl buccal film (Breakyl; Meda Pharmaceuticals) has been launched in the UK for the treatment of breakthrough pain in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. The film is currently available in 200, 400 and 800microgram dosage forms and as with other forms of transmucosal fentanyl must be individually titrated for each patient. The formulations are not bio-equivalent with other fentanyl products. Each buccal film costs £5. As this product has been available in the US, information on its use is alreadyincluded in the recently updated on-line PCF fentanyl (transmucosal) monograph. For the SPC, click here.
FDA approves first hydrocodone m/r capsule
The U.S. Food and Drug Administration (FDA) has approved a hydrocodone m/r capsule (Zohydro ER; Zogenix Inc) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. Zohydro ER is a schedule II controlled drug and is the first FDA-approved single-entity (not combined with another analgesic) and modified-release hydrocodone product. It is available as 10mg, 15mg, 20mg, 30mg, 40mg and 50mg m/r capsules. For the full prescribing information, click here.
SMC accepts orodispersible ondansetron
The Scottish Medicines Consortium (SMC) has accepted ondansetron orodispersible films (Setofilm; Norgine) for restricted NHS use for its authorized indications in patients with an enhanced risk of aspiration or who have difficulty swallowing. For more information, click here.
Oral ketoconazole tablets discontinued in UK
Janssen Pharmaceuticals has discontinued ketoconazole 200mg tablets (Nizoral). This follows the EU-wide review of the risk of hepatotoxicity with oral ketoconazole and the MHRA statement that oral ketoconazole-containing products should no longer be prescribed for fungal infections as the risk of liver injury outweighs the benefits (see our news article 06-08-2013). Topical ketoconazole formulations (creams, ointments, and shampoos) have very low systemic absorption and continue to be available for use as indicated. For more information, click here.
Prepared by Sarah Charlesworth and Andrew Wilcock