UK MHRA: Information sent to HCPs in May 2014 about the safety of medicines

The product information for ACWY Vax states an antibody persistence of at least 3 years. New data, however, demonstrate a reduction in antibody titres between 1 and 2 years after ACWY Vax vaccination. Individuals who remain at high risk of exposure to Neisseria meningitidis should be considered for revaccination earlier than currently recommended. 

Conjugate vaccines are recommended when revaccination within 2 years after administration of the previous ACWY Vax dose is considered. Please refer to local guidelines.

Take a baseline electrocardiogram (ECG) before starting invirase. Patients with a QT interval >450 msec should not take invirase. The starting dose is 500 mg twice daily for the first 7 days. The maintenance dose is 1000 mg twice daily.

For treatment-naïve patients, take a follow-up ECG 10 days after starting invirase. Stop invirase if the QT-interval is >480 msec or >20 msec longer than the baseline reading. Invirase should always be taken with ritonavir 100mg twice daily and appropriate antiretroviral agents.

Rienso is contraindicated in people with known hypersensitivity to the active substance or any of its excipients, or serious hypersensitivity to other parenteral iron products.
Hypersensitivity risk is increased in people with known allergies, immune or inflammatory conditions, and those with a history of severe asthma, eczema, or other atopic allergy. In these people, only use Rienso if the benefit clearly outweighs the risk.

Only administer Rienso when resuscitation facilities and staff trained to evaluate and manage anaphylactic reactions are immediately available.

Before each administration inform people of the risk of hypersensitivity and the relevant symptoms and tell them to seek urgent medical attention if a reaction occurs.

Closely monitor people for signs of hypersensitivity, including severe hypotension, during and for at least 30 minutes after each administration of Rienso.

See also the letter sent in January 2014 (71Kb) and the Drug Safety Update article from August 2013.