In the event of an inadvertent temperature excursion the following data may be used:
The product can be removed from the refrigerator for a period of 30 days at room temperature (up to 30°C) when protected from light.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact Amgen Ltd in cases where additional stability data is required. Refer to the current BNF for company contact details.
15 March 2021
London MI Service
Lactation Safety Information
Long half-life increases risk of accumulation in breastfed infants
No published evidence of safety
Significant adverse effects found in adults
As used for prolonged period, monitor infant for increased platelet count
Nplate · Newly diagnosed immune thrombocytopenia (ITP) in adults, and refractory in children
Licence extension / variation
Development and Regulatory status
Jan 21 · Licence change approved in UK and EU .
Dec 20 · Changes to the indication allowing use in newly diagnosed adult patients with ITP have been recommended for EU approval by CHMP - the amended indication is "Adults: ... for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Paediatrics: ... for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) .
Oct 19 · Licence extension approved by the FDA .
Dec 18 · Amgen submits sBLA to US FDA. Application is for use in adult patients who have had ITP for 12 months or less and who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The licence extension is supported by data from 311 patients who were diagnosed with ITP within 12 months prior to study enrolment .
Engineered Fc-peptide fusion protein. Activates the thrombopoietin (TPO) receptor prompting growth and maturation of of bone marrow cells.
ITP occurs in about 3 in 100,000 adults every year. Unlike ITP in children, most adults with ITP will continue to have a low number of platelets indefinitely. ITP occurs in about 2 to 5 of every 100,000 children. It is most common in children around the age of 5 or 6 years, but it can occur at any age. The condition often occurs about 2-3 weeks after an infection (often a common viral infection). The symptoms often disappear over 6-8 weeks, and by six months in most cases .
Newly diagnosed immune thrombocytopenia (ITP) in adults, and refractory in children