Safety in Lactation: Drugs for bleeding disorders

18 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Antifibrinolytics & haemostatics Etamsylate is a…
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Refrigerated Storage

AdvateShire Pharmaceuticals Limited

Shire Pharmaceuticals Limited
Powder and solvent for solution for injection 5ml water (250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU)

During the shelf life, the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months. The end of the 6 months storage at room temperature should be recorded on the product carton. The product may not be returned to refrigerated storage again. Please also refer to the manufacturer’s product literature for recommended storage information at

Yes reduce to 6 months if exposed to temperature excursions described above. The revised expiry date must not exceed the expiry date stated on the product.

Please contact Shire for products exposed to conditions other than described above. Refer to the current BNF for company contact details.

21 October 2020
London MI Service

Lactation Safety Information

Synonym: Recombinant coagulation factor VIII
No published evidence of safety
Unlikely to enter milk and not absorbed from the infant’s GI tract
Factor VIII is a normal component of maternal and infant plasma
20 October 2016

New Medicines

Iblias (EU), Kovaltry (EU,US), Kogenate PFHaemophilia A in children and adults


Iblias (EU), Kovaltry (EU,US), Kogenate PF
New formulation

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Feb 20Bayer has no plans to launch in the UK [11].
Sep 19Has been available in the US since March 2016 [10].
Mar 18Bayer has no immediate plans to launch in UK [9].
Mar 16Approved in the US [8].
Feb 16Approved in EU [7].
Dec 15EU positive opinion for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Iblias can be used for all age groups [6].
Dec 14Filed in the EU and US, for the treatment of hemophilia A in children and adults. The submission was based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials. [5]
Dec 14Global filings planned before end 2014 [1].


Plasma protein-free recombinant factor VIII formulated with sucrose.
Haemophilia affects 1 in 5,000 to 1 in 10,000 male live births [3].
Haemophilia A in children and adults

Trial or other data

Dec 14Bayer is conducting a PIII trial of BAY 818973, a plasma protein-free formulation of recombinant octocog alfa formulated with sucrose, for treatment of haemophilia A (NCT01029340). The trial has enrolled 68 patients at multiple sites worldwide and is expected to be completed by April 2012 [2].
Sep 13Results from PIII NCT01029340 (Leopold) study reported. The study assessed the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study also compared 2 different assays for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients received the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose was measured based on the Chromogenic Substrate Adjusted assay CS/ADJ) [4].
Mar 13PIII NCT01029340 study completes [4].

Evidence based evaluations