Prior to initiation of treatment: obtain an electrocardiogram (ECG) to determine whether a first-dose observation (FDO) is needed. FDO is required in select patients with pre-existing cardiac conditions. Review results of a recent complete blood count (CBC) with differential white blood cell (WBC) count obtained within 6 months prior to treatment initiation or after discontinuation of prior therapy. Recent (i.e. within 6 months) transaminase and bilirubin levels should be reviewed before initiation. Obtain an evaluation of the fundus, including the macula. Women should obtain a negative pregnancy test prior to initiating treatment.
Refer to the SmPC for further information on requirements prior to treatment initiation.
*4-hour first-dose observation is recommended for patients with sinus bradycardia, first- or second-degree AV blocks, Mobitz type I (Wenckebach),
or a history of myocardial infarction or heart failure occurring more than 6 months prior to treatment initiation and in a stable condition. Refer to the SmPC for further details including when cardiologist advice should be obtained before initiation of PONVORY®.
†PONVORY® contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
‡Co-administration with strong inducers of multiple metabolic pathways of PONVORY® may decrease the systemic exposure of PONVORY®. It is unclear whether this decrease is clinically relevant.
In the development program, peripheral lymphocyte levels returned to the normal range in >90% of healthy subjects within 1 week of stopping therapy.§
The short half-life (approximately 33 hours) means that PONVORY® is rapidly eliminated from the body following treatment discontinuation.¶
Ability to adapt to unpredictable events that may require treatment interruption or discontinuation, such as the occurrence of an adverse event or serious infection
Flexibility to plan for vaccination requirements and family planning goals which may require treatment interruption or switch
PONVORY® is contraindicated in women of childbearing potential not using effective contraception. For further information, please refer to the PONVORY® SmPC.
§ PONVORY® causes a reversible, dose-dependent reduction in peripheral lymphocyte levels. PONVORY® may therefore increase the risk of infections. Monitoring for signs and symptoms of infection should be continued for 1-2 weeks after PONVORY® is discontinued.
¶ Severe exacerbations of disease, including disease rebound, have been rarely reported after discontinuation of an S1PR modulator. The possibility of severe exacerbation of disease should be considered after stopping treatment. Patients should be observed for a severe increase in disability upon treatment discontinuation and appropriate treatment should be instituted, as required.
See the SmPC for further information on discontinuing treatment and vaccinations.