KIENDRA Film-coated tablet Ref.[115230] Active ingredients: Siponimod

Patient selection

Before initiation of treatment with KIENDRA the CYP2C9 genotype of the patient should be determined. KIENDRA should not be used in patients with a CYP2C9*3*3 genotype (see section 4.4 Pharmacogenomics).

For recommendations related to switching treatment from other disease modifying therapies to KIENDRA, see section 4.4 Prior treatment with immunosuppressive or immune-modulating therapies.

Treatment initiation

Treatment has to be initiated with a starter pack that lasts for 5 days (see section 5.1 Pharmacodynamic Properties). The dose titration starts with 0.25 mg once daily on day 1 and 2, followed by once daily doses of 0.5 mg on day 3 (two tablets of 0.25 mg), 0.75 mg on day 4 (three tablets of 0.25 mg), and 1.25 mg on day 5 (five tablets of 0.25 mg), to reach the maintenance dose of 2 mg* KIENDRA starting on day 6.

Table 1. Dose titration regimen to reach siponimod maintenance dosage:

^* The recommended maintenance dose is 1 mg daily for patients with CYP2C9 *2*3 or *1*3 genotype. See “Special population – Pharmacogenomics” below.

During the first 6 days of treatment initiation the recommended daily dose should be taken once daily in the morning with or without food.

If a titration dose is missed on one day during the first 6 days of treatment, treatment needs to be re-initiated with a new starter pack.

General target population

The recommended maintenance dose of KIENDRA is 2 mg taken once daily with or without food. For patients with a CYP2C9 *1*3 or *2*3 genotype see below (Special populations – Pharmacogenomics).

Re-initiation of maintenance therapy after treatment interruption

If KIENDRA maintenance treatment is interrupted for 4 or more consecutive daily doses, treatment has to be re-initiated with a new starter pack (see Treatment initiation above). Treatment interruptions for up to 3 missed consecutive daily doses do not require re-titration and treatment should be continued at the maintenance dose level.

Special populations

Pharmacogenomics

KIENDRA should not be used in patients with a CYP2C9*3*3 genotype (see sections 4.4 Pharmacogenomics.

The recommended maintenance dose of KIENDRA in patients with a CYP2C9 *2*3 or *1*3 genotype is 1 mg once daily (see sections 4.4). For treatment initiation in these patients the same starter pack should be used (see Treatment initiation).

Renal impairment

No KIENDRA dose adjustments are needed in patients with renal impairment.

Hepatic impairment

No KIENDRA dose adjustments are needed in patients with hepatic impairment.

Paediatric patients (below 18 years)

No studies have been performed in paediatric patients.

Elderly patients (65 years or above)

No KIENDRA dose adjustment is needed in patients aged 65 years and over.

Method of administration

KIENDRA tablets should be taken orally and swallowed whole with water, with or without food.

There is no specific antidote or treatment for KIENDRA overdoses. Treatment should be supportive and symptomatic treatment.

It is important to observe for signs and symptoms of bradycardia, which should include overnight monitoring. Regular measurements of pulse rate and blood pressure are required and electrocardiograms should be performed (see sections 4.2 and 4.4). This is especially important if the overdose constitutes first dose exposure to KIENDRA or occurs during the dose titration phase of KIENDRA.

Neither dialysis nor plasma exchange would result in meaningful removal of siponimod from the body.

24 months.

Store in a refrigerator between 2 to 8°C before dispensing. Do not freeze. After dispensing: store below 25 °C for up to 3 months.

Store in the original package.

KIENDRA 0,25 mg film-coated tablets in blisters composed of PA/AL/PVC-AL blister packs. Pack sizes: 12 or 120 tablets per pack.

KIENDRA 2 mg film-coated tablets in blisters composed of PA/AL/PVC-AL blister packs. Pack sizes: 28 tablets per pack.