OTEZLA TABLET 30 MG [SIN15203P]

Product Info

OTEZLA TABLET 30 MG

[SIN15203P]

4.1 Therapeutic Indications

Otezla is indicated for:

• Otezla, alone or in combination with a disease-modifying anti-rheumatic drug (DMARD), is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients who have had an inadequate response, intolerance, or contraindication to a prior DMARD therapy.

• The treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

• The treatment of adult patients with oral ulcers associated with Behçet’s Disease who are candidates for systemic therapy.

4.2 Dose and method of administration

Dosage (dose and interval)

For psoriasis, psoriatic arthritis and Behçet’s Disease, treatment with Otezla should be initiated by physicians experienced in the diagnosis and treatment of these diseases.
The recommended dose of Otezla is 30 mg twice daily taken orally approximately 12 hours apart. An initial titration schedule is required as shown below in Table 1. No re-titration is required after initial titration.

Method of administration

Otezla tablets should be swallowed whole, either with or without food. The tablets should not be crushed, split or chewed.

If patients miss a dose, the next dose should be taken as soon as possible. If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time.

Dosage adjustment

No dose adjustment is necessary for elderly patients (≥ 65 years of age).

Renal impairment

No dose adjustment is needed in patients with mild renal impairment. There are limited data on moderate renal impairment. The dose of Otezla should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockroft-Gault equation). For initial dose titration in this group, it is recommended that Otezla be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped.

Hepatic impairment

Dose adjustment is not required in patients with hepatic impairment. The safety of Otezla has not been evaluated in PsA or PSOR patients with hepatic impairment.

Monitoring advice

In the event of intolerable adverse events, interruption or discontinuation of Otezla should be considered.

4.3 Contraindications

Otezla is contraindicated:

• In patients with known hypersensitivity to the active substance or to any of the excipients.

• During pregnancy and in nursing women.