ERIVEDGE Hard capsule Ref.[9090] Active ingredients: Vismodegib

Erivedge should only be prescribed by or under the supervision of a specialist physician experienced in the management of the approved indication.

Posology

The recommended dose is one 150 mg capsule taken once daily.

Missed doses

If a dose is missed, patients should be instructed not to take the missed dose but to resume with the next scheduled dose.

Duration of treatment

In clinical trials, treatment with Erivedge was continued until disease progression or until unacceptable toxicity. Treatment interruptions of up to 4 weeks were allowed based on individual tolerability.

Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.

Special populations

Elderly

No dose adjustment is required in patients ≥65years of age (see section 5.2). Of a total number of 138 patients in 4 clinical trials of Erivedge in advanced basal cell carcinoma, approximately 40% of patients were ≥65 years old and no overall differences in safety and efficacy were observed between these patients and younger patients.

Renal impairment

Mild and moderate renal impairment is not expected to impact the elimination of vismodegib and no dose adjustment is needed. Very limited data is available in patients with severe renal impairment. Patients with severe renal impairment should be carefully monitored for adverse reactions.

Hepatic impairment

No dose adjustment is required in patients with mild, moderate or severe hepatic impairment defined based on National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG)-criteria for hepatic impairment:

• mild: total bilirubin (TB) ≤ upper limit of normal (ULN), aspartate aminotransferase (AST) > ULN or ULN < TB ≤ 1.5 x ULN, AST any
• moderate: 1.5 x ULN < TB < 3 x ULN, AST any
• severe: 3 x ULN < TB < 10 x ULN, AST any (see section 5.2)

Paediatric population

The safety and efficacy of Erivedge in children and adolescents aged below 18 years have not been established.

Due to safety concerns (see sections 4.4 and 5.3), this medicinal product should not be used in children and adolescents aged below 18 years.

Method of administration

Erivedge is for oral use.The capsules must be swallowed whole with water, with or without food (see section 5.2). The capsules must not be opened, to avoid unintended exposure to patients and health care providers.

Erivedge has been administered at doses 3.6 times higher than the recommended 150 mg daily dose. No increases in plasma vismodegib levels or toxicity were observed during these clinical trials.

Shelf life: 4 years.

Do not store above 30°C.

Keep the bottle tightly closed in order to protect from moisture.

HDPE bottle with a child-resistant closure containing 28 hard capsules. Each pack contains one bottle. The bottle cap material is Polypropylene. The cap liner is aluminum foil-lined waxed pulp board.

Any unused medicinal product at the end of treatment must immediately be disposed of by the patient in accordance with local requirements (if applicable, e.g. by returning the capsules to the pharmacist or physician).