FOTIVDA Hard capsule Ref.[7672] Active ingredients: Tivozanib

Fotivda should be supervised by a physician experienced in the use of anticancer therapies.

Posology

The recommended dose of tivozanib is 1340 microgram once daily for 21 days, followed by a 7-day rest period to comprise one complete treatment cycle of 4 weeks.

This treatment schedule should be continued until disease progression or unacceptable toxicity.

No more than one dose of Fotivda must be taken per day.

Dose modification

The occurrence of undesirable effects may require temporary interruption and/or dose reduction of tivozanib therapy (see section 4.4). In the pivotal study, the dose was reduced for grade 3 events and interrupted for grade 4 events.

When dose reduction is necessary, the tivozanib dose can be reduced to 890 microgram once daily with the normal treatment schedule of 21 days of dosing, followed by a 7-day rest period.

Missed dose

In the case of a missed dose a replacement dose must not be taken to make up for a forgotten dose. The next dose should be taken at the next scheduled time.

In the case of vomiting a replacement dose should not be taken; the next dose should be taken at the next scheduled time.

Special populations

Paediatric population

The safety and efficacy of tivozanib in children and adolescents aged below 18 years have not been established. No data are available. There is no relevant use of tivozanib in the paediatric population in the indication advanced renal cell carcinoma.

Elderly patients

No dose adjustment is required in patients 65 years of age or older (see sections 4.4 and 5.1).

Patients with renal impairment

No dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2). Caution is advised in patients with severe renal impairment due to limited experience and in patients undergoing dialysis as there is no experience of tivozanib in this patient population.

Patients with hepatic impairment

All patients should have liver function tests evaluated, including aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and alkaline phosphatase (AP), to determine hepatic function before starting and during treatment with tivozanib.

Tivozanib is not recommended in patients with severe hepatic impairment. Patients with moderate hepatic impairment should only be treated with one tivozanib 1340 microgram capsule every other day as they may be at an increased risk of adverse reactions due to increased exposure with the dose of 1340 microgram every day (see section 4.4 and section 5.2). No dose adjustment is required when administering tivozanib to patients with mild hepatic impairment. Tivozanib should be used with caution in patients with mild and moderate hepatic impairment with close monitoring of tolerability.

Method of administration

Fotivda is for oral use.

Fotivda may be taken with or without food (see section 5.2). The capsules must be swallowed whole with a glass of water and must not be opened.

Two patients received excessive doses of tivozanib during the monotherapy studies. A patient with a history of hypertension experienced aggravated uncontrolled hypertension that was fatal after taking 3 doses of 1340 microgram tivozanib in one day (total 4020 microgram). No adverse reaction was experienced by the second patient who took 2 doses of 1340 microgram tivozanib in one day (total 2680 microgram).

Blood pressure should be well controlled prior to initiating tivozanib and patients should be monitored for hypertension during treatment (see section 4.4).

In cases of suspected overdose, tivozanib should be discontinued and the patient monitored for hypertension and treated as needed with standard anti-hypertensive therapy. There is no specific treatment or antidote for tivozanib overdose.

Shelf life: 5 years.

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

White HDPE bottle with a child resistant closure containing 21 hard capsules.

Each pack contains 1 bottle.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.