SIGNIFOR Solution for injection Ref.[9563] Active ingredients: Pasireotide

Posology

The recommended initial dose is 0.6 mg pasireotide by subcutaneous injection twice a day.

Two months after the start of Signifor therapy, patients should be evaluated for clinical benefit. Patients who experience a significant reduction in urinary free cortisol (UFC) levels should continue to receive Signifor for as long as benefit is derived. A dose increase to 0.9 mg may be considered based on the response to the treatment, as long as the 0.6 mg dose is well tolerated by the patient. Patients who have not responded to Signifor after two months of treatment should be considered for discontinuation.

Management of suspected adverse reactions at any time during the treatment may require temporary dose reduction of Signifor. Dose reduction by decrements of 0.3 mg twice a day is suggested.

If a dose of Signifor is missed, the next injection should be administered at the scheduled time. Doses should not be doubled to make up for a missed dose.

Switch from intramuscular to subcutaneous formulation

There are no clinical data available on switching from the intramuscular to the subcutaneous pasireotide formulation. If such a switch should be required, it is recommended to maintain an interval of at least 28 days between the last intramuscular injection and the first subcutaneous injection, and to initiate the subcutaneous injections at a dose of 0.6 mg pasireotide twice a day. The patient should be monitored for response and tolerability and further dose adjustments may be needed.

Special populations

Paediatric population

The safety and efficacy of Signifor in children and adolescents aged 0 to 18 years have not been established. No data are available.

Elderly patients (≥65 years)

Data on the use of Signifor in patients older than 65 years are limited, but there is no evidence to suggest that dose adjustment is required in these patients (see section 5.2).

Renal impairment

No dose adjustment is required in patients with impaired renal function (see section 5.2).

Hepatic impairment

Dose adjustment is not required in patients with mildly impaired hepatic function (Child Pugh A). The recommended initial dose for patients with moderate hepatic impairment (Child Pugh B) is 0.3 mg twice a day (see section 5.2). The maximum recommended dose for these patients is 0.6 mg twice a day. Signifor should not be used in patients with severe hepatic impairment (Child Pugh C) (see sections 4.3 and 4.4).

Method of administration

Signifor is to be administered subcutaneously by self injection. Patients should receive instructions from the physician or a healthcare professional on how to inject Signifor subcutaneously.

Use of the same injection site for two consecutive injections is not recommended. Sites showing signs of inflammation or irritation should be avoided. Preferred injection sites for subcutaneous injections are the top of the thighs and the abdomen (excluding the navel or waistline).

For further details on handling, see section 6.6.

Doses up to 2.1 mg twice a day have been used in healthy volunteers, with the adverse reaction diarrhoea being observed at a high frequency.

In the event of overdose, it is recommended that appropriate supportive treatment be initiated, as dictated by the patient’s clinical status, until resolution of the symptoms.

Shelf life: 3 years.

Store in the original package in order to protect from light.

One-point-cut colourless, type I glass ampoule containing 1 ml of solution.

Each ampoule is packed in a cardboard tray which is placed in an outer box.

Packs containing 6 ampoules or multipacks containing 18 (3 × 6), 30 (5 × 6) or 60 (10 × 6) ampoules.

Not all pack sizes may be marketed.

Signifor solution for injection should be free of visible particles, clear and colourless. Do not use Signifor if the solution is not clear or contains particles.

For information on the instructions for use, please see the end of the package leaflet “How to inject Signifor”.

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