Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800, Puteaux, France
Treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.
Treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed.
The 60 mg strength is only to be used in the treatment of acromegaly.
The recommended initial dose for the treatment of acromegaly is 40 mg of pasireotide every 4 weeks.
The dose may be increased to a maximum of 60 mg for patients whose growth hormone (GH) and/or insulin-like growth factor-1 (IGF-1) levels are not fully controlled after 3 months of treatment with Signifor at 40 mg.
Management of suspected adverse reactions or over-response to treatment (IGF-1 < lower limit of normal) may require temporary dose reduction of Signifor. The dose may be decreased either temporarily or permanently.
The recommended initial dose for the treatment of Cushing’s disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks. The patient should be evaluated for clinical benefit after the first month of treatment and periodically thereafter. The dose may be titrated every 2 to 4 months based on response and tolerability. The maximum dose of Signifor in Cushing’s disease is 40 mg every 4 weeks. If no clinical benefit is observed, the patient should be considered for discontinuation.
Management of suspected adverse reactions or over-response to treatment (cortisol levels < lower limit of normal) may require dose reduction, interruption or discontinuation of Signifor.
There are no clinical data available on switching from the subcutaneous to the intramuscular pasireotide formulation. If such a switch should be required, the recommended initial dose for the treatment of Cushing’s disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks. The patient should be monitored for response and tolerability and further dose adjustments may be needed.
If a dose of Signifor is missed the missed injection should be administered as soon as possible. The next dose should then be planned for 4 weeks after the injection is administered in order to resume the normal schedule of one dose every 4 weeks.
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).
No dose adjustment is required in patients with impaired renal function (see section 5.2).
Dose adjustment is not required in patients with mildly impaired hepatic function (Child Pugh A).
Acromegaly: the recommended initial dose for acromegaly patients with moderate hepatic impairment (Child Pugh B) is 20 mg every 4 weeks, and the maximum recommended dose for these patients is 40 mg every 4 weeks (see section 5.2).
Cushings disease: the recommended initial dose for Cushing’s disease patients with moderate hepatic impairment (Child Pugh B) is 10 mg every 4 weeks, and the maximum recommended dose for these patients is 20 mg every 4 weeks (see section 5.2).
Signifor should not be used in patients with severe hepatic impairment (Child Pugh C) (see sections 4.3 and 4.4).
The safety and efficacy of Signifor in children and adolescents aged 0 to 18 years have not been established. No data are available.
Signifor is to be administered by deep intramuscular injection by a trained healthcare professional. Signifor suspension must only be prepared immediately before administration.
The site of repeat intramuscular injections should be alternated between the left and right gluteal muscle.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
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.
3 years.
Store in a refrigerator (2°C–8°C). Do not freeze.
Powder: brownish vial (glass) with rubber stopper (chlorobutyl rubber), containing the active substance (pasireotide).
Solvent: colourless pre-filled syringe (glass) with front and plunger stopper (chlorobutyl rubber), containing 2 ml solvent. Unit packs (all strengths): each unit pack contains a blister tray with one injection kit (one vial and, in a separate sealed section, one pre-filled syringe, one vial adapter and one safety-engineered needle for injection).
Multipacks (40 mg and 60 mg strengths only): each multipack contains 3 intermediate cartons, each containing a blister tray with one injection kit (one vial and, in a separate sealed section, one pre-filled syringe, one vial adapter and one safety engineered needle for injection).
Not all pack sizes or strengths may be marketed.
There are two critical steps in the reconstitution of Signifor. Not following them could result in failure to deliver the injection appropriately.
Included in the injection kit:
a. One vial containing the powder
b. One pre-filled syringe containing the solvent
c. One vial adapter for medicinal product reconstitution
d. One safety injection needle (20G x 1.5′′)
Follow the instructions below carefully to ensure proper reconstitution of Signifor powder and solvent for suspension for injection before deep intramuscular injection.
Signifor suspension must only be prepared immediately before administration.
Signifor should only be administered by a trained healthcare professional.
To prepare Signifor for deep intramuscular injection, please adhere to the following instructions:
An audible “click” confirms proper activation. Dispose of syringe immediately in a sharps container.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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