Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Skin monitoring

Setmelanotide may lead to generalised increased skin pigmentation and darkening of pre-existing nevi because of its pharmacologic effect (see sections 4.8 and 5.1). Full body skin examinations should be conducted annually to monitor pre-existing and new skin pigmentary lesions before and during treatment with setmelanotide.

Heart rate and blood pressure monitoring

Heart rate and blood pressure should be monitored as part of standard clinical practice at each medical visit (at least every 6 months) for patients treated with setmelanotide.

Prolonged penile erection

Spontaneous penile erections have been reported in clinical trials with setmelanotide (see section 4.8).
Patients who have a penile erection lasting longer than 4 hours should be instructed to seek emergency medical attention for potential treatment of priapism.

Depression

In clinical trials, depression has been reported in patients treated with setmelanotide (see section 4.8).
Patients with depression should be monitored at each medical visit during treatment with IMCIVREE.
Consideration should be given to discontinuing IMCIVREE if patients experience suicidal thoughts or behaviours.

Paediatric population

The prescribing physician should periodically assess response to setmelanotide therapy. In growing children, the impact of weight loss on growth and maturation should be evaluated. The prescribing physician should monitor growth (height and weight) using age- and sex-appropriate growth curves.

Excipients

Benzyl alcohol
This medicinal product contains 10 mg benzyl alcohol in each ml. Benzyl alcohol may cause allergic reactions.

IMCIVREE-SPC-0124-V1
Patients who are pregnant or breastfeeding should be advised of the potential risk from the excipient benzyl alcohol, which might accumulate over time and cause metabolic acidosis. This medicinal product should be used with caution in patients with hepatic or renal impairment, because of the potential risk from the excipient benzyl alcohol which might accumulate over time and cause metabolic acidosis (see also section 4.2).

Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free.”

Effects on Driving

4.7   Effects on ability to drive and use machines

IMCIVREE has no or negligible influence on the ability to drive and use machines.