SOOLANTRA Cream Ref.[8175] Active ingredients: Ivermectin

Patients may experience transient aggravation of rosacea, which usually resolves within 1 week under continuation of the treatment as might be expected due to a reaction to the dying Demodex mites.

In case of severe worsening with a strong dermal reaction, the treatment should be discontinued.

Soolantra has not been studied in patients with renal or hepatic impairment.

The medicinal product contains:

• cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis),
• methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed),
• and propylene glycol which may cause skin irritation.

No interaction studies have been performed (see section 5.2 for Biotransformation).

In vitro studies have shown that ivermectin is primarily metabolised by CYP3A4. Consequently, caution is advised when ivermectin is administered concomitantly with potent CYP3A4 inhibitors as the plasma exposure may be significantly increased.

Pregnancy

There are no or a limited amount of data from the topical use of ivermectin in pregnant women. Oral reproductive toxicity studies have shown that ivermectin is teratogenic in rats and rabbits (see section 5.3), however due to the low systemic exposure following topical administration of the product at the proposed posology, there is a low safety concern for a human foetus. Soolantra is not recommended during pregnancy.

Breast-feeding

Following oral administration, ivermectin is excreted in human milk in low concentrations. Excretion in human milk following topical administration has not been evaluated. Available pharmacokinetic/toxicological data in animals have also shown excretion of ivermectin in milk. A risk to a suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Soolantra therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

No human data on the effect of ivermectin on fertility are available. In rats, there was no effect on mating or fertility with ivermectin treatment.

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

Summary of the safety profile

The most commonly reported adverse reactions are skin burning sensation, skin irritation, pruritus and dry skin, all occurring in 1% or less of patients treated with the medicinal product in clinical trials.

They are typically mild to moderate in severity, and usually decrease when treatment is continued.

No meaningful differences in the safety profile were observed between subjects 18 to 65 years and subjects ≥65 years of age.

Tabulated list of adverse reactions

The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data) and were reported with Soolantra in clinical studies (see Table 1).

Table 1. Adverse reactions:

^* Adverse reaction reported from post-marketing data.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.

Not applicable.