Soolantra 10mg/g cream

What is Soolantra?

Soolantra 10 mg/g cream is a prescription-only medicine applied to the skin of the face. Each gram contains 10 mg of ivermectin (1%), and it is a white to pale yellow hydrophilic cream supplied in a laminated tube with a child-resistant cap; the SmPC lists 2 g, 15 g, 30 g, 45 g and 60 g tubes, although not all pack sizes are marketed. The marketing authorisation holder is Galderma (UK) Limited (PL 10590/0063).

In the UK, Soolantra is licensed for the topical treatment of the inflammatory lesions of rosacea (papulopustular rosacea) in adults, that is, the papules (red bumps) and pustules (pus-filled spots) of the condition. It is for adults aged 18 and over only, and it is not licensed for acne or for any other skin condition.

How does Soolantra work?

Ivermectin belongs to the avermectin class of medicines. The SmPC explains that the way Soolantra works in the inflammatory lesions of rosacea is not known, but that it may be linked to two properties of ivermectin: an anti-inflammatory effect, which has been observed in animal models of skin inflammation, and the killing of Demodex mites, which have been reported to be a factor in the inflammation of the skin in rosacea. Ivermectin kills parasites by binding to glutamate-gated chloride channels found in invertebrate nerve and muscle cells.

Only a small amount of ivermectin is absorbed through the skin. In a study under maximal-use conditions, the systemic exposure at steady state was lower than after a single 6 mg oral dose of ivermectin, and exposure levels reached a plateau by two weeks of treatment with no evidence of accumulation over 12 weeks.

How to use Soolantra

Always use Soolantra exactly as your prescriber has told you, and read the patient information leaflet in your pack.

• Soolantra is for adults and for use on the skin of the face only. Do not use it on other parts of the body, especially not on moist surfaces such as the eyes, mouth or other mucosa, and do not swallow it.
• Apply it once a day. Squeeze a pea-sized amount of cream onto each of the five areas of the face (forehead, chin, nose and each cheek), then spread it as a thin layer across the entire face, avoiding the eyelids, lips and any mucosa such as the inside of the nose and the mouth.
• If cream gets in or near the eyes, eyelids, lips, mouth or mucosa, wash the area immediately with plenty of water.
• Do not apply cosmetics such as other face creams or make-up before the daily application; they can be used once the cream has dried.
• Wash your hands immediately after applying the cream.
• If you forget a dose, do not use a double dose to make up for it.
• The tube has a child-resistant cap: push down and turn anticlockwise to open, and push down and turn clockwise to close. Do not squeeze the tube while opening or closing it.
• Once opened, use the tube within 6 months. No special storage conditions are needed.

Use Soolantra daily over the whole treatment course, and keep using it for as long as your prescriber has advised, as the pimples and spots reduce only after several applications.

How long is Soolantra used for?

The SmPC dose is one application a day for up to 4 months, and the treatment course may be repeated. How long you need to use Soolantra varies from person to person and depends on the severity of the rosacea; your prescriber will tell you how long to use it for. The leaflet says you may notice an improvement after 4 weeks of treatment. If there is no improvement after 3 months, the SmPC and leaflet advise stopping Soolantra and consulting your doctor.

Possible side effects of Soolantra

Like all medicines, Soolantra can cause side effects, although not everybody gets them. The most commonly reported reactions in clinical trials were a burning sensation of the skin, skin irritation, itching and dry skin, each occurring in 1% or fewer of the people treated; they are typically mild to moderate and usually decrease as treatment continues.

• Common (may affect up to 1 in 10 people): skin burning sensation.
• Uncommon (may affect up to 1 in 100 people): skin irritation, itching (pruritus), dry skin, and worsening of rosacea.
• Not known (frequency cannot be estimated): redness of the skin (erythema), contact dermatitis (allergic or irritant), swelling of the face, and raised liver enzymes (transaminases).

At the start of treatment, some people experience a temporary worsening of their rosacea, which usually resolves within one week while treatment continues; the SmPC notes this might be expected as a reaction to the dying Demodex mites. Talk to your doctor if this happens, and stop the treatment if the worsening is severe with a strong skin reaction. Suspected side effects can be reported through the MHRA Yellow Card scheme.

Precautions when using Soolantra

• Soolantra is for adults only: safety and efficacy in children and adolescents under 18 have not been established.
• Liver problems: Soolantra has not been studied in people with liver or kidney impairment, and the SmPC advises caution in severe hepatic impairment. Tell the prescriber if you have liver problems.
• Other medicines: no interaction studies have been performed. Ivermectin is broken down mainly by the liver enzyme CYP3A4, so the SmPC advises caution if it is used alongside potent CYP3A4 inhibitors, as the amount in the blood may be significantly increased. Tell the prescriber about every medicine you use, including those bought without a prescription.
• Pregnancy: there are no or limited data on topical ivermectin in pregnancy, and Soolantra is not recommended during pregnancy.
• Breastfeeding: ivermectin passes into breast milk in low concentrations after oral use, and excretion after topical use has not been evaluated, so a risk to the baby cannot be excluded. A decision is made with the prescriber about whether to stop breastfeeding or not to use Soolantra. Tell the prescriber if you are pregnant, planning a pregnancy or breastfeeding.
• Soolantra has no or negligible influence on the ability to drive or use machines.
• Excipients: the cream contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions such as contact dermatitis, methyl and propyl parahydroxybenzoate (E218 and E216), which may cause allergic reactions (possibly delayed), and propylene glycol, which may cause skin irritation.
• Environment: ivermectin is very toxic to invertebrates and a risk has been identified for water and soil. Do not dispose of unused cream via wastewater or household waste; ask your pharmacist how to dispose of medicines you no longer use.

Who should not use Soolantra

Do not use Soolantra if you are allergic (hypersensitive) to ivermectin or to any of the other ingredients: glycerol, isopropyl palmitate, carbomer, dimeticone, disodium edetate, citric acid monohydrate, cetyl alcohol, stearyl alcohol, macrogol cetostearyl ether, sorbitan stearate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), phenoxyethanol, propylene glycol, oleyl alcohol, sodium hydroxide and purified water.

Soolantra is not for children or adolescents under 18 and is not recommended in pregnancy. If you are breastfeeding, have liver problems, take other medicines or have reacted to a skin product before, tell the prescriber during your consultation so that they can decide whether Soolantra is suitable for you.

Soolantra and other rosacea treatments

Soolantra is one of several prescription treatments licensed for the papules and pustules of rosacea, and a prescriber chooses between them on your diagnosis, the severity and pattern of your rosacea, other medicines you take and how your skin has reacted before:

• Soolantra is the ivermectin option: a cream applied once a day to the face, for adults.
• Rozex is a 0.75% metronidazole gel or cream, applied twice a day.
• Finacea is a 15% azelaic acid gel, applied twice a day.
• Efracea is doxycycline 40 mg modified-release capsules taken by mouth once a day.

The Soolantra SmPC states that it can be used on its own or as part of a combination treatment, and describes a study of Soolantra together with doxycycline 40 mg modified-release capsules in severe rosacea. Whether a combination is appropriate for you is a prescribing decision; do not combine rosacea treatments on your own initiative.

Is Soolantra available on the NHS?

Yes. Soolantra can be prescribed on the NHS by a GP or a dermatologist where they consider it appropriate, and the usual NHS prescription charge or exemption applies. MediHealth Direct supplies Soolantra on a private prescription after an online consultation, so the price shown on this page is the private cost of the medicine, not an NHS charge.

Patient information leaflet

Read the official leaflet before you use Soolantra and keep it for reference: Soolantra 10 mg/g cream patient information leaflet (medicines.org.uk). The prescriber information this page is based on is the Soolantra Summary of Product Characteristics.

Getting Soolantra from MediHealth Direct

Soolantra is a prescription-only medicine, so it can only be supplied against a prescription. To request it, complete an online consultation about your skin and your medical history. A UK-registered prescriber reviews your answers and decides whether Soolantra is appropriate for you; if it is, a private prescription is issued and the medicine is dispensed by our GPhC-registered pharmacy. If a different treatment would suit you better, the prescriber will say so.

FAQs about Soolantra

What is Soolantra used for?

Soolantra 10 mg/g cream is licensed in the UK for the topical treatment of the inflammatory lesions of rosacea, the papules (red bumps) and pustules (spots) of papulopustular rosacea, in adults aged 18 and over. It is applied once a day to the face only. It is not licensed for acne, for the redness of rosacea on its own, or for any other skin condition, and it is not for children or adolescents.

How long does Soolantra take to work?

The patient leaflet says you may notice an improvement after 4 weeks of treatment, and that the pimples and spots reduce only after several applications, so it is important to keep applying the cream daily for as long as your prescriber has advised. The SmPC dose is once a day for up to 4 months, and the course may be repeated. If there is no improvement after 3 months, stop Soolantra and consult your doctor.

Can my rosacea get worse when I start Soolantra?

Yes, temporarily, in some people. The SmPC describes a transient worsening of rosacea at the start of treatment that usually resolves within one week while treatment continues, which might be expected as a reaction to the dying Demodex mites. The leaflet says this is uncommon and advises talking to your doctor if it happens. If the worsening is severe, with a strong skin reaction, the SmPC advises stopping the treatment.

How much Soolantra should I apply?

Apply a pea-sized amount of cream to each of the five areas of the face (forehead, chin, nose and each cheek), then spread it as a thin layer across the entire face, avoiding the eyelids, lips and any mucosa, once a day. Wash your hands immediately afterwards. Do not apply make-up or other face creams before the daily application; they can be used once the cream has dried. If you forget a dose, do not double the next one.

Is Soolantra an antibiotic?

No. Ivermectin, the active ingredient of Soolantra, is an avermectin: an antiparasitic medicine that also has anti-inflammatory effects. The SmPC says the way it works in rosacea is not known but may be linked to its anti-inflammatory effects and to killing Demodex mites, which have been reported to be a factor in the skin inflammation of rosacea. The metronidazole in Rozex and the doxycycline in Efracea are the antibiotic options for rosacea.

Can I use Soolantra during pregnancy or while breastfeeding?

Soolantra is not recommended during pregnancy, as there are no or limited data on topical ivermectin in pregnant women. If you are breastfeeding, the leaflet says you should not use Soolantra, or should stop breastfeeding before starting it, because a risk to the baby cannot be excluded; your doctor can help you decide between the two. Tell the prescriber during your consultation if you are pregnant, planning a pregnancy or breastfeeding.

Can I use Soolantra with other rosacea treatments?

The SmPC states that Soolantra can be used on its own or as part of a combination treatment, and describes a study of Soolantra together with doxycycline 40 mg modified-release capsules in severe rosacea. Whether a combination is appropriate for you is a prescribing decision based on your diagnosis and the other medicines you take, so tell the prescriber about every treatment you use and do not add another rosacea product yourself.

Can I use Soolantra on my body or near my eyes?

No. Soolantra is licensed for use on the skin of the face only. Do not use it on other parts of the body, and especially not on moist surfaces such as the eyes, the mouth or any mucosa, and do not swallow it. Avoid the eyelids and lips when spreading the cream. If it gets in or near the eyes, eyelids, lips, mouth or mucosa, wash the area immediately with plenty of water.