Rapalimus gel 0.2% for skin lesions in tuberous sclerosis (sirolimus, rapamycin)

General information on Japanese Rapalimus gel 0.2% for skin lesions in tuberous sclerosis (sirolimus, rapamycin)

Package details: 1 tube * 10 g

Manufacturer: Nobelpharma Co., Ltd., Japan

Active ingredients: sirolimus (chemical formula C51H79NO13)

Medical effect: Rapalimus gel is effective for the treatment of skin erosions associated with tuberous sclerosis complex.

Contraindications and precautions: do not use for pregnant or breastfeeding women.

Do not use on mucous membrane. When applying around eyes, take care not to get the medicine into your eyes. Do not apply on the injured areas.

If the area of application is exposed to sunlight or ultraviolet rays, allergy-like symptoms may occur. Patient should take measures such as applying sunscreen on and around the application area.

After opening, store in a refrigerator at 2-8 degrees Celsius. Do not freeze.

If an allergic reaction occurs, stop using the medicine and consult with your doctor. If you’re taking any other medication or receiving any other treatment, you have to consult with your doctor before use.

Dosage and administration

Apply an appropriate amount to the affected area 2 times a day. In general, the maximum single dose is 0.2 g (approx. 0.5 cm) for 5 years old or younger, 0.3 g (approx. 0.75 cm) for 6 to 11 years old, and 0.4 g (approx. 1 cm) for 12 years old or older.

How effective are Rapalimus gel 0.2% from Japan for skin lesions in tuberous sclerosis (sirolimus, rapamycin)?

Rapalimus gel contains sirolimus, also called rapamycin, a macrolide compound produced the bacterium Streptomyces hygroscopicus. It works by inhibiting a protein kinase called mTOR (mechanistic target of rapamycin) which is activated in patients with tuberous sclerosis complex. As the result, Rapalimus gel suppresses excessive cell proliferation and improves the skin lesions.

Who should use Rapalimus gel 0.2% from Japan?

Rapalimus gel is effective for the treatment of skin lesions associated with tuberous sclerosis complex. Studies of Japanese scientists showed that topical gel with sirolimus is safe and well-tolerated even in long-term (from 52 to 136 weeks) use (M. Wataya-Kaneda, H. Nagai et al. “Safety and Efficacy of the Sirolimus Gel for TSC Patients With Facial Skin Lesions in a Long-Term, Open-Label, Extension, Uncontrolled Clinical Trial”. Dermatology and Therapy, 2020, 10(4): 635–650).