Sonidegib
Skin Neoplasms
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Drug Status
Government Approvals
US(FDA)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
Hedgehog Pathway Inhibitor
Controlled Drug Substance
No
Sonidegib
Summary
Sonidegib is used to treat adults with locally advanced basal cell carcinoma (BCC). This is a type of skin cancer that has recurred after surgery or radiation, or in patients who cannot undergo these treatments.
Sonidegib works by inhibiting a pathway in the body known as the hedgehog pathway. This pathway is crucial for the growth and division of cancer cells. By blocking it, Sonidegib can slow down or stop the proliferation of these cells, reducing tumor size and preventing further spread.
The usual daily dose of Sonidegib for adults is 200 mg. It is taken orally once a day on an empty stomach, at least 1 hour before or 2 hours after a meal.
Common side effects of Sonidegib include muscle spasms, hair loss, altered taste, fatigue, nausea, and decreased appetite. Serious adverse effects can include musculoskeletal reactions and a condition called rhabdomyolysis, which involves damage to the muscles.
Sonidegib is not recommended for use in children or pregnant women due to potential adverse effects on growth and development, and risk of severe birth defects or fetal death. Both men and women must use effective contraception during treatment and for a specified period after the last dose. Patients should not donate blood or semen during treatment and for a period after.
Indications and Purpose
How does Sonidegib work?
Sonidegib works by inhibiting the hedgehog signaling pathway, which is crucial for the growth and division of cancer cells. By blocking this pathway, Sonidegib helps to slow down or stop the proliferation of cancer cells, thereby reducing tumor size and preventing further spread.
Is Sonidegib effective?
Sonidegib has been shown to be effective in treating locally advanced basal cell carcinoma (BCC) that has recurred after surgery or radiation, or in patients who are not candidates for these treatments. Clinical trials have demonstrated a significant objective response rate, with many patients experiencing partial or complete tumor shrinkage.
What is Sonidegib?
Sonidegib is used to treat adults with locally advanced basal cell carcinoma that has recurred after surgery or radiation, or in patients who cannot undergo these treatments. It works by inhibiting the hedgehog pathway, which is involved in the growth and spread of cancer cells, thereby slowing or stopping tumor growth.
Directions for Use
For how long do I take Sonidegib?
Sonidegib is typically used until disease progression or unacceptable toxicity occurs. The exact duration of use can vary based on individual patient response and tolerance to the medication.
How do I take Sonidegib?
Sonidegib should be taken once daily on an empty stomach, at least 1 hour before or 2 hours after a meal. Patients should avoid consuming grapefruit or grapefruit juice while taking this medication, as it can affect the drug's metabolism and efficacy.
How should I store Sonidegib?
Sonidegib should be stored at room temperature, between 68°F to 77°F (20°C to 25°C), in its original container, tightly closed, and out of reach of children. It should be kept away from excess heat and moisture, and not stored in the bathroom. Unused medication should be disposed of through a take-back program.
What is the usual dose of Sonidegib?
The usual daily dose of Sonidegib for adults is 200 mg taken orally once a day on an empty stomach, at least 1 hour before or 2 hours after a meal. Sonidegib is not recommended for use in children due to potential adverse effects on growth and development.
Warnings and Precautions
Can I take Sonidegib with other prescription drugs?
Sonidegib can interact with strong and moderate CYP3A inhibitors and inducers, which can affect its metabolism and efficacy. Patients should avoid using these medications concurrently with Sonidegib. It is important to inform your healthcare provider of all medications you are taking to avoid potential interactions.
Can Sonidegib be taken safely while breastfeeding?
Women are advised not to breastfeed during treatment with Sonidegib and for 20 months after the last dose due to the potential for serious adverse reactions in breastfed infants. It is important to discuss alternative feeding options with a healthcare provider.
Can Sonidegib be taken safely while pregnant?
Sonidegib is contraindicated during pregnancy due to the risk of severe birth defects or fetal death. Women of reproductive potential must have a negative pregnancy test before starting treatment and use effective contraception during treatment and for at least 20 months after the last dose. There is strong evidence from animal studies showing embryotoxicity and teratogenicity.
Is it safe to exercise while taking Sonidegib?
Sonidegib may cause muscle spasms and pain, which could potentially limit the ability to exercise. If you experience these symptoms, it is important to discuss them with your healthcare provider to determine the best course of action.
Is Sonidegib safe for the elderly?
Elderly patients (65 years and older) may experience a higher incidence of serious adverse reactions and may require dose adjustments or closer monitoring. It is important for elderly patients to discuss their overall health and any other medications they are taking with their healthcare provider before starting Sonidegib.
Who should avoid taking Sonidegib?
Sonidegib can cause severe birth defects or fetal death, so it is contraindicated in pregnant women. Both men and women must use effective contraception during treatment and for a specified period after the last dose. Patients should not donate blood or semen during treatment and for a period after. Musculoskeletal adverse reactions are common, and patients should report any unexplained muscle pain or weakness.
