Sonidegib

Sonidegib is a prescription medication used for the treatment of locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

• Sonidegib is available under the following different brand names: Odomzo

Common side effects of Sonidegib include:

• muscle spasms
• hair loss
• changes in the sense of taste
• fatigue
• nausea
• musculoskeletal pain
• diarrhea
• weight loss
• decreased appetite
• muscle pain
• abdominal pain
• headache
• vomiting
• itching

Serious side effects of Sonidegib include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• severe or unexplained muscle pain or weakness (even if this occurs after you have stopped taking the medication)
• little or no urination
• dark-colored urine

Rare side effects of Sonidegib include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to the FDA at 1-800-FDA-1088.

Adult dosage

Capsule

1. 200 mg

Basal cell carcinoma

Adult dosage

• 200 mg orally once a day
• Continue treatment until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sonidegib has severe interactions with no other drugs
• Sonidegib has serious interactions with at least 61 other drugs
• Sonidegib has moderate interactions with at least 40 other drugs
• Sonidegib has minor interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • cyclophosphamide
  • larotrectinib

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sonidegib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sonidegib?”

Cautions

• Can cause embryo-fetal death or severe birth defects when administered to a pregnant woman
• Advise patients not to donate blood or blood products while taking sonidegib and for at least 20 months after the last dose because their blood or blood products might be given to women of reproductive potential
• Musculoskeletal adverse reactions, which may be accompanied by serum creatine kinase elevations, occur with Hedgehog (Hh) pathway inhibitors
• Premature fusion of the epiphyses has been reported in pediatric patients exposed to sonidegib and other Hh pathway inhibitors; cases of progressive epiphyseal fusion reported in pediatric patients receiving other Hh pathway inhibitors; not indicated for use in pediatric patients
• Avoid coadministration with moderate/strong CYP3A inhibitors or inducers

Pregnancy and Lactation

• Based on the Sonidegib mechanism of action, can cause fetal harm when administered to a pregnant woman
• There are no available data on the use in pregnant women
• In animal reproduction studies, oral administration of sonidegib during organogenesis at doses below the recommended human dose of 200 mg resulted in embryotoxicity, fetotoxicity, and teratogenicity in rabbits (teratogenic effects observed included severe midline defects, missing digits, and other irreversible malformations)
• Verify the pregnancy status of women of reproductive potential before initiating
• Advise women of reproductive potential to use effective contraception during treatment and for at least 20 months after the last dose
• Do not donate blood for at least 20 months after the last dose
• Males
  • Unknown if sonidegib is present in semen
  • Advise men  to use condoms, even after a vasectomy, to avoid potential drug exposure to pregnant partners and women partners of reproductive potential during treatment and for at least 8 months after the last dose
  • Do not donate semen for at least 8 months or blood for at least 20 months
• Lactation
  • Unknown if distributed in human breast milk
  • Because of the potential for serious adverse reactions in breastfed infants from sonidegib, advise a nursing woman not to breastfeed during treatment and for 20 months after the last dose