WARNING

Odomzo (sonidegib) has potential risks and side effects associated with its use. Here is a brief overview of some of the risks:

• Muscle spasms and pain: Odomzo can cause muscle spasms, pain, and weakness. This may affect various muscle groups in the body, including the arms, legs, back, and abdomen.
• Hair loss: Hair loss, also known as alopecia, is a common side effect of Odomzo treatment. This can affect the hair on the scalp as well as other body hair.
• Changes in taste sensation: Some people may experience changes in taste, including a metallic or bitter taste in the mouth while taking Odomzo.
• Nausea and vomiting: Odomzo can cause nausea and vomiting. It is important to report these symptoms to your healthcare provider as they can provide medications or recommendations to help manage these side effects.
• Fatigue: Fatigue, or excessive tiredness, is another potential side effect of Odomzo. It is important to get enough rest and conserve energy while undergoing treatment.
• Rhabdomyolysis: In rare cases, Odomzo has been associated with a condition called rhabdomyolysis, which is the breakdown of muscle tissue that can lead to kidney damage. Seek medical attention immediately if you experience severe muscle pain, weakness, or dark urine.
• Birth defects: Odomzo has the potential to harm an unborn baby. Pregnant women should avoid Odomzo, and both men and women of reproductive age should use effective contraception during treatment and for a certain period afterward.

It is important to note that this is not an exhaustive list of risks and side effects associated with Odomzo. Each person may react differently to the medication, and it is crucial to discuss any concerns or potential risks with a healthcare professional before starting treatment. They can provide personalized information and guidance based on your specific medical history and circumstances.

Why is this medication prescribed?

Odomzo (generic name sonidegib) is a prescription medication used for the treatment of a type of skin cancer called basal cell carcinoma (BCC). BCC is the most common type of skin cancer, and it typically develops in the basal cells, which are located in the lower part of the epidermis (the outermost layer of the skin).

Odomzo belongs to a class of drugs known as hedgehog pathway inhibitors. It works by blocking a protein called smoothened, which is part of the hedgehog signaling pathway. This pathway plays a role in the growth and development of cells, and when it is overactive, it can contribute to the development of certain cancers, including basal cell carcinoma.

Odomzo is generally prescribed for adults with locally advanced BCC, which means the cancer has spread to nearby tissues or structures but has not metastasized (spread to distant parts of the body). It may be used when surgery or radiation therapy is not appropriate or when the cancer cannot be completely removed with these treatments alone.

How should this medicine be used?

The usage instructions for Odomzo (sonidegib) can vary depending on the specific instructions provided by your healthcare professional. It is important to carefully follow their guidance and the instructions on the prescription label. Here is a general overview of how Odomzo is typically used:

• Dosage: Odomzo is usually available as capsules with specific strengths. The recommended dosage can vary based on factors such as the individual’s condition and medical history. Your healthcare provider will determine the appropriate dosage for you.
• Timing: Odomzo is usually taken once a day, preferably at the same time each day. It can be taken with or without food. Follow the specific instructions provided by your healthcare professional.
• Swallowing: Take Odomzo capsules whole with a glass of water. Do not crush, chew, or open the capsules.
• Duration of treatment: The duration of Odomzo treatment can vary depending on the individual’s response to the medication and the specific condition being treated. Your healthcare provider will advise you on how long you should continue taking Odomzo.
• Other medications: Inform your healthcare professional about all the medications, supplements, and herbal products you are taking, as they may interact with Odomzo. They will provide guidance on any necessary adjustments or precautions.
• Pregnancy and contraception: Odomzo can cause harm to an unborn baby. If you are pregnant, planning to become pregnant, or of reproductive age, it is crucial to discuss effective contraception methods with your healthcare provider before starting Odomzo. Reliable contraception should be used during treatment and for a certain period afterward, as recommended by your healthcare provider.
• Follow-up appointments: Your healthcare provider will monitor your progress during Odomzo treatment. It is important to attend scheduled follow-up appointments and inform them of any side effects or concerns you may have.

Remember that these instructions are a general overview, and individual circumstances may vary. Always follow the specific instructions provided by your healthcare professional and consult them for any questions or clarifications regarding the use of Odomzo.

Other uses for this medicine

Odomzo (sonidegib) is primarily used for the treatment of locally advanced basal cell carcinoma (BCC) that cannot be treated with surgery or radiation therapy. It is specifically indicated for this purpose and approved by regulatory authorities for this use.

What special precautions should I follow?

Regarding special precautions for Odomzo, here are some important considerations:

• Pregnancy and breastfeeding: Odomzo can cause harm to an unborn baby, so it is important to avoid pregnancy during treatment and for a certain period afterward. It is also not recommended to breastfeed while taking Odomzo, as it may pass into breast milk and harm the nursing infant.
• Contraception: Effective contraception should be used by both men and women of reproductive age during Odomzo treatment and for a certain period afterward, as recommended by your healthcare provider.
• Muscle-related side effects: Odomzo may cause muscle spasms, pain, and weakness. If you experience severe muscle pain or weakness, it is important to seek medical attention immediately, as this could be a sign of a serious condition called rhabdomyolysis, which involves muscle breakdown and can lead to kidney damage.
• Pre-existing liver disease: Odomzo may have an impact on liver function. Inform your healthcare provider if you have a history of liver disease, as special precautions or monitoring may be necessary.
• Other medications: Inform your healthcare provider about all the medications, supplements, and herbal products you are taking, as some drugs may interact with Odomzo. This includes over-the-counter medications. Your healthcare provider will determine if any adjustments or precautions are necessary.
• Side effects: Odomzo can cause various side effects, including hair loss, changes in taste, nausea, vomiting, fatigue, and others. It is important to report any side effects to your healthcare provider, as they can provide guidance and support to manage them effectively.

It is crucial to note that this information is not exhaustive, and there may be additional precautions and considerations for Odomzo that are specific to individual cases. Always consult with your healthcare provider for personalized advice and guidance regarding the use of Odomzo and any specific precautions you should take.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with taking Odomzo (sonidegib). However, it is always a good idea to maintain a healthy and balanced diet during your treatment. A nutritious diet can help support your overall well-being and provide the necessary nutrients your body needs.

What should I do if I forget a dose?

If you forget to take a dose of Odomzo, it is recommended to take it as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, it is best to skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are unsure about what to do, it is always best to consult your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Odomzo (sonidegib) can cause various side effects. Here is a list of potential side effects associated with Odomzo use:

• Muscle spasms, pain, and weakness: Odomzo can lead to muscle-related side effects, including muscle spasms, pain, and weakness. These symptoms may affect different muscle groups in the body.
• Hair loss: Odomzo treatment can cause hair loss, known as alopecia. This can affect the hair on the scalp as well as other body hair.
• Changes in taste sensation: Some individuals may experience changes in taste, such as a metallic or bitter taste in the mouth while taking Odomzo.
• Nausea and vomiting: Odomzo can cause nausea and vomiting. If these symptoms are severe or persistent, it is important to inform your healthcare provider.
• Fatigue: Fatigue, or excessive tiredness, is a potential side effect of Odomzo treatment. It is important to get enough rest and conserve energy during treatment.
• Diarrhea: Odomzo may cause diarrhea. It is important to stay hydrated and notify your healthcare provider if you experience severe or persistent diarrhea.
• Decreased appetite: Some individuals may experience a decrease in appetite while taking Odomzo.
• Weight loss: Weight loss can occur as a side effect of Odomzo treatment.
• Decreased fertility: Odomzo may affect fertility in both males and females. It is important to discuss fertility preservation options with your healthcare provider before starting treatment if fertility is a concern.
• Other common side effects: Other common side effects of Odomzo can include headache, back pain, joint pain, skin reactions, dry skin, and constipation.

It is important to note that this is not an exhaustive list of side effects, and individual experiences may vary. Some individuals may experience no side effects or only mild ones, while others may experience more severe or rare side effects. It is essential to promptly report any side effects to your healthcare provider, as they can provide guidance, support, and potential strategies to manage them effectively.

What should I know about storage and disposal of this medication?

• Storage: Odomzo should be stored at room temperature, away from excessive heat, moisture, and light. Follow the specific storage instructions on the medication label.
• Keep out of reach of children and pets: Ensure that Odomzo is stored in a secure place, out of the reach of children and pets, to prevent accidental ingestion.
• Do not use expired medication: Check the expiration date on the Odomzo packaging and do not use it if it has expired. Properly dispose of expired or unused medication.
• Disposal: Dispose of Odomzo capsules in accordance with local regulations and guidelines. Do not throw them in the regular trash or flush them down the toilet unless specifically instructed to do so. Contact your local pharmacy or healthcare provider for information on safe disposal methods or take-back programs in your area.

In case of emergency/overdose

In case of an emergency or overdose, it is important to seek immediate medical attention. Contact your local emergency services or call your local poison control center for assistance. Provide them with as much information as possible, including the medication name (Odomzo), the strength, the dosage you have taken, and any symptoms or concerns you may have.

What other information should I know?

It is also important to inform healthcare professionals about all the medications, supplements, and herbal products you are taking, as well as any medical conditions or allergies you may have before starting Odomzo. This information will help them make informed decisions about your treatment and monitor your progress effectively.

Additionally, be sure to follow all the instructions provided by your healthcare provider, including attending scheduled follow-up appointments and reporting any side effects or concerns you may experience during Odomzo treatment.

As always, it is recommended to consult your healthcare provider or pharmacist for specific information and guidance related to storage, disposal, emergencies, or any other concerns you may have regarding Odomzo.