(soe ni DEG ib)
Sonidegib is the generic name for the trade name drug Odomzo®. In some cases, health care professionals may use the trade name Odomzo® when referring to
the generic drug name sonidegib.
Sonidegib is a targeted therapy. It is a hedgehog pathway inhibitor- (For more detail, see "How this drug works," below.)
What Sonidegib Is Used For:
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.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Sonidegib Is Given:
Sonidegib is a capsule, taken by mouth, once daily, taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
Take sonidegib exactly as prescribed.
Swallow sonidegib whole. Do not crush, dissolve or open capsules.
Do not change your dose or stop sonidegib unless your health care provider tells you to.
If you miss a dose, do not make up; resume dosing with the next scheduled dose.
Do not take more than 1 dose of sonidegib at one time. Call your health care provider right away if you take too much.
The amount of sonidegib that you will receive depends on many factors, your general health or other health problems, and the type of cancer or
condition being treated. Your doctor will determine your dose and schedule.
Important things to remember about the side effects of sonidegib:
Most people do not experience all of the side effects listed.
Some side effects are predictable in terms of their onset and duration.
There are many options to help minimize or prevent side effects.
There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
The following side effects are common (occurring in greater than 30%) for patients taking
These side effects are less common side effects (occurring in about 10-29%) of patients receiving
[US Boxed Warning]: Sonidegib can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Sonidegib is embryotoxic,
fetotoxic, and teratogenic in animals. Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of
reproductive potential to use effective contraception during treatment with sonidegib and for at least 20 months after the last dose. Advise males of the
potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with
sonidegib and for at least 8 months after the last dose. It is not known if sonidegib is present in semen. Males with female partners of reproductive
potential should use condoms even following a vasectomy. Advise male patients not to donate sperm during sonidegib treatment and for at least 8 months
after the last sonidegib dose.
Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always
inform your health care provider if you experience any unusual symptoms.
When to contact your doctor or health care provider:
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
Fever of 100.4° F (38°C or higher, chills)
Any medication can cause an allergic reaction. Signs of an allergic reaction include: wheezing; chest tightness; fever; seizures; or swelling of the
face, lips, tongue or throat.
Always inform your health care provider if you experience any unusual symptoms.
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of
Less severe allergy can also be associated with itching or cough.
Diarrhea (4-6 episodes in a 24-hour period).
Nausea (interferes with ability to eat and unrelieved with prescribed medication).
Vomiting (vomiting more than 4-5 times in a 24 hour period).
Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness.
Always inform your health care provider if you experience any unusual symptoms.
Before starting sonidegib treatment, make sure you tell your doctor about any other medications you are taking (including prescription,
over-the-counter, vitamins, herbal remedies, etc.).
Do not receive any kind of immunization or vaccination without your doctor's approval while taking sonidegib.
The use of sonidegib during pregnancy may cause birth defects or death of the unborn baby.
Females will need to have a pregnancy test to show that they are NOT pregnant before starting this drug.
Effective contraception is required for females during treatment and for at least 20 months after completion of treatment.
Male patients need to use condoms with a female partner during treatment with sonidegib and for at least 8 months after the last dose, even following a
Male patients should not donate sperm during sonidegib treatment and for at least 8 months after the last dose.
Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
Do not breast feed while taking sonidegib and for 20 months after the last dose of sonidegib.
Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
If you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and
chewing gum may also help.
Avoid sun exposure. Wear SPF 30 (or higher) sun block and protective clothing.
In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
Get plenty of rest.
Maintain good nutrition.
If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other
suggestions that are effective in managing such problems.
Monitoring and Testing:
If you are female, you will be checked for pregnancy before taking sonidegib. You will be checked regularly by your health care professional while you are
taking sonidegib, to monitor side effects and check your response to therapy
How Sonidegib Works:
Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date,
cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately,
some of our normal cells divide rapidly too, causing multiple side effects.
Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells.
This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects.
Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or
communicate with other cells.
There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function
of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There
are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the
cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to
the cells, ultimately causing the cells to starve.
Basal cell cancer is associated with mutations in the “Hedgehog” pathway. Hedgehog controls cell growth in embryos, while generally it is not active in
adult tissue cells. Hedgehog mutations associated with basal cell cancer can activate the pathway resulting in uncontrolled growth of skin basal cells.
Sonidegib works by interfering with the proteins involved in activating the Hedgehog signal.
Research continues to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.
We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in
this website is meant to be helpful and educational, but is not a substitute for medical advice.