What Is Odomzo?
Odomzo (sonidegib) is a hedgehog pathway inhibitor indicated for the treatment of adult patients with 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.
What Are Side Effects of Odomzo?
Common side effects of Odomzo 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, and
- itching
Dosage for Odomzo
The recommended dose of Odomzo is 200 mg orally once daily taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
What Drugs, Substances, or Supplements Interact with Odomzo?
Odomzo may interact with saquinavir, telithromycin, azole antifungals, nefazodone, atanzavir, diltiazem, carbamazepine, efavirenz, modafinil, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's Wort. Tell your doctor all medications and supplements you use.
Odomzo During Pregnancy or Breastfeeding
Odomzo is not recommended for use during pregnancy. It may harm a fetus. Women should use effective contraception during treatment with Odomzo and for at least 20 months after the last dose. Men should use condoms, even after a vasectomy, to avoid potential drug exposure to pregnant partners and female partners of reproductive potential during treatment with Odomzo and for at least 8 months after the last dose. Breastfeeding is not recommended while using Odomzo and for at least 20 months after the last dose.
Additional Information
Our Odomzo (sonidegib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
Self-examination is important in the detection of skin cancer. See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Sonidegib can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have:
- severe or unexplained muscle pain or weakness (even if this occurs after you have stopped taking sonidegib);
- little or no urinating; or
- dark colored urine.
Common side effects may include:
- stomach pain, nausea, vomiting, diarrhea;
- loss of appetite, weight loss;
- tiredness;
- itchy skin, hair loss; or
- changes in your sense of taste.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Sun-Damaged Skin: Pictures of Sun Spots, Wrinkles, Sunburns See SlideshowSIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Musculoskeletal Adverse Reactions [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of ODOMZO was evaluated in BOLT, a randomized, double-blind, multiple cohort trial in which 229 patients received ODOMZO at either 200 mg (n=79) or 800 mg (n=150) daily. The frequency of common adverse reactions including muscle spasms, alopecia, dysgeusia, fatigue, nausea, decreased weight, decreased appetite, myalgia, pain, and vomiting was greater in patients treated with ODOMZO 800 mg as compared to 200 mg.
The data described below reflect exposure to ODOMZO 200 mg daily in 79 patients with locally advanced BCC (laBCC; n=66) or metastatic BCC (mBCC; n=13) enrolled in Study 1. Patients were followed for at least 18 months unless discontinued earlier. The median duration of treatment with ODOMZO was 11.0 months (range 1.3 to 33.5 months).
The study population characteristics were: median age of 67 years (range 25 to 92; 59% were ≥65 years), 61% male, and 90% white. The majority of patients had prior surgery (75%), radiotherapy (24%), systemic chemotherapy (4%), or topical or photodynamic therapies (18%) for treatment of BCC. No patient had prior exposure to a Hh pathway inhibitor.
ODOMZO was permanently discontinued in 34% of patients or temporarily interrupted in 20% of patients for adverse reactions. Adverse reactions reported in at least two patients that led to discontinuation of the drug were: muscle spasms, and dysgeusia (each 5%), asthenia, increased lipase, and nausea (each 4%), fatigue, decreased appetite, alopecia, and decreased weight (each 3%). Serious adverse reactions occurred in 18% of patients.
The most common adverse reactions occurring in ≥10% of patients treated with ODOMZO 200 mg were muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, and pruritus (Table 1).
The key laboratory abnormalities are described in Table 2.
Table 1: Adverse Reactions Occurring in ≥10% of Patients in BOLT
| Adverse Reaction | ODOMZO 200 mg (N=79) |
|
| All Gradesa % |
Grade 3 % |
|
| Musculoskeletal and connective tissue | ||
| Muscle spasms | 54 | 3 |
| Musculoskeletal pain | 32 | 1 |
| Myalgia | 19 | 0 |
| Skin and subcutaneous tissue | ||
| Alopecia | 53 | 0 |
| Pruritus | 10 | 0 |
| Nervous system | ||
| Dysgeusia | 46 | 0 |
| Headache | 15 | 1 |
| General | ||
| Fatigue | 41 | 4 |
| Pain | 14 | 1 |
| Gastrointestinal | ||
| Nausea | 39 | 1 |
| Diarrhea | 32 | 1 |
| Abdominal pain | 18 | 0 |
| Vomiting | 11 | 1 |
| Investigations | ||
| Decreased weight | 30 | 3 |
| Metabolism and nutrition | ||
| Decreased appetite | 23 | 1 |
| a No Grade 4 adverse reactions were reported. | ||
Table 2: Key Laboratory Abnormalitiesa in BOLT
| Laboratory Test | ODOMZO 200 mg (N=79) |
|
| All Grades % |
Grades 3-4 % |
|
| Chemistry | ||
| Increased serum creatinine | 92b | 0 |
| Increased serum creatine kinase (CK) | 61 | 8 |
| Hyperglycemia | 51 | 4 |
| Increased lipase | 43 | 13 |
| Increased alanine aminotransferase | 19 | 4 |
| Increased aspartate aminotransferase | 19 | 4 |
| Increased amylase | 16 | 1 |
| Hematology | ||
| Anemia | 32 | 0 |
| Lymphopenia | 28 | 3 |
|
a Based on worst post-treatment laboratory value regardless of baseline; grading by CTCAE v4.03. b The serum creatinine level remained within normal range in 76% (60/79) of patients. |
||
Amenorrhea
Amenorrhea lasting for at least 18 months occurred in two of 14 pre-menopausal women treated with ODOMZO 200 mg or 800 mg once daily.
Read the entire FDA prescribing information for Odomzo (Sonidegib Capsules)
© Odomzo Patient Information is supplied by Cerner Multum, Inc. and Odomzo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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