Odomzo (sonidegib) is a selective smoothened inhibitor that binds to smoothened receptors and prevents abnormal activation of the Hedgehog pathway, which is associated with uncontrolled cellular growth and proliferation.
Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
This information is based on the European Summary of Product Characteristics. The prescribing information in your country may vary; please consult your local prescribing information and/or contact your local Novartis representative.
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IMPORTANT SAFETY INFORMATION
Important note: please see the locally approved full prescribing information.
Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy. Dosage and administration for adults is one 200 mg dose taken orally once daily on an empty stomach, at the same time each day.
Odomzo is contraindicated in women who are pregnant or breast-feeding.
Creatine phosphokinase (CK) levels should be checked prior to starting treatment and as clinically indicated thereafter, for example, if muscle related symptoms are reported. If clinically notable elevation of CK is detected, renal function should be assessed. Dose modification or interruption guidelines should be followed. Patients should be closely monitored for muscle related symptoms if Odomzo is used in combination with certain medications that may increase the potential risk of developing muscle toxicity. Doctors should closely monitor patients with neuromuscular disorders due to an increased risk of muscle toxicity.
Patients should be instructed not to donate blood while taking Odomzo and for at least 20 months after ending treatment.
Women of childbearing potential must use highly effective contraception while receiving Odomzo. Contraception must be continued for 20 months after ending treatment. Negative pregnancy status must be confirmed by a test performed by a healthcare provider prior to initiation of Odomzo treatment. Odomzo must not be used during pregnancy. Women must not breast feed while taking Odomzo and for at least 20 months after ending treatment.
Men should not father a child or donate semen while taking Odomzo and for at least 6 months after ending treatment. Sexually active males must use a condom, regardless of vasectomy status, during intercourse and for at least 6 months after ending treatment.
Male and female fertility may be compromised with Odomzo. Fertility preservation strategies should be discussed prior to starting treatment with Odomzo.
Odomzo can cause side effects. Very common (>=10%) adverse drug reactions include amenorrhea, decreased appetite, dysgeusia, headache, nausea, diarrhea, vomiting, abdominal pain, alopecia, pruritus, muscle spasms, myalgia, musculoskeletal pain, fatigue, pain, and weight loss. Common (between 1 to 10%) adverse drug reactions include constipation, dyspepsia, gastroesophageal reflux disorder, rash, abnormal hair growth, myopathy (muscular fatigue and muscular weakness), and dehydration.
Very common laboratory abnormalities include decreased hemoglobin, decreased lymphocyte count, increased amylase, increased blood glucose, increased lipase, increased serum creatine phosphokinase, increased serum creatinine, increased alanine amino transaminase (ALT), and increased aspartate amino transaminase (AST).
Concomitant use of strong CYP3A inhibitors and inducers must be avoided. If a strong CYP3A inducer must be used concomitantly with Odomzo, consideration should be given to increasing the dose of Odomzo by 200 mg increments to a maximum daily dose of 800 mg.
Doctors should carefully monitor patients for adverse drug reactions with concomitant use of substrates of CYP2B6 and CYP2C9 enzymes or BCRP transporter, especially those with a narrow therapeutic range.
Due to overlapping toxicities, patients taking Odomzo who are also taking medications known to increase the risk of muscle-related toxicity may be at increased risk of developing muscle-related adverse events. Patients should be closely monitored and dose adjustments should be considered if muscle symptoms develop.