sonidegib (Rx)

Brand and Other Names:Odomzo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 200mg

Basal Cell Carcinoma

Indicated for adults 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

200 mg PO qDay

Continue treatment until disease progression or unacceptable toxicity

Dosage Modifications

Renal impairment: No dose adjustment required

Hepatic impairment

  • Mild-to-severe (Child-Pugh class A to C): No dosage adjustment required

Interrupt treatment

  • Severe or intolerable musculoskeletal adverse reactions
  • First occurrence of serum CK elevation between 2.5 and 10x ULN
  • Recurrent serum CK elevation between 2.5 and 5x ULN
  • Resume dose at 200 mg qDay upon resolution of clinical signs and symptoms

Permanently discontinue

  • Serum CK elevation >2.5x ULN with worsening renal function
  • Serum CK elevation >10x ULN
  • Recurrent serum CK elevation >5x ULN
  • Recurrent severe or intolerable musculoskeletal adverse reactions

Dosing Considerations

Before initiation

  • Verify the pregnancy status of females of reproductive potential
  • Obtain serum CK levels and renal function tests

Safety and efficacy not established

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Interactions

Interaction Checker

and sonidegib

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            All grades of severity listed unless otherwise indicated

            >10% (All Grades)

            Increased serum creatinine (92%)

            Increased serum creatine kinase (61%)

            Muscle spasms (54%)

            Alopecia (53%)

            Hyperglycemia (51%)

            Dysgeusia (46%)

            Increased lipase (43%)

            Fatigue (41%)

            Nausea (39%)

            Diarrhea (32%)

            Anemia (32%)

            Musculoskeletal pain (32%)

            Decreased weight (30%)

            Lymphopenia (28%)

            Decreased appetite (23%)

            Myalgia (19%)

            Increased ALT or AST (19%)

            Abdominal pain (18%)

            Increased amylase (16%)

            Headache (15%)

            Pain (14%)

            Vomiting (11%)

            >10% (Grade 3-4)

            Increased lipase (13%)

            1-10% (All Grades)

            Pruritus (10%)

            1-10% (Grade 3)

            Increased serum creatine kinase (8%)

            Hyperglycemia (4%)

            Increased ALT/AST (4%)

            Muscle spasms (3%)

            Decreased weight (3%)

            Lymphopenia (3%)

            Decreased appetite (1%)

            Musculoskeletal pain (1%)

            Nausea (1%)

            Diarrhea (1%)

            Vomiting (1%)

            Increased amylase (1%)

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            Warnings

            Black Box Warnings

            Based on sonidegib’s mechanism of action, can cause embryo-fetal death or severe birth defects when administered to a pregnant woman

            Sonidegib is embryotoxic, fetotoxic, and teratogenic in animals

            Verify pregnancy status of females of reproductive potential prior to initiating; advise females of reproductive potential to use effective contraception during treatment and for at least 20 months after the last dose

            Advise male patients to use condoms, even after a vasectomy, to avoid potential drug exposure to pregnant partners and female partners of reproductive potential during treatment and for at least 8 months after the last dose

            Contraindications

            None

            Cautions

            Can cause embryo-fetal death or severe birth defects when administered to a pregnant woman (see Black Box Warnings and Pregnancy sections)

            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 a female 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 of 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

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            Pregnancy & Lactation

            Pregnancy

            Based on sonidegib’s 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 pregnancy status of females of reproductive potential prior to initiating

            Advise females 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 male patients to use condoms, even after a vasectomy, to avoid potential drug exposure to pregnant partners and female partners of reproductive potential during treatment and for at least 8 months after the last dose
            • Do not donate semen for at least 8 month 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

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Hedgehog (Hh) pathway inhibitor; the Hh signaling pathway is important in embryogenesis, but in adults, it is mostly inactive; signaling is relayed by key proteins, including smoothened (SMO)

            Hh ligand-expressing cancerous epithelial cells that are activated by the Hh signaling pathway may cause growth promotion; sonidegib binds to and inhibits SMO, a transmembrane protein involved in Hedgehog signal transduction

            Absorption

            <10% of oral dose is absorbed

            Peak plasma time: 2-4 hr (fasting)

            Peak plasma concentration: 1030 ng/mL

            Minimum plasma concentration: 890 ng/mL

            AUC: 22 mcg·h/mL

            Distribution

            Protein bound: >97%

            Vd (Vss/F): 9,166 L

            Metabolism

            Primarily metabolized by CYP3A

            The main circulating compound was unchanged sonidegib (36% of circulating radioactivity)

            Elimination

            Half-life: 28 days

            Excretion: 70% feces; 30% urine

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            Administration

            Instructions

            Swallow capsule on an empty stomach, at least 1 hr before or 2 hr after a meal

            If a dose is missed, resume dosing with the next scheduled dose

            Storage

            Store at controlled room temperature (25°C [77°F]); excursions permitted to 15-30°C (59-86°F)

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.