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  • Odomzo 200 mg
    / Taro


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    30 X 200 mg

    partial basket chart 64576

    Related information


    Dosage

    The recommended dose is 200 mg sonidegib taken orally once daily at least two hours after a meal and at least one hour before the following meal, at the same time each day. Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity develops.
    Dose modifications for creatine phosphokinase (CK) elevations and muscle‑related adverse events: Temporary dose interruption and/or dose reduction of this drug therapy may be required for CK elevations and muscle‑related adverse events. For recommendations for dose interruption and/or dose reduction of this drug therapy in the management of symptomatic CK elevations and muscle‑related adverse events (such as myalgia, myopathy, and/or spasm).
    See prescribing information for full details.


    Indications

    Treatment of adult patients with locally advanced basal cell carcinoma which cannot be treated with curative surgery or radiation therapy.


    Contra-Indications

    Hypersensitivity to active substance or any of its excipients. Pregnancy. Lactation.  Woman of childbearing potential who do not comply with the Sonidegib diphosphate Pregnancy Prevention Programme.


    Special Precautions

    Muscle‑related adverse events: All patients starting therapy with Sonidegib must be informed of the risk of muscle‑related adverse events, including the possibility of rhabdomyolysis. They must be instructed to report promptly any unexplained muscle pain, tenderness or weakness occurring during treatment with Sonidegib or if symptoms persist after discontinuing treatment. CK levels should be checked prior to starting treatment and as clinically indicated thereafter, e.g. 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. Management of high‑grade CK elevation using supportive therapy, including proper hydration, should be considered according to local standards of medical practice and treatment guidelines.
    Embryofoetal death or severe birth defects: Sonidegib may cause embryo‑foetal death or severe birth defects when administered to pregnant women. Based on the mechanism of action, in animal studies, sonidegib has been shown to be teratogenic and foetotoxic. Women taking Sonidegib must not be pregnant or become pregnant during treatment and for 20 months after ending treatment.
    Criteria defining a woman of childbearing potential: A woman of childbearing potential is defined in the Sonidegib Pregnancy Prevention Programme as a sexually mature female who: Has menstruated at any time during the previous 12 consecutive months. Has not undergone a hysterectomy or a bilateral oophorectomy, or who does not have medically‑confirmed permanent premature ovarian failure. Does not have a XY genotype, Turner’s syndrome or uterine agenesis, becomes amenorrhoeic following cancer therapy, including treatment with Sonidegib.
    For men: Sonidegib may pass into the semen. To avoid potential foetal exposure during pregnancy, a male patient must understand that: Sonidegib exposes a teratogenic risk to the unborn child if he engages in unprotected sexual activity with a pregnant woman. He must always use the recommended contraception. He will tell his healthcare provider if his female partner becomes pregnant while he is taking Sonidegib or during the 6 months after his final dose.
    For healthcare professionals: Healthcare professionals must educate patients so they understand and acknowledge all the conditions of the Sonidegib Pregnancy Prevention Programme.
    Contraception
    Women of child‑bearing potential: Women of child‑bearing potential must use two methods of recommended contraception, including one highly effective method and a barrier method, while taking Sonidegib and for 20 months after ending treatment.
    Men: Male patients, even those who have had a vasectomy, must always use a condom (with spermicide, if available) when having sex with a female partner while taking Sonidegib and for 6 months after ending treatment.
    Pregnancy testing: The pregnancy status of women of child‑bearing potential must be established within 7 days prior to the initiation of Sonidegib treatment and monthly during treatment by means of a test performed by a healthcare professional. Pregnancy tests should have a minimum sensitivity of 25 mIU/ml as per local availability. In the event of pregnancy, treatment must not be initiated. In case of pregnancy occurring during treatment, Sonidegib must be stopped immediately. Patients who present with amenorrhoea during treatment with Sonidegib should continue monthly pregnancy testing while on treatment.
    Prescribing and dispensing restrictions for women of childbearing potential: The initial prescription and dispensing of Sonidegib should occur within 7 days of a negative pregnancy test. Prescriptions of Sonidegib should be limited to 30 days of treatment, with continuation of treatment requiring a new prescription.
    Educational material: In order to help healthcare providers and patients avoid embryonic and fetal exposure to Sonidegib, the Marketing Authorisation Holder will provide educational materials (Sonidegib Pregnancy Prevention Programme) to reinforce the potential risks associated with use of the medicinal product.
    Blood donation: Patients should be instructed not to donate blood while taking Sonidegib and for at least 20 months after ending treatment.
    Semen donation: Male patients should not donate semen while taking Sonidegib and for at least 6 months after ending treatment.
    See prescribing information for full details.


    Side Effects

    Decreased appetite, Dehydration, Dysgeusia, Headache, Nausea, Diarrhoea, Abdominal pain, Vomiting, Dyspepsia, Constipation, Gastro oesophageal reflux disorder, Alopecia, Pruritus, Rash, Abnormal hair growth, Muscle spasms, Musculoskeletal pain, Myalgia, Myopathy [muscular fatigue and muscular weakness].
    See prescribing information for full details.


    Drug interactions

    Sonidegib undergoes metabolism primarily by CYP3A4, and concomitant administration of strong inhibitors or inducers of CYP3A4 can increase or decrease sonidegib concentrations significantly.
    Food interaction: The bioavailability of sonidegib is increased in the presence of food. Sonidegib must be taken at least two hours after a meal and at least one hour before the following meal.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Due to the risk of embryofoetal death or severe birth defects caused by sonidegib, women taking Sonidegib must not be pregnant or become pregnant during treatment and for 20 months after ending treatment. Sonidegib is contraindicated in woman of childbearing potential who do not comply with the Sonidegib Pregnancy Prevention Programme.
    See prescribing information for full details.
    Lactation: It is unknown whether sonidegib is excreted in human milk. Because of the potential for serious adverse drug reactions, such as serious developmental defects in breast‑fed newborns/infants from sonidegib, women must not breast‑feed while taking Sonidegib or for 20 months after ending treatment.


    Overdose

    In dose escalation studies, Sonidegib diphosphate was administered at doses up to 3000 mg orally once daily. Patients should be monitored closely for adverse events and given appropriate supportive measures in all cases of overdose.


    Important notes

    Storage: Do not store above 25°C. Protect from moisture
    Shelf life: 2 years.


    Manufacturer
    Patheon Inc. Canada
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