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ERIVEDGE ® (vismodegib) capsule
2015-08-17 07:26:48 来源: 作者: 【 】 浏览:332次 评论:0
  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ERIVEDGE safely and effectively. See full prescribing information for ERIVEDGE.

    ERIVEDGE ® (vismodegib) capsule for oral use
    Initial U.S. Approval: 2012
    WARNING: EMBRYO-FETAL TOXICITY
    See full prescribing information for complete boxed warning.

    ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations.

    Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE therapy. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE therapy. Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential. Advise pregnant women of the potential risks to a fetus. (5.1, 5.3, 8.1, 8.3)

     INDICATIONS AND USAGE

    ERIVEDGE® (vismodegib) capsule is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. (1)
    DOSAGE AND ADMINISTRATION

    The recommended dose is 150 mg orally once daily. (2)
    DOSAGE FORMS AND STRENGTHS

    150 mg capsules. (3)
    CONTRAINDICATIONS

    None. (4)
    WARNINGS AND PRECAUTIONS

    • Blood donation: Advise patients not to donate blood or blood products while receiving ERIVEDGE and for 7 months after the final dose of ERIVEDGE. (5.2)
    • Semen donation: Advise males not to donate semen during and for 3 months after therapy (5.3, 8.3)
    ADVERSE REACTIONS
    • The most common adverse reactions (incidence of ≥ 10%) are muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia.

    To report SUSPECTED ADVERSE REACTIONS, contact Genentech, Inc. at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)

    USE IN SPECIFIC POPULATIONS
    • Lactation: Breastfeeding not recommended. (8.2)
    • Females and Males of Reproductive Potential: May cause amenorrhea in females. (8.3)
    See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

    Revised: 5/2015

  • FULL PRESCRIBING INFORMATION: CONTENTS*
  • 1 INDICATIONS AND USAGE

     

    ERIVEDGE capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

  • 2 DOSAGE AND ADMINISTRATION

     

    The recommended dose of ERIVEDGE is 150 mg taken orally once daily until disease progression or until unacceptable toxicity [see Clinical Studies (14)].

    ERIVEDGE may be taken with or without food. Swallow capsules whole. Do not open or crush capsules.

    If a dose of ERIVEDGE is missed, do not make up that dose; resume dosing with the next scheduled dose.

  • 3 DOSAGE FORMS AND STRENGTHS

     

    ERIVEDGE (vismodegib) capsules, 150 mg. The capsule has a pink opaque body and a grey opaque cap, with "150 mg" printed on the capsule body and "VISMO" printed on the capsule cap in black ink.

  • 4 CONTRAINDICATIONS

     

    None.

  • 5 WARNINGS AND PRECAUTIONS

     

     

    5.1 Embryo-Fetal Toxicity

    Based on its mechanism of action, ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. In animal reproduction studies, vismodegib was embryotoxic, fetotoxic, and teratogenic at maternal exposures lower than the human exposures at the recommended dose of 150 mg/day.

    Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE therapy. Advise females of reproductive potential to use effective contraception during therapy with ERIVEDGE and for 7 months after the final dose. Advise male patients to use condoms, even after a vasectomy, to avoid potential drug exposure in pregnant partners and female partners of reproductive potential during therapy and for 3 months after the final dose of ERIVEDGE. Advise pregnant women of the potential risk to a fetus [see Use in Specific Populations (8.1, 8.3) and Clinical Pharmacology (12.1)].

     

    5.2 Blood Donation

    Advise patients not to donate blood or blood products while receiving ERIVEDGE and for 7 months after the final dose of ERIVEDGE.

     

    5.3 Semen Donation

    Vismodegib is present in semen. It is not known if the amount of vismodegib in semen can cause embryo-fetal harm. Advise male patients not to donate semen during and for 3 months after the final dose of ERIVEDGE [see Use in Specific Populations (8.1, 8.3)].

  • 6 ADVERSE REACTIONS

     

     

    6.1 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.

    ERIVEDGE capsule was administered as monotherapy at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials enrolling a total of 138 patients with advanced basal cell carcinoma (BCC). The median age of these patients was 61 years (range 21 to 101), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (305 days; range 0.7 to 36 months); 111 patients received ERIVEDGE for 6 months or longer.

    The most common adverse reactions (≥ 10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia (Table 1).

    Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC Patients
    MedDRA Preferred Term* All aBCC Patients (N = 138)
    All Grades (%) Grade 3 (%) Grade 4 (%)
    *
    MedDRA = Medical Dictionary for Regulatory Activities.
    aBCC = Advanced Basal Cell Carcinoma.
    Grading according to NCI-CTCAE v3.0.
    Gastrointestinal disorders      
      Nausea 42 (30.4%) 1 (0.7%) -
      Diarrhea 40 (29.0%) 1 (0.7%) -
      Constipation 29 (21.0%) - -
      Vomiting 19 (13.8%) - -
    General disorders and administration site conditions      
      Fatigue 55 (39.9%) 7 (5.1%) 1 (0.7%)
    Investigations      
      Weight loss 62 (44.9%) 10 (7.2%) -
    Metabolism and nutrition disorders      
      Decreased appetite 35 (25.4%) 3 (2.2%) -
    Musculoskeletal and connective tissue disorders      
      Muscle spasms 99 (71.7%) 5 (3.6%) -
      Arthralgias 22 (15.9%) 1 (0.7%)  
    Nervous system disorders      
      Dysgeusia 76 (55.1%) - -
      Ageusia 15 (10.9%) -
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