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JollyRX
205, Al Qaizi Building, Al Muteena Street, Deira , AE
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61adb870ef82a93ef219feb8 ERIVEDGE 150 MG 28 CAP. https://cdn1.storehippo.com/s/6052eead9e1cf8aa024c48c8/61adb89ef7a2111f9c4e5730/webp/erivedge-150-mg-28-cap-.png

What is ERIVEDGE and how is it used?

ERIVEDGE is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body, or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation. It is not known if ERIVEDGE is safe and effective in children.

What are the possible side effects of ERIVEDGE?

ERIVEDGE can cause serious side effects, including:

  • See “What is the most important information I should know about ERIVEDGE?”
  • Severe skin reactions. Severe skin reactions have happened in some people taking ERIVEDGE. You may need to be treated in a hospital because these severe skin reactions can be life-threatening or lead to death.

Tell your healthcare provider right away if you develop any of the following signs or symptoms of a severe skin reaction, including:

    • blisters or peeling of your skin
    • high fever or flu-like symptoms
    • blisters on your lip, or around your mouth or eyes
    • enlarged lymph nodes
    • mouth sores or genital sores
    • skin pain and burning

Your healthcare provider may permanently stop ERIVEDGE if you develop a severe skin reaction.

  • Bone growth problems. Bone growth problems have happened in children who have been exposed to ERIVEDGE. These problems may continue even after stopping treatment with ERIVEDGE.

The common side effects of ERIVEDGE are:

  • muscle spasms
  • nausea
  • hair loss
  • diarrhea
  • change in how things taste or loss of taste
  • decreased appetite
  • weight loss
  • constipation
  • tiredness
  • joint pain
  • vomiting

DESCRIPTION

Vismodegib is an inhibitor of the hedgehog (Hh) signaling pathway, which is described chemically as 2-Chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide. The molecular formula is C19H14Cl2N2O3S. The molecular weight is 421.30 g/mol and the structural formula is:

ERIVEDGE® (vismodegib) capsule Structural Formula Illustration

Vismodegib is a crystalline free base with a pKa (pyridinium cation) of 3.8, appearing as a white to tan powder. The solubility of vismodegib is pH dependent with 0.1 μg/mL at pH 7 and 0.99 mg/mL at pH 1. The partition coefficient (log P) is 2.7.

Each ERIVEDGE (vismodegib) capsule for oral administration contains 150 mg vismodegib and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone, sodium starch glycolate, talc, and magnesium stearate (non-bovine). The capsule shell contains gelatin, titanium dioxide, red iron oxide, and black iron oxide. The black printing ink contains shellac and black iron oxide.

INDICATIONS

ERIVEDGE 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.

DOSAGE AND ADMINISTRATION

Important Safety Information

Verify pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE [see Use In Specific Populations].

Recommended Dosage

The recommended dosage of ERIVEDGE is 150 mg taken orally once daily, with or without food, until disease progression or until unacceptable toxicity.

Swallow capsules whole. Do not open or crush capsules.

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

Dosage Modifications For Adverse Reactions

Withhold ERIVEDGE for up to 8 weeks for intolerable adverse reactions until improvement or resolution. Treatment durations shorter than 8 weeks prior to interruptions have not been studied.

Permanently discontinue ERIVEDGE if patients experience severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS) [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

Capsules: 150 mg with “150 mg” printed on pink opaque body and “VISMO” printed on grey opaque cap in black ink.

Storage And Handling

ERIVEDGE capsules have 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.

ERIVEDGE capsules are available in bottles of 28 capsules (NDC 50242-140-01). Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Premature Fusion of the Epiphyses [see WARNINGS AND PRECAUTIONS]

PRECAUTIONS

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 once daily [see Use In Specific Populations].

Females Of Reproductive Potential

Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during therapy with ERIVEDGE and for 24 months after the final dose [see Use In Specific Populations].

Males

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

Blood Donation

Advise patients not to donate blood or blood products while receiving ERIVEDGE and for 24 months after the final dose of ERIVEDGE.

Severe Cutaneous Adverse Reactions

Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during treatment with ERIVEDGE [see ADVERSE REACTIONS].

Permanently discontinue ERIVEDGE in patients with these reactions [see DOSAGE AND ADMINISTRATION].

Premature Fusion Of The Epiphyses

Premature fusion of the epiphyses has been reported in pediatric patients exposed to ERIVEDGE. In some cases, fusion progressed after drug discontinuation [see Use In Specific Populations]. ERIVEDGE is not indicated for pediatric patients.

CLINICAL PHARMACOLOGY

Mechanism Of Action

Vismodegib is an inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

Pharmacodynamics

Cardiac Electrophysiology

ERIVEDGE did not prolong the QT interval to any clinically relevant extent following 7 days of 150 mg once-daily dosing (at steady state).

Pharmacokinetics

The pharmacokinetics of vismodegib were studied in healthy subjects and patients. Following daily oral dosing, the pharmacokinetics of vismodegib appear to be nonlinear with steady state achieved within 7 days. Increasing the dose from 150 mg to 540 mg (1 to 3.6 times the recommended dose) does not result in higher steady state plasma concentrations. Average plasma concentration of vismodegib at steady state (Css,avg) is ~23 μM following 150 mg once daily dose.

Absorption

The single dose absolute bioavailability of vismodegib is 32%. Absorption is saturable as evidenced by the lack of dose proportional increase in exposure after a single dose of 270 mg or 540 mg vismodegib.

Effect Of Food

Cmax and AUC0-24hr of vismodegib at steady state are not affected by food.

Distribution

The volume of distribution of vismodegib ranges from 16.4 to 26.6 L. Vismodegib plasma protein binding in patients is > 99%. Vismodegib binds to both human serum albumin and alpha-1-acid glycoprotein (AAG) and binding to AAG is saturable.

Male patients had an average concentration of vismodegib in semen on day 8 that was 6.5% of the average steady state concentration (Css) observed in plasma.

Elimination

The estimated elimination half-life (t½) of vismodegib is 4 days after continuous once-daily dosing and 12 days after a single dose.

Metabolism

Greater than 98% of the total circulating drug-related components are the parent drug. Metabolic pathways of vismodegib in humans include oxidation, glucuronidation, and pyridine ring cleavage. The two most abundant oxidative metabolites recovered in feces are produced in vitro by recombinant CYP2C9 and CYP3A.

Excretion

Vismodegib and its metabolites are eliminated primarily by the hepatic route with 82% of the administered dose recovered in the feces and 4.4% recovered in urine.

Specific Populations

Weight (41-140 kg), age (26-89 years), sex, mild to moderate renal impairment (creatinine clearance of 30 to 79 mL/min), mild hepatic impairment (normal total bilirubin and aspartate transaminase (AST) > upper limit of normal (ULN) or total bilirubin > 1 to 1.5 times ULN), moderate hepatic impairment (total bilirubin > 1.5 to 3 times ULN), or severe hepatic impairment (total bilirubin > 3 to 10 times ULN) had no clinically relevant effects on the systemic exposure of vismodegib. The impact of severe renal impairment on the pharmacokinetics of vismodegib is unknown.

Drug Interaction Studies

Clinical Studies

No clinically significant differences in vismodegib pharmacokinetics were observed when used concomitantly with fluconazole (moderate CYP2C9 and CYP3A4 inhibitor), itraconazole (strong CYP3A4 inhibitor and P-gp inhibitor) and rabeprazole (gastric acid reducing agent, proton pump inhibitor).

No clinically significant differences in the pharmacokinetics of the following drugs were observed when used concomitantly with vismodegib: rosiglitazone (a CYP2C8 substrate) or ethinyl estradiol and norethindrone (oral contraceptive).

In Vitro Studies

Vismodegib is an inhibitor of the transporter BCRP and is not an inducer of CYP1A2, CYP2B6, or CYP3A.

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ERIVEDGE 150 MG 28 CAP.

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Description of product

What is ERIVEDGE and how is it used?

ERIVEDGE is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body, or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation. It is not known if ERIVEDGE is safe and effective in children.

What are the possible side effects of ERIVEDGE?

ERIVEDGE can cause serious side effects, including:

  • See “What is the most important information I should know about ERIVEDGE?”
  • Severe skin reactions. Severe skin reactions have happened in some people taking ERIVEDGE. You may need to be treated in a hospital because these severe skin reactions can be life-threatening or lead to death.

Tell your healthcare provider right away if you develop any of the following signs or symptoms of a severe skin reaction, including:

    • blisters or peeling of your skin
    • high fever or flu-like symptoms
    • blisters on your lip, or around your mouth or eyes
    • enlarged lymph nodes
    • mouth sores or genital sores
    • skin pain and burning

Your healthcare provider may permanently stop ERIVEDGE if you develop a severe skin reaction.

  • Bone growth problems. Bone growth problems have happened in children who have been exposed to ERIVEDGE. These problems may continue even after stopping treatment with ERIVEDGE.

The common side effects of ERIVEDGE are:

  • muscle spasms
  • nausea
  • hair loss
  • diarrhea
  • change in how things taste or loss of taste
  • decreased appetite
  • weight loss
  • constipation
  • tiredness
  • joint pain
  • vomiting

DESCRIPTION

Vismodegib is an inhibitor of the hedgehog (Hh) signaling pathway, which is described chemically as 2-Chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide. The molecular formula is C19H14Cl2N2O3S. The molecular weight is 421.30 g/mol and the structural formula is:

ERIVEDGE® (vismodegib) capsule Structural Formula Illustration

Vismodegib is a crystalline free base with a pKa (pyridinium cation) of 3.8, appearing as a white to tan powder. The solubility of vismodegib is pH dependent with 0.1 μg/mL at pH 7 and 0.99 mg/mL at pH 1. The partition coefficient (log P) is 2.7.

Each ERIVEDGE (vismodegib) capsule for oral administration contains 150 mg vismodegib and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone, sodium starch glycolate, talc, and magnesium stearate (non-bovine). The capsule shell contains gelatin, titanium dioxide, red iron oxide, and black iron oxide. The black printing ink contains shellac and black iron oxide.

INDICATIONS

ERIVEDGE 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.

DOSAGE AND ADMINISTRATION

Important Safety Information

Verify pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE [see Use In Specific Populations].

Recommended Dosage

The recommended dosage of ERIVEDGE is 150 mg taken orally once daily, with or without food, until disease progression or until unacceptable toxicity.

Swallow capsules whole. Do not open or crush capsules.

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

Dosage Modifications For Adverse Reactions

Withhold ERIVEDGE for up to 8 weeks for intolerable adverse reactions until improvement or resolution. Treatment durations shorter than 8 weeks prior to interruptions have not been studied.

Permanently discontinue ERIVEDGE if patients experience severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS) [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

Capsules: 150 mg with “150 mg” printed on pink opaque body and “VISMO” printed on grey opaque cap in black ink.

Storage And Handling

ERIVEDGE capsules have 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.

ERIVEDGE capsules are available in bottles of 28 capsules (NDC 50242-140-01). Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Premature Fusion of the Epiphyses [see WARNINGS AND PRECAUTIONS]

PRECAUTIONS

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 once daily [see Use In Specific Populations].

Females Of Reproductive Potential

Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during therapy with ERIVEDGE and for 24 months after the final dose [see Use In Specific Populations].

Males

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

Blood Donation

Advise patients not to donate blood or blood products while receiving ERIVEDGE and for 24 months after the final dose of ERIVEDGE.

Severe Cutaneous Adverse Reactions

Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during treatment with ERIVEDGE [see ADVERSE REACTIONS].

Permanently discontinue ERIVEDGE in patients with these reactions [see DOSAGE AND ADMINISTRATION].

Premature Fusion Of The Epiphyses

Premature fusion of the epiphyses has been reported in pediatric patients exposed to ERIVEDGE. In some cases, fusion progressed after drug discontinuation [see Use In Specific Populations]. ERIVEDGE is not indicated for pediatric patients.

CLINICAL PHARMACOLOGY

Mechanism Of Action

Vismodegib is an inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

Pharmacodynamics

Cardiac Electrophysiology

ERIVEDGE did not prolong the QT interval to any clinically relevant extent following 7 days of 150 mg once-daily dosing (at steady state).

Pharmacokinetics

The pharmacokinetics of vismodegib were studied in healthy subjects and patients. Following daily oral dosing, the pharmacokinetics of vismodegib appear to be nonlinear with steady state achieved within 7 days. Increasing the dose from 150 mg to 540 mg (1 to 3.6 times the recommended dose) does not result in higher steady state plasma concentrations. Average plasma concentration of vismodegib at steady state (Css,avg) is ~23 μM following 150 mg once daily dose.

Absorption

The single dose absolute bioavailability of vismodegib is 32%. Absorption is saturable as evidenced by the lack of dose proportional increase in exposure after a single dose of 270 mg or 540 mg vismodegib.

Effect Of Food

Cmax and AUC0-24hr of vismodegib at steady state are not affected by food.

Distribution

The volume of distribution of vismodegib ranges from 16.4 to 26.6 L. Vismodegib plasma protein binding in patients is > 99%. Vismodegib binds to both human serum albumin and alpha-1-acid glycoprotein (AAG) and binding to AAG is saturable.

Male patients had an average concentration of vismodegib in semen on day 8 that was 6.5% of the average steady state concentration (Css) observed in plasma.

Elimination

The estimated elimination half-life (t½) of vismodegib is 4 days after continuous once-daily dosing and 12 days after a single dose.

Metabolism

Greater than 98% of the total circulating drug-related components are the parent drug. Metabolic pathways of vismodegib in humans include oxidation, glucuronidation, and pyridine ring cleavage. The two most abundant oxidative metabolites recovered in feces are produced in vitro by recombinant CYP2C9 and CYP3A.

Excretion

Vismodegib and its metabolites are eliminated primarily by the hepatic route with 82% of the administered dose recovered in the feces and 4.4% recovered in urine.

Specific Populations

Weight (41-140 kg), age (26-89 years), sex, mild to moderate renal impairment (creatinine clearance of 30 to 79 mL/min), mild hepatic impairment (normal total bilirubin and aspartate transaminase (AST) > upper limit of normal (ULN) or total bilirubin > 1 to 1.5 times ULN), moderate hepatic impairment (total bilirubin > 1.5 to 3 times ULN), or severe hepatic impairment (total bilirubin > 3 to 10 times ULN) had no clinically relevant effects on the systemic exposure of vismodegib. The impact of severe renal impairment on the pharmacokinetics of vismodegib is unknown.

Drug Interaction Studies

Clinical Studies

No clinically significant differences in vismodegib pharmacokinetics were observed when used concomitantly with fluconazole (moderate CYP2C9 and CYP3A4 inhibitor), itraconazole (strong CYP3A4 inhibitor and P-gp inhibitor) and rabeprazole (gastric acid reducing agent, proton pump inhibitor).

No clinically significant differences in the pharmacokinetics of the following drugs were observed when used concomitantly with vismodegib: rosiglitazone (a CYP2C8 substrate) or ethinyl estradiol and norethindrone (oral contraceptive).

In Vitro Studies

Vismodegib is an inhibitor of the transporter BCRP and is not an inducer of CYP1A2, CYP2B6, or CYP3A.

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