Names and pronunciation
(vis′moe-deg′ib) ERIVEDGE
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Drug reference
(vis′moe-deg′ib) ERIVEDGE
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Func. class.: Antineoplastic biologic response modifier Func. class.: Vitamin, fat soluble Func. class.: Vit C—water-soluble vitamin
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Chem. class.: Signal transduction inhibitor (STI) Chem. class.: Retinol
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Do not confuse: vismodegib/vemurafenib/vandatanib
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ACTION: A hedgehog (Hh) signaling pathway inhibitor ACTION: Needed for normal bone, tooth development; visual dark adaptation; skin disease; mucosa tissue repair; assists with production of adrenal steroids, cholesterol, RNA ACTION: Wound healing, collagen synthesis, antioxidant, carbohydrate metabolism V
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USES: Patients who have metastatic basal cell carcinoma, locally advanced USES: Vit A deficiency USES: Vit C deficiency, scurvy; delayed wound, bone healing; chronic disease; urine acidification; before gastrectomy; dietary supplement
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Unlabeled uses: Common cold preven tion
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CONTRAINDICATIONS: Hyper sensitivity, breastfeeding, females at risk of becoming pregnant; pregnancy, males who do not adhere to contraceptive measures, children/adolescents <18 yr CONTRAINDICATIONS: Preg nancy (IM), hypersensitivity to vit A, malabsorption syndrome, hypervitami nosis A, IV administration Precautions: Pregnancy (PO), breastfeed ing, impaired renal function, children, hepatic disease, infants, alcoholism, hepatitis CONTRAINDICATIONS: Tartra zine, sulfite sensitivity; G6PD deficiency Precautions: Pregnancy, gout, diabetes, renal calculi (large doses)
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Black Box Warning: Intrauterine fetal death, male-mediated teratogenicity, pregnancy Precautions: Children, blood donation renal/hepatic impairment, CV disease, history of pancreatitis, history of gall bladder disease, osteoporosis, respira tory disease Black Box Warning: Pregnancy: Obtain pregnancy test of all women within 7 days before therapy; contraception is needed during and for 24 mo after treat ment; men receiving this product should use condoms with spermicide (even after vasectomy) during sexual inter course with female partners and for 2 mo after the last dose; semen donation is contraindicated during treatment and for 3 mo after treatment; report expo sure during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555 GI toxicity: nausea, vomiting, anorexia, diarrhea, constipation Black Box Warning: Pregnancy: Teach patients to notify providers immediately if pregnancy is suspected (or in a female partner for male patients); use effec tive contraception during and for 7 mo after treatment; men taking this product should use condoms with spermicide (even after vasectomy) and for 2 mo after the last dose; if product is used during pregnancy, should be apprised of the potential hazard to the fetus; en courage exposed women (either directly or through seminal fluid) to enroll in the ERIVEDGE pregnancy pharmacovigi lance program • About reason for treatment, expected results • That if dose is missed, do not take, but resume scheduled doses; to swallow whole, not to crush or chew • Not to donate blood during therapy or for ≥24 mo after conclusion of pro duct • Amenorrhea: it is unknown if revers ible after completion of treatment Aquasol A
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SIDE EFFECTS CNS: Syncope, paresthesia, ischemic stroke, depression CV: Hemorrhage, atrial fibrillation, cardiac failure, deep vein thrombosis (DVT), hypo- volemic shock, angina, MI GI: Nausea, vomiting, dysgeusia, con stipation, anorexia, diarrhea GU: Amenorrhea, azotemia INTEG: Alopecia META: Hyponatremia MISC: Fatigue, decreased weight V MS: Arthralgia RESP: Pneumonia, pulmonary embolism SIDE EFFECTS CNS: Headache, increased intracranial pressure, intracranial hypertension, leth argy, malaise EENT: Gingivitis, papilledema, exoph thalmos, inflammation of tongue and lips GI: Nausea, vomiting, anorexia, abdomi nal pain, jaundice INTEG: Drying of skin, pruritus, increased pigmentation, night sweats, alopecia META: Hypomenorrhea, hypercalcemia MS: Arthralgia, retarded growth, hard areas on bone SIDE EFFECTS CNS: Headache, insomnia, dizziness, fatigue, flushing GI: Nausea, vomiting, diarrhea, anorexia, heartburn, cramps GU: Polyuria, urine acidification, oxalate/ urate renal stones, dysuria HEMA: Hemolytic anemia in patients with G6PD INTEG: Inflammation at inj site
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INTERACTIONS Increased effect of each product: P-gp inhibitors (amiodarone, clarithromycin, cyclosporine, dilTIAZem, erythromycin, itraconazole, ketoconazole, nelfinovir, nicardipine, propefenone, guiNIDine, ritonavir, saquinavir, tacrolimus, tamoxi fen, verapamil); CYP2C19 substrates (amitriptyline, clomipramine, imipra mine, citalopram, diazepam, phenytoin, phenobarbital, lansoprazole, omepra zole, pantoprazole, rabeprazole,, esop meprazole, clopidogrel, propanolol, carisoprodol, chloramphenicol, cyclo phosphamide, indomethacin, nelfinavir, niLUTAmide, progesterone, teniposide, warfarin) Increase: vismodegib effect—osimertinib Increase: effect of sofosbuvir, velpatasvir, topotecan Increase: INR levels—warfarin; increase INR monitoring INTERACTIONS Increase: levels of vit A—corticosteroids, oral contraceptives Decrease: absorption of vit A—mineral oil, cholestyramine, colestipol Drug/Lab Test False increase: bilirubin, serum cholesterol INTERACTIONS Drug/Lab Test False negative: occult blood, urine bili rubin, leukocyte determination
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TREATMENT OF OVERDOSE: Discontinue product (a-skor′bic)
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DOSAGE AND ROUTES • Adult: PO 150 mg/day DOSAGE AND ROUTES • Adult and child >8 yr: PO 100,000- 500,000 international units/day × 3 days then 50,000 international units/day × 2 wk; dose based on severity of deficiency; maintenance 10,000-20,000 interna tional units for 2 mo • Child 1-8 yr: IM 5000-15,000 interna tional units/day × 10 days • Infant <1 yr: IM 5000-15,000 interna tional units/day × 10 days Maintenance • Child 4-8 yr: IM 15,000 international units/day × 2 mo • Child <4 yr: IM 10,000 international units/day × 2 mo DOSAGE AND ROUTES Dietary supplementation • Adult: PO 50-500 mg/day • Child 14-18 yr: PO 65 mg (female), 75 mg (male) • Child 9-13 yr: PO 45 mg/day • Child 4-8 yr: PO 25 mg/day • Child 1-3 yr: PO 15 mg/day • Infant: PO 40-50 mg/day Scurvy • Adult: PO/SUBCUT/IM/IV 100-250 mg/day × 2 wk, then 50 mg or more daily • Child: PO/SUBCUT/IM/IV 100-300 mg/day × 2 wk, then 35 mg or more daily Wound healing/chronic disease/ fracture (may be given with zinc) • Adult: SUBCUT/IM/IV/PO 200-500 mg/day for 1-2 mo • Child: SUBCUT/IM/IV/PO 100-200 mg added doses for 1-2 mo Urine acidification • Adult: PO 4-12 g/day in divided doses • Child: PO 500 mg q6-8hr
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Available forms: Cap 150 mg Available forms: Caps 10,000, 25,000, 50,000 international units; drops 5000 international units; inj 50,000 interna tional units/mL; tabs 10,000, 25,000, 50,000 international units Available forms: Tabs 25, 50, 100, 250, 500, 1000, 1500 mg; effervescent tabs 1000 mg; chewable tabs 100, 250, 500 mg; timed-release tabs 500, 750, 1000, 1500 mg; timed-release caps 500 mg; crys 4 g/tsp; powder 4 g/tsp; liq 35 mg/0.6 mL; sol 100 mg/mL; syr 20 mg/mL, 500 mg/5 mL; inj SUBCUT, IM, IV 100, 250, 500 mg/mL
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Administer: • Should be initiated and monitored only under the supervision of a health care provider qualified in the use of cancer therapies and with a full under standing of the risk of ERIVEDGE ther apy and monitoring requirements • Can cause embryo-fetal death or severe birth defects • Not recommended for use in patients with severe renal or hepatic impairment; limited data are available for these patients • ERIVEDGE is available only through the controlled distribution program, the ERIVEDGE Pregnancy Prevention Pro gram (EPPP): 1-888-748-8926 • Can cause irreversible premature fu sion of the epiphyses in children • Give without regard to food • Swallow whole, do not open or crush caps • If a dose is missed, do not take addi tional dose, take at usual time • Store at 77°F (25°C) Administer: PO route • With food (PO) for better absorption • Do not administer IV because of risk of anaphylactic shock; IM only • Oral preparations not indicated for vit A deficiency in those with malabsorp tion syndrome • Store in tight, light-resistant container IM route • Give deep in large muscle mass; do not use deltoid muscle for administration of >1 mL Administer: PO route • Do not crush or chew ext rel tabs or caps • Caps may be opened and contents mixed with jelly IV, direct route • 100 mg undiluted by direct IV over at least 1 min; rapid infusion may cause fainting Intermittent IV INFUSION route • Diluted with D5W, D5NaCl, NS, LR, Ring er’s, sodium lactate and given over 15 min Syringe compatibilities: Metoclopramide, aminophylline, theophylline Y-site compatibilities: Warfarin
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Assess: Assess: • Nutritional status: yellow and dark green vegetables, yellow/orange fruits, vit A–fortified foods, liver, egg yolks • Vit A deficiency: decreased growth; night blindness; dry, brittle nails; hair loss; urinary stones; increased infec tion; hyperkeratosis of skin; drying of cornea • Pregnancy/breastfeeding: do not use IM in pregnancy, fetal complications may occur; breastfeeding is considered safe at recommended dietary levels Assess: • I&O ratio; urine pH (acidification) • Ascorbic acid levels throughout treat ment if continued deficiency is suspected • Nutritional status: citrus fruits, vege tables • Inj sites for inflammation • Thrombophlebitis if receiving large dose • Pregnancy/breastfeeding: use only recommended dietary allowances in pregnancy, breastfeeding
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Evaluate: • Therapeutic response: decreased spread of tumor Evaluate: • Therapeutic response: increased growth rate, weight; absence of dry skin and mucous membranes, night blindness Evaluate: • Therapeutic response: absence of an orexia, irritability, pallor, joint pain, hyper keratosis, petechiae, poor wound healing
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CLINICAL CONSIDERATIONS CLINICAL CONSIDERATIONS CLINICAL CONSIDERATIONS
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Patient and caregiver information: Patient and caregiver information: • That if dose is missed, it should be omitted • That ophthalmic exams may be re quired periodically throughout therapy • Not to use mineral oil while taking this product • To notify prescriber of nausea, vom iting, lip cracking, loss of hair, head ache • Not to take more than prescribed amount Patient and caregiver information: • Necessary foods to include in diet, such as citrus fruits • That smoking decreases vit C levels; not to exceed prescribed dose; that excesses will be excreted in urine, ex cept when taking timed-release forms
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PHARMACOKINETICS Protein binding >99%, elimination half- life 4 days PHARMACOKINETICS Stored in liver, kidneys, fat; excreted (metabolites) in urine, feces PHARMACOKINETICS PO/INJ: Readily absorbed PO, metabo lized in liver; unused amounts excreted in urine (unchanged), metabolites; crosses placenta, breast milk
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• Infant <1 yr: IM 5000-15,000 interna tional units/day × 10 days Maintenance
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• Infant: PO 40-50 mg/day Scurvy
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