Erivedge^® (Capsules) Instructions for Use

Marketing Authorization Holder

F. Hoffmann-La Roche, Ltd (Switzerland)

Manufactured By

Patheon Inc. (Canada)

Packaging and Quality Control Release

F.Hoffmann-La Roche, Ltd (Switzerland)

ATC Code

L01XJ01 (Vismodegib)

Active Substance

Vismodegib (Rec.INN registered by WHO)

Dosage Form

Erivedge®

Capsules 150 mg: 28 pcs.

Dosage Form, Packaging, and Composition

Capsules hard, size No. 1; with a grey, opaque cap and a light pink, opaque body; with the inscription “VISMO” in black on the cap and the inscription “150mg” in black on the body; capsule contents are a white or almost white powder.

Excipients: microcrystalline cellulose – 87.3 mg, lactose monohydrate – 71.5 mg, sodium lauryl sulfate – 7 mg, povidone K29/32 – 10.5 mg, sodium starch glycolate – 17.5 mg, talc – 3.5 mg, magnesium stearate – 1.7 mg; capsule shell – 71-81 mg: body – iron oxide red (E172), titanium dioxide (E171), gelatin, cap – iron oxide black (E172), titanium dioxide (E171), gelatin; printing ink for capsule inscription – shellac, iron oxide black (E172).

28 pcs. – high-density polyethylene bottles (1) – cardboard packs with a protective holographic sticker (for first opening control).

Clinical-Pharmacological Group

Antineoplastic drug

Pharmacotherapeutic Group

Antineoplastic agent

Pharmacological Action

Antineoplastic agent, Hedgehog signaling pathway inhibitor.

The mechanism of action involves the control of one of the key proteins involved in the development of basal cell carcinoma. This may slow or stop the growth of cancer cells, or cause their death.

Indications

Treatment of metastatic or locally advanced basal cell carcinoma: in case of recurrence after surgical treatment; when surgical treatment or radiation therapy is not advisable.

ICD codes

Dosage Regimen

Take one 150 mg capsule orally once daily.

Swallow the capsule whole with a glass of water. Do not crush or chew the capsule.

Take the dose at approximately the same time each day, with or without food.

Continue treatment for as long as your physician directs, based on clinical benefit and tolerability.

If a dose is missed, skip that dose and take the next scheduled dose at the regular time. Do not take a double dose to make up for a forgotten one.

In case of a suspected overdose, contact your physician or a poison control center immediately.

Do not donate blood or blood components during therapy and for at least 24 months after the final dose.

Male patients must not donate sperm during treatment and for 3 months after the last dose.

Adverse Reactions

Severe skin reactions Stevens-Johnson syndrome/toxic epidermal necrolysis, DRESS syndrome (skin reactions are often preceded by fever and flu-like symptoms); acute generalized exanthematous pustulosis.

Very common decreased appetite, dysgeusia or ageusia, nausea, diarrhea, constipation, vomiting, dyspepsia, alopecia, pruritus, rash, muscle spasms, arthralgia, pain in extremity, amenorrhea, weight decreased, fatigue, pain.

Common dehydration, hypogeusia, upper abdominal pain, abdominal pain, increased liver enzyme levels or increased CPK levels, eyebrow and eyelash loss, hair growth abnormal, chest pain, back or side pain, pain in muscle, tendon, ligament, bone, asthenia.

Unknown precocious puberty, drug-induced liver injury, premature closure of epiphyseal growth plates.

Contraindications

Hypersensitivity to vismodegib, children and adolescents under 18 years of age, suspected or confirmed pregnancy, breastfeeding period, concomitant use of St. John’s wort preparations.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Vismodegib may cause cessation of bone growth and precocious puberty (earlier than 8 years in girls and earlier than 9 years in boys). This may occur even after discontinuation of vismodegib treatment.

Special Precautions

The patient should not become a donor of blood or its components during treatment and for 24 months after the last dose of vismodegib.

Male patients are prohibited from sperm donation during treatment and for 2 months after the last dose of vismodegib.

Vismodegib may cause cessation of bone growth and precocious puberty (earlier than 8 years in girls and earlier than 9 years in boys). This may occur even after discontinuation of vismodegib treatment. Problems with tooth and bone growth were observed in animal studies of vismodegib.

Drug Interactions

If concomitant use with CYP3A4 isoenzyme inducers is necessary, medical supervision is required.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.