vismodegib

Trade Name:

Erivedge®

Appearance:

capsule

Monograph Name:

vismodegib

Monograph Body:

Drug Monograph

A - Drug Name

vismodegib

COMMON TRADE NAME(S): Erivedge®

B - Mechanism of Action and Pharmacokinetics

The Hedgehog pathway is a key regulator of cell differentiation and growth during embryogenesis. This pathway is normally inactive in adults; mutations resulting in a constitutive active status are implicated in the development and progression of a number of cancers, including basal cell carcinoma and medulloblastoma. The Hedgehog pathway signals through the transmembrane Smoothened (SMO) protein, inducing the Hedgehog target genes involved in cell proliferation, survival and differentiation. The patch homologue 1 transmembrane receptor (PTCH1) normally has inhibitive effects on SMO signalling. Vismodegib inhibits the SMO protein, preventing Hedgehog signal transduction from a mutated overactive SMO or mutated inactive PTCH1.

Absorption

Absorption is saturable as exposure did not increase above the recommended dose (up to 540 mg daily). Weight, age (range 26-89), creatinine clearance (range 30-80 mL/min) and sex do not have significant effects on exposure.

Bioavailability

31.8%

Effects with food

None

Time to reach steady state

Within ~7 days

Distribution

Vismodegib binds to serum albumin and alpha-1-acid glycoprotein.

PPB

>99%

Cross blood brain barrier?

Unknown

Metabolism

Metabolized primarily by the liver and metabolic pathways including oxidation and glucuronidation, etc. Several minor metabolites are produced by multiple CYP450 enzymes.

Main enzymes involved

CYP2C9, CYP3A4, CYP3A5

Inhibitor of

CYP2C8, CYP2C9, CYP2C19, BCRP

Elimination

Slowly eliminated by a combination of metabolism (main route) and excretion of parent drug.

Half-life

12 days (single dose), 4 days (steady state)

Feces

82% of dose

Urine

4% of dose

C - Indications and Status

Health Canada Approvals:

Basal cell carcinoma (BCC)

Refer to the product monograph for a full list and details of approved indications.

Vismodegib may only be prescribed and dispensed by physicians and pharmacists registered with the Erivedge® Pregnancy Prevention Program (EPPP). Patients must also be registered and meet all conditions of the program. Call 1-888-748-8926 or log onto www.erivedge.ca

D - Adverse Effects

Emetogenic Potential:

Minimal – No routine prophylaxis; PRN recommended

Extravasation Potential: Not applicable

The following adverse effects were reported in ≥ 5% of advanced BCC patients in clinical trials. Severe, life-threatening or post-marketing adverse events are also included.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Arrhythmia (rare)	E
	Arterial thromboembolism (rare)	E
	Cardiotoxicity (rare)	E D
	Hypertension (≥5%)	E
	Hypotension (orthostatic; rare)	E
	Venous thromboembolism (rare)	E
Dermatological	Alopecia (64%)	E D
	Other - Acute generalized exanthematous pustulosis (rare)	E
	Rash (9%) (may be severe)	E
	Stevens-Johnson syndrome (rare)	E
	Toxic epidermal necrolysis (rare)	E
Gastrointestinal	Abdominal pain (6%)	E
	Anorexia, weight loss (45%)	E
	Constipation (21%)	E
	Diarrhea (29%)	E
	Dyspepsia (9%)	I E
	Dysphagia (5%)	E
	Flatulence (7%)	E
	GI hemorrhage (rare)	E
	GI obstruction (rare)	E
	Nausea, vomiting (30%)	I
General	Edema (7%)	E
	Fatigue (40%)	E
Hematological	Anemia (7%) , lymphopenia (mild to moderate)	E
Hepatobiliary	↑ LFTs (25%) (severe <1%)	E
	Pancreatitis (rare, may be severe)	E
Hypersensitivity	DRESS syndrome (rare)	E
	Hypersensitivity (mild)	I
Infection	Infection (10%) (UTI, URTI)	E
Metabolic / Endocrine	Abnormal electrolyte(s) (29%) (severe 4%, decreased Na, K, Mg)	E
Musculoskeletal	Fracture (rare)	D
	Musculoskeletal pain (72%)	E
	Rhabdomyolysis (also increased CPK; rare)	E
Neoplastic	Secondary malignancy (9%) (squamous cell carcinoma)	E D
Nervous System	Anxiety (8%)	E
	Depression (7%)	E
	Dizziness (6%)	E
	Dysgeusia (55%)	E
	Headache (13%)	E
	Insomnia (11%)	E
	Other (paranoia - rare)	E
	Paresthesia (6%)	E
	Syncope (may be severe)	E
Renal	Creatinine increased (13%) (may rarely be severe)	E D
Reproductive and breast disorders	Irregular menstruation (30%) (amenorrhea)	E
Respiratory	Cough, dyspnea (19%)	E

* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.

** I = immediate (onset in hours to days) E = early (days to weeks)
D = delayed (weeks to months) L = late (months to years)

The most common side effects for vismodegib include musculoskeletal pain, alopecia, dysgeusia, anorexia, weight loss, fatigue, irregular menstruation, nausea, vomiting, abnormal electrolyte(s), diarrhea and ↑ LFTs.

Elevations in liver enzymes are mainly grades 1 and 2 in severity. Severe increases have been transient and have not led to treatment interruption or discontinuation in the majority of the cases. However, some serious cases of hepatotoxicity necessitating dose interruption or discontinuation have been observed, including cholestasis, hepatitis, and hepatocellular injury. Risk factors may include pre-existing liver disease, underlying malignancy and its complications, concomitant hepatotoxic medications, and systemic infections.

Pancreatitis (including one fatal case) has been reported.

Syncope may be severe in some cases where vismodegib was held and then restarted after symptom resolution.

Thromboembolic events, such as deep vein thrombosis and pulmonary embolism (including one fatal case) have been reported.

Prolonged symptoms (persisting at least 12 months post-treatment discontinuation) of weight loss, muscle spasm, dysgeusia and ageusia have been reported.

E - Dosing

Refer to protocol by which patient is being treated.

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.

Vismodegib may only be prescribed and dispensed by physicians and pharmacists registered with the EPPP. Patients must also be registered and meet all conditions of the program. Call 1-888-748-8926 or log onto www.erivedge.ca

Women of child-bearing potential must have a negative pregnancy test within 7 days before starting treatment.

Adults:

Oral: 150 mg once daily

Dosage with Toxicity:

There are no dose reductions for vismodegib. Interruptions up to 8 weeks are allowed for intolerable side effects* or for a planned surgical procedure. New onset of cutaneous squamous cell carcinoma should be managed according to the standard of care.

*intolerable side effects: Grade 3 or 4 related toxicities that are likely to be clinically significant, life-threatening or irreversible

The following were excluded in the phase II clinical trial:

Hematologic or metabolic/chemistry abnormalities not considered clinically significant
Nausea, vomiting, or diarrhea that are adequately controlled after optimization of medical management.
Transient and manageable grade 3 infection
Asymptomatic thromboembolism found incidentally on imaging and managed with anti-coagulation therapy

Toxicity	Action
Pancreatitis	Consider hold or discontinuation
Grade 3 or 4 treatment-related	Hold up to 8 weeks
Planned surgery	Hold up to 8 weeks
Grade 3 or 4 hepatotoxicity	Hold or discontinue
Severe cutaneous adverse reactions (SCARs) (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, acute generalized exanthematous pustulosis)	Discontinue

Dosage with Hepatic Impairment:

Hepatic Impairment	Total bilirubin / AST		AST	Vismodegib dose
Mild	≤ ULN	And	>ULN	No change; exercise caution
Mild	>ULN to 1.5x ULN	And	any	No change; exercise caution
Moderate	>1.5 to < 3x ULN	And	any	No change; exercise caution
Severe	3 to <10x ULN	And	any	Not recommended for use

Dosage with Renal Impairment:

The safety and efficacy of vismodegib have not been established in patients with severe renal impairment.

Creatinine clearance (ml/min)	Vismodegib dose
≥ 50	No change
30 to 49	No change
< 30	No data

Dosage in the elderly:

No specific dose adjustment is necessary. However, monitor with caution.

Children:

CONTRAINDICATED in patients aged below 18 years as efficacy and safety have not been established. Precocious puberty, severe irreversible changes in reproductive (male), dental and bone growth were observed in pediatric or post-natal animal studies.

F - Administration Guidelines

Capsules must be swallowed whole with a glass of water and not crushed or opened; can be taken with or without food.
If dose is missed, skip this dose and give the next scheduled dose. Do not double the dose to make up for the missed one.
Store at room temperature (15 - 30°C), in original package away from moisture and heat.

G - Special Precautions

Contraindications:

Patients who have a hypersensitivity to this drug or any of its components
In patients aged below 18 years
Females patients of childbearing potential and male patients who do not comply with the EPPP requirements
Breastfeeding female patients

Other Warnings/Precautions:

Vismodegib is not recommended for use in patients with severe hepatic impairment. Use with caution in patients with mild to moderate hepatic impairment.
Use with caution in patients with a history of pancreatitis and gallbladder disease.
Patients should not donate blood or semen while taking vismodegib, during dose interruptions and for 24 months (2 months for semen) after stopping therapy.
Contains lactose; carefully consider use in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption
Patients with history of significant cardiovascular disease or risk factors for syncope: Severe related adverse events have been reported in these patients groups. There was no effect of vismodegib on the QT interval.

Other Drug Properties:

Carcinogenicity: Probable
Cases of cutaneous squamous cell carcinoma have been reported in advanced BCC patients.

Pregnancy and Lactation:

Genotoxicity: No
Clastogenicity: No
Embryotoxicity: Yes
Fetotoxicity: Yes
Teratogenicity: Yes

Vismodegib is contraindicated in pregnancy and in males and females of childbearing potential who do not comply with the EPPP.

REFER TO THE EPPP FOR COMPLETE DETAILS. Vismodegib can cross the placenta and cause fetal malformations. Females of childbearing potential as defined by EPPP (including those who are either menstruating, amenorrheic but have not entered menopause or are perimenopausal) must be capable of understanding and complying with the patient registration, education, and safety requirements of the ERIVEDGE® program, regular pregnancy testing (7 days prior to initiating vismodegib treatment, monthly during treatment and interruptions and for 24 months after the last dose) and the use of two simultaneous contraception methods (including 1 acceptable barrier method with spermicide) for at least one month prior to starting treatment, during treatment, during dose interruptions, and for 24 months following the last dose of vismodegib. If pregnancy occurs or is suspected during treatment, vismodegib must be discontinued and patients referred to a gynaecologist/obstetrician for evaluation and counselling.

Male patients must be capable of understanding and complying with the patient registration, education, and safety requirements of the EPPP, including mandatory contraceptive measures for men (condoms with spermicide should be used even with vasectomized males) while taking vismodegib, during dose interruptions and for 2 months after stopping therapy. Also, male patients should not donate semen during the above period of time. If the female sexual partner becomes pregnant, the female partner should be referred to a gynecologist/obstetrician for evaluation and counselling.

Any suspected exposure to vismodegib during pregnancy must be reported immediately to the EPPP at 1-888-748-8926 or through forms available for healthcare professionals on www.erivedge.ca
Breastfeeding:
Breastfeeding is contraindicated during treatment and dose interruptions, and for 24 months after the last dose.
Fertility effects: Yes

These effects may be irreversible. Amenorrhea occurred in 30% of females of childbearing potential in clinical trials, and animal studies indicate decreased male fertility. Fertility preservation strategies should be discussed prior to starting treatment.

H - Interactions

Vismodegib is a substrate of CYP3A4, CYP2C9 and P-gp in vitro.

Concurrent use of vismodegib with oral contraceptives (ethinyl estradiol and norethindrone) did not alter oral contraceptive levels.

CYP3A4 induction is not predicted to significantly change vismodegib exposure. Although administration with a fluconazole (a moderate CYP3A4 and CYP2C9 inhibitor) increased mean vismodegib AUC and steady-state concentrations by 1.3-fold, no dose adjustment for vismodegib is required.

Administration of vismodegib with a proton pump inhibitor (e.g. rabeprazole) or strong inhibitor of CYP3A4 and P-gp (e.g. itraconazole) had no effect on steady state exposure of vismodegib. Dose adjustment for vismodegib is not required.

Vismodegib does not significantly alter the exposure of CYP2C8 or CYP3A4 substrates (e.g. rosiglitazone). Dose adjustment is not required.

Vismodegib is a possible inhibitor of BCRP, CYP2C9 and CYP2C19. Use caution when administering vismodegib and these respective substrates with a narrow therapeutic range.

I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.

Recommended Clinical Monitoring

Monitor Type	Monitor Frequency
Liver function tests	Baseline, before each cycle, and as clinically indicated
Renal function tests	Baseline and before each cycle
Lipase, amylase	Baseline and as clinically indicated
Controlled distribution program requirements regarding pregnancy tests for women of child-bearing potential	As per the EPPP
Clinical toxicity assessment for musculoskeletal pain, fatigue, syncope, hypersensitivity, diarrhea, anorexia and other GI, cardiovascular effects, thromboembolism and psychiatric effects	At each visit

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

Monitor Type	Monitor Frequency
Electrolytes, including magnesium	baseline and as clinically indicated

J - Supplementary Public Funding

Exceptional Access Program (EAP Website)

vismodegib - Treatment for metastatic basal cell carcinoma (BCC) or with locally advanced BCC (including patients with basal cell nevus syndrome, i.e. Gorlin syndrome), according to specific criteria ()

K - References

Keating GM. Vismodegib in locally advanced or metastatic basal cell carcinoma. Drugs 2012;72(11):1535-41.

Poggi L, Kolesar JM. Vismodegib for the treatment of basal cell skin cancer. Am J Health-Syst Pharm 2013;70:1033-8.

Prescribing Information: Erivedge® (vismodegib). Genentech USA Inc., January 2012.

Product Monograph: Erivedge® (vismodegib). Hoffmann-La Roche Ltd., May 2020.

Summary of Product Characteristics: Erivedge® (vismodegib). Roche Products Ltd. (UK), July 12, 2013.

August 2023 Modified Adverse Effects, Dosage with toxicity, Pregnancy/lactation sections

L - Disclaimer

Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.

The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.

Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.

While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.

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Info Sheet Name:

vismodegib (patient)

Info Sheet Introduction:

For treating a type of skin cancer called basal cell carcinoma

Info Sheet Date: Tuesday, October 10, 2023 Info Sheet body:

Medication Information Sheet

vismodegib (VIS-mo-DEG-ib)

This document provides general information about your medication. It does not replace the advice of your health care professional. Always discuss your therapy with your health care professional and refer to the package insert for more details.

Other Name: Erivedge®

Appearance:

capsule

What is this medication for?

For treating a type of skin cancer called basal cell carcinoma

What should I do before I have this medication?

Tell your health care team if you have or had significant medical condition(s), especially if you have / had:
- liver or gallbladder problems
- pancreas problems
- kidney problems
- any allergies
Your doctor and pharmacy must be registered with Erivedge® Pregnancy Prevention Program.
You must register with and follow the requirements of the Erivedge® Pregnancy Prevention Program before taking vismodegib.
This drug contains a small amount of lactose. If you cannot tolerate lactose, talk to your health care team
People with cancer have a higher risk of getting other cancers or developing blood clots. Some cancer medications may increase these risks, especially if used for a long period of time. Discuss any concerns about this medication with your health care team.

Remember to:

Tell your health care team about all of the other medications you are taking.
Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.

You will have a blood test to check for hepatitis B before starting treatment. See the Hepatitis B and Cancer Medications pamphlet for more information.

How will this medication affect sex, pregnancy and breastfeeding?

The use of this medication in men or women may cause harm to the unborn baby if pregnancy occurs. Let your health care team know if you or your partner is pregnant, becomes pregnant during treatment, or if you are breastfeeding.
If there is ANY chance that you or your partner may become pregnant, you and your partner together must:
- ► Use 2 effective forms of birth control at the same time while taking this drug AND have regular pregnancy tests. (see the Erivedge® program for full details of requirements). Discuss with your healthcare team.
Do not breastfeed while taking vismodegib and for 24 months after the last dose.
Some females taking vismodegib have stopped having periods. It is not known if the periods will come back. Talk to your doctor if you wish to have children in the future.
This medication may affect fertility (ability to get pregnant).

How is this medication given?

This medication is usually taken once a day by mouth.
Take the dose at about the same time each day.
Swallow whole with a glass of water, with or without food.
If you miss a dose, skip this and take your next dose as you normally do. Do not take an extra dose to make up for the missed dose.

Do not crush or open the capsules, as this may increase side effects.

What else do I need to know while on this medication?

This medication can interact with other medications and can result in the treatment not working as well or cause severe side effects.
Make sure your health care team knows about all your medications (prescription, over-the-counter, herbals and supplements). Check with your health care team before starting or stopping any of them.
Drinking alcohol and smoking during your treatment may increase some side effects and make your medication less effective. Speak to your health care team about smoking and drinking alcohol while on treatment.
For mild aches and pain or fever:
- If you feel unwell, take your temperature before taking any medications for pain or fever. They may hide a fever.
- You may take acetaminophen (Tylenol®) tablets. Ask your health care team about the right dose for you.
- Ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or aspirin (acetylsalicylic acid, ASA), including low dose aspirin for heart conditions, may increase your chance of bleeding. Talk to your health care team before you start or stop these medications.
- Talk to your health care team or go to the closest emergency room right away if you have a fever. See the Fever pamphlet for more information.

Do not donate blood while taking vismodegib and for 24 months after the last dose.
Do not donate semen during treatment and for 2 months after stopping therapy.

How should I safely store this medication?

Keep this medication in the original packaging at room temperature in a dry place, away from heat and light. Keep out of sight and reach of children and pets.
Do not throw out any unused medications at home. Bring them to your pharmacy to be thrown away safely.

What are the side effects of this medication?

You may not have all of the side effects below. You may have side effects that are not listed.

Side effects and what to do	When to contact doctor?
Very Common Side Effects (50 or more out of 100 people)

Mild joint, muscle pain or cramps;
Headache (less common)

Take your pain medication as prescribed by your doctor.
You can take acetaminophen (Tylenol®) tablets as needed for mild aches and pains. Ask your doctor or pharmacist about the right dose for you.
Talk to your doctor or pharmacist first before taking ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or aspirin. These medication may increase bleeding risk.
Rest often and try light exercise as it may help.

Rarely these symptoms may persist for many months even after you stop your treatment.

Contact your health care team if no improvement or if severe

Hair thinning or loss

Use a gentle soft brush and avoid hair sprays, bleaches, dyes and perms.
In most cases, your hair will grow back after treatment, but the texture or colour may change.

Talk to your health care team if this bothers you

Taste changes

Eat food that needs less chewing.
Taste foods at different temperatures, since the flavor may change.
Try different forms of foods, like fresh, frozen or canned.
Experiment with non-spicy foods, spices and seasonings.

Rarely these symptoms may persist for many months even after you stop your treatment.

Contact your health care team if no improvement or if severe

Side effects and what to do	When to contact doctor?
Common Side Effects (25 to 49 out of 100 people)

Low appetite, weight loss

You may not feel like eating or you may lose weight.
Try to eat foods that you like and eat small meals throughout the day.
You may need to take meal supplements to help keep your weight up.
Talk to your health care team if you have a low appetite.
See our Loss of appetite pamphlet for more information.

Rarely these symptoms may persist for many months even after you stop your treatment.

Contact your health care team if no improvement or if severe

Fatigue (tiredness)

Be active and aim to get 30 minutes of moderate exercise (you are able to talk comfortably while exercising) on most days. Check with your health care team before starting any new exercise.
Pace yourself, do not rush. Put off less important activities. Rest when you need to.
Eat well and stay hydrated by drinking at least 6 to 8 glasses of water or other liquids every day (unless your doctor told you to drink more or less).
Avoid driving or using machinery if you are feeling tired

See our Fatigue pamphlet for more information.

Contact your health care team if no improvement or if severe

Changes in your menstrual periods

You may have changes in your menstruation cycle (periods) or menstruation flow (heavy or light periods).

Contact your health care team if no improvement or if severe

Nausea and vomiting (generally mild)

May occur in hours to days after your treatment.

If you have nausea or vomiting:

Take anti-nausea medication(s) as prescribed to you by your doctor.
Drink clear liquids and have small meals. Get fresh air and rest.
Do not eat spicy, fried foods or foods with a strong smell.
Limit caffeine (e.g. coffee, tea) and alcohol.
Contact your health care team if the prescribed anti-nausea medications are not helping to control your nausea and vomiting.

Also see Nausea & Vomiting pamphlet for more information.

Contact your health care team if no improvement or if severe

Salt imbalances

It may cause muscle twitching, severe weakness or cramping, confusion and irregular heartbeat.

Get emergency medical help right away

Diarrhea

May happen days to weeks after you get your treatment.

If you have diarrhea :

Take anti-diarrhea medication if your health care team prescribed it.
Avoid foods or drinks with artificial sweetener (e.g. chewing gum, “diet” drinks), coffee and alcohol.
Eat many small meals and snacks instead of 2 or 3 large meals.
Drink at least 6 to 8 cups of liquids each day. Talk to your health care team if you can’t drink 6-8 cups of liquids each day when you have diarrhea. You may need special liquids with salt and sugar, called Oral Rehydration Therapy.

See the Diarrhea pamphlet for more information.

Contact your health care team if no improvement or if severe

Abnormal liver lab tests (may be severe)

Your doctor may monitor your liver regularly with a blood test but you may not have any symptoms.
Rarely this may be severe and you may have yellowish skin or eyes, unusually dark pee or pain on the right side of your belly. Talk to your health care team right away (urgently) if this happens.

Contact your health care team if no improvement or if severe

Side effects and what to do	When to contact doctor?
Less Common Side Effects (10 to 24 out of 100 people)

Constipation

To help prevent constipation:

Drink more liquids and eat well. Drink at least 6 to 8 cups of liquids each day unless you have been told otherwise.
Be Active. Exercise can help to keep you regular.
Try to eat more fiber (e.g. fruits with skin, leafy greens and whole grains). If you take opioid pain medication, ask your health care team if eating more fibre is right for you.

To help treat constipation:

If you have not had a bowel movement in 2 to 3 days you may need to take a laxative. Ask your health care team what to do.

See the Constipation Pamphlet for more information.

Contact your health care team if no improvement or if severe

Cough; feeling short of breath (rarely may be severe)

You may have cough and feel short of breath without any signs of infection, such as a sore throat or a stuffed nose.

If you have severe chest pain, shortness of breath or are coughing up blood you should seek emergency medical help right away.

Contact your health care team if no improvement or if severe

Abnormal kidney lab tests (may be severe)

Signs of a kidney problem include swelling, passing very little or no pee, or new unusual weight gain. If you have these signs, call your health care team or go to your closest emergency department.
To prevent bladder or kidney problems, drink lots of water or other liquids. Your doctor may ask you to drink at least 6 to 8 cups (2 L) per day on treatment days, unless you have been told otherwise.
Your doctor may check your kidney function regularly.

Contact your health care team if no improvement or if severe

Trouble falling asleep

This may be caused by one of your medications and may improve once your body gets used to the medication or when your treatment ends.
Talk to your doctor if this bothers you.

Contact your health care team if no improvement or if severe

Fever, chills, infection

You have a fever if your temperature taken in your mouth (oral temperature) is:

38.3°C (100.9°F) or higher at any time OR
38.0°C (or 100.4°F) or higher for at least one hour.

While you are taking vismodegib:

Keep a digital thermometer at home and take your temperature if you feel hot or unwell (for example, chills).
Avoid taking medications that treat a fever before you take your temperature (for example, Tylenol®, acetaminophen, Advil® or ibuprofen) as they may hide a fever.
Do not eat or drink anything hot or cold right before taking your temperature.
Wash your hands often.
Check with your doctor before getting any vaccines, surgeries, medical procedures or visiting your dentist.

If you have a fever, talk to your health care team or go to the closest emergency room.

Get emergency medical help right away

Other rare, but serious side effects are possible.
If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:

new growths on your skin
severe rash, with or without fever, rash with skin blistering or peeling
trouble speaking, difficulty using your arms or legs, confusion or fainting
chest pain, irregular heartbeat
pain, swelling and hardening of the vein in an arm or leg
severe belly pain
vomiting blood or what looks like coffee-grounds; stool (poo) that is black/tarry coloured or has bright red blood in it
having paranoid thoughts
severe muscle pain or weakness

Who do I contact if I have questions or need help?

My cancer health care provider is: ______________________________________________

During the day I should contact:________________________________________________

Evenings, weekends and holidays:______________________________________________

Other Notes:

____________________________________________________________________________

August 2023 Modified "What is this medication for" and "Rare side effects" sections

For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.

The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.

A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

Info Sheet (English):

vismodegib patient.pdf Info Sheet (French):

vismodegib pour le patient.pdf Monograph:

vismodegib.pdf Funding Program: Exceptional Access Program Funding Instance:

vismodegib - Treatment for metastatic basal cell carcinoma (BCC) or with locally advanced BCC (including patients with basal cell nevus syndrome, i.e. Gorlin syndrome), according to specific criteria

Phonetic Spelling:

VIS-mo-DEG-ib

Cancer Type: Skin Basal Cell Type of Content: Drug Monograph Status: Null Info Sheet Status: Null Global Date: Monday, August 21, 2023 Universal Date: 2023-10-10 00:00:00 AddThis: Title URL: vismodegib Drug Display Status: Active Revision Summary:
Patient Info Sheet FR: Updated/revised information sheet (Fiche d’information mise à jour/révisée)