Patient Medication Information: uses, side effects, how to take - SPC-Vismodegib
What the medication is used for:
SPC-Vismodegib is used to treat adults with a type of skin cancer called advanced basal cell carcinoma (BCC). It is used when the cancer:
- has spread to other parts of the body (called “metastatic” basal cell carcinoma)
- has spread to surrounding areas (called “locally advanced” basal cell carcinoma) and your doctor decides that it cannot be treated with surgery or radiation.
What it does:
DNA in skin cells can become damaged. This damage can change how certain proteins in a cell work and turn those cells into skin cancer. SPC-Vismodegib works by controlling a key protein involved in cancer. This may slow or stop the cancer cells from growing, or may kill them. As a result, your skin cancer may shrink.
When it must not be used:
if you are pregnant, think you may be pregnant, or are planning to become pregnant,
- if you are breastfeeding,
- if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the VPPP,
- if you are male and are unable or unwilling to follow the necessary contraceptive measures listed in the VPPP,
- if you are less than 18 years of age,
- if you are allergic to vismodegib or any of the other ingredients of this medicine
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking SPC-Vismodegib.
What the medicinal ingredient is: vismodegib
What the non-medicinal ingredients are:
Capsule content: microcrystalline cellulose PH101; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; povidone K30LP; sodium starch glycolate; talc.
Capsule shell (body): gelatin; titanium dioxide; iron oxide red. Capsule shell (cap): gelatin; titanium dioxide; iron oxide black.
Printing ink: includes Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, Black Iron Oxide, Potassium Hydroxide, Purified Water.
What dosage forms it comes in:
Capsule, 150 mg
SPC-Vismodegib is an opaque cap and pink opaque body capsule, imprinted with “V150” on cap with black ink. SPC-Vismodegib is supplied in high density polyethylene (HDPE) bottles (28 capsules per bottle).
BEFORE you use SPC-Vismodegib, talk to your doctor or pharmacist if you:
- are pregnant, may be pregnant, or thinking about becoming pregnant
- are breastfeeding
- have liver problems
- have kidney problems
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- SPC-Vismodegib treatment should be started and monitored only under the supervision of a physician qualified in the use of cancer therapies and with a full understanding of the risks of SPC-Vismodegib therapy and monitoring requirements.
- SPC-Vismodegib can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.
- Vismodegib has not been studied in patients with severe impaired kidney function.
- SPC-Vismodegib is not recommended for use in patients with severe impaired liver function
- SPC-Vismodegib is only available under a controlled distribution program called the SPC-Vismodegib Pregnancy Prevention Program (VPPP).
- In children SPC-Vismodegib can cause bones to stop growing. This is called epiphyses premature fusion. It can happen even after stopping SPC-Vismodegib. This is a permanent effect.
- Serious skin reactions have been reported in association with vismodegib treatment. Stop using SPC-Vismodegib and seek medical attention immediately if you notice any symptoms such as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals or eyes (often preceded by fever and flu- like symptoms).
IMPORTANT: PLEASE READ
Contraception and pregnancy testing
Both males and females of childbearing potential need to take precautions so that a female is not exposed to SPC-Vismodegib during pregnancy.
Your doctor will counsel you and give you educational materials on the contraception requirements and risks of SPC-Vismodegib in pregnancy.
For females:
- Your healthcare provider will discuss with you whether you can become pregnant or not.
For females who can become pregnant:
- Your healthcare provider will talk to you about the possible risks of SPC-Vismodegib to your unborn baby if you become pregnant.
- SPC-Vismodegib may affect your ability to have children. Some females taking SPC-Vismodegib have stopped having periods. If this happens to you, it is not known if your periods will come back. Talk to your doctor if you wish to have children in the future.
Pregnancy Testing:
Your healthcare provider will make sure to test you for pregnancy:
- within 7 days before starting treatment to make sure you are not pregnant,
- every month during treatment (including dose interruptions), and
- for 24 months after you stop treatment.
- Even if you stop menstruating, you will have to continue your regular monthly pregnancy tests during treatment.
Contraception Requirements:
- Your healthcare provider will talk to you about what contraceptive methods are right for you during this time.
- Unless you commit to not having sexual intercourse, you must use 2 forms of acceptable contraceptive methods together, one of these must be a barrier method with a spermicide.
- You must use appropriate contraception for at least 4 weeks before starting SPC-Vismodegib, during treatment (including dose interruptions) and for 24 months after you stop treatment.
- Even if your periods have stopped, are irregular, or have abnormal menstrual bleeding, you must continue using the two recommended methods of contraception.
- You must talk to your healthcare provider during the course of treatment and during the 24 months after you stopped treatment with SPC-Vismodegib before changing any contraceptive methods you have already agreed to use.
If you have previously chosen to not having sexual intercourse as a way to prevent pregnancy but you have changed your mind, you must talk to your doctor and
commit to using 2 recommended methods of contraception together, as described above.
Tell your healthcare provider right away if you:
- become pregnant
- think that you may be pregnant
- have unprotected sexual intercourse
- think your contraception has failed
For females who can breastfeed:
- Do not breastfeed during your treatment (including dose interruptions) and for 24 months after you stop taking SPC-Vismodegib. It is not known if SPC-Vismodegib can pass into your breast milk and harm your baby.
For male patients:
- You must advise your female sexual partners that you are taking SPC-Vismodegib and of the potential serious risks to an unborn baby if she becomes pregnant by you while you are on treatment (including dose interruptions) or for 2 months after you stop treatment.
- SPC-Vismodegib is present in semen.
- To protect your female partner from being exposed to SPC-Vismodegib, always use a condom with spermicide, even after a vasectomy, when you have sexual intercourse with a female partner. Do this during treatment (including dose interruptions) and for the 2 months after you stop treatment.
- You should not donate semen at any time during treatment (including dose interruptions) and for the 2 months after you stop treatment.
Tell your healthcare provider right away if:
- your female partner becomes pregnant
- your female partner thinks she may be pregnant
- you have unprotected sexual intercourse
- you think your contraception has failed
Exposure to SPC-Vismodegib during pregnancy
SPC-Vismodegib must not be used during pregnancy. If you are female and are taking SPC-Vismodegib and think you may be pregnant, you must stop SPC-Vismodegib treatment and talk to your healthcare provider immediately.
If you are male and think that your female sexual partner may have been exposed to SPC-Vismodegib during pregnancy, talk to your healthcare provider immediately. Pregnant females who may have been exposed to SPC-Vismodegib during pregnancy should share information about their pregnancy when they are contacted.
What you should avoid while taking SPC-Vismodegib
- Do not donate blood or blood products while you are taking SPC-Vismodegib and for 24 months after you stop taking SPC-Vismodegib.
- Do not share your medicine with anyone even if they have the same symptoms as you.
IMPORTANT: PLEASE READ
Know the medicines you take and keep a list of your medicines with you. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Include prescription and non-prescription medicines, vitamins, and herbal medicines.
Take SPC-Vismodegib exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one 150 mg capsule each day.
You can take SPC-Vismodegib with or without food.
- Swallow SPC-Vismodegib capsules whole.
- Do not open or crush the capsules.
Overdose:
Missed Dose:
If you miss a dose, do not take a double dose. Skip the missed dose and just take your next scheduled dose.
Like all medicines, SPC-Vismodegib can cause side effects.
Very common side effects
These side effects may affect more than 1 in 10 patients:
- muscle spasm
- hair loss
- loss of taste (or a change in the way things taste)
- weight loss
- feeling tired
- feeling sick (nausea)
- diarrhea
- loss of monthly periods in women who can get pregnant
- constipation
- vomiting
- joint pain
Common side effects
- increases in liver enzymes (eg. feel tired or weak, abdominal pain, skin or eyes turn yellow)
- dehydration
- high and low blood pressure
- difficulty in swallowing
back pain
Muscle spasm, loss of taste (or a change in the way things taste) and weight loss can continue to occur up to 12-months after you stop taking SPC-Vismodegib.
SPC-Vismodegib can cause abnormal blood test results. Your healthcare provider will do a blood test before you start taking SPC-Vismodegib and periodically during treatment and will interpret the results.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
The following serious side effects have occurred in clinical trials with vismodegib.
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
Common (occurring between 1 and 10 of every 100 patients in clinical trials) | Pneumonia | ✓ | ||||
| Heart failure (e.g. shortness of breath, fatigue, fainting, heart palpitations, swelling in legs, ankles, feet) | ✓ | |||||
| Broken hip | ✓ | |||||
| Bleeding in the digestive system (e.g. blood in your stool) | ✓ | |||||
| Skin infection (e.g. redness, warmth, swelling, and pain of skin) | ✓ | |||||
| Blood clots in the lungs (e.g. shortness of breath, chest pain) | ✓ | |||||
| Blood clots in the legs, which may cause pain in legs when walking or exercising | ✓ | |||||
| Bleeding | ✓ | |||||
| Scaly red patches, open sores with raised border, or warts | ✓ | |||||
Fainting or sudden and temporary loss of consciousness | ✓ | |||||
PROPER USE OF THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
- loss of appetite
INTERACTIONS WITH THIS MEDICATION
If you think you, or a person you are caring for, have taken too much SPC-Vismodegib, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
IMPORTANT: PLEASE READ
This is not a complete list of side effects. For any unexpected effects while taking SPC-Vismodegib, contact your doctor or pharmacist.
- Keep SPC-Vismodegib capsules out of sight and reach of children.
- SPC-Vismodegib should be stored at 15-30 °C. Store in the original package.
- Keep the bottle tightly closed in order to protect from moisture and heat.
It is recommended that SPC-Vismodegib not be disposed of in household waste or waste water. Please return any unused SPC-Vismodegib to a registered pharmacy.
If you want more information about SPC-Vismodegib:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Consumer
Information by visiting the Health Canada
Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), or by calling 1-866-840-1340.
To report an adverse event related to SPC-Vismodegib, please contact 1-866-840-1340.
Brampton, ON L6T 1C1
Last revised:
SEPT 28, 2026
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owner(s).
HOW TO STORE IT
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.