Important Safety Information¹

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SARCLISA^®. Talk about any health conditions or problems you may have.

Precautions

While your doctor is monitoring you during your treatment, you should keep certain precautions in mind.

Pregnancy and Breastfeeding

If you are pregnant, think you might be pregnant or are planning to become pregnant during your SARCLISA^® treatment, tell your doctor or nurse immediately. You and your doctor will discuss and decide whether the benefit of receiving SARCLISA^® is greater than the risk of the medicine to your baby. Women being treated with SARCLISA^® must use effective contraception during treatment and for at least 5 months after treatment.

If you are producing breast milk, you and your doctor will decide whether the benefit of breastfeeding is greater than the risk of the medicine to your baby. The medicine may pass into the mother’s milk and it is not known whether it will affect the baby.

Infusion-Related Reactions

Infusion-related reactions can happen during SARCLISA^® infusion or after the infusion and may be serious. Tell your doctor or nurse immediately if you feel unwell during or after an infusion of SARCLISA^®. These symptoms may include:

Feeling short of breath
Cough
Stuffy or runny nose
Chills
Nausea
Vomiting

Severe symptoms of infusion-related reactions are less common, including:

High blood pressure (hypertension)
Low oxygen level in the blood (hypoxia)
Low blood pressure (hypotension)
Fast heartbeat (tachycardia)
High level of blood sugar (hyperglycemia)
Swollen face, lips, mouth, tongue or throat

If you have an infusion-related reaction, you may need other medicines to treat your symptoms or the infusion may need to be slowed down or stopped. When these reactions go away or get better, the infusion can be started again.

Blood Transfusion

If you need a blood transfusion, you will need to take a blood test first so that your blood type can be matched. SARCLISA^® can affect the evaluation of the results of this blood test. Tell the person doing the test that you are taking SARCLISA^®. Your doctor should do blood tests to match your blood type before you start treatment with SARCLISA^®.

White Blood Cell Counts

SARCLISA^® can decrease the number of your white blood cells, which are important in fighting infections. Your doctor will monitor your white blood cells during SARCLISA^® treatment. You may receive other medications to treat low white blood cells.

Your doctor may prescribe an antibiotic or antiviral medicine (for example, for herpes zoster) to help prevent infection, or a medicine to help increase your white blood cell counts during treatment with SARCLISA^®.

Infections

SARCLISA^®, when combined with other drugs including pomalidomide and dexamethasone or carfilzomib and dexamethasone, may increase the risk of infections. These infections can be severe or life-threatening. Tell your doctor right away if you have a fever or chill, feel very tired, have a cough or have flu-like symptoms.

Difficulty Driving or Using Machines

SARCLISA^® is not expected to affect your ability to drive or use machines; however, fatigue and dizziness have been reported by patients taking SARCLISA^®. If you experience any side effects, it is recommended that you not drive or use any machines before discussing with your doctor, pharmacist or nurse.

Heart Problems

SARCLISA^® can cause heart problems and/or make your heart beat faster. Tell your doctor or nurse if you have any heart problems, or if you have ever taken a medicine for your heart. During SARCLISA^® treatment, if you feel heart racing, irregular heartbeat, dizziness, shortness of breath, chest pain, cough or leg swelling, contact your doctor or nurse immediately.

New Cancers

New cancers have happened in patients during treatment with SARCLISA^®. It is not clear if SARCLISA^® has caused the new cancers. Your doctor will monitor you for new cancers.

Possible Side Effects

These are not all the possible side effects you may feel when taking SARCLISA^®. If you experience any side effects not listed here, contact your healthcare professional:

Headache
Dizziness
Feeling tired
Decreased appetite
Hiccups
Runny or stuffy nose, sneezing, coughing, sore or scratchy throat (infection of the upper airways, such as nose, sinuses or throat)
Nausea, vomiting
Diarrhea
Abdominal pain or discomfort
Heartburn
Swelling of the hands or legs
Muscle, bone or joint pain
Decreased body weight
Feeling anxious
Blurred vision
High blood sugar
Loss of bladder control (urinary incontinence)
High blood pressure (hypertension)
Hot flushes

Other Possible Side Effects You Should Know About

Very Common (1 in 10 people)

Infusion-Related Reactions

Symptoms can include one or more of the following: feeling short of breath; cough; stuffy or runny nose; chills; nausea; high blood pressure (hypertension); fast heartbeat; low blood pressure; swollen face, lips, mouth, tongue or throat.

If you experience any of these symptoms, stop taking SARCLISA^® and get immediate medical help.

Low Number of Blood Cells (Platelets, White Blood Cells and Red Blood Cells)

Platelets (thrombocytopenia)
- Symptoms may include unusual bruising or bleeding
White blood cells (neutropenia or lymphopenia)
Red blood cells (anemia)
- Symptoms may include fatigue, loss of energy, weakness or shortness of breath

Lung Infections

Infections may include pneumonia, bronchitis and lower respiratory tract infections.

Symptoms can include congestion, cough (may produce phlegm), body ache, tiredness, wheezing, shortness of breath, chest pain when breathing or coughing, fever, sweating and chills, and confusion or change of mental awareness (mostly in older patients).

Shortness of Breath

Common (less than 1 in 10, but more than 1 in 100)

Herpes Viral Infection

This infection can present as a cold sore, shingles or chickenpox. Symptoms can include a sore on the lip or in the mouth, painful blisters on the skin, fever, feeling tired, body ache, rash, or red spots and blisters over the entire body.

Irregular or Rapid Heartbeat

Symptoms can include heart racing, irregular heartbeat, dizziness, shortness of breath and chest pain.

Squamous Cell Carcinoma of the Skin

This may appear as a firm, red nodule or a flat sore with a rough scaly patch on the skin, lips or inside the mouth.

Pulmonary Embolism

Symptoms can include suddenly feeling short of breath, sharp chest pain, cough, heart racing, sweating, feeling anxious and fainting.

Heart Problems

Symptoms may present as difficulty breathing, cough, or leg swelling when SARCLISA^® is given with carfilzomib and dexamethasone.

Rare (may affect up to 1 in 100 people)

Serious Allergic Reaction (Anaphylactic Reaction)

These symptoms may include rash; itching; difficulty breathing; shortness of breath; swelling of the face, mouth, throat or tongue; cold, clammy skin; palpitations; dizziness; weakness or fainting.

Reporting Side Effects

If you develop any symptoms or experience side effects that are not listed on this website, talk to your doctor or nurse. 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) 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.

Who should not take SARCLISA^®?

You should not take SARCLISA^® if you are allergic to isatuximab or any of the other ingredients in SARCLISA^®.

SARCLISA^® is not recommended for use in children and adolescents under the age of 18.