Patient Medication Information: uses, side effects, how to take - Kadcyla

What is Kadcyla used for?

Kadcyla pronounced “Kad-s(eye)-la” is used to treat people with breast cancer when:

the cancer cells produce a large amount of HER2 proteins - your healthcare provider will test your cancer for this
you have already received the medicine trastuzumab separately or in combination with a chemotherapy medicine from the class called taxane e.g. paclitaxel or docetaxel

Serious Warnings and Precautions

Medication Errors: There is a risk of Kadcyla overdose due to medication errors. Verify with the healthcare professional that the authorized Kadcyla (trastuzumab emtansine) dose and NOT trastuzumab is used.
Liver Problems: Kadcyla can cause inflammation and damage to liver cells. Severe liver damage may result in liver failure and death. To monitor liver problems, your blood will be checked regularly for increases in levels of liver enzymes.
Heart Problems: Kadcyla can weaken the heart muscle leading to problems pumping the blood around your body and causing shortness of breath at rest, chest pain, swollen ankles or arms, and a sensation of rapid or irregular heartbeats. Your heart function will be checked before and regularly during treatment.
Bleeding Problems: Platelets in the blood help blood clot. Kadcyla can lower the number of platelets in your blood and cause life-threatening bleeding. In some cases, bleeding has been fatal. The risk of bleeding is increased when taking Kadcyla with other medications used to thin your blood or prevent blood clots. Your doctor should provide additional monitoring if you are taking one of these other drugs.
Lung problems: Kadcyla can cause lung problems, including inflammation (swelling) of the lung tissue, leading to lung failure and death.
Embryo-fetal toxicity (Harm to Unborn Baby): Kadcyla can cause harm to the fetus (unborn baby), or death of the fetus, when taken by a pregnant woman. Women who could become pregnant need to use two effective birth control methods during Kadcyla treatment and for at least 7 months after treatment with Kadcyla.

the cancer has spread to areas near the breast or to other parts of your body (metastasized)
the cancer has not spread to other parts of the body and treatment is going to be given after surgery (treatment after surgery is called adjuvant therapy)

How does Kadcyla work?

Kadcyla is made up of two types of medicine that are linked together. One part belongs to a group of medicines called monoclonal antibodies (trastuzumab) and the other belongs to a group of medicines called anti-mitotics (DM1).

Kadcyla recognizes the cancer cells in the body by attaching to HER2 proteins. When Kadcyla attaches to the HER2 cancer cells, it may slow or stop the growth of the cancer or may also kill the cancer cells. After Kadcyla attaches to HER2 proteins, it enters the cancer cells where it releases the anti-mitotic drug DM1. DM1 may also kill the cancer cells.

What are the ingredients in Kadcyla?

Medicinal ingredients: trastuzumab and DM1

Non-medicinal ingredients: polysorbate 20, sodium hydroxide, succinic acid, and sucrose.

Kadcyla comes in the following dosage forms:

Single-use vial containing either 100 mg or 160 mg of trastuzumab emtansine.

Do not use Kadcyla if:

You are allergic to this drug, to any ingredients in the formulation (see ’What are the ingredients in Kadcyla’), or to a component of the container. If you are not sure, talk to your healthcare professional before you are given Kadcyla.

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

have ever had a serious infusion-related (allergic) reaction when treated with trastuzumab
are receiving treatment with blood thinner medications
have any history of liver problems. Your doctor will check your blood to test your liver function before and regularly during treatment.
are pregnant, think you may be pregnant or are planning to have a baby.

Other warnings you should know about:

Kadcyla can make some existing conditions worse, or cause side effects. See ‘What are the possible side effects of using Kadcyla?’ below.

Patients aged below 18 years: Kadcyla should not be used in these patients as there is no information on how well it works and if it is safe to use in these younger patients.

Pregnancy, breast-feeding and fertility: Kadcyla is not recommended if you are pregnant. There is no information about the safety of Kadcyla in pregnant women. Kadcyla may affect fertility based on animal studies.

Tell your doctor before using Kadcyla if you are pregnant, think you may be pregnant or are planning to have a baby.
Use effective contraception to avoid becoming pregnant while you are being treated with Kadcyla. Also, use this contraception for 7 months after your last dose. Female partners of male patients should also use effective contraception. Talk to your healthcare provider about the best contraception for you.
If you do become pregnant during treatment with Kadcyla, tell your healthcare provider straight away.

Do not breast-feed during treatment with Kadcyla and for 7 months after stopping treatment. It is not known whether the ingredients in Kadcyla pass into breast-milk. Talk to your doctor about this.

Driving and using machines: Kadcyla may impair your ability to drive or use machines by causing symptoms such as tiredness, headache, dizziness, and blurred vision. If you experience infusion-related reactions (e.g. flushing, shivering fits, fever, trouble breathing, low blood pressure, rapid heartbeat, sudden swelling of your face, tongue, or trouble swallowing) do not drive and use machines until symptoms abate completely.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Kadcyla:

Tell your healthcare professional if you are taking, have recently taken or might take any other medicines.

This includes medicines obtained without a prescription and herbal medicines. In particular, tell your healthcare professional if you are taking blood thinners.

How to take Kadcyla:

Kadcyla will be given to you by a healthcare professional in a hospital or clinic:

Usual dose:

It is given by a drip into a vein (intravenous infusion) once every 3 weeks at a starting dose of 3.6 mg of Kadcyla for every kilogram of your body weight.
The first infusion will be given to you over 90 minutes. You will be watched by a healthcare provider while it is being given and for at least 90 minutes following the initial dose, in case you have any side effects.
If the first infusion is well tolerated, the infusion on your next visit may be given over 30 minutes. You will be watched by a healthcare provider while it is being given and for at least 30 minutes following the dose, in case you have any side effects.
The total number of infusions that you will be given depends on how you respond to the treatment and which indication is treated.
If you experience side effects, your doctor may decide to carry on your treatment but lower your dose, delay the next dose or stop the treatment.

Overdose:

If you think you have been given too much Kadcyla, tell your healthcare professional, hospital emergency department or regional poison control centre immediately even if there are no symptoms.

There is a risk of Kadcyla overdose due to medication errors. Verify with the healthcare professional that the authorized Kadcyla (trastuzumab emtansine) dose and NOT trastuzumab dose is used.

Missed Dose:

If you forget or miss your Kadcyla appointment, discuss this as soon as possible with your healthcare professional to make another appointment.

Do not stop having this medicine without talking to your healthcare professional first. If you have any further questions on the use of this medicine, ask your healthcare professional.

What are possible side effects from using Kadcyla?

Like all medicines, this medicine can cause unwanted effects. Tell your health care professional if you notice any of the side effects given below.

Very common (may affect more than 1 in 10 people):

Jaundice
Unexpected bleeding
Tiredness
Feeling sick (nausea, vomiting)
Headache
Muscle or joint pain
Abdominal pain
Constipation
Nerve damage
Diarrhea
Dry mouth
Swelling of the mouth
Chills or flu like symptoms
Difficulty sleeping
Decrease in your potassium levels (shown in a blood test)
Decreased red blood cells (shown in a blood test)

Common (may affect up to 1 in 10 people):

Heart problems
Allergic reactions during or following infusions
Decreased white blood cells (shown in a blood test)
Swollen mouth or eyelids
Dry eyes, watery eyes or blurred vision
Increase in blood pressure
Dizziness
Loss of taste
Itching
Breathing problems, including shortness of breath
Memory loss

Uncommon (may affect up to 1 in 100 people):

Kadcyla can cause a condition known as nodular regenerative hyperplasia of the liver. Over time, this may lead to symptoms such as a bloated sensation or swelling of the abdomen due to fluid accumulation or bleeding from abnormal blood vessels in the gullet or rectum.

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

If you get any of the side effects after your treatment with Kadcyla has been stopped, talk to your doctor and tell them that you have been treated with Kadcyla.

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
VERY COMMON Unexpected bleeding from the nose, gums	✓
Your skin and whites of your eyes get yellow		✓
COMMON Shortness of breath at rest, chest pain, swollen ankles or arms, sensation of rapid or irregular heartbeats		✓
Tenderness or redness of your skin, pain, or swelling at the injection site. In rare cases, burning sensation, blistering and ulcerative injury can be developed		✓
Flushing, shivering fits, fever, trouble breathing, low blood pressure, rapid heartbeat, sudden swelling of your face, tongue, trouble swallowing		✓
Tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet	✓
Shortness of breath, cough with fever		✓
UNCOMMON	✓

Blood in stools, swelling of the abdomen
If you become pregnant		✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

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 (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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Kadcyla will be stored by the healthcare professionals at the hospital or clinic.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton after EXP. The expiry date refers to the last day of that month.
Store vials in a refrigerator at 2-8°C.

When prepared as a solution for infusion, Kadcyla is stable for up to 24 hours at 2-8°C, and must be discarded thereafter. Do not use Kadcyla if you notice any particles or it is the wrong colour (see ‘What dosage forms it comes in’).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

If you want more information about Kadcyla:

Talk to your healthcare professional
Find the full product monograph that is prepared for health professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.rochecanada.com, or by calling 1-888-762-4388

Last Revised: October 13, 2022

Kadcyla^®is a registered trade-mark of F. Hoffmann-La Roche AG, used under license

Hoffmann-La Roche Limited

Mississauga, ON L5N 5M8

Kadcyla: Uses, Side Effects and Dosage