100 mg and 160 mg powder for concentrate for infusion solution
trastuzumab emtansine
What Kadcyla is and what it is used for
What Kadcyla is
Kadcyla contains the active substance trastuzumab emtansine which consists of two linked parts:
- trastuzumab – a monoclonal antibody that binds selectively to an antigen (a target protein) called human epidermal growth factor receptor 2 ( HER2 ). HER2 is found in large amounts on the surface of certain cancer cells and stimulates cell growth there. When trastuzumab binds to HER2 , the growth of cancer cells is stopped, leading to their death.
- DM1 – a substance against cancer that becomes active when Kadcyla enters the cancer cell.
What Kadcyla is used for
Kadcyla is used to treat breast cancer in adults when:
- the cancer cells have abnormally many HER2 – protein you – your doctor will test your cancer cells for this.
- You have already been given a medicine containing trastuzumab and a medicine containing taxa.
- either the cancer has spread to areas near the breast or to other parts of the body (metastasized).
- or when the cancer has not spread to other parts of the body and the treatment is to be given after surgery (treatment after surgery where all known cancer has been removed is called adjuvant treatment).
What you need to know before you use Kadcyla
Do not use Kadcyla
- if you are allergic to trastuzumab emtansine or any of the other ingredients of this medicine (listed in section 6).
You should not use Kadcyla if the above applies to you. If you are not sure, talk to your doctor or nurse before using Kadcyla.
Warnings and cautions
Talk to your doctor or nurse before using Kadcyla if:
- you have had a severe infusion-related reaction when using trastuzumab which is characterized by symptoms such as hot flashes, chills, fever, shortness of breath, difficulty breathing, palpitations or a drop in blood pressure,
- you are being treated with blood thinners (eg warfarin or heparin ),
- you have ever had liver problems. Your doctor will take blood samples to check your liver function before and regularly during treatment.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Kadcyla.
Be aware of side effects.
Cancel may aggravate certain existing conditions or cause side effects. See section 4 for more information on the possible side effects.
Tell your doctor or nurse immediately if you notice the following serious side effects while using Kadcyla:
- Respiratory problems : Cadcyla can cause severe breathing problems such as shortness of breath (either at rest or while performing any type of activity), and coughing. These can be signs of inflammation in the lungs which can be serious and even life threatening. If you develop lung disease, your doctor may stop treatment with this medicine.
- Liver problems : Kadcyla can cause inflammation or damage to cells in the liver that can prevent the liver from functioning normally. Inflamed or damaged liver cells can leak more than normal amounts of certain substances (liver enzymes) into the bloodstream, resulting in elevated levels of liver enzymes in blood samples. In most cases, you get no symptoms. Some symptoms may be that the skin and whites of the eyes turn yellow (jaundice). Your doctor will check your blood to test your liver function before and regularly during treatment.
Another rare disorder that can occur in the liver is a condition called nodular regenerative hyperplasia.(NRH). This deviation means that the structure of the liver changes and can change the function of the liver. Over time, it can lead to symptoms such as a bloated feeling or swelling in the abdomen due to fluid retention or bleeding from altered blood vessels in the esophagus or rectum. - Heart problems : Kadcyla can affect the heart muscle. When the heart muscle is weak, patients may develop symptoms such as shortness of breath at rest or during sleep, chest pain, swollen legs or arms and a feeling of rapid or irregular heartbeat. Your doctor will check your heart function before and regularly during treatment. You should tell your doctor immediately if you get any of the above symptoms.
- Infusion-related reactions or allergic reactions : Kadcyla may cause hot flashes, tremors, fever, difficulty breathing, low blood pressure , rapid heartbeat, sudden swelling of the face, tongue or difficulty swallowing during infusion one or after infusion one during the first day of treatment. Your doctor or nurse will check if you get any of these side effects . If you experience a reaction, they will slow down the drip rate or stop the infusion and may give you a treatment to counteract the side effects . Infusion one can be continued after the symptoms have improved.
- Bleeding problems: Kadcyla can reduce the number of platelets in the blood. Because platelets help coagulate the blood, you can get unexpected bruising or bleeding (such as nosebleeds or gum bleeding). Your doctor will check your blood regularly for signs of a low platelet count . You should tell your doctor immediately if you notice any unexpected bruising or bleeding.
- Neurological problems : Kadcyla can damage the nerves. You may experience a tingling sensation, pain, numbness, itching , crawling and tingling in the hands and feet. Your doctor or nurse will monitor you for signs and symptoms of neurological problems.
- Injection site reactions : If you experience a burning sensation, pain or tenderness at the infusion site during infusion , it may indicate that Kadcyla has leaked outside the blood vessel. Tell a doctor or nurse immediately. If Kadcyla has leaked outside the blood vessel, increased pain, discoloration, blisters and skin detachment (skin necrosis) may occur within days or weeks after the infusion .
Tell your doctor or nurse immediately if you experience any of the above side effects.
Children and young people
Kadcyla is not recommended for anyone under 18 years of age. This is because there is no information on how the medicine works for this age group.
Other medicines and Kadcyla
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are using:
- blood-thinning drugs such as warfarin or drugs that reduce the risk of blood clots such as acetylsalicylic acid
- antifungal medicines containing ketoconazole , itraconazole or voriconazole
- antibiotics for infections that contain clarithromycin or telithromycin
- HIV medicines containing atazanavir, indinavir, nelfinavir, ritonavir or saquinavir,
- antidepressants containing nefazodone.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Kadcyla.
Pregnancy
Kadcyla is not recommended if you are pregnant as this medicine may cause harm to the unborn baby.
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
- Use effective contraception to avoid getting pregnant while you are being treated with Kadcyla. Consult a doctor about the most suitable method of contraception for you.
- Also use this method of contraception 7 months after the last dose of Kadcyla. Talk to your doctor before stopping contraception.
- Male patients or their female partners should also use effective contraception.
- Tell your doctor immediately if you become pregnant during treatment with Kadcyla.
Breast-feeding
You should not breastfeed during treatment with Kadcyla. You should also not breastfeed for 7 months after the last infusion of Kadcyla. It is unknown if the substances in Kadcyla are converted to breast milk. Talk to your doctor about this.
Driving and using machines
Kadcyla is not expected to affect your ability to drive, ride a bicycle, use tools or machines. If you experience hot flashes, tremors, fever, difficulty breathing, low blood pressure or rapid heartbeat (infusion-related reaction), blurred vision, fatigue, headache, or dizziness, do not drive, cycle, use tools or machines until these reactions have stopped.
Important information about some of the ingredients of Kadcyla
This medicine contains less than 1 mmol sodium (23 mg) per dose. It is practical “sodium-free”.
How to use Kadcyla
You will receive Kadcyla from a doctor or nurse at a hospital or clinic:
- It is given as a drip into a vein ( intravenous infusion ).
- You will receive an infusion every three weeks.
How much you get
- You will receive 3.6 mg of Kadcyla for every kilogram of your body weight. Your doctor will calculate the correct dose for you.
- The first infusion one you get in 90 minutes. You will be observed by a doctor or nurse while the infusion is in progress and for at least 90 minutes after the starting dose in case you get any side effects .
- If the first infusion is well tolerated, infusion one during your next visit can be given for 30 minutes. You will be observed by a doctor or nurse while infusion one is in progress and for at least 30 minutes after dose one in case you get any side effects .
- The total number of infusions you receive depends on how you respond to the treatment and what indication is being treated.
- If you experience side effects , your doctor may decide to continue treatment but lower the dose , delay the next dose or stop the treatment.
If you forget a treatment with Kadcyla
If you forget or miss your Kadcyla treatment visit, make an appointment for another visit as soon as possible. Do not wait for your next scheduled visit.
If you stop taking Kadcyla
Do not stop treatment with this medicine without talking to a doctor first.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, talk to your doctor or nurse immediately.
Very common (may affect more than 1 in 10 people):
- Cadcyla can cause inflammation or damage to liver cells resulting in elevated levels of liver enzymes in blood samples. In most cases during treatment with Kadcyla, liver enzyme levels rise slightly and temporarily, causing no symptoms or affecting liver function.
- Unexpected bruising or bleeding (such as nosebleeds).
- Stinging sensation, pain, numbness, itching , crawling and tingling in the hands and feet. These symptoms may indicate nerve damage.
Common (may affect up to 1 in 10 people):
- Hot flushes, tremors, fever, difficulty breathing, low blood pressure or rapid heartbeat during infusion or up to 24 hours after infusion – these are so-called infusion-related reactions.
- Heart problems can occur. Most patients do not get symptoms of heart problems. If symptoms occur, they may include: cough, shortness of breath at rest or while sleeping in supine position, chest pain and swollen ankles or arms, a feeling of rapid or irregular heartbeat.
Uncommon (may affect up to 1 in 100 people):
- Pneumonia can cause breathing problems such as shortness of breath (either at rest or during any type of activity), cough or cough attacks with dry cough – these are signs of inflammation in the lung tissue.
- Your skin and whites of the eyes turn yellow (jaundice) – these can be signs of severe liver damage.
- Allergic reactions can occur and most patients have mild symptoms such as itching or pressure over the chest. In more severe cases, swelling of the face or tongue, difficulty swallowing or difficulty breathing may occur.
No known frequency:
- If Kadcyla infusion solution leaks into an area around the infusion site, you may develop pain, discoloration, blisters and skin detachment (skin necrosis) at the infusion site. Tell a doctor or nurse immediately.
Tell your doctor or nurse immediately if you experience any of the above side effects.
Other side effects include
Very common:
- decreased number of red blood cells (shown in a blood test)
- nausea (vomiting)
- diarrhea
- dry mouth
- urinary tract infection
- constipation
- magont
- cough
- respiratory distress
- inflammation of the mouth
- difficulty sleeping
- muscle or joint pain
- fever
- headache
- feeling tired
- weakness
Usual:
- chills or flu-like symptoms
- decreased levels of potassium (shown in a blood test)
- rash
- decreased white blood cell count (shown in a blood test)
- dry eyes, watery eyes or blurred vision
- redness or infection
- indigestion
- swollen legs and / or arms
- gum bleeding
- high blood pressure
- dizziness
- taste disorders
- itching
- memory difficulties
- hair loss
- hand and foot skin reaction (palmoplantar erythrodystesis syndrome)
- nail changes
Uncommon:
- Another disorder that can be caused by Kadcyla is a condition called nodular regenerative hyperplasia (NRH) in the liver. This abnormality causes the structure of the liver to change. Patients develop several nodules in the liver that can alter liver function. Over time, it can lead to symptoms such as a bloated feeling or swelling in the abdomen due to fluid retention or bleeding from altered blood vessels in the esophagus or rectum.
- If the Kadcyla infusion solution leaks into an area around the infusion site, you may develop soreness or redness of the skin or swelling at the infusion site.
If you get any side effects after treatment with Kadcyla, talk to your doctor or nurse and tell them you have been treated with Kadcyla.
How to store Kadcyla
Kadcyla is stored by 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 expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
- When Kadcyla is ready as an infusion solution, it is stable for up to 24 hours between 2 ° C and 8 ° C and must be discarded.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is trastuzumab emtansine.
- Kadcyla 100 mg: One vial of powder for concentrate for solution for infusion contains 100 mg trastuzumab emtansine. After reconstitution , one vial contains 5 ml of solution containing 20 mg / ml trastuzumab emtansine.
- Kadcyla 160 mg: One vial of powder for concentrate for solution for infusion contains 160 mg trastuzumab emtansine. After reconstitution , one vial contains 8 ml of solution containing 20 mg / ml trastuzumab emtansine.
- The other ingredients are succinic acid, sodium hydroxide (see section 2 under the heading ‘Important information about some of the ingredients of Kadcyla’, sucrose and polysorbate 20).
What the medicine looks like and contents of the pack
- Kadcyla is a white to slightly yellow lyophilised powder for concentrate for solution for infusion , which is supplied in glass vials.
- Kadcyla is available in packs of 1 vial .
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil Barell Strasse 1
D 79639 Grenzach Wyhlen
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| SwedenRoche ABTel: +46 (0) 8 726 1200 | Finland / FinlandRoche OyPuh / Tel: +358 (0) 10 554 500 |