Ado-trastuzumab Emtansine

Ado-trastuzumab emtansine is a prescription medication used to treat a certain type of breast cancer. It used when the cancer has spread to other parts of the body and has not improved or has worsened after treatment with other medications. Ado-trastuzumab emtansine belongs to a group of drugs called antibody-drug conjugates. It works by killing cancer cells.

Ado-trastuzumab emtansine injection comes as a powder to be mixed with liquid and injected slowly into a vein by a healthcare professional.

Common side effects include constipation, nausea, headache, and fatigue. Do not drive or operate heavy machinery until you know how this medication will affect you.

Breast cancer is a cancer that forms in the cells of the breasts. Some women have (HER2+) breast cancer. (HER2+) stands for Human Epidermal growth factor receptor 2 positive. (HER2) is a special protein found on breast cancer cells that controls cancer growth and spread.

Ado-trastuzumab emtansine is approved for treatment of HER2 positive breast cancer, because it is specifically designed to target the HER2 protein. By binding to the HER2 protein, ado-trastuzumab emtansine prevents the growth of cancer cells.

HER2 testing is done to see whether treatment with ado-trastuzumab emtansine will likely be effective in treating breast cancer. If testing is not done, treatment with this medication may not be an effective treatment.

Ado-trastuzumab emtansine is a prescription medication used to treat a certain type of breast cancer. It used when the cancer has spread to other parts of the body and has not improved or has worsened after treatment with other medications.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
 

Ado-trastuzumab Emtansine may be found in some form under the following brand names:

• Kadcyla

Common side effects include the following:

• constipation
• diarrhea
• upset stomach
• sores in the mouth and throat
• dry mouth
• changes in ability to taste
• joint or muscle pain
• headache
• dry, red, or teary eyes
• blurry vision
• trouble falling asleep or staying asleep

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
 

Ado-trastuzumab emtansine should be taken with caution with certain other medications that can change the way it is metabolized. Let your doctor know about other medications including supplements you may be taking before starting ado-trastuzumab emtansine. Medications that interact with ado-trastuzumab include:

• Ketoconazole
• Itraconazole
• Telithromycin
• Clarithromycin
• Ritonavir
• Indinavir
• Nelfinavir
• Salquinavir
• Nefazdone
• Chloramphenicol
• Clozapine

This is not a complete list of interactions with ado-trastuzumab emtasine. 

Serious side effects have been reported with ado-trastuzumab emtansine including the following:

• Ado-trastuzumab emtansine injection may cause serious infusion-related reactions, which may occur during the infusion of the medication. If you experience any of the following symptoms, tell your doctor immediately: flushing; fever; chills; dizziness; lightheadedness; fainting; shortness of breath; difficulty breathing; or fast, irregular, or pounding heartbeat.
• Ado-trastuzumab emtansine may cause serious or life-threatening liver problems. Tell your doctor if you have or have ever had liver disease, including hepatitis. Your doctor will order laboratory tests regularly before and during your treatment to see if ado-trastuzumab emtansine is affecting your liver. Your doctor may tell you that you should not receive this medication if the tests show that you have liver problems. Tell your doctor and pharmacist about all the medications you are taking so they can check whether any of your medications may increase the risk that you will develop liver damage during your treatment with ado-trastuzumab emtansine. Call your doctor immediately if you experience any of the following symptoms: nausea, vomiting, extreme tiredness, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, dark-colored urine, or flu-like symptoms.
• Ado-trastuzumab emtansine also may cause serious or life-threatening heart problems. Tell your doctor if you have or have ever had heart disease, a heart attack, chest pain, or irregular heartbeats. Your doctor will order tests before and during your treatment to see if your heart is working well enough for you to safely receive ado-trastuzumab emtansine. Your doctor may tell you that you should not receive this medication if the tests show your heart's ability to pump blood has decreased. If you experience any of the following symptoms, call your doctor immediately: cough; shortness of breath; swelling of the arms, hands, feet, ankles or lower legs; weight gain (more than 5 pounds [about 2.3 kilograms] in 24 hours); dizziness; loss of consciousness; or fast, irregular, or pounding heartbeat.
• Tell your doctor if you are pregnant or plan to become pregnant. Ado-trastuzumab emtansine may harm your unborn baby. You should use birth control to prevent pregnancy during your treatment and for 6 months after your treatment. Talk to your doctor about birth control methods that will work for you. If you become pregnant during your treatment with ado-trastuzumab emtansine, call your doctor immediately.

Do not drive or operate heavy machinery until you know how this medication will affect you.

Grapefruit and grapefruit juice may interact with this medication and can lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before receiving ado-trastuzumab emtansine,

• tell your doctor and pharmacist if you are allergic to ado-trastuzumab emtansine, trastuzumab, any other medications, or any of the ingredients in ado-trastuzumab emtansine injection. Ask your doctor or pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had any of the conditions mentioned in the "Ado-trastuzumab Emtansine Precautions" section.
• tell your doctor if you have or have ever had trouble breathing, even when resting, or any other medical condition.
• tell your doctor if you are breast-feeding. You should not breast-feed while receiving ado-trastuzumab emtansine.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Ado-trastuzumab emtansine may harm your unborn baby. You should use birth control to prevent pregnancy during your treatment and for 6 months after your treatment. Talk to your doctor about birth control methods that will work for you. If you become pregnant during your treatment with ado-trastuzumab emtansine, call your doctor immediately.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if this medication crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using this medication.
 

Ado-trastuzumab emtansine injection comes as a powder to be mixed with liquid and injected slowly into a vein by a healthcare professional. It is usually injected once every 3 weeks. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose is 3.6 mg/kg given every 3 weeks (21-day cycle).

Since this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

Keep all appointments with your doctor and the laboratory.

• Do not substitute ado-trastuzumab emtansine for or with trastuzumab.
• Hepatotoxicity, liver failure and death have occurred in patients treated with ado-trastuzumab emtansine. Monitor hepatic function prior to initiation and prior to each dose. Institute dose modifications or permanently discontinue as appropriate.
• Ado-trastuzumab emtansine may lead to reductions in left ventricular ejection fraction (LVEF). Assess LVEF prior to initiation. Monitor and withhold dosing or discontinue as appropriate.
• Can cause fetal harm. Advise women of potential risk to the fetus.