Ado-trastuzumab emtansine Intravenous

Name: Ado-trastuzumab emtansine Intravenous

Commonly used brand name(s)

In the U.S.

  • Kadcyla

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antibody Drug Conjugate

Before Using ado-trastuzumab emtansine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ado-trastuzumab emtansine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ado-trastuzumab emtansine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ado-trastuzumab emtansine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ado-trastuzumab emtansine injection in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving ado-trastuzumab emtansine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ado-trastuzumab emtansine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atazanavir
  • Boceprevir
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Nefazodone
  • Nelfinavir
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Telithromycin
  • Tipranavir
  • Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ado-trastuzumab emtansine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use ado-trastuzumab emtansine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of ado-trastuzumab emtansine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Heart failure, history of or
  • Interstitial lung disease or
  • Liver disease or
  • Peripheral neuropathy (nerve disorder) or
  • Pneumonitis (lung disease) or
  • Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

Precautions While Using ado-trastuzumab emtansine

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Using ado-trastuzumab emtansine while you are pregnant may cause very serious birth defects. Use an effective form of birth control to keep from getting pregnant during treatment and for 7 months after the last dose. There is also a potential for ado-trastuzumab emtansine to cause birth defects if the father is using it when his sexual partner becomes pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper right stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

ado-trastuzumab emtansine may cause heart failure. Your doctor may test your heart before and during treatment. Contact your doctor right away if you have chest pain, increased coughing, trouble breathing, rapid weight gain, or swelling in your ankles or legs. These could be symptoms of heart failure.

Tell your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while receiving ado-trastuzumab emtansine. These could be symptoms of a serious lung problem.

Ado-trastuzumab emtansine may cause a serious infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a fever, chills, chest pain, fast or uneven heartbeat, lightheadedness, dizziness, fainting, headache, rash, trouble breathing, or weakness while you receive the medicine or after the infusion.

ado-trastuzumab emtansine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Talk with your doctor before using ado-trastuzumab emtansine if you plan to have children. Some men and women who use ado-trastuzumab emtansine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Uses

Ado-trastuzumab emtansine is used alone to treat certain types of breast cancer. This medication is used to treat tumors that produce more than the normal amount of a certain substance called HER2 protein.

This medication is called a monoclonal antibody and microtubule inhibitor conjugate. Ado-trastuzumab emtansine works by attaching to the HER2 cancer cells and blocking them from dividing and growing. It may also destroy the cancer cells or signal the body (immune system) to destroy the cancer cells.

How to use Ado-Trastuzumab Emtansine Solution, Reconstituted (Recon Soln)

See also Warning and Side Effects sections.

Ado-trastuzumab emtansine may also be called trastuzumab emtansine. However, ado-trastuzumab emtansine is not the same as trastuzumab. Do not substitute trastuzumab for ado-trastuzumab emtansine.

This medication is given by slow injection into a vein by a health care professional. It is given as directed by your doctor, usually once every 3 weeks. Your first infusion will be given over at least 90 minutes.

The dosage, the speed of your injection, and the length of time you receive ado-trastuzumab emtansine is based on your body weight, medical condition, and response to treatment.

To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.

Your doctor may prescribe other medications (such as acetaminophen, diphenhydramine) for you to take before the start of your treatment to help prevent serious side effects.

Side Effects

See also Warning section.

Diarrhea, redness/irritation at the injection site, dizziness, muscle/joint/back pain, stomach/abdominal pain, constipation, trouble sleeping, nausea, vomiting, mouth sores, dry mouth, changes in taste, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: bone pain, increased coughing, swelling of the hands/ankles/feet, unusual tiredness, severe headache, tingling/numbness (such as in the hands, feet, leg), mental/mood changes, fast/pounding heartbeat, muscle cramps, easy bruising/bleeding.

This drug has caused very serious (rarely fatal) bleeding. Get medical help right away if you develop symptoms of very serious bleeding, including: weakness on one side of the body, slurred speech, vision changes, confusion, severe stomach/abdominal pain, trouble breathing, vomit that is bloody or looks like coffee grounds, black/tarry stool.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

This medication can sometimes cause a serious infusion reaction with serious lung problems. Immediately tell your doctor of the following side effects that occur while this drug is being given or within 24 hours after your treatment is finished, such as chills, fever, flushing, wheezing, shortness of breath, nausea, headache, dizziness, fainting, rash, and weakness.

Ado-trastuzumab emtansine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Ado-Trastuzumab Emtansine Solution, Reconstituted (Recon Soln) side effects by likelihood and severity.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as heart exams, platelet counts, liver function, bilirubin level) should be done before you start using this medication and while you are using it. A pregnancy test should also be done before starting treatment. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a clinic or hospital and will not be stored at home.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

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