Treatment FAQ

what treatment comes after kadcyla

by Linnea Casper Published 3 years ago Updated 2 years ago
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Enhertu is the second HER2-targeting ADC approved by the US Food and Drug Administration (FDA) after Roche's Kadcyla (ado-trastuzumab etamine), which was approved in 2013 for HER2-positive (HER2+) unresectable or metastatic breast cancer in the second line.Oct 20, 2021

Precautions

Kadcyla is used both for early breast cancer and for breast cancer that has spread to other parts of the body (metastatic). Kadcyla is usually given after other cancer medications have been tried without success. Kadcyla should not be used in place of Herceptin (trastuzumab). Do not use Kadcyla if you are pregnant. It could harm the unborn baby.

What should I know about Kadcyla before taking it?

For HER2+ metastatic breast cancer that has spread, Kadcyla is given once every 3 weeks on an ongoing basis. In both cases, you may need to stop treatment if the cancer returns or the side effects are intolerable.

When should I stop taking Kadcyla for metastatic breast cancer?

Kadcyla is usually given once every 3 weeks. Your doctor will determine how long to treat you. You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results. -Administer the first infusion over 90 minutes.

How long does it take for a Kadcyla infusion to work?

Cardiac Toxicity: Kadcyla administration may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate left ventricular function in all patients prior to and during treatment with Kadcyla. Withhold treatment for clinically significant decrease in left ventricular function.

Can Kadcyla cause low LVEF?

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Is there an alternative to Kadcyla?

Enhertu (chemical name: fam-trastuzumab-deruxtecan-nxki) more than doubled the 12-month progression-free survival rate than Kadcyla (chemical name: T-DM1 or ado-trastuzumab emtansine) in people diagnosed with metastatic HER2-positive breast cancer that had been previously treated, according to results from the DESTINY- ...

How long can you be on Kadcyla?

Official answer. If you have been diagnosed with HER2+ early-stage breast cancer, Kadcyla is given as an intravenous (IV) infusion every 3 weeks for a total of 14 cycles. Treatment with Kadcyla for HER2+ early-stage breast cancer usually lasts less than a year.

What is the difference between Kadcyla and Herceptin?

Kadcyla was designed to deliver emtansine to cancer cells in a targeted way by attaching emtansine to Herceptin. Herceptin then carries emtansine to the HER2-positive cancer cells. This way, the emtansine is less toxic to healthy cells and more effective in treating cancer cells.

Is Enhertu better than Kadcyla?

Treatment with Enhertu (trastuzumab deruxtecan) reduced the risk for disease progression or death compared with Kadcyla (trastuzumab emtansine) in patients with HER2-positive metastatic breast cancer who were previously treated with trastuzumab and a taxane, according to recent study results.

When should I stop Kadcyla?

For HER2+ early breast cancer, KADCYLA is given every 3 weeks for 14 rounds of infusion—sometimes called "cycles"—unless the cancer comes back or side effects cause the treatment to be stopped sooner. Treatment with KADCYLA typically would last less than a year.

How bad are Kadcyla side effects?

Taking Kadcyla may lead to severe heart problems, such as decreased heart function, and congestive heart failure (CHF). With CHF, your heart can't pump blood efficiently. Kadcyla has a boxed warning about the risk of this side effect. This is a serious warning from the Food and Drug Administration (FDA).

Does Kadcyla lower your immune system?

This treatment affects the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.

Is Kadcyla chemotherapy or immunotherapy?

Official answer. Kadcyla is made up of two cancer-fighting medicines: a HER2-targeted drug treatment and a chemotherapy drug. It is used for the treatment of patients with HER2+ breast cancer.

Is Kadcyla given with Perjeta?

If you're willing to participate in a clinical trial, you may have the option of being treated with a combination of Kadcyla and Perjeta.

How much is Kadcyla cost?

The cost for Kadcyla intravenous powder for injection 100 mg is around $3,637 for a supply of 1 powder for injection, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.

How long does Enhertu last?

Enhertu is typically given once every 3 weeks. You'll continue taking it for as long as your doctor prescribes.

Does Kadcyla cause hair loss?

Your hair may get thinner. But you are unlikely to lose all the hair from your head. Hair loss usually starts after your first or second treatment. It is almost always temporary, and your hair will usually grow back after treatment finishes.

What is tdm1 chemotherapy?

T-DM1 chemotherapy refers to treatment with Kadcyla, which is a targeted treatment that may be used to treat HER2-positive breast cancer in women w...

How long can you take Kadcyla?

For HER2+ early-stage breast cancer, Kadcyla is given as an intravenous (IV) injection every 3 weeks for a total of 14 cycles. For HER2+ metastatic...

Is Kadcyla a chemotherapy drug? How does it work?

Kadcyla is made up of two cancer-fighting medicines: a HER2-targeted drug treatment and a chemotherapy drug. It is used for the treatment of patien...

What are the adverse reactions to Kadcyla?

The most frequent adverse reactions leading to dose reduction of Kadcyla (in ≥ 1% of patients) included thrombocytopenia, increased transaminases, blood bilirubin and fatigue. Adverse reactions that led to dose delays occurred in 106 (14%) of Kadcyla treated patients.

When to monitor for kadcyla?

Monitor women who received Kadcyla during pregnancy or within 7 months prior to conception for oligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care.

Does Kadcyla cause left ventricular dysfunction?

Patients treated with Kadcyla are at increased risk of developing left ventricular dysfunction. A decrease of LVEF to < 40% has been observed in patients treated with Kadcyla. Serious cases of heart failure, with no fatal cases, have been observed in clinical trials with Kadcyla. In EMILIA, left ventricular dysfunction occurred in 1.8% of patients in the Kadcyla-treated group and 3.3% of patients in the lapatinib plus capecitabine-treated group. In KATHERINE, left ventricular dysfunction occurred in 0.4% of patients in the Kadcyla-treated group and 0.6% of patients in the trastuzumab-treated group [see Adverse Reactions (6.1)].

Is there a kadcyla program?

There is a pregnancy pharmacovigilance program for Kadcyla. If Kadcyla is administered during pregnancy, or if a patient becomes pregnant while receiving Kadcyla or within 7 months following the last dose of Kadcyla, health care providers and patients should immediately report Kadcyla exposure to Genentech at 1-888-835-2555.

Can you re-escalate Kadcyla?

Do not re-escalate the Kadcyla dose after a dose reduction is made. If a planned dose is delayed or missed, administer as soon as possible; do not wait until the next planned cycle. Adjust the schedule of administration to maintain a 3-week interval between doses.

Is Kadcyla a single agent?

Kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab -based treatment.

Is kadcyla a tumor lysis syndrome?

Tumor lysis syndrome (TLS): Cases of possible TLS have been reported in patients treated with Kadcyla. Patients with significant tumor burden (e.g., bulky metastases) may be at a higher risk. Patients could present with hyperuricemia, hyperphosphatemia, and acute renal failure which may represent possible TLS. Providers should consider additional monitoring and/or treatment as clinically indicated.

How long does it take for kadcyla to leak?

If this happens, it is more likely to happen within 24 hours of the infusion.

How to contact Genentech about kadcyla?

Nosebleeds. You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. Talk to a healthcare professional for more information about the benefits and risks of KADCYLA.

How to report kdcyla exposure?

If you are exposed to KADCYLA during pregnancy or if you become pregnant within 7 months following your last dose of KADCYLA, you are encouraged to report KADCYLA exposure to Genentech by calling 1-888-835-2555. If you are a male patient with a female partner that could become pregnant, birth control should be used during treatment ...

How long after kdcyla can you breastfeed?

You should not breastfeed during treatment and for 7 months after the last dose of KADCYLA.

Can kadcyla cause liver problems?

KADCYLA may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine, or itching. Heart problems.

Can you take Kadcyla with blood thinners?

KADCYLA can cause life-threatening bleeding. Taking KADCYLA with other medications used to thin your blood (antiplatelet) or prevent blood clots (anticoagulation) can increase your risk of bleeding. Your doctor should provide additional monitoring if you are taking one of these other drugs while on KADCYLA.

Can Kadcyla cause bleeding?

Even when blood thinners are not also being taken, life-threatening bleeding may occur with KADCYLA. Low platelet count may happen during treatment with KADCYLA. Platelets help your blood to clot. Signs of low platelets may include easy bruising, bleeding, and prolonged bleeding from cuts.

How is kadcyla given?

How Kadcyla Is Given: Kadcyla™ is given through an infusion into a vein (intravenous, IV) The amount of Kadcyla™ that you will receive depends on many factors, including your weight, your general health or other health problems, and the type of cancer or condition being treated.

What are the side effects of Kadcyla?

Some severe but rare possible side effects of Kadcyla™ include: Liver problems (liver failure)

What is the treatment for a blood vessel that is a target receptor?

Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve. Kadcyla™ has the component of an antibody type of targeted therapy.

What is targeted therapy?

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects.

Why is cancer treatment focused on killing rapidly dividing cells?

To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects. Targeted therapy is about identifying other features of cancer cells.

Is Kadcyla safe after therapy?

Kadcyla™ side effects are often predictable in terms of their onset, duration, and severity. Kadcyla™ side effects will improve after therapy is complete. Kadcyla™ side effects may be quite manageable. There may be options to minimize or prevent the side effects of Kadcyla™.

Is Kadcyla a taxane?

Kadcyla™ is used as a single agent to treat HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: Received prior therapy for metastatic disease, or.

Drug details

Kadcyla, also called T-DM1, is a biologic medication. Biologic medications are made from living cells.

Effectiveness

For information about the effectiveness of Kadcyla, see the “ Kadcyla uses ” section below.

Serious side effects

Serious side effects from Kadcyla aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Alternatives for treatment of early or metastatic HER2-positve breast cancer

Examples of other drugs that may be used to treat early or metastatic HER2-positive breast cancer * include:

Is Kadcyla a chemotherapy drug?

Yes and no. Kadcyla contains emtansine (a chemotherapy drug) that’s been chemically linked to ado-trastuzumab (a monoclonal antibody).

Does Kadcyla cause hair loss?

Kadcyla doesn’t cause hair loss in most people who take the drug. And hair loss wasn’t reported as a side effect in Kadcyla’s prescribing information.

Does Kadcyla cure breast cancer?

There’s no known cure for cancer, but some treatments may help you reach remission. With remission, you’ll have lessened signs and symptoms from your cancer.

What are the most important safety information about kadcyla?

What is the most Important Safety Information I should know about KADCYLA? Liver problems. KADCYLA may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine, or itching.

How long does it take for kadcyla to leak?

If this happens, it is more likely to happen within 24 hours of the infusion.

How to report kdcyla exposure?

If you are exposed to KADCYLA during pregnancy or if you become pregnant within 7 months following your last dose of KADCYLA, you are encouraged to report KADCYLA exposure to Genentech by calling 1-888-835-2555.

How to contact Genentech about kadcyla?

Nosebleeds. You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. Talk to a healthcare professional for more information about the benefits and risks of KADCYLA.

How long after kdcyla can you breastfeed?

You should not breastfeed during treatment and for 7 months after the last dose of KADCYLA.

Can you take Kadcyla with blood thinners?

KADCYLA can cause life-threatening bleeding. Taking KADCYLA with other medications used to thin your blood (antiplatelet) or prevent blood clots (anticoagulation) can increase your risk of bleeding. Your doctor should provide additional monitoring if you are taking one of these other drugs while on KADCYLA.

Does Kadzyla cause heart problems?

Heart problems. KADCYLA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness of breath, cough, rapid weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness, ...

How does Kadcyla work?

Kadcyla was designed to deliver emtansine to cancer cells in a targeted way by attaching emtansine to Herceptin. Herceptin then carries emtansine to the HER2-positive cancer cells. Metastatic breast cancer is breast cancer that has come back in a part of the body away from the breast, such as the bones, liver, or brain.

How does herceptin work?

About one out of every four breast cancers is HER2-positive. Herceptin works by attaching to the HER2 protein and blocking it from receiving growth signals. Emtansine, like some other chemotherapy medicines, disrupts the way cells grow.

Is kadcyla a combination of chemotherapy?

Kadcyla is a combination of Herceptin and the chemotherapy medicine emtansine. In Kadcyla, the emtansine is attached to the Herceptin. In earlier studies on Kadcyla, it was reported that the chemotherapy medicine maytansine was attached to Herceptin to form Kadcyla. Emtansine is a derivative of maytansine.

Is Kadcyla a taxane?

In the TH3RESA study, the researchers compared Kadcyla to a woman’s doctor’s choice of treatments for metastatic, HER2-positive breast cancer that had been previously treated with Herceptin, Tykerb, and a taxane chemotherapy to see which would offer more benefits.

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Indications and Usage For Kadcyla

Trastuzumab emtansine is used 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.

May Treat: HER2 positive carcinoma of breast

Drug Class: Antineoplastic - Antibody-Drug Conjugates (ADCs) · Antineoplastic-HER2 Targeted Antibody-Microtubule Inhibitor Conjugate

Availability: Prescription Required

Pregnancy: Consult your doctor. This medication may be harmful to an unborn child.

Lactation: This drug should not be given to breastfeeding mothers

May Treat: HER2 positive carcinoma of breast

Drug Class: Antineoplastic - Antibody-Drug Conjugates (ADCs) · Antineoplastic-HER2 Targeted Antibody-Microtubule Inhibitor Conjugate

Availability: Prescription Required

Pregnancy: Consult your doctor. This medication may be harmful to an unborn child.

Lactation: This drug should not be given to breastfeeding mothers

Alcohol: Avoid intake while taking this medication

Driving: May cause drowsiness or dizziness. Use caution

Manufacturer: GENENTECH, INC.

Precautions

  • Do not change brands without checking with Dr.
  • See doctor regularly for examinations.
  • Call MD if new abdominal pain/yellowing eyes/skin

  • Do not change brands without checking with Dr.
  • See doctor regularly for examinations.
  • Call MD if new abdominal pain/yellowing eyes/skin
  • Tell MD now if dizzy, trouble breathing, faint.
  • Do not take while breast feeding or when pregnant
  • May make you dizzy. Use caution when driving.
  • Call MD if fatigue/sore throat/infection occurs.
  • Call Dr. if easy bruising or bleeding occur

Kadcyla Dosage and Administration

Dosage Forms and Strengths

Warnings and Precautions

Adverse Reactions

  • Metastatic Breast Cancer
    Kadcyla®, as a single agent, is indicated for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: 1. Received prior therapy for metastatic disease, or 2. …
  • Early Breast Cancer
    Kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab -based treatment. Select patients for therapy based on an FDA-approved companion diagnostic …
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Drug Interactions

  • Patient Selection
    Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens [see Indications and Usage (1), Clinical Studies (14)].Assessment of HER2 protein overexpression and/or HER2 gene amplification should be performed using FDA-approved tests …
  • Recommended Doses and Schedules
    Do not substitute trastuzumab for or with Kadcyla. The recommended dose of Kadcyla is 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle). Do not administer Kadcyla at doses greater than 3.6 mg/kg. Closely monitor the infusion site for possible subcutaneous infi…
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Use in Specific Populations

  • Lyophilized powder in single-dose vials: 100 mg per vial or 160 mg per vial of ado-trastuzumab emtansine.
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Overdosage

  • Hepatotoxicity
    Hepatotoxicity, predominantly in the form of asymptomatic, transient increases in the concentrations of serum transaminases, has been observed in clinical trials with Kadcyla [see Adverse Reactions (6.1)]. Serious hepatotoxicity, including 3 fatal cases, has been observed in cl…
  • Left Ventricular Dysfunction
    Patients treated with Kadcyla are at increased risk of developing left ventricular dysfunction. A decrease of LVEF to < 40% has been observed in patients treated with Kadcyla. Serious cases of heart failure, with no fatal cases, have been observed in clinical trials with Kadcyla. In EMILIA, lef…
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Kadcyla Description

  • The following adverse reactions are discussed in greater detail in other sections of the label: 1. Hepatotoxicity [see Warnings and Precautions (5.1)] 2. Left Ventricular Dysfunction [see Warnings and Precautions (5.2)] 3. Embryo-Fetal Toxicity [see Warnings and Precautions (5.3)] 4. Pulmonary Toxicity [see Warnings and Precautions (5.4)] 5. Infusion-Related Reactions, Hypersensitivity Re…
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Kadcyla - Clinical Pharmacology

  • No formal drug-drug interaction studies with Kadcyla have been conducted. In vitrostudies indicate that DM1, the cytotoxic component of Kadcyla, is metabolized mainly by CYP3A4 and to a lesser extent by CYP3A5. Concomitant use of strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, teli…
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