Assistance options for your eligible patients

Several options are available that may help patients with the out-of-pocket (OOP) costs of KADCYLA

Find the right patient assistance option for your patient using the Patient Assistance Tool.

  • Is your patient insured?

  • Does the patient's insurance cover his or her Genentech medicine?

  • Does your patient have commercial insurance?

  • Has your patient already been referred to the Genentech Oncology Co-pay Assistance Program and is either ineligible or no longer receiving assistance?

  • Has your patient already been referred to an independent co-pay assistance foundation and is either ineligible or no longer receiving assistance?

  • Is the patient 18 years of age or older?

Your Patient Might Qualify for a Referral to the Genentech Oncology Co-pay Assistance Program

If eligible commercially insured patients need assistance with their out-of-pocket costs, KADCYLA Access Solutions can refer them to the Genentech Oncology Co-pay Assistance Program.*

 

Learn More

 

*Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their medications and or administration of their Genentech medication. Patient must be taking the Genentech medication for an FDA-approved indication. See full Terms and Conditions at CopayAssistanceNow.com.

Your Patient Might Qualify for a Referral to an Independent Co-pay Assistance Foundation

For eligible patients with commercial or public health insurance, KADCYLA Access Solutions offers referrals to independent co-pay assistance foundations.*

 

Learn More

 

*Genentech does not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from KADCYLA Access Solutions. The foundations to which we refer patients are not exhaustive or indicative of Genentech’s endorsement or financial support. There may be other foundations to support the patient's disease state.

Your Patient Might Qualify for a Referral to the Genentech Patient Foundation

The Genentech Patient Foundation provides free Genentech medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.*

 

Learn More

 

*To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine should try to pursue other forms of financial assistance, if available, and meet certain income requirements. Uninsured patients and insured patients without coverage for their medicine must meet a different set of income requirements.

Does Your Patient Have Commercial Insurance?

KADCYLA Access Solutions can refer eligible patients to the Genentech Oncology Co-pay Assistance Program* for help with the OOP cost associated with KADCYLA

Does Your Patient Have Insurance?

If eligible publicly or commercially insured patients have difficulty paying their co-pay, co-insurance, or other OOP costs, KADCYLA Access Solutions can refer them to an independent co-pay assistance foundation supporting their diagnosis.

Does Your Patient Have No Insurance or Have Financial Concerns?

The Genentech Patient Foundation helps people affected by serious medical conditions get the KADCYLA they have been prescribed. People who do not have health insurance, who have health insurance that does not cover their KADCYLA, or who can’t afford their OOP costs and meet eligibility criteria may get free medicine.

*Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their medications and/or administration of their Genentech medication. Patient must be taking the Genentech medication for an FDA-approved indication. See full Terms and Conditions at CopayAssistanceNow.com.

Genentech and KADCYLA do not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from KADCYLA Access Solutions. The foundations to which we refer patients are not exhaustive or indicative of Genentech’s or KADCYLA's endorsement or financial support. There may be other foundations to support the patient’s disease state.

To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine should try to pursue other forms of financial assistance, if available, and meet certain income requirements. Uninsured patients and insured patients without coverage for their medicine must meet a different set of income requirements.

KADCYLA Access Solutions provides helpful access and reimbursement support to assist your patients and practice after KADCYLA is prescribed.
Learn how we help.

Determine which financial assistance option might be right for your patient with the Patient Assistance Tool

To enroll in Genentech patient support services, patients always complete the Patient Consent Form. Prescribers choose a form based on the specific patient needs:

  • If the patient needs help understanding coverage, financial assistance to help pay for their co-pays or educational support, use the Prescriber Service Form
  • If the patient meets income requirements and has no insurance, insurance but no coverage or insurance and finds out-of-pocket costs unaffordable even after seeking help paying for their co-pays, use the Prescriber Foundation Form

Each program has its own time period in which your eligible patients will receive assistance. You can call us at (877) GENENTECH/(877) 436-3683 for more information.

Indications

Early Breast Cancer (EBC)

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 for KADCYLA.

Metastatic Breast Cancer (MBC)

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:

  • Received prior therapy for metastatic disease, or
  • Developed disease recurrence during or within six months of completing adjuvant therapy.

Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA.

Important Safety Information

BOXED WARNINGS: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO-FETAL TOXICITY

  • Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in patients treated with KADCYLA. Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. Reduce dose or discontinue KADCYLA as appropriate in cases of increased serum transaminases or total bilirubin
  • 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
  • Embryo-Fetal Toxicity: Exposure to KADCYLA during pregnancy can result in embryo-fetal harm. Advise patients of these risks and the need for effective contraception

Warnings and Precautions

Hepatotoxicity

Hepatotoxicity, predominantly in the form of asymptomatic increases in the concentrations of serum transaminases, has been observed in clinical trials with KADCYLA. Serious hepatotoxicity, including 3 fatal cases, has been observed in clinical trials (n=1624) with KADCYLA as single-agent. The two fatal cases of severe drug-induced liver injury and associated hepatic encephalopathy occurred in MBC clinical trials with KADCYLA. Some of the patients experiencing hepatotoxicity had comorbidities and/or concomitant medications with known hepatotoxic potential.

Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. Patients with known active liver disease (such as hepatitis B virus or hepatitis C virus) were excluded from EMILIA (for patients with metastatic breast cancer [MBC]) and KATHERINE (for patients with early breast cancer [EBC]) studies. Reduce dose or discontinue KADCYLA as appropriate in cases of increased serum transaminases and/or total bilirubin. Permanently discontinue KADCYLA treatment in patients with serum transaminases >3 × ULN and concomitant total bilirubin >2 × ULN.

In clinical trials of KADCYLA, cases of nodular regenerative hyperplasia (NRH) of the liver have been identified from liver biopsies (5 cases out of 1624, 1 of which was fatal). Two of these five cases of NRH were observed in EMILIA and two were observed in KATHERINE. Diagnosis can be confirmed only by histopathology. NRH should be considered in all patients with clinical symptoms of portal hypertension and/or cirrhosis-like pattern seen on the computed tomography scan of the liver but with normal transaminases and no manifestations of cirrhosis. Upon NRH diagnosis, KADCYLA treatment must be permanently discontinued.

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 group and 3.3% of patients in the lapatinib + capecitabine group. In KATHERINE, left ventricular dysfunction occurred in 0.4% of patients in the KADCYLA group and 0.6% of patients in the trastuzumab group.

Based on limited data from a retrospective observational study, 22% (7 of 32) of patients with HER2-positive MBC with a baseline LVEF of 40-49% treated with KADCYLA developed congestive heart failure (CHF) or a >10% reduction in LVEF.

Assess LVEF prior to initiation of KADCYLA and at regular intervals (e.g. every 3 months) during treatment to ensure the LVEF is within the institution’s normal limits. KADCYLA has not been studied in an adequately controlled study in patients with LVEF <50%.

For patients with MBC, if at routine monitoring LVEF is <40%, or is 40% to 45% with a ≥10% absolute decrease below the pretreatment value, withhold KADCYLA and repeat LVEF assessment within approximately 3 weeks. Permanently discontinue KADCYLA if the LVEF has not improved or has declined further.

For patients with EBC, if at routine monitoring LVEF is <45%, or is 45% to 49% with a ≥10% absolute decrease below the pretreatment value, withhold KADCYLA and repeat LVEF assessment within approximately 3 weeks. Permanently discontinue KADCYLA if the LVEF has not improved or has declined further.

Embryo-Fetal Toxicity

KADCYLA can cause fetal harm when administered to a pregnant woman. Cases of oligohydramnios, and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities and neonatal death were observed in the post-marketing setting in patients treated with trastuzumab, the antibody component of KADCYLA. DM1, the cytotoxic component of KADCYLA, can cause embryo-fetal toxicity, based on its mechanism of action.

Verify the pregnancy status of females of reproductive potential prior to the initiation of KADCYLA. Advise pregnant women and females of reproductive potential that exposure to KADCYLA during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of KADCYLA. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with KADCYLA and for 4 months following the last dose.

If KADCYLA is administered during pregnancy, or if a patient becomes pregnant while receiving KADCYLA or within 7 months of the last dose of KADCYLA, immediately report exposure to Genentech at 1-888-835-2555.

Pulmonary Toxicity

Cases of interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or fatal outcome, have been reported in clinical trials with KADCYLA. Signs and symptoms include dyspnea, cough, fatigue, and pulmonary infiltrates.

In patients with MBC, pneumonitis was reported at an incidence of 0.8% (7 out of 884 treated patients), with one case of Grade 3 pneumonitis. The overall incidence of pneumonitis was 1.2% in EMILIA.

In KATHERINE, pneumonitis was reported at an incidence of 1.1% (8 out of 740 patients treated with KADCYLA), with one case of Grade 3 pneumonitis. Radiation pneumonitis was reported at an incidence of 1.8% (11 out of 623 patients treated with adjuvant radiotherapy and KADCYLA), with 2 cases of Grade 3 radiation pneumonitis.

Permanently discontinue treatment with KADCYLA in patients diagnosed with ILD or pneumonitis. For patients with radiation pneumonitis in the adjuvant setting, KADCYLA should be permanently discontinued for Grade ≥ 3 or for Grade 2 not responding to standard treatment.

Patients with dyspnea at rest due to complications of advanced malignancy and comorbidities and receiving concurrent pulmonary radiation therapy may be at increased risk of pulmonary toxicity.

Infusion-Related Reactions, Hypersensitivity Reactions

Treatment with KADCYLA has not been studied in patients who had trastuzumab permanently discontinued due to infusion-related reactions (IRR) and/or hypersensitivity; treatment with KADCYLA is not recommended for these patients.

Infusion-related reactions, characterized by one or more of the following symptoms—flushing, chills, pyrexia, dyspnea, hypotension, wheezing, bronchospasm, and tachycardia—have been reported in clinical trials of KADCYLA. In EMILIA, the overall incidence of IRR in patients treated with KADCYLA was 1.4%. In KATHERINE, the overall incidence of IRR in patients treated with KADCYLA was 1.6%. In most patients, these reactions resolved over the course of several hours to a day after the infusion was terminated.

KADCYLA treatment should be interrupted in patients with severe IRR and permanently discontinued in the event of a life-threatening IRR. Patients should be observed closely for IRR, especially during the first infusion.

One case of a serious, allergic/anaphylactic-like reaction has been observed in clinical trials of single-agent KADCYLA. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use.

Hemorrhage

Cases of hemorrhagic events, including central nervous system, respiratory, and gastrointestinal hemorrhage, have been reported in clinical trials with KADCYLA. Some of these bleeding events resulted in fatal outcomes. In EMILIA, the overall incidence of hemorrhage was 32% in the KADCYLA group and 16% in the lapatinib + capecitabine group. The incidence of Grade ≥ 3 hemorrhage was 1.8% in the KADCYLA group and 0.8% in the lapatinib + capecitabine group. In KATHERINE, the overall incidence of hemorrhage was 29% in the KADCYLA group and 10% in the trastuzumab group. The incidence of Grade ≥ 3 hemorrhage was 0.4% in the KADCYLA group, with one fatal case of intracranial hemorrhage, and 0.3% in the trastuzumab group.

Although in some of the observed cases, the patients were also receiving anticoagulation therapy or antiplatelet therapy, or had thrombocytopenia; in others, there were no known additional risk factors. Use caution with these agents and consider additional monitoring when concomitant use is medically necessary.

Thrombocytopenia

Thrombocytopenia was reported in clinical trials of KADCYLA. The majority of these patients had Grade 1 or 2 events (< LLN to ≥50,000/mm3) with the nadir occurring by day 8 and generally improving to Grade 0 or 1 (≥75,000/mm3) by the next scheduled dose. In clinical trials of KADCYLA, the incidence and severity of thrombocytopenia were higher in Asian patients.

In EMILIA, the overall incidence of thrombocytopenia was 31% in the KADCYLA group and 3.3% in the lapatinib + capecitabine group. The incidence of Grade ≥ 3 thrombocytopenia was 15% in the KADCYLA group and 0.4% in the lapatinib + capecitabine group. In Asian patients, the incidence of Grade ≥ 3 thrombocytopenia was 45% and 1.3%, respectively.

In KATHERINE, the overall incidence of thrombocytopenia was 29% in the KADCYLA group and 2.4% in the trastuzumab group. The incidence of Grade ≥ 3 thrombocytopenia was 6% in the KADCYLA group and 0.3% in the trastuzumab group. In Asian patients, the incidence of Grade ≥ 3 thrombocytopenia was 19% and 0%, respectively. The overall incidence of thrombocytopenia in the KADCYLA group for Asian patients was 50%.

Monitor platelet counts prior to initiation of KADCYLA and prior to each KADCYLA dose. KADCYLA has not been studied in patients with platelet counts <100,000/mm3 prior to initiation of treatment. In the event of decreased platelet count to Grade ≥ 3 (<50,000/mm3), do not administer KADCYLA until platelet counts recover to Grade 1 (≥75,000/mm3). Closely monitor patients with thrombocytopenia (< 100,000/mm3) and patients on anti-coagulant treatment during treatment with KADCYLA.

Neurotoxicity

Peripheral neuropathy, mainly as Grade 1 and predominantly sensory, was reported in clinical trials of KADCYLA. In EMILIA, the overall incidence of peripheral neuropathy was 21% in the KADCYLA group and 14% in the lapatinib + capecitabine group. The incidence of Grade ≥ 3 peripheral neuropathy was 2.2% and 0.2%, respectively.

In KATHERINE, the overall incidence of peripheral neuropathy was 32% in the KADCYLA group and 17% in the trastuzumab group. Peripheral neuropathy, including sensory and motor peripheral neuropathy, was not resolved in 30% of cases for KADCYLA treated patients at the time of the primary IDFS analysis for KATHERINE. The incidence of Grade ≥ 3 peripheral neuropathy was 1.6% in the KADCYLA group and 0.1% in the trastuzumab group.

KADCYLA should be temporarily discontinued in patients experiencing Grade 3 or 4 peripheral neuropathy until resolution to Grade ≤ 2. Monitor patients on an ongoing basis for signs/symptoms of neurotoxicity.

Extravasation

In KADCYLA clinical studies, reactions secondary to extravasation have been observed. These reactions, observed more frequently within 24 hours of infusion, were usually mild and comprised erythema, tenderness, skin irritation, pain, or swelling at the infusion site. Specific treatment for KADCYLA extravasation is unknown. Closely monitor the infusion site for possible subcutaneous infiltration during drug administration.

Adverse Reactions

Early Breast Cancer

The most common adverse reactions seen with KADCYLA in the KATHERINE trial (frequency >25%) were fatigue, nausea, increased transaminases, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, peripheral neuropathy, and arthralgia. The most common NCI–CTCAE (version 3) Grade ≥ 3 adverse reactions (frequency >2%) were thrombocytopenia and hypertension.

Metastatic Breast Cancer

The most common adverse reactions (≥25%) with KADCYLA were fatigue, nausea, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, increased transaminases, constipation and epistaxis. In EMILIA, the most common NCI–CTCAE (version 3) Grade ≥ 3 adverse reactions (frequency >2%) were thrombocytopenia, increased transaminases, anemia, hypokalemia, peripheral neuropathy, and fatigue.

Use in Specific Populations

Lactation

There is no information regarding the presence of ado-trastuzumab emtansine in human milk, the effects on the breastfed infant, or the effects on milk production. DM1, the cytotoxic component of KADCYLA, may cause serious adverse reactions in breastfed infants based on its mechanism of action. Advise women not to breastfeed during treatment and for 7 months following the last dose of KADCYLA.

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.

Please see full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.