Adotrastuzumab emtansine is currently approved by the u. Srp provides national leadership in the science of cancer surveillance as well as analytical tools and methodological expertise in collecting, analyzing, interpreting, and disseminating reliable populationbased statistics. Adotrastuzumab emtansine tdm1 in human epidermal growth. Kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u.
In some cases, health care professionals may use the generic name adotrastuzumab emtansine when referring to the trade drug name. No information is available on the clinical use of ado trastuzumab during breastfeeding. Adotrastuzumab emtansine in metastatic her2positive. Apr 01, 20 adotrastuzumab emtansine kadcylagenentech has received fda approval for the management of human epidermal growth factor receptor 2 her2positive metastatic breast cancer. The antibody is the humanized antiher2 igg1, trastuzumab. Lyophilized powder in single kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u. Trastuzumab emtansine is an antibodydrug conjugate. Ado trastuzumab emtansine is also being studied in the treatment of other types of cancer. C91 injection, adotrastuzumab emtansine, 1 mg findacode. Injection, adotrastuzumab emtansine, 1 mg j9354 hcpcs codes.
Kadcyla ado trastuzumab should not be used in place of herceptin trastuzumab. Adotrastuzumab emtansine monograph for professionals. National comprehensive cancer network, nccn, and nccn guidelines are trademarks owned by the national comprehensive cancer network, inc. The nccn compendium is a derivative work of the nccn guidelines. Adotrastuzumab emtansine intravenous route description and. Adotrastuzumab emtansine tdm1 or kadcyla tm is an antibodydrug conjugate adc designed to deliver the antimitotic mertansine dm1 drug to epithelial cancer cells overexpressing the. Kadcyla ado trastuzumab emtansine prior auth criteria proprietary information. Seer is supported by the surveillance research program srp in ncis division of cancer control and population sciences dccps. Injection, adotrastuzumab emtansine, 1 mg j9354 hcpcs. Appropriate studies performed to date have not demonstrated geriatricspecific problems that would limit the usefulness of adotrastuzumab emtansine injection in the elderly. Kadcyla adotrastuzumab emtansine dose, indications. Adotrastuzumab emtansine drugs and lactation database. Adotrastuzumab emtansine intravenous route before using.
Tell your caregivers if you feel any burning, pain, or swelling around the iv needle when ado. Adotrastuzumab emtansine is used to treat a her2positive breast cancer. This human epidermal growth factor receptor 2 her2targeted antibodydrug conjugate is approved for the treatment of patients with. Symptomatic congestive heart failure new york heart association classification iiiv. Adotrastuzumab emtansine kadcyla procedure code j9354 to be a benefit of the cshcn services program. Adotrastuzumab emtansine chemotherapy drug information. Adotrastuzumab emtansine kadcyla procedure code j9354 to.
The plan revises and updates pharmacy medical necessity guidelines. C91 injection, adotrastuzumab emtansine, 1 mg the above description is abbreviated. Cpt11 7ethyl1041piperidino1piperidinocarbonyloxycamptothecin, female rhesus monkeys n. Cpt11 7 ethyl1041piperidino1piperidinocarbonyloxycamptothecin, female rhesus monkeys n. This code description may also have includes, excludes, notes, guidelines, examples and other information.
Ado trastuzumab emtansine may also be used for purposes. Tell your doctor about the allergy and what signs you had. Ado trastuzumab emtansine is usually given after other cancer medications have been. Ado trastuzumab emtansine is a her2targeted antibodydrug conjugate. Adotrastuzumab emtansine injection may cause serious infusionrelated reactions, which may occur during or shortly after the infusion of the medication.
Because trastuzumab is a large protein molecule with a molecular weight of 145,531, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infants gastrointestinal tract. Kadcyla adotrastuzumab emtansine dosing, indications. However, ado trastuzumab emtansine also contains the small molecule cytotoxin. Use ado trastuzumab emtansine with caution in patients with hepatic disease. Adotrastuzumab emtansine is given as an infusion into a vein. Prior therapy with ado trastuzumab emtansine patients who had prior trastuzumab or other her2 targeted agents are eligible. Adotrastuzumab emtansine last updated on april 27, 2020 2020 memorial sloan kettering cancer center. Prior therapy with adotrastuzumab emtansine patients who had prior trastuzumab or other her2 targeted agents are eligible. Adotrastuzumab emtansine intravenous route description. Ado trastuzumab emtansine is used to treat a certain type of breast cancer that has spread to other parts of the body. Adotrastuzumab emtansine is a her2targeted antibodydrug conjugate. Adotrastuzumab emtansine trastuzumabdm1 for treatment of. Trastuzumab emtansine in her2positive metastatic breast cancer. Log in to print or send this list to your patient and.
Adotrastuzumab emtansine tdm1 is used to treat a type of breast cancer that has metastasized to other parts of the body and has not improved, or has. Ado trastuzumab emtansine injection is used to treat her2positive metastatic breast cancer cancer that has spread in patients who have previously received other medicines eg, trastuzumab, taxane medicine that did not work well or whose cancer has returned during or within 6 months of completing treatment. Adotrastuzumab emtansine exhibits similar activity and binding affinity to the her2 receptor as trastuzumab. Trial of adotrastuzumab emtansine for patients with her2.
Adotrastuzumab emtansine injection is used to treat her2positive metastatic breast cancer cancer that has spread in patients who have previously received other medicines eg, trastuzumab, taxane. Use caution with these agents and consider recent major changes. Adotrastuzumab emtansine tdm1 is used to treat a type of breast cancer that has metastasized to other parts of the body and has not improved, or has worsened, after treatment with other medications. Genentechroche is a human epidermal growth factor receptor 2 her2 antibodydrug conjugate that comprises the humanized antiher2.
Adotrastuzumab emtansine is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Fda approves adotrastuzumab emtansine for early breast. Kadcyla adotrastuzumab emtansine chemotherapy, side. Symptomatic congestive heart failure new york heart association. Trastuzumab emtansine also known as ado trastuzumab emtansine and sold under the trade name kadcyla, is an antibodydrug conjugate consisting of the humanized monoclonal antibody trastuzumab herceptin covalently linked to the cytotoxic agent dm1. Adotrastuzumab emtansine is used to treat a certain type of breast cancer that has. Drugs administered other than oral method, chemotherapy drugs. Dm1 approximately 2 to 17fold more potent than paclitaxel on a molar basis. Kadcyla is a prescription medicine used as an adjuvant after surgery treatment for her2positive early breast cancer when the patient has taken neoadjuvant before surgery treatment including a taxane and trastuzumab herceptin and there is cancer remaining in the tissue removed during surgery. Adotrastuzumab emtansine national cancer institute. Adotrastuzumab emtansine kadcylagenentech has received fda approval for the management of human epidermal growth factor receptor 2 her2positive metastatic breast cancer. Kadcyla adotrastuzumab emtansine magellan provider.
The small molecule cytotoxin, dm1, is a microtubule inhibitor. Kadcyla medicare coverage and copay details goodrx. A healthcare provider will give you this injection. Nov 09, 2018 ado trastuzumab emtansine is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Selected laboratories need to be proficient with ihc and fish technology to ensure reliable results. Unstable ventricular arrhythmia requiring treatment. Adotrastuzumab emtansine kadcyla, also known as trastuzumab dm1 or tdm1, is an. Adotrastuzumab emtansine is the generic name for kadcyla. Sample coding information for kadcyla adotrastuzumab emtansine and information on the resources for denials and appeals offered by kadcyla access solutions. Adotrastuzumab emtansine is an antiher2 monoclonal antibody combined with a microtubular inhibitor.
Trastuzumab emtansine an overview sciencedirect topics. Restricted access do not disseminate or copy without approval. J9354 injection, adotrastuzumab emtansine, 1 mg the above description is abbreviated. Adotrastuzumab emtansine kadcyla breast cancer news.
Do not confuse ado trastuzumab emtansine kadcyla with trastuzumab herceptin. Ado trastuzumab emtansine is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Adotrastuzumab emtansine is also used after surgery for a certain type of breast cancer in women who have had treatment with other chemotherapy medications before surgery, but there was still cancer. Adotrastuzumab emtansine in metastatic her2positive breast. For the purposes of this article, the descriptor advanced practice registered nurse. This medicine is used both for early breast cancer and for breast cancer that has spread to other parts of the body metastatic. On may 3, 2019, the food and drug administration approved adotrastuzumab emtansine kadcyla, genentech, inc. This medicine is usually given after other treatments have failed. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Ado trastuzumab emtansine injection may cause serious infusionrelated reactions, which may occur during or shortly after the infusion of the medication.
Adotrastuzumab emtansine adotrastuzumab emtansine kadcyla, genentech is an antiher2 monoclonal antibodydrug conjugate indicated for the treatment of her2positive breast cancer. Background adotrastuzumab emtansine kadcyla, manufactured by genentech, is a human epidermal growth factor receptor 2 her2targeted antibodydrug conjugate fda approved for the treatment of. Adotrastuzumab emtansine by injection national library. Food and drug administration fda for treatment of metastatic, her2positive breast cancer that has grown despite other her2targeting. Kadcyla is a prescription medicine used as an adjuvant after surgery treatment for her2positive early breast cancer when the patient has taken neoadjuvant before surgery treatment including a taxane.
J9354 hcpcs code inj, adotrastuzumab emt 1mg hcpcs. Ado trastuzumab emtansine tdm1 is an antibody drug conjugate linking trastuzumab to the chemotherapeutic agent dm1. Ado trastuzumab emtansine is used to treat a her2positive breast cancer. Code used to identify the appropriate methodology for developing unique pricing amounts under part b. Bcbsa medical policy reference manual electronic version. Codes in the optum360 hcpcs level ii follow the ama cpt book conventions to. J9354 hcpcs code for injection, adotrastuzumab emtansine, 1 mg. Other considerations her2 testing is essential to determine if patients are appropriate for adotrastuzumab emtansine therapy. J9354 is a valid 2020 hcpcs code for injection, adotrastuzumab. Hcpcs code j9354 for injection, adotrastuzumab emtansine, 1 mg as maintained by cms falls under chemotherapy drugs.
It should take 90 minutes for you to receive your first dose of ado trastuzumab emtansine. Adotrastuzumab emtansine kadcyla, also known as trastuzumabdm1 or tdm1, is an. Adotrastuzumab emtansine memorial sloan kettering cancer. Adotrastuzumab emtansine fails phase iiiii gatsby trial. Appropriate studies performed to date have not demonstrated geriatricspecific problems that would limit the usefulness of ado trastuzumab emtansine injection in the elderly. Jul 25, 2014 adotrastuzumab emtansine kadcyla procedure code j9354 to be a benefit of the cshcn services program. In some cases, health care professionals may use the generic name adotrastuzumab emtansine when referring to the trade drug name kadcyla. Adotrastuzumab emtansine injection is used to treat her2positive metastatic breast cancer cancer that has spread to other parts of the body in patients who have already received other medicines that. Trastuzumab emtansine also known as adotrastuzumab emtansine and sold under the trade name kadcyla, is an antibodydrug conjugate consisting of the humanized monoclonal antibody trastuzumab.
The recommended ado trastuzumab emtansine dose is 3. Myocardial infarction or unstable angina within 6 months of enrollment. See full prescribing information for complete boxed warning do not substitute kadcyla for or with trastuzumab. J9354 is a valid 2020 hcpcs code for injection, adotrastuzumab emtansine, 1 mg or just inj, adotrastuzumab emt 1mg for short, used in medical care. If you have an allergy to ado trastuzumab emtansine or any other part of this drug. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. The therapy is specifically indicated for those who have already undergone unsuccessful treatment with trastuzumab herceptingenentech and a taxane. Ado trastuzumab emtansine 1 mg iv j9354 adrenalin chloride, see adrenalin, epinephrine adrenalin, epinephrine 0. As of 20, this field contains the consumer friendly descriptions for the ama cpt codes.
Monitor transaminases and bilirubin prior to initiation of therapy and before each dose. Use adotrastuzumab emtansine with caution in patients with hepatic disease. Ado trastuzumab emtansine is usually given after other treatments have failed. This drug will likely be quite expensive and you may want to consider using a goodrx discount instead of medicare to find the best price for this prescription. A phase i, multicenter, openlabel, doseescalation study of singleagent ado trastuzumab emtansine was initiated to assess its safety, tolerability, and pharmacokinetics in patients with her2positive metastatic breast cancer who had previously received trastuzumab krop et al. Upon binding to subdomain iv of the her2 receptor, ado trastuzumab emtansine undergoes receptormediated internalization and. Trastuzumab emtansine or adotrastuzumab emtansine tdm1 is an adc with the her2targeted antitumor. Ado trastuzumab emtansine is used to treat a certain type of breast cancer.
Dm1 is a derivative of maysantine, a potent microtubule inhibitor associated with treatmentlimiting diarrhea, neuropathy, and fatigue impeding its early clinical development. A doctor or nurse will watch you closely to see how your body reacts to this medication. A phase i, multicenter, openlabel, doseescalation study of singleagent adotrastuzumab emtansine was initiated to assess its safety, tolerability, and pharmacokinetics in. Ado trastuzumab emtansine kadcyla is available as preservative free powder for injection in a 100 and 160mg vial. Adotrastuzumab emtansine is used to treat a certain type of breast. Fda approves adotrastuzumab emtansine for early breast cancer. Ado trastuzumab emtansine is used to treat a her2positive breast cancer that has spread to other parts of the body. J9354 injection, adotrastuzumab emtansine, 1 mg findacode. Ado trastuzumab emtansine injection is used to treat her2positive metastatic breast cancer cancer that has spread to other parts of the body in patients who have already received other medicines that did not work well.