This leaflet was prepared by hoffmannla roche limited. The printed package leaflet of the medicinal product must state the name and. Kadcyla is currently approved by the fda for the treatment of patients with her2positive, metastatic breast cancer previously treated with a taxane and herceptin. Weve made enrollment simpler, faster and more intuitive with some key changes to our forms.
Kadcyla administration may lead to reductions in left ventricular ejection fraction lvef. The approval is based on data showing kadcyla cut the risk of disease. Kadcyla 100 mg injectable 502420088xx kadcyla 160 mg injectable 502420087xx vii. Ime clinical criteria adotrastuzumab emutansine kadcyla page 2 of 2 references continued development of utilization management criteria may also involve research into other. The approval was based on the phase 3 emilia trial, in which kadcyla significantly improved survival versus tykerbcapecitabine, with a median os of 30. Kadcyla fda prescribing information, side effects and uses. The schedule of administration should be adjusted to maintain a 3 2 of 21 reference id. Adotrastuzumab emtansine kadcyla drug description adc. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of kadcyla while maintaining optimal therapeutic outcomes. Kadcyla can cause fetal harm when administered to a pregnant woman.
Xelodawarfarin interaction xeloda warfarin interaction. Initial approval criteria 1 coverage is provided in the following conditions. Kadcyla 100 mg vial 1 vial every 21 days kadcyla 160 mg vial 3 vials every 21 days b. Institute dose modifications or permanently discontinue as appropriate. 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. Do not mix kadcyla, oradminister as an infusion,withother medicinal products. Kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab based treatment. Adotrastuzumab emtansine kadcyla is available as preservative free powder for injection in a 100 and 160mg vial. Sps can dispense genentech medicines to your office. Kadcyla has a black box warning for hepatoxicity, cardiac toxicity, and embryofetal toxicity. This reduces the stimulation for cancer cells to divide and grow. These partners have agreed to distribute only products purchased directly from genentech and not to distribute kadcyla through secondary channels. Herceptin trastuzumab is a recombinant dnaderived humanized monoclonal antibody that selectively binds with high affinity in a cellbased assay kd 5 nm to the extracellular domain of the human epidermal growth factor receptor 2 protein, her2. Note assessment report as adopted by the chmp with all information of a commercially confidential nature deleted.
Download, view or print all the forms and documents you need to get started with kadcyla access solutions, including enrollment forms, tips and checklists. Side effects of kadcyla adotrastuzumab emtansine injection. 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 18888352555. Select patients for therapy based on an fdaapproved companion diagnostic for kadcyla. 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. Select patients for therapy based on an fdaapproved companion diagnostic for kadcyla see dosage and. Herceptinkadcyla sgm p2016 cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Nerlynx as a single agent is indicated for the extended adjuvant treatment of adult patients with earlystage.
The prescriber service form and the patient consent form are required for enrollment in genentech access solutions. Trastuzumab alone stops growth of cancer cells by binding to the her2 receptor, whereas trastuzumab emtansine undergoes receptormediated. Kadcyla extends survival in heavily pretreated patients. Kadcyla is a cancer medicine that contains the active substance trastuzumab emtansine. Kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumabbased. For healthcare professionals nerlynx neratinib tablets. Kadcyla access solutions works with sps to help patients receive their medicines. Fda approves roches kadcyla for adjuvant treatment of people.
Recommended doses and schedules do not substitute trastuzumab for or with kadcyla. Kadcyla tdm1 is a targeted therapy used to treat her2positive. In order to improve traceability of biological medicinal products, the tradename of the. It is used to treat advanced or metastatic breast cancer cancer that has spread to other parts of the body in adults who previously received trastuzumab and a taxane type of cancer medicine. Tdm1 reduced the risk of death by 32 percent and improved median overall survival os by almost seven months compared with physicians choice of therapy in heavily pretreated patients with her2positive advanced breast cancer. Evaluate left ventricular function in all patients prior to and during treatment with kadcyla. Lyophilized powder in single kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u. Several payment sources exist for cancer drugs in ontario, depending on the drug, disease indication, and how and where it is delivered. Adotrastuzumab emtansine kadcyla national drug monograph. Highlights of prescribing information initial dose of 4. Herceptin trastuzumab, herceptin hylecta trastuzumab and. Criteria for approval breast cancer authorization of 3 months may be granted for members who are prescribed kadcyla as a single agent for her2positive recurrent or metastatic breast cancer when one of the following criteria is met. Restricted access do not disseminate or copy without approval.
Adotrastuzumab emtansine tdm1 is a her2antibodydrug conjugate. Kadcyla equals standard of care, causes fewer side effects. Kadcyla extends survival in heavily pretreated patients with. Before prescribing keytruda, please read the selected safety information on pages 8 to 10 and the accompanying prescribing information.
Dailymed kadcyla adotrastuzumab emtansine injection. Information for physicians regarding kadcyla adotrastuzumabemtansineinfusion at provis infusion clinic thank you for allowing provis to assist in your patients care. Medication order form kadcyla adotrastuzumabemtansine. Jan 03, 2019 kadcyla adotrastuzumab emtansine is a new class of chemotherapy drug called an antibodydrug conjugate used to treat breast cancer. Use caution with these agents and consider recent major changes. Kadcyla may cause serious heart problems, including some that dont have symptoms, such as reduced heart function, and some that do. Kadcyla trastuzumab emtansine for injection monotherapy is indicated for the treatment of. Horning, md, roches chief medical officer and head of global product. Calculate volume reconstituted ml selecting the appropriate vial kadcyla is supplied as a sterile powder for concentrate and comes in 2 vial types. Kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumabbased treatment. March 30, 2020 page 3 of 5 applicable ndcs 502420088xx kadcyla 100 mg singleuse vial 502420087xx kadcyla 160 mg singleuse vial applicable diagnosis codes c33 malignant neoplasm of trachea c34. Reduce dose or discontinue kadcyla as appropriate in cases of increased serum transaminases or total bilirubin. In combination with chemotherapy followed by gazyva.
See full prescribing information for complete boxed warning. Kadcyla dose should not be reescalated after a dose reduction is made. Kadcyla adotrastuzumab emtansine is a new class of chemotherapy drug called an antibodydrug conjugate used to treat breast cancer. Prior authorization protocol kadcyla adotrastuzumab. Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with her2positive early breast cancer who have residual invasive disease, in the breast andor lymph nodes, after neoadjuvant taxanebased and her2targeted therapy. In earlier studies on kadcyla, it was reported that the chemotherapy medicine maytansine was attached to herceptin to form kadcyla. These highlights do not include all the information needed to use. Kadcyla adotrastuzumab emtansine for injection, for intravenous use. Gazyva dosing and administration guide indications gazyva is a cd20directed cytolytic antibody and is indicated. One week after the last weekly dose of herceptin, administer 6 mgkg as an iv infusion over 30. Kadcyla adotrastuzumab emtansine magellan provider. Policy document for kadcyla adotrastuzumab emtansine. Genentechroche is a human epidermal growth factor receptor 2 her2 antibodydrug conjugate that comprises the humanized antiher2 igg1 antibody trastuzumab linked to the antimitotic agent mertansine a maytansine derivative. Gleevec imatinib mesylate tablets, for oral use initial u.
Grapefruit may also increase plasma concentrations of lapatinib and should be avoided. Kadcyla, inntrastuzumab emtansine european medicines agency. From insert kadcyla is a her2targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with her2positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Please see full prescribing information for additional important safety information, including boxed warnings. Common and rare side effects for kadcyla intravenous. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. Patients receiving concomitant capecitabine and oral coumarin. It is recommended to monitor liver function prior to initiation and prior to each dose. 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 herceptin covalently linked to the cytotoxic agent dm1. In combination with chemotherapy followed by gazyva monotherapy in patients achieving at least a partial remission.
Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. The herceptin part of kadcyla may also encourage the bodys own immune cells to help destroy the cancer cells. Member has symptomatic visceral disease or visceral crisis b. Jul 15, 2014 effective for dates of service on or after july 1, 2014, adotrastuzumab emtansine kadcyla, procedure code j9354, will be a benefit of texas medicaid for clients of any age. Find information about common, infrequent and rare side effects of kadcyla intravenous.
While these serious side effects are rare about 12% of people treated with kadcyla will experience them, its important to know about them. The search was limited to studies performed in humans and published in the english language. The safety and efficacy of kadcyla in pediatric patients have not been established 1. In kadcyla, the emtansine is attached to the herceptin. Nov 01, 2019 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 18888352555. Kadcyla is a combination of herceptin chemical name. Monitor and withhold dosing or discontinue as appropriate. Closely monitor the infusion site for possible subcutaneous infiltration during drug administration see warnings and precautions 5. The herceptin part of kadcyla1,2 the herceptin part of kadcyla works by attaching to her2 proteins on breast cancer cells. Administer kadcyla as an intravenous infusion only with a 0. Doctors call kadcyla an antibodydrug conjugate targeted therapy. Kadcyla can only be used when the cancer has been shown to. Adotrastuzumab emtansine kadcyla procedure code j9354 to. Herceptin trastuzumab, herceptin hylectatm trastuzumab and hyaluronidaseoysk, kadcyla adotrastuzumab and perjeta pertuzumab precertification request aetna precertification notification.
The sps can also provide coverage and reimbursement support. Kadcyla may also lead to reductions in left ventricular ejection fraction lvef. Kadcyla package insert, 220 revision nccn guidelines on breast cancer v 2. Adotrastuzumab emtansine also know as tdm1 kadcyla. Table 1 dose reduction schedule dose reduction schedule dose level starting dose 3. Cl 110 medication order kadcyla v2cl 110 medication order kadcyla page2 of 2 sept. Adjuvant therapy of locally advanced or early stage breast cancer 3. Herceptin kadcyla sgm p2016 cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Kadcyla, as a single agent, is indicated for the treatment of patients with human epidermal growth factor receptor 2 her2positive, metastatic breast cancer who previously received trastuzumab and. If patients must be coadministered, a strong cyp3a4 inhibitor, based on pharmacokinetic studies, a dose reduction to 500 mgday of lapatinib is predicted to adjust the lapatinib auc to the range. Effect of prophylaxis or neratinib dose escalation on neratinibrelated diarrhea and tolerability in patients with her2positive earlystage breast cancer. Kadcyla trastuzumab emtansine for injection monotherapy is.859 1522 1545 395 1265 842 907 527 915 169 1383 247 295 1207 1165 1343 963 84 359 482 1008 608 822 1314 84 665 703 448