Prozac fluoxetine hydrochloride capsules label fda. Ime clinical criteria adotrastuzumab emutansine kadcyla page 2 of 2 references continued development of utilization management criteria may also involve research into other. Serious fetal harm can occur if adotrastuzumab emtansine is administered during pregnancy or within 7 months prior to conception. Medication order form kadcyla adotrastuzumabemtansine. Sep 30, 2019 trastuzumab is a humanized igg1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, her2. Highlights of prescribing information these highlights. 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 medicine that did not work well or whose cancer has returned during or within 6 months of completing treatment. 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. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. J9354 hcpcs code inj, adotrastuzumab emt 1mg hcpcs. Pregnancy should be avoided by females taking adotrastuzumab emtansine during therapy and for 7 months after the last dose. Basaglar should be the same as the other insulin glargine.
Kadcyla adotrastuzumab emtansine injection for iv use. Jan 03, 2019 kadcyla adotrastuzumab emtansine is a sterile, white to offwhite preservative free lyophilized powder in singleuse vials. The genentech biooncology copay card is available only for commercially insured patients. Lantus insulin glargine injection for subcutaneous injection. Ixempra ixabepilone dosing and administration guide. Serious infusion reactions and cardiopulmonary arrest infusion reactions. 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.
While these serious side effects are rare about 12% of people treated with kadcyla will experience them, its important to know about them. 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 a taxane, separately or in combination. 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. Side effects of kadcyla adotrastuzumab emtansine injection. Kadcyla is a her2targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for. Trastuzumab herceptin trastuzumab, herzuma trastuzumab. Trastuzumab is produced by recombinant dna technology in a mammalian cell chinese hamster ovary culture which may contain the antibiotic gentamicin.
In combination with chemotherapy followed by gazyva monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage ii bulky, iii or iv follicular lymphoma fl. Infed iron dextran injection usp is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Adotrastuzumab emtansine is a her2targeted antibodydrug conjugate. Mitoxantrone hydrochloride mitoxantrone hydrochloride this product information is intended only for residents of the united states. Dailymed kadcyla adotrastuzumab emtansine injection.
Oct 02, 20 kadcyla adotrastuzumab emtansine rochegenentech launch date. Following reconstitution, each singleuse vial contains adotrastuzumab emtansine 20 mgml, polysorbate 20 0. 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. Referrals to the genentech biooncology copay card kadcyla. We would like to make the coordination of systemic therapy at the provis clinic and your facility as easy and seamless as possible for both you and your patient. Jan 03, 2019 kadcyla is for intravenous infusion only.
Initial approval criteria 1 coverage is provided in the following conditions. Kadcyla is used to treat her2positive breast cancer. 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. It is given as directed by your doctor, usually once every 3 weeks. Food and drug administration fda is alerting health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug kadcyla adotrastuzumab emtansine in some medicationrelated electronic systems poses a risk of mixup with herceptin trastuzumab and may result in medication errors. Trastuzumab herceptin trastuzumab, herzuma trastuzumabpkrb, kanjinti trastuzumabanns, ogivri trastuzumabdkst, ontruzant trastuzumabdttb, trazimera trastuzumabqyyp bolded medications are the preferred products these medications are included in this policy but are not available in the market as of yet. Save money on your prescription by switching to tevas fdaapproved generic version, bleomycin for injection, usp. Severe local tissue necrosis will occur if there is extravasation during administration. 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. Our discount and coupon prices are based on contracts between a pharmacy or pharmacy purchasing group and a pharmacy benefit manager pbm, who provides. Quest integration medicare advantage original effective date. Breast cancer kadcyla adotrastuzumab emtansine is a her2targeted antibody and microtubule inhibitor conjugate indicated for the treatment of patients with her2positive, metastatic breast. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for horizant gabapentin enacarbil. Kadcyla adotrastuzumab emtansine dose, indications.
Monitor serum transaminases and bilirubin prior to initiation of kadcyla treatment and prior to each kadcyla dose. The search was limited to studies performed in humans and published in the english language. Immediately slide green safety guard over needle with the needle pointing away from you. Johns wort may decrease ixabepilone plasma concentrations unpredictably and should be avoided safety information. Kadcyla can cause fetal harm when administered to a pregnant woman. Highlights of prescribing information microsatellite. Torisel kit temsirolimus injection, for intravenous infusion only initial u. Kadcyla fda prescribing information, side effects and uses. These highlights do not include all the information needed to use halaven safely and effectively. Highlights of prescribing information initial dose of 4 mg. Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. Patients using medicare, medicaid, medigap, veterans affairs va, department of defense dod, tricare or any other governmentfunded program to pay for their medications are not eligible. Adotrastuzumab emtansine kadcyla procedure code j9354 to.
Yervoy ipilimumab can result in severe and fatal immunemediated adverse reactions. Infusion reactions and cardiopulmonary arrest 1 indications and usage 1. Kadcyla 100 mg vial 1 vial every 21 days kadcyla 160 mg vial 3 vials every 21 days b. A literature search was performed on pubmedmedline 1966 to october 2014 using the search terms and kadcyla. One side thank you card or insert card ready to print pdf file. Herceptin kadcyla sgm p2016 cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Please click here for full prescribing information for lantus or scan qr code. The nccn compendium is a derivative work of the nccn guidelines. These immunemediated reactions may involve any organ system.
Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. Patients receiving concomitant capecitabine and oral coumarin. Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. Kadcyla adotrastuzumab emtansine is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Patients should have either received prior therapy for. Serious irreversible myocardial toxicity with delayed congestive. Policy document for kadcyla adotrastuzumab emtansine. Here are the other common side effects of kadcyla or adotrastuzumab emtansine muscle pain, joint pain, tired feeling, headache, bleeding, and easy bruising. Herceptin trastuzumab, herceptin hylectatm trastuzumab and hyaluronidaseoysk, kadcyla adotrastuzumab and perjeta pertuzumab precertification request aetna precertification notification. Highlights of prescribing information these highlights do not include all the information needed to use torisel safely and effectively.
Kadcyla,as a single agent, is indicated for the treatment of patients with her2positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Weve made enrollment simpler, faster and more intuitive with some key changes to our forms. Kadcyla is given as an intravenous infusion in 21day cycles while a patient is receiving kadcyla therapy, drugs containing ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole should be avoided. Xelodawarfarin interaction xeloda warfarin interaction. Kadcyla extends survival in heavily pretreated patients with. Kadcyla is used both for early breast cancer and for breast cancer that has spread to other parts of the body metastatic. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for adrucil fluorouracil. Withhold or discontinue imfinzi to manage adverse reactions as described in table 2. See full prescribing information for complete boxed warning.
The prescriber service form and the patient consent form are required for enrollment in genentech access solutions. Before prescribing keytruda, please read the selected safety information on pages 8 to 10 and the accompanying prescribing information. Each vial contains 100 mg or 160 mg adotrastuzumab emtansine. Cytokine release syndrome crs, which may be lifethreatening or fatal, occurred in patients receiving blincyto. Cytokine release syndrome and neurological toxicities see full prescribing information for complete boxed warning. About goodrx prices and kadcyla coupons goodrx s cash prices are based on multiple sources, including published price lists, purchases, claims records, and data provided by pharmacies. 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. Kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u. Each ml contains the equivalent of 50 mg of elemental iron as an iron dextran complex, approximately 0. Indications the indications below including fdaapproved indications and compendial uses are considered a. The search was limited to studies performed in humans and. Use caution with these agents and consider recent major changes indications and usage 1. Full prescribing information 1 indications and usage zaltrap, in combination with. Adotrastuzumab emtansine kadcyla is available as preservative free powder for injection in a 100 and 160mg vial.
Cl 110 medication order kadcyla v2cl 110 medication order kadcyla page2 of 2 sept. Withhold or discontinue imfinzi to manage adverse reactions as. Kadcyla adotrastuzumabemtansineinfusion at provis infusion clinic thank you for allowing provis to assist in your patients care. Gazyva dosing and administration guide indications gazyva is a cd20directed cytolytic antibody and is indicated. Insert needle and inject all the liquid subcutaneously. Find the package insert of sekisui medical ivd product. This medication is given by slow injection into a vein by a health care professional. Kadcyla ado trastuzumab emtansine lines of business.
Adriamycin must not be given by the intramuscular or subcutaneous route. The genentech spoilage replacement program provides for replacement of infused, injected and selfadministered products, which are prescribed and prepared for a labeled indication, yet not administered due to unforeseen patient clinical circumstances, subject to certain limitations and conditions set forth by genentech. Jul 28, 2016 hello, just came back from our trip visiting the hallwang clinic in germany. 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. If changing patients from another insulin glargine product, 100 unitsml, to basaglar, the dose of.
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