Herceptin trastuzumab for injection 150 mgvial is supplied in a singledose vial as a lyophilized sterile powder, under vacuum. The twoinone treatment kept breast cancer at bay in women with a type of. Other targeted agents, such as trastuzumab, sunitinib and crizotinib, also have. Lucentis ranibizumab injection is a prescription medicine for the treatment of patients with. Herceptin trastuzumab is a monoclonal antibody drug used to prevent the recurrence ofand or treatment of breast cancer that has spread beyond the breast. Herceptin sc190507 1 australian product information herceptin sc trastuzumab solution for injection 1. The injection site should be alternated between the left and right thigh. The study is based on trastuzumab the active ingredients of herceptin and herceptin. You might have the original drug called herceptin, or a biosimilar such as herzuma or ontruzant. Intravitreal aflibercept eylea injection for cystoid. Herceptin fda prescribing information, side effects and uses. Nurse guide for subcutaneous trastuzumab administration. Retinal texture could provide early biomarker of alzheimers disease. Cystoid macular edema secondary to albuminbound paclitaxel.
I posted this query re herceptin sideeffects out of curiousity. Nurse guide for subcutaneous trastuzumab administration summary trastuzumab subcutaneous injection is given as a flat dose of 600mg5ml. Herceptin is used to treat certain types of breast cancer or stomach cancer other cancer medicines are sometimes used in combination with herceptin. Herceptin is indicated for the treatment of adult patients with her2 positive metastatic breast cancer mbc as monotherapy for the treatment of those patients. Herceptin is the brand name of a medicine called trastuzumab. Herceptin trastuzumab herceptin hylecta trastuzumab and hyaluronidaseoysk kadcyla adotrastuzumab emtansine lucentis ranibizumab injection ocrevus ocrelizumab perjeta pertuzumab polivy polatuzumab vedotinpiiq pulmozyme dornase alfa inhalation solution. Severe acneiform eruption following trastuzumab therapy. Although less effective, treatment may be reduced to 3 once monthly doses, followed by less frequent dosing i. This medication is given by slow injection into a vein by a health care professional, usually once every week or once every 3 weeks.
Each carton contains one singledose vial of herceptin. Side effects requiring immediate medical attention. Feb 14, 20 these results have been further used to select a fixed 600 mg subcutaneous dose of trastuzumab. Herceptin sc binds selectively to a protein called human epidermal growth factor receptor 2 her2. Herceptin hylecta trastuzumab and hyaluronidaseoysk.
Avastin bevacizumab is an effective, firstline option when used together with other medicines for certain types of cancers, but it has to be given in a clinic or hospital and it has. Trastuzumab sc should be transferred from the vial to a syringe utilising locally agreed safety guidelines for the administration of subcutaneous medication. As a consequence, trastuzumab was discontinued for three months. Herceptin 600 mg solution for injection in vial summary of product. Pdf bilateral macular ischemia and severe visual loss. A study suggests that an injectable form of herceptin chemical name. Not all people have serious side effects, but side effects with herceptin therapy are common. Herceptin is the brand name of the prescription drug trastuzumab, which is used along with other medicines to treat certain types of breast cancer and stomach cancer its also used to prevent. Trastuzumab is a targeted cancer drug and is also known by its brand name, herceptin, herzuma and ontruzant. Symptoms usually occur during or within 24 hours of herceptin administration.
If you are able to get pregnant, a pregnancy test will be done to show that you are not pregnant before starting herceptin trastuzumab injection intravenous. Avastin is the brand name for the drug, which is called bevacizumab. Macular edema and vision loss may resolve with discontinuation of therapy, but the pigmentary changes and the retinal deposits persist. Be sure to contact your doctor if you are experiencing any of the following. Monitor patients until symptoms completely resolve. Va worsened and cmt increased under trastuzumab treatment. Some of the dosage forms listed on this page may not apply to the brand name avastin for the consumer. Dec 06, 2018 the data below are based on the exposure of 294 patients to herceptin in combination with a fluoropyrimidine capecitabine or 5fu and cisplatin study 7. Ocular side effects of systemically administered chemotherapy. Use herceptin trastuzumab injection intravenous as ordered by your doctor.
The ophthalmological complications of targeted agents in cancer. This document contains side effect information about bevacizumab. See macular edema, central serous retinopathy, and serous retinal detachment above. Amdf is a patientcentered foundation that supports potentially gamechanging agerelated macular degeneration amd research, education and advocacy in order to improve quality of life and treatment outcomes for all those affected by amd macular. Our patient showed a 10% improvement in bcva and significant resolution of macular edema in oct scan, although mferg response remained decreased yet, bettershaped peaks and no areas of eccentral vision. Six months also significantly reduced treatment related side effects, including heart. Herceptin is sometimes used when the cancer has spread to other parts of the body metastatic. Tamoxifen troubles tamoxifen has long been known to cause eye problems, including dryness, irritation, cataracts, and deposits in the retina, in the area of the macula, that result in macular edema, said k. Some of these reported disorders might be related to macular ischemia. Comparison of antivegf treatments for wet amd american. On ehealthme, you can monitor immune system disorder in herceptin from patients like you, same gender and age related publications that referenced our studies.
Along with its needed effects, bevacizumab the active ingredient contained in avastin may cause some unwanted effects. In the herceptin plus chemotherapy arm, the initial dose of herceptin 8 mgkg was administered on day 1 prior to chemotherapy followed by 6 mgkg every 21 days until disease progression. Macular ischemia has not been reported as a side effect of trastuzumab. Her2 is found in large amounts on the surface of some cancer cells. Use of mvasi bevacizumabawwb prior to the use of avastin and other bevacizumab biosimilar products.
Trastuzumab herceptin cancer information cancer research uk. The targeted therapy, considered a breakthrough when it was developed for. Dec 09, 2019 swelling of the face, fingers, or lower legs. Initial dose of 4 mgkg over 90 minute iv infusion, then 2 mgkg over 30 minute iv infusion weekly for 12 weeks with paclitaxel or docetaxel or 18 weeks. Read more about the prescription drug trastuzumab injection. Side effects of herceptin trastuzumab, warnings, uses.
Bilateral macular ischemia and severe visual loss following trastuzumab therapy. Multiple antivegf drugs are available to treat amd, but four are commonly used for the condition. Do people take herceptin have injection site extravasation. Watch for ocular effects of breast cancer drugs american. Herceptin treatment was permanently discontinued in patients who developed congestive heart failure, or persistentrecurrent lvef decline see dosage and administration. Other drugs may be given before herceptin trastuzumab injection intravenous to. Herceptin is a targeted therapy that works by attaching to the her2. Avastin is a drug used to treat wet agerelated macular degeneration amd. Before using trastuzumab, tell your doctor or pharmacist if you are allergic to it. Three of these, ranibizumab brand name lucentis, aflibercept brand name eylea and brolucizumab brand name beovu, were designed specifically for the treatment of amd. Will you have injection site extravasation with herceptin.
There is a black box warning for herceptin warning of the possibility of heart failure in some patients. It is given as an infusion into a vein over a period of time. However, retinal andor visual disorders were noted in 6 1. The women in the study were taught how to give themselves the herceptin injection. Macular edema is often associated with these deposits, which are typically located in the paramacular region. Hospitals and eye professionals are receiving regular guidance from the royal college of ophthalmologists as well as public health england to ensure everything possible is being done to make sure patients receive their eye injections in a safe environment. Your doctor will stop treatment if any serious side effects occur. An independent copay assistance foundation is a charitable organization providing financial assistance to patients with specific disease states. Twoinone drug combining herceptin with chemotherapy keeps. Although some people may have a lifethreatening side effect, most do not. A study of avastin bevacizumab plus herceptin trastuzumab in patients with primary inflammatory her2positive breast cancer. This product may contain inactive ingredients such as benzyl alcohol, which can cause allergic reactions or other problems.
If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Holash j, davis s, papadopoulos n, croll sd, ho l, russell m, et al. If you have an allergy to trastuzumab or any other part of herceptin trastuzumab injection intravenous. Herceptin can help control the growth of cancer cells that contain high amounts of human epidermal growth factor receptor 2 her2. Twoinone drug combining herceptin with chemotherapy keeps womens.
Sanofiaventis us llc, bridgewater, new jersey and paclitaxel taxol. Saleh m, bourcier t, noel g, speegschatz c, gaucher d. I take herceptin and perjeta together and i have been plagued with debilitating, temporary joint pain cant move my shoulders and jaw that shows up about 4872 hrs later and last about that same length of time. Biosimilar trastuzumabanns injection and trastuzumabdkst injection are highly similar to trastuzumab injection and work the same way as trastuzumab injection in the body. Its used to treat some types of breast cancer, oesophageal cancer and stomach cancer. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Herceptin is used to treat certain types of breast cancer or stomach cancer. Both groups had about the same number of side effects having a low white blood cell count was the most common. Adotrastuzumab emtansine is an antibodydrug conjugate. Adjuvant treatment of her2overexpressing breast cancer. Some people with the dry form of amd can develop the wet form. Cystoid macular edema cme without capillary leakage is a rare subcategory of cme recently associated with the taxane drugs docetaxel taxotere.
It is injected into the eye to help slow vision loss from these diseases. Herceptin may result in the death of an unborn baby or birth defects. Macular edema following retinal vein occlusion rvo diabetic macular edema dme diabetic retinopathy dr myopic choroidal neovascularization mcnv important safety information. Australian product information herceptin sc trastuzumab. If youve got the dry form now, its important to keep a check on your vision. It is a treatment for cancers that have large amounts of a protein called human epidermal growth factor receptor 2 her2, such as. Latin american journal of ophthalmology cystoid macular.
Qualitative and quantitative composition herceptin sc vial contains 600mg5ml of trastuzumab. Saleh m, bourcier t, noel g, speegschatz c, gaucher d, bilateral macular ischemia and severe visual loss following trastuzumab therapy, acta oncologica, 2011 apr. Coronavirus and your macular degeneration care american. Eye injections during the coronavirus outbreak macular.
Feb 28, 2020 if you are 65 or older, use herceptin trastuzumab injection intravenous with care. Contraception should be used while receiving herceptin and for 7 months after your last dose of herceptin. Learn about avastin bevacizumab solution for iv infusion, including benefits, risks, possible side effects, patient support, and options for financial help. Now, am feeling so yucky today following yesterdays treatment, my 7th, that i had to leave work early. The researchers wanted to know if the injectable form of herceptin works as well as and is as safe as the iv version to treat her2positive stage. Lucentis is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in lucentis. Intravitreal injection of bevacizumab for cystoid macular edema in retinitis pigmentosa. A fourth drug, bevacizumab brand name avastin, was originally. Your doctor gives you this therapy through an injection directly into your eye. The 600 mg dose should be administered as a subcutaneous injection only over 25 minutes every three weeks. Women injecting themselves with herceptin had a slightly higher rate of serious infection 24 women compared to women getting the iv herceptin. Lucentis ranibizumab dose, indications, adverse effects. Chalam, md, phd, mba, professor and chair of ophthalmology at the university of florida college of medicine in jacksonville. Will you have immune system disorder with herceptin.
Although acneiform rash, also known as papulopustular eruption, is a common cutaneous toxicity of epidermal growth factor receptor egfr inhibitors,1 it has not been shown to be associated with trastuzumab therapy. We present a 57yearold referred reduced visual acuity who was in treatment with paclitaxel for developing metastatic breast adenocarcinoma. Herceptin trastuzumab is an effective, firstline option when used together with other medicines for certain types of breast and stomach cancers, but it has many side effects and needs a lot of monitoring. Dec 06, 2018 herceptin administration can result in serious and fatal infusion reactions and pulmonary toxicity. Trastuzumab injection herceptin side effects, medical. Significant vision loss occurs in only a subset of these patients. The american diabetes association ada recommends an intravitreous antivascular endothelial growth factor antivegf agent, such as ranibizumab, as firstline therapy for the management of eyes with centralinvolved diabetic macular edema cidme. We report a case of bilateral ischemic maculopathy following intravenous therapy of trastuzumab in a 50yearold woman.
Trastuzumab injection, trastuzumabanns injection, and trastuzumabdkst injection are biologic medications medications made from living organisms. Herceptin was administered at 4 mgkg on the day of initiation of paclitaxel and then at a dose of 2 mgkg weekly for a total of 52 weeks. Consumer information about the medication trastuzumab injection herceptin, includes side effects, drug interactions, recommended dosages, and storage information. Herceptin trastuzumab side effects, dosage, interactions. Indicated, in combination with in combination with paclitaxel plus cisplatin or topotecan, for persistent, recurrent, or metastatic cervical cancer. The most common and effective treatment for wet agerelated macular degeneration wet amd is called antivegf therapy. Medication should be stopped immediately, and referral to a retina specialist is recommended. Herceptin trastuzumab for breast cancer her2 side effects. Bilateral macular ischemia and severe visual loss following. A new subcutaneous formulation of trastuzumab herceptin, genentechroche has been approved by the european commission.
Prior to administration select patients based on her2 protein overexpression or her2 gene amplification in tumor specimens. The pharmacokinetic, efficacy, and safety profiles of this fixed subcutaneous dose were evaluated in a noninferiority randomized, openlabel, multicenter phase iii hannah enhanced treatment with neoadjuvant herceptin study. Ophthalmoscopic examination, optical coherence tomography, and autofluorescence show the cystoid macular edema, but fluorescein angiography is normal, without leakage of dye in the late times. It is also used to treat diabetic eye disease and other problems of the retina. Genentech continues to maintain that lucentis is the most appropriate medicine for wet amd as supported by clinical and other scientific data, the. Herceptin is supplied as an injection for intravenous administration. About the american macular degeneration foundation amdf amdf is a patientcentered foundation that supports potentially gamechanging agerelated macular degeneration amd research, education and advocacy in order to improve quality of life and treatment outcomes for all those affected by amd macular. Referrals to independent copay assistance foundations. A study of avastin bevacizumab plus herceptin trastuzumab. Herceptin sc trastuzumab drug medicine information.
Common side effects include rash, nausea and vomiting, insomnia, and weight loss. If you have had daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone before, talk with your doctor. Preferred product language will be added as follows. Hospital eye units are being asked to take the following actions. Conclusion macular ischemia often leads to legal blindness. Interrupt herceptin infusion for dyspnea or clinically significant hypotension. Eye injections to treat wet agerelated macular degeneration. Herceptin hylecta is supplied as an injection for subcutaneous administration. Herceptin 600 mg solution for injection in vial summary. Other cancer medicines are sometimes used in combination with herceptin. Bilateral macular ischemia and severe visual loss following trastuzumab therapy article pdf available in acta oncologica stockholm, sweden 503.
Herceptin 600 mg solution for injection in vial summary of. Herceptin trastuzumab is a cancer medicine that interferes with the growth and spread of cancer cells in the body. If you are or become pregnant while receiving herceptin or within 7 months after your last dose of herceptin, you should immediately report herceptin exposure to. Because herceptin is an antibody, it is possible to have a reaction. Apr 30, 2015 no testing has been made on macular edema associated with rp and this case report is the first clue of efficacy of aflibercept. The recommended dose of herceptin hylecta is 600 mg10,000 units 600 mg trastuzumab and 10,000 units hyaluronidase administered. When lucentis ranibizumab received fda approval in late june 2006, the new macular degeneration drug was celebrated as a major medical breakthrough with about 200,000 new cases of advanced, agerelated macular degeneration amd identified each year in the united states, many older americans with more severe or wet forms of amd endured inevitable, gradual loss of central vision. Jul 17, 2008 a study of avastin bevacizumab plus herceptin trastuzumab in patients with primary inflammatory her2positive breast cancer. Retina trastuzumab has rarely been associated with macular edema, macular ischemia, and serous retinal detachment, which can lead to severe vision loss. An intravitreal injection of bevacizumab may provide an effective, safe, and inexpensive option for patients with agerelated macular degeneration who are losing vision secondary to macular.
950 1386 1100 57 402 679 757 1367 913 443 559 504 1460 562 1184 1005 80 164 1335 1166 992 315 111 1312 308 1451 1378 1139 1159 1230 374 1215 176 384 942 1204 996 338