For certain toxicities, an initial dose reduction of 20% should be made, followed by an additional. Faslodex 500 mg should be administered intramuscularly into the buttocks gluteal area slowly 12 minutes per injection as two 5 ml injections, one in each buttock, on days 1, 15, and 29 and once monthly thereafter 1. Fatal infusionrelated reactions within 24 hours of rituxan infusion. Halaven is a microtubule inhibitor, therefore, it is expected to cause fetal harm when administered to pregnant women. Halaven is usually given after at least 2 other combinations of chemotherapy medications have been tried without successful treatment of symptoms. Event description recommended halaven dose permanently reduce the 1. Halaven is a prescription medicine used to treat adults with breast cancer that has spread to other parts of the body, and who have already received other types of. Halaven eribulin dosing, indications, interactions, adverse. Highlights of prescribing information these highlights do not include all the information needed to use halaven. Halaven treated patients received a median of 5 cycles range. If you have any further questions, ask your doctor or nurse.
Myobloc, the first and only approved botulinum toxin type b, is approved for the treatment of cervical dystonia and chronic sialorrhea. Store undiluted halaven in the syringe for up to 4 hours at room temperature or for up to 24 hours under refrigeration 40f or 4c. Yescarta is a cd19directed genetically modified autologous t cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large bcell lymphoma after two or more. In trial et743sar3007, the incidence of grade 3 or 4 neutropenia, based on laboratory values, was 43% 1678. Embryofetal toxicity and teratogenicity occurred in pregnant rats that received eribulin mesylate at approximately half of the recommended human dose based on. Dailymed dacarbazine injection, powder, for solution. A faslodex 250 mg starting dose is recommended for patients with moderate hepatic impairment childpugh class b 1. Here we provide general billing and coding information for halaven eribulin mesylate injection and related services. The recommended dose of eribulin as the ready to use solution is 1. Nov 21, 2019 halaven is usually given on day 1 and day 8 of a treatment cycle. Halaven eribulin mesylate page 3 of 6 unitedhealthcare medicare advantage policy guideline approved 09112019 proprietary information of unitedhealthcare. Restricted access do not disseminate or copy without approval. Halaven is used to treat breast cancer that has spread to other parts of the body halaven is usually given after at least 2 other combinations of chemotherapy medications have been tried without successful treatment of symptoms.
Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. Halaven is used to treat breast cancer that has spread to other parts of the body. Please check with the payor to verify coding or special billing requirements. Highlights of prescribing information these highlights do not include all the information needed to use advair diskus safely and effectively. The chemical name is desalanyl1, serine125 human interleukin2. Severe mucocutaneous reactions, some with fatal outcomes 5. Pharmacokinetics of eribulin mesylate in cancer patients.
Highlights of prescribing information these highlights do not include all the information needed to use tecentriq safely and effectively. Epirubicin is intended for intravenous or intravesical administration only. Dosing and administration faslodex fulvestrant injection. Eribulin may inhibit the important drug metabolising enzyme cyp3a4. The recommended dose of halaven in patients with moderate hepatic impairment childpugh b is 0. Ixempra ixabepilone dosing and administration guide. Dosages greater than 200 mcg per kg per minute provide little. Highlights of prescribing information halaven information. Halaven is a clear, colourless aqueous solution for injection provided in glass vials containing 2 ml or 3ml of solution.
Please refer to the full prescribing information of fulvestrant. Dacarbazine for injection 200 mgvial is reconstituted with 19. This leaflet was prepared by eisai limited, mississauga, on. Halaven eribulin prior auth criteria proprietary information. Description proleukin aldesleukin, a human recombinant interleukin2 product, is a highly purified protein with a molecular weight of approximately 15,300 daltons. Halaven eribulin mesylate halaven fep clinical rationale rationale for inclusion in pa program background halaven is a prescription medicine used to treat patients with metastatic breast cancer, who have already received at least 2 other types of anticancer medicines for their breast cancer once it has spread to other parts of the body. Highlights of prescribing information these highlights do not include all the information needed to use arzerra safely and effectively. Halaven eribulin dosing, indications, interactions. See full prescribing information for complete boxed warning. Official site myobloc rimabotulinumtoxinb injection. See full prescribing information for advair diskus. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. The effective maintenance dose for continuous and stepwise dosing is 50 to 200 mcg per kg per minute, although doses as low as 25 mcg per kg per minute have been adequate.
Table 2 lists the recommended dosage reductions of. Before prescribing keytruda, please read the selected safety information on pages 8 to 10 and the accompanying prescribing information. The chmp noted that, when halaven was used as a thirdline therapy for breast cancer after at least two previous treatments with cancer medicines for advancedmetastatic disease, it prolonged the length of time that patients lived and the safety profile is within what is expected for chemotherapy medicines. Medication management please refer to the fda labelpackage insert for details regarding these topics. Cytotoxic agent epirubicin should be administered only under the supervision of qualified physicians experienced in cytotoxic therapy. Eribulin was approved by the fda in november for treatment of metastatic breast cancer patients who have previously received at least two chemotherapeutic regimens in. Contraindications yondelis is contraindicated in patients with known severe hypersensitivity, including anaphylaxis, to trabectedin. Halaven eribulin mesylate injection is a sterile, clear, colorless solution in a single use vial, one vial per carton, with a latexfree rubber stopper. For healthcare professionals for unresectable or metastatic liposarcoma or leiomyosarcoma after an anthracycline. Ixempra, a microtubule inhibitor, in combination with capecitabine is indicated for the treatment of metastatic or locally advanced breast cancer in patients after failure of an anthracycline and a taxane 1. Halaven fda prescribing information, side effects and uses. Highlights of prescribing information for advair diskus. Bystolic may be used alone or in combination with other antihypertensive agents see drug interactions 7.
Arzerra ofatumumab injection, for intravenous use initial u. Halaven is given by intravenous iv injection in your vein. And breast cancer used as subsequent therapy in metastatic disease for patients who have previously received. Moderate and strong cyp3a4 inducers, including enzymeinducing aeds such asphenytoin, carbamazepine, and.
In a clinical study of more than 750 women, halaven was compared with other chemotherapies or hormone therapies commonly used to treat metastatic breast cancer mbc. The calculated dose of the resulting solution is drawn into a syringe and administered only intravenously. Dailymed imbruvica ibrutinib capsule imbruvica ibrutinib. Drugs az pill identifier supplements symptom checker diseases dictionary media. Women of childbearing potential must be advised to avoid becoming pregnant whilst they or their male partner are receiving halaven and have to use effective contraception during and up to 3. Halaven improved median overall survival in metastatic breast cancer vs treatment of physicians choice.
Halaven treatment should be given under the supervision of a doctor experienced in the use of anticancer medicines. Although some women lived longer and some women did not live as long, women who were treated with halaven lived, on average, 25% longer. Abraxane is indicated for the firstline treatment of locally advanced or metastatic nonsmall cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. Highlights of prescribing information when administering. Frequency is considered excessive when services are performed more frequently than listed in the package insert or generally accepted by peers and the reason for additional services is not justified by documentation. Medication management please refer to the fda label package insert for details regarding these topics. Consequently, the us eribulin package insert recommends that the eribulin mesylate dose be reduced from 1. It is not known whether halaven is excreted into human milk.
Dec 05, 2017 randomization was stratified by geographic region, her2neu status, and prior capecitabine exposure. Highlights of prescribing information coadministration with. Pdf although metastatic breast cancer remains essentially incurable, many patients. See what is the most important information i should know about halaven. Monitor patients and discontinue rituxan infusion for severe reactions 5. Halaven is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. See full prescribing information for complete boxed warning coadministration of norvir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious andor lifethreatening adverse events due to possible effects of norvir on the hepatic metabolism of certain drugs.
Please click here for important safety information, including boxed warning regarding hepatic impairment, and click here 3 for full prescribing information. Pediatrics halaven in pediatric patients have not been. Oct 22, 2019 halaven eribulin is a cancer medicine that interferes with the growth and spread of cancer cells in the body. If a dose has been delayed for toxicity and toxicities have recovered to grade 2 severity or less, resume halaven at a reduced dose as set out in table 1. Ixempra as monotherapy is indicated for the treatment of metastatic or locally.
Highlights of prescribing information extended treatment in. The dose to be given is calculated using the patients height and weight. Ixempra is a prescription medicine used to treat locally advanced or metastatic breast cancer when certain other medicines have not worked or no longer work. Halaven is the first and only single agent to show a significant overall survival benefit in patients with thirdline metastatic breast cancer 14. And breast cancer used as subsequent therapy in metastatic disease for patients who have previously received therapy with an anthracycline and a taxane.
Apr 08, 2020 the administration of imbruvica with a highfat and highcalorie meal 800 calories to 1,000 calories with approximately 50% of total caloric content of the meal from fat increased ibrutinib c max by 2 to 4fold and auc by approximately 2fold, compared with administration of ibrutinib after overnight fasting. Refer to the pembrolizumab prescribing information for recommended pembrolizumab dosing information. Mar 25, 2011 hemonc today during the past several decades, significant advances in breast cancer management have led to increased os for patients with this disease. Halaven is usually given on day 1 and day 8 of a treatment cycle. Description halaven eribulin mesylate injection is a nontaxane microtubule dynamics. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions to halaven in nursing infants, breast feeding must be avoided. Halaven can cause changes in your heartbeat called qt prolongation. Please refer to the full prescribing information for the aromatase inhibitor being used. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. Halaven eribulin is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Page 3 of 44 full prescribing information 1 indications and usage 1. Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Store diluted solutions of halaven for up to 4 hours at room temperature or up to 24 hours under refrigeration. Halaven eribulin mesylate injection, for intravenous use. There are no known drugdrug interactions with faslodex 1. Neutropenic sepsis, including fatal cases, can occur. Halaven is indicated for the treatment of patients with. Faslodex 500 mg is administered as the same dose whether it is used as monotherapy or in combination with ribociclib, palbociclib, or abemaciclib 1. Halaven is given in cycles of treatment, with each cycle lasting 21 days. Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic.
Halaven should only be administered under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products. Each vial also contains anhydrous citric acid and mannitol. Halaven should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus. Because faslodex is an injection administered by a health care professional, you can confirm that your patients are. Halaven eribulin mesylate injection for intravenous administration initial us approval. Specific package insert requirement for epirubicin caution. Halaven is indicated for the treatment of patients with metastatic breast cancer who have. Halaven is given as intravenous into a vein injections over 21 day cycles. The printed package leaflet of the medicinal product must state the name. Advair diskus fluticasone propionate and salmeterol inhalation powder, for oral inhalation use initial u.
Correct coding is the responsibility of the provider submitting a claim for the item or service. Do not reescalate halaven dose after it has been reduced. T ab l e1 i st dv rc onw h f5% g, cu sl ity, fr o mhe nd s1 p gfa lodex5 0 intramuscularly once a month with faslodex 250 mg intramuscularly once a month. Halaven eribulin mesylate for treatment of mbc halaven. Tecentriq atezolizumab injection, for intravenous use initial u.
The recommended dose of halaven in patients with moderate renal impairment creatinine clearance of 3050 mlmin is 1. The resulting solution contains 10 mgml of dacarbazine having a ph of 3. And patient has been diagnosed with one of the following subtypes of sts. However, eribulin is a substrate for the drug efflux transporter pglycoprotein p gp. Halaven package insert guideline initial approval criteria coverage is provided in the following conditions. Read all of this leaflet carefully before you start using this medicine.
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