To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: *If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site. Haematological adverse events after carboplatin AUC 7: patients with Crea-Cl <125mL/min vs>125mL/min and no dose capping. Monitor Closely (1)carboplatin, denosumab. Either increases effects of the other by immunosuppressive effects; risk of infection. %PDF-1.5 % Tell your doctor right away if you develop any of the following symptoms: easy bruising/bleeding, signs of infection (such as sore throat that doesn't go away, fever), unusual tiredness, rash, itching, swelling, severe dizziness, or trouble breathing.Vomiting is a common side effect of this medication. No new hAEs other than grade 1 occurred before day 10 and after day 24. In retrospect, the main reasons to apply dose capping were consideration of the alerts by the FDA and GOG on the one hand, and concerns of excessive toxicity in older patients with numerically very high doses (if uncapped) on the other hand. Another approach for determining the initial dose of carboplatin injection is the use of mathematical formulae, which are based on a patient's pre-existing renal function or renal function and desired platelet nadir. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: aminoglycoside antibiotics (such as gentamicin, neomycin), amphotericin B, certain anti-seizure medications (hydantoins such as phenytoin), certain "water pills" (loop diuretics such as furosemide, bumetanide). With a median follow-up time of the whole cohort of 60 months (22136 months), one patient (1.3%) experienced a relapse 24 months after adjuvant treatment and was salvaged with combination chemotherapy. ID: 325 v.4. Most The following factors were analysed: incidence of hAE, grade of hAE according to common clinical toxicity criteria for adverseevents (V.4.0) andtime of nadir of hAEs. Use Caution/Monitor. Chemotherapy and biotherapy guidelines and recommendations for practice. Monitor Closely (1)carboplatin and paromomycin both increase nephrotoxicity and/or ototoxicity. Avoid concurrent or sequential use to decrease risk for ototoxicity. belatacept and carboplatin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. people have Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression. 1-4. . Use Caution/Monitor. Use Caution/Monitor. Dosing of Carboplatin Dosing for carboplatin is far different than dosing for cisplatin. Avoid concurrent or sequential use to decrease risk for ototoxicity. Patients received an intravenous carboplatin dose of 560 mg/m 2 (in children 10 kg) or 18.7 mg/kg (in children <10 kg) during one hour. Unlike cisplatin, it has minimal protein binding and distributes well into ascites, pleural fluid, liver, kidney, skin and tumor tissues. As a temporary measure, it has been suggested that physicians limit the dose of car- boplatin in order to avoid overdosing if they are using the IDMS method to measure serum creatinine. http://www.hoparx.org/uploads/files/newsletterfall_2010.pdf/; Adverseevents with clinical interventions, 3% (1 hospitalisation with febrile neutropaenia grade3), 3% (1 platelet transfusion in thrombocytopaenia grade4). As a consequence, great variations in monitoring for haematological toxicities, frequency and timing of follow-up visits and insecurity of expectable haematological acute adverse events (hAEs) exist. Carboplatin Injection, as a single agent, has been shown to be effective in patients with recurrent ovarian carcinoma at a dosage of 360 mg/m2 IV on day 1 every 4 weeks (alternatively see Formula Dosing). CLINICAL STUDIES: Use with Cyclophosphamide for Initial Total Dose (mg) = (target AUC) (GFR + 25). Use Caution/Monitor. Use Caution/Monitor. 1Clinic for Medical Oncology and Haematology, Cantonal Hospital St Gallen, St Gallen, Switzerland, 2Department of Oncology/Haematology, Cantonal Hospital Grisons, Chur, Switzerland. Use Caution/Monitor.carboplatin, streptozocin. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com. Access your plan list on any device mobile or desktop. 2.2. Monitor Closely (1)carboplatin decreases effects of sipuleucel-T by pharmacodynamic antagonism. . Carboplatin is administered primarily through IV infusion. Use caution when switching patients from long-acting therapies with immune effects. Treatment is usually repeated every four . Monitor Closely (1)carboplatin decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Some clinical guidelines recommend capping of the carboplatin dose at, for example, creatinine-clearance (Crea-Cl) of 125mL/min because of concerns of excessive toxicity. carboplatin decreases effects of influenza virus vaccine (H5N1), adjuvanted by pharmacodynamic antagonism. Use Caution/Monitor. Additive myelosuppression. Appropriate patient weight and serum creatinine should be used when estimating GFR for use in the Calvert equation. Day 1 . Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Use Caution/Monitor. They often give patients 500 mg of carboplatin. Minor/Significance Unknown. Carboplatin Injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. This is a retrospective analysis of acute haematotoxicity of patients with stage I seminoma treated with adjuvant carboplatin area under the curve (AUC) 7 in routine practice in two Swiss centres in 20052015, and a comparison of incidence and grade (according to Common Terminology Criteria for Adverse Events v4.0) of haematological adverse events (hAEs) in patients with Crea-Cl <125 mL/min vs >125mL/min without dose capping. Daily low-dose carboplatin plus concurrent thoracic radiotherapy is the standard treatment for elderly patients with unresectable clinical stage (c-Stage) III non-small cell lung cancer (NSCLC) in . Use Caution/Monitor. government site. Monitor Closely (1)carboplatin decreases levels of phenytoin by unknown mechanism. Monitor Closely (1)carboplatin and tobramycin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Clinical data to support such recommendations are lacking, especially in patients with seminoma. . carboplatin (generic) This drug is available at a higher level co-pay. Use Caution/Monitor. For patients with abnormal renal function, the usual formulas are less likely to be problematic. Carboplatin is approved to be used alone or with other drugs to treat: Ovarian cancer that is advanced. Use Caution/Monitor. Use Caution/Monitor. Additive myelosuppression. Use Caution/Monitor. For carboplatin Manufacturer advises avoid if creatinine clearance less than 30 mL/minute (consult product literature), see Prescribing in renal impairment. Themain inclusion criteria were a normal blood count at treatment and a minimum of two documented blood count measurements during the first 8 weeks after treatment. Combination treatment: 300 mg/m IV (plus cyclophosphamide 600 mg/m IV) q4Weeks, Dose adjustment may not be necessary; not studied, Do not repeat dose until ANC >2000 AND platelets >100000, Off-label: testicular cancer, head and neck cancer, cervix cancer, small cell lung cancer, progressive diffuse large B-cell lymphoma, Calvert formula should be used to calculate dosing. In order to provide you with relevant and meaningful content we need to know more about you. Other dosage regimens . Serious - Use Alternative (1)carboplatin, ciltacabtagene autoleucel. Monitor Closely (1)siponimod and carboplatin both increase immunosuppressive effects; risk of infection. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. Monitor Closely (1)carboplatin, carmustine. Use Caution/Monitor. Carboplatin dosing. Not eating before your treatment may help relieve vomiting. Immune hypersensitivity reaction (2-9.2%), The drug should be administered under the supervision of an experienced cancer chemotherapy physician. This study indicated there was a larger mean difference in pre- and post-platelet count in patients receiving uncapped carboplatin compared to patients receiving capped carboplatin with no differences in toxicities. Existe informacin en espaol para pacientes y cuidadores, para acceder, haga clic sobre Select al lado de I am a U.S. Compare formulary status to other drugs in the same class. Carboplatin is also being studied in the treatment of . Carboplatin has no appreciable schedule-dependent activity and even in low-dose weekly fractions requires antiemetics. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis. Bethesda, MD 20894, Web Policies carboplatin and streptozocin both increase nephrotoxicity and/or ototoxicity. Serious - Use Alternative (1)carboplatin, tisagenlecleucel. Use Caution/Monitor. Modify Therapy/Monitor Closely. carboplatin and cidofovir both increase nephrotoxicity and/or ototoxicity. This website also contains material copyrighted by 3rd parties. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs. Four (5.4%) patients had no hAEs. NOTE: Aluminum reacts with carboplatin causing precipitate formation and loss of potency, therefore, needles or intravenous sets containing aluminum parts that may come in contact Carboplatin Injection is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum-containing compounds. trastuzumab deruxtecan, carboplatin. Prescribing and dispensing information For carboplatin Carboplatin can be given in an outpatient setting. Minor/Significance Unknown. 2, or mg/kg. A total of 15 hAEs occurred, with a mean of 1.7 hAEs per patient, 87% (13/15) of them were of grade 1and no clinical interventions were necessary. The site is secure. Renal excretion is the major route of elimination for carboplatin. Ainsworth NL, Marshall A, Hatcher H, et al.. Avoid or Use Alternate Drug. Performance of formulae based estimates of glomerular filtration rate for carboplatin dosing in stage 1 seminoma. carboplatin and tacrolimus both increase nephrotoxicity and/or ototoxicity. Alternatively, 400 mg/m 2 as a 24-h infusion for 2 consecutive d can be used Head and Neck and Small Cell Lung Cancer Adult: IV 300-400 mg/m 2 q4wk Child: IV Up to 560 mg/m 2 once q4wk or up to 175 mg/m 2 q2wk. Additive myelosuppression. Monitor Closely (1)sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of carboplatin by Other (see comment). Toxicity after single-dose carboplatin area under the curve 7 is generally mild with a low rate (2.7%) of haematological adverse events (hAEs) necessitating clinical interventions. Nevertheless, our conclusions can be substantiated due to the very similar proportion and equal distribution of low-grade toxicities as well as the very few severe hAEs between the different groups with Crea-Cl>125mL/minor <125mL/min and capping versus nocapping, respectively. WARNING: Carboplatin can cause severe blood disorders (such as anemia, bone marrow suppression) that can result in infection and bleeding problems. Invest New Drugs. Modify Therapy/Monitor Closely. ropeginterferon alfa 2b, carboplatin. Monitor Closely (1)carboplatin, zidovudine. Use Caution/Monitor. 300-600 mg/m IV q4Weeks ; Sarcoma (bone/soft tissue) 400 mg/m/day for 2 days every 21 days; Reply to the letter to the editor Measured and estimated glomerular filtration rate for carboplatin dose calculation' by Cathomas et al, Measurement or estimation of glomerular filtration rate in seminoma patients: quite another cup of tea. Use Caution/Monitor. AEs that occurred in at least 5% of patients (both Safety and Expansion phases) are . Any clinician seeking to apply or consult the NCCN Guidelines is expected to use independent medical judgment in the context of . carboplatin and pentamidine both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Monitor Closely (1)carboplatin and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor. Use Caution/Monitor. Additive myelosuppression. carboplatin, dose capping, creatinine clearance, seminoma stage I, toxicity, Treatment of stage I seminoma, with one course of adjuvant carboplatin or surveillance, risk-adapted recommendations implementing patient autonomy: a report from the Swedish and Norwegian Testicular Cancer Group (SWENOTECA). Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment. Would you like to proceed? Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Lauritsen J, Gundgaard MG, Mortensen MS, et al.. Therefore, without a clear therapeutic advantage and potentially greater logistical issues (such as venous access and travels to a clinic), few oncologists are persuaded that PC-1W should replace PC-3W regimens. sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of carboplatin by Other (see comment). Avoid or Use Alternate Drug. Serious - Use Alternative (1)carboplatin decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. levels of both drugs, risk of serious infection, myelosuppression, nephrotoxicity, auditory, vestibular, other adverse effects (additive effects) dengue tetravalent vaccine, live. No hAEs other than grade 1 occurred before day 10 and after day 24. 5th ed. Monitor Closely (1)carboplatin, lomustine. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. Up to three quarters of patients dosed by the CG formula and one quarter of patients dosed by the CKD-EPI equation receive a carboplatin dose over 10% and 20% different, respectively, than the dose that they should receive on the basis of mGFR ( 12, 30 ). AUC values of 4 to 6 and 6 to 8 mg/mL. carboplatin decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. `5`{ 'HW ?qD2>zn% Jq According to our knowledge, this is the first study to assess toxicities associated with capping versus non-capping of carboplatin doses in patients with seminoma stage I and a very high GFR. Minor/Significance Unknown. carboplatin, tofacitinib. Use Caution/Monitor. Repeat cycle every 3 weeks for 6 cycles. sharing sensitive information, make sure youre on a federal Avoid or Use Alternate Drug. In addition, this study provides a rationale for efficient use of healthcare services without compromising patients safety. Additive myelosuppression. Concomitant chemotherapeutic drugs were vincristine 1.5 mg/m 2 and etoposide 150 mg/m 2, administration of which are part of the local standard treatment protocol. Normal vision usually returns within several weeks after the end of treatment. . How carboplatin works. D Additive myelosuppression. 74 patients with 229 documented measurements were included (median 3/patient). Avoid or Use Alternate Drug. An official website of the United States government. Use Caution/Monitor. Consult your doctor for more details.Tell your doctor if you are pregnant or plan to become pregnant. carboplatin and cyclosporine both increase nephrotoxicity and/or ototoxicity. informational and educational purposes only. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. Drug therapy may be needed to prevent or relieve nausea and vomiting. The majority (31 of 45) involved a fixed dose for carboplatin. Ethics approval: Ethics Committee of Eastern Switzerland, St Gallen. Use Caution/Monitor. Monitor Closely (1)busulfan, carboplatin. To view formulary information first create a list of plans. Table 7 Percentage of carboplatin doses, calculated using the eGFR, within 5, 10, 20, 30 and 50% of the carboplatin dose calculated using the rGFR Full size table Discussion Platinum coordination compound; covalently binds to DNA; cross-links strands of DNA, Additive: cisplatin, etoposide, floxuridine, ifosfamide, ifosfamide with etoposide, paclitaxel, Y-site (partial list): allopurinol, etoposide PO4, filgrastim, gemcitabine, granisetron, linezolid, ondansetron, paclitaxel, piperacillin-tazobactam, propofol, Administer IV over 15 min or continuous IV infusion over 24 hr, May also be administered intraperitoneally, When administered as sequential infusions, taxane derivatives (docetaxel, paclitaxel) should be administered before platinum derivatives to limit myelosuppression and to enhance efficacy, Do not use aluminum-containing needles or IV administration sets that may come in contact with carboplatin (aluminum can cause precipitate formation and loss of potency). Either increases toxicity of the other by immunosuppressive effects; risk of infection. Concomitant therapy is expected to increase the risk of immunosuppression. Use Caution/Monitor. Carboplatin is a second-generation platinum compound with a broad spectrum of antineoplastic properties. The Cmax values and areas under the plasma concentration versus time curves from 0 to infinity (AUC inf) increase linearly with dose, although the increase was slightly more than dose proportional. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada). This effect is apparently cell-cycle nonspecific. Either increases toxicity of the other by immunosuppressive effects; risk of infection. This third-party website is neither owned nor controlled by Pfizer, and Pfizer does not endorse and is not responsible for the content or services of this site. Kelleher LO, eds. Carboplatin injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Canada residents can call a provincial poison control center. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. 2004. Monitor Closely (1)belatacept and carboplatin both increase immunosuppressive effects; risk of infection. carboplatin and paromomycin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Our scientific content is evidence-based, scientifically balanced and non-promotional. 308 0 obj <>/Filter/FlateDecode/ID[<9271021D123C0E4BAAB0444203BCD96B><05D27424B8DD6B4899D1DFAF2CF78C78>]/Index[283 152]/Info 282 0 R/Length 123/Prev 190069/Root 284 0 R/Size 435/Type/XRef/W[1 3 1]>>stream Pharmacokinetics of carboplatin in a . Copyright(c) 2022 First Databank, Inc. Either increases effects of the other by immunosuppressive effects; risk of infection. If neutrophil and platelet counts are lower, dose of carboplatin should be reduced by 50-75% of initial dose. Either increases effects of the other by immunosuppressive effects; risk of infection. Monitor Closely (1)carboplatin, cyclophosphamide. Other (see comment). The study was approved by the respective local ethical committees. between carboplatin plasma clearance, renal function and drug-induced toxicity.14-16 GFR-based dosing of carboplatin is fairly standard, with patients prescribed a dose designed to theoretically achieve a targeted AUC (see below; Refs. carboplatin and colistin both increase nephrotoxicity and/or ototoxicity. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC. But the pattern of hAEs with more than 80% being grade 1 was similar in both groups, and the differences are not statistically significant. commonly, these are generic drugs. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. Patients with creatinine clearance values below 60 mL/min are at increased risk of severe bone marrow suppression. Use Caution/Monitor. Endometrial cancer. In these studies, GFR was measured by 51Cr-EDTA clearance. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine. This combination may also be used with other drugs or treatments or to treat other types of cancer. carboplatin and foscarnet both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. FDA Center for Drug Evaluation and Research. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. Monitor Closely (1)carboplatin and pentamidine both increase nephrotoxicity and/or ototoxicity. Either increases toxicity of the other by pharmacodynamic synergism. hb```g``uAb@q!vB1!A]C S1 Use Caution/Monitor. This is a retrospective analysis of a cohort of patients with stage I seminoma treated with adjuvant carboplatin AUC 7 in routine practice in two Swiss centres between 2005 and 2015. carboplatin and oxaliplatin both increase nephrotoxicity and/or ototoxicity. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects. Modify Therapy/Monitor Closely. Preferred Regimens (High-Dose Chemotherapy) Carboplatin + Etoposide 11 Carboplatin 700mg/m 2 IV Etoposide 750mg/m 2 IV. Avoid or Use Alternate Drug. 14,15,17). carboplatin, axicabtagene ciloleucel. Carboplatin Injection is supplied as a sterile, pyrogen-free, aqueous solution available in 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL or 600 mg/60 mL multiple-dose vials containing 10 mg/mL of carboplatin for Carboplatin, like cisplatin, produces predominantly interstrand DNA cross-links rather than DNA-protein cross-links. If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
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