Written by: Brandy Persson, PharmD, BCPS, BCOP and Rebecca Fanning, PharmD, BCPS, Cone Health

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Description: Fam-trastuzumab deruxtecan-nxki is indicated for the treatment of:

  • Adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer previously treated with two or more anti-HER2-based regimens.1,2 This indication is under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.1,6

The purpose of this PQI is to provide guidance for management of fam-trastuzumab deruxtecan-nxki.

 

Background: Fam-trastuzumab deruxtecan-nxki is a HER2 directed antibody-drug conjugate (ADC). Fam-trastuzumab deruxtecan-nxki was FDA approved for metastatic breast cancer in December 2019 based on results from the DESTINY-Breast01 trial that established its efficacy and safety in patients previously treated with trastuzumab emtansine. The overall response (complete response and partial response) was 60.9%. Secondary endpoints included a median progression free survival of 16.4 months in all patients and 18.1 months in 24 patients enrolled with asymptomatic brain metastases.2 Fam-trastuzumab deruxtecan-nxki was FDA approved in January 2021 for patients with gastric and gastroesophageal junction adenocarcinoma based on the results of the DESTINY-Gastric01 trial. This study evaluated the safety and efficacy versus physician’s choice chemotherapy (irinotecan or paclitaxel monotherapy) in patients who had progressed on at least two prior regimens which included trastuzumab, a fluoropyrimidine and a platinum agent.  The study demonstrated a statistically significant improvement in the major efficacy outcomes of median overall survival (12.5 vs 8.4 mo) and confirmed objective response rate (43% vs 12%).  Additional efficacy outcomes of median progression free survival (5.6 vs 3.5 mo) and median duration of response (11.3 vs 3.9 mo) were also improved.6

 

PQI Process:

  • Review the medical record:
    • Ensure patient is an appropriate candidate for fam-trastuzumab deruxtecan-nxki
    • Confirm no history of interstitial lung disease (ILD), pneumonitis, or other lung condition
      • These patients were excluded from the DESTINY-Breast01 and DESTINY-Gastric01 studies
      • Although not a contraindication, ILD/pneumonitis is a boxed warning
    • Assess Left Ventricular Ejection Fraction (LVEF) prior to initiation
  • Patients with LVEF < 50% were not studied2,6
    • Evaluate CBC prior to initiation, as well as prior to each dose, and as clinically indicated
  • Review treatment plan:
    • Verify premedication orders:
      • Antiemetics – Moderately emetogenic3– 5-HT3 antagonist + dexamethasone prior to treatment and consideration for days 2 and 3; PRN antiemetic available for home use
      • Acetaminophen + H1 blocker may be included to prevent infusion related reactions per institutional policy or provider preference
        • Slow or interrupt infusion rate if patient develops infusion-related symptoms
      • Verify dosing of fam-trastuzumab deruxtecan-nxki1
        • Breast cancer: 5.4 mg/kg intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity
        • Gastric cancer: 6.4 mg/kg intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity
        • No dose adjustments required for mild or moderate renal or hepatic impairment
        • Patients with severe renal or hepatic impairment were not studied
      • Monitoring:1
        • CBC: baseline, then before each treatment cycle
          • Hold for neutrophil count < 1,000 cells/mm3 or a platelet count < 50,000/microliter
          • Growth factor support may be used to maintain counts when appropriate2,5,6
        • LVEF: baseline and at regular intervals during treatment as clinically indicated
          • Discontinue treatment if LVEF < 40%, if an absolute LVEF decrease of > 20% from baseline LVEF or symptomatic congestive heart failure
        • ILD and pneumonitis: Monitor, consider imaging, and promptly investigate signs and symptoms including cough, dyspnea, fever, and new or worsening respiratory symptoms
          • Permanently discontinue in all patients with ≥ grade 2 ILD/ pneumonitis, promptly initiate systemic corticosteroid treatment (ex. ≥1 mg/kg/day prednisone) and continue upon improvement for at least 14 days followed by gradual taper (ex. at least 4 weeks)
        • Evaluate the need for dose modifications. Do not re-escalate dose after dose reduction is made
          • Dose modifications for breast cancer:
            • First dose reduction: 4.4 mg/kg
            • Second dose reduction: 3.2 mg/kg
            • Further required dose reductions: Discontinue treatment
          • Dose modifications for gastric cancer:
            • First dose reduction: 5.4 mg/kg
            • Second dose reduction: 4.4 mg/kg
            • Further required dose reductions: Discontinue treatment
          • Preparation:1
            • Reconstitute fam-trastuzumab deruxtecan-nxki 100 mg vials with 5 mL of Sterile Water for Injection, USP for a final concentration of 20 mg/mL
            • Inject dose into a 100 mL bag of 5% Dextrose Injection, USP (do not use sodium chloride)
            • Fam-trastuzumab deruxtecan-nxki is compatible with an infusion bag made of polyvinylchloride, or polyolefin (copolymer of ethylene and polypropylene)
          • Administration:1
            • First infusion is administered over 90 minutes with an infusion set made of polyolefin or polybutadiene and a 0.2- or 0.22-micron in-line polyethersulfone or polysulfone filter
              • If patient tolerates the first infusion, subsequent infusions may be given over 30 minutes
            • 5% dextrose is recommended for priming and flushing the administrative line
            • Cover the infusion bag to protect from light

 

Patient Centered Activities:

  • Patient Education:1,5
    • Provide Intravenous Cancer Treatment Education (IVE) Sheet
    • Instruct patient to report any new/worsening shortness of breath, dry cough, wheezing, or fever
    • Caution patient regarding increased risk of infection and infection prevention methods
    • Review prompt reporting of any chest pain/tightness, rapid weight gain, significant swelling in ankles or trouble breathing due to weakened pumping action of the heart muscle
    • Remind patient that this drug may cause significant hair loss
    • Instruct patient to report adverse events including fever, diarrhea, nausea/vomiting or fatigue
    • Ensure patient has access to supportive medications
      • Anti-nausea: 5-HT3 receptor antagonist, metoclopramide, or prochlorperazine
      • Anti-diarrheal: loperamide
    • Patient Assistance: NCODA Financial Assistance Tool

References:

  1. EnhertuÒ (fam-trastuzumab deruxtecan-nxki) [prescribing information]. Basking Ridge, NJ: Daiichi Sankyo, Inc.
  2. Modi S, Saura C, Yamashita T, et al; DESTINY-Breast01 Investigators. Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med 2020;382(7):610-621.
  3. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Antiemesis. Version 2.2020.
  4. ENHERTU4U: Patent Access to Treatment. https://www.enhertu4u.com/patient/affording-your-medicine.html.
  5. Fam-trastuzumab Derutecan-nxki (EnhertuÒ). JNCCN Spotlights:  https://jnccn360.org/breast/jnccn-spotlights/fam-trastuzumab-deruxtecan-nxki.
  6. Shitara K, Bang YJ, Iwasa S, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med 2020; 382:2419-2430.
Important notice: National Community Oncology Dispensing Association, Inc. (NCODA), has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional.  This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented.  NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.
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Written By: Pedro C. Barata, MD, Tulane University

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Description: The purpose of this PQI is to review the clinical considerations around the use of tivozanib (Fotivda®) for patients with relapse or refractory advanced renal cell carcinoma.

 

Background: Tivozanib is a small molecule that inhibits the phosphorylation of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2 and VEGFR-3.1

On March 2021, tivozanib was approved by the FDA for the treatment of advanced or metastatic renal cell carcinoma in patients who have previously received two or more prior systemic therapies, based on the phase III trial TIVO-3.2,3 With a median follow-up of 19 months, patients treated with tivozanib had a significantly longer median progression free survival (5.6 vs. 3.9 months, hazard ratio 0.73, p=0.016) and higher objective response rate (18 vs. 8%) than sorafenib. Treatment-related adverse events with tivozanib were common (84%) but manageable with grade 3 or higher adverse events occurring in less than 5% except hypertension (20%). Treatment-related adverse effects led to dose interruptions in 48% and dose reductions in 24%.

PQI Process:

  • Verify dosage: the recommended starting dose of tivozanib is 1.34 mg once daily, with or without food for 21 days followed by 7 days off treatment for a 28-day cycle4
  • Dose interruptions and/or dose reduction may be needed to manage adverse reactions (see below)3,4
  • Dose reductions required for patients with moderate hepatic impairment (Tbili >1.5-3 times ULN with any AST)
  • Monitor thyroid levels at baseline and every 2-3 months
  • Check pregnancy status in females of reproductive potential
  • Review patient medication list for possible drug-drug interactions
    • Strong CYP3A4 inducer: avoid concomitant use of strong CYP3A inducers with tivozanib4

Dose Modifications for Adverse Reactions

Adverse ReactionSeverityDose modifications
HypertensionGrade 3Withhold for Grade 3 that persists despite optimal antihypertensive therapy

Resume at reduced dose when hypertension is controlled at less than or equal to Grade 2

Grade 4Permanently discontinue
Cardiac FailureGrade 3Withhold until improves to Grade 0 to 1 or baseline

Resume at a reduced dose or discontinue depending on the severity and persistence of adverse reaction

Grade 4Permanently discontinue
Arterial Thromboembolic EventsAny GradePermanently discontinue
Hemorrhagic EventsGrade 3 or 4Permanently discontinue
Proteinuria2 grams or greater proteinuria in 24 hoursWithhold until less than or equal to 2 grams of proteinuria per 24 hours

Resume at a reduced dose

Permanently discontinue for nephrotic syndrome

Reverse Posterior Leukoencephalopathy SyndromeAny GradePermanently discontinue
Other Adverse ReactionsPersistent or intolerable Grade 2 or 3 adverse reaction

Grade 4 laboratory abnormality

Withhold until improves to Grade 0 to 1 or baseline

Resume at reduced dose

Grade 4 adverse reactionPermanently discontinue

 

Patient Centered Activities:

  • Provide Oral Chemotherapy Education (OCE) sheet and review with patient
  • Instruct patient to monitor blood pressure at home and report any increases from baseline
  • Ensure that the patient has access to loperamide to use as needed for diarrhea and to call the provider if loperamide does not control
  • Patient Assistance: NCODA Financial Assistance Tool 

References:

  1. Eskens, Ferry ALM, et al. “Biologic and clinical activity of tivozanib (AV-951, KRN-951), a selective inhibitor of VEGF receptor-1,-2, and-3 tyrosine kinases, in a 4-week-on, 2-week-off schedule in patients with advanced solid tumors.” Clinical Cancer Research22 (2011): 7156-7163.
  2. Rini BI, Pal SK, Escudier BJ, et al: Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study. The Lancet Oncology 21:95-104, 2020.
  3. Chang E, Weinstock C, Zhang L, et al: FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma. Clinical Cancer Research, 2021.
  4. Fotivda®(tivozanib) [prescribing information]. AVEO Oncology.
Important notice: NCODA has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional.  This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented.  NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.
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Written by: Eric Dallara, RPh, New England Cancer Specialist
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Description:  Diarrhea is the main toxicity of neratinib treatment occurring in 95% of patients in the ExteNET trial on the neratinib arm in which antidiarrheal prophylaxis was not protocol specified.1 Various prevention and treatment strategies for diarrhea have been studied and will be discussed in this document.

 

Background: Neratinib is indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab based therapy. Neratinib is also indicated in combination with capecitabine in metastatic/advanced HER2-positive breast cancer following 2 or more anti-HER2 based regimens. The majority (95%) of patients experienced diarrhea in the first month of treatment in ExteNET.  Median time to onset of any grade diarrhea is 2 days (8 days for Grade 3) and median cumulative duration of diarrhea was 59 days (5 days for Grade 3). The Phase 2 CONTROL trial was designed to investigate various approaches to preventing and managing diarrhea in patients on neratinib, including various anti-diarrheal combinations, as well as a dose escalation arm. Mature data is available for budesonide and colestipol, as well as dose escalation from the CONTROL trial.4 All preventative strategies from the CONTROL trial reduced the incidence, duration, and severity of diarrhea, and also reduced neratinib discontinuation when compared to the pivotal ExteNET trial.

 

PQI Process: Upon receipt of neratinib prescription:

  • Consider dose escalation based on data update FDA approved updated package insert (see Supplemental Information)
  • Diarrhea Prophylaxis – Diarrhea occurs in 95% of the patients without prophylaxis protocol
    • Begin prophylaxis with the first dose or neratinib and continue for 2 cycles depending on the regimen selected and the patient response
    • Ensure patient has instructions and supply of loperamide and consider colestipol or budesonide (see Supplemental Information for dosing)
    • Refer to Oncolytic Induced Diarrhea PQI
    • Identify drug-drug interactions and side effect profiles of loperamide, colestipol, and budesonide when making clinical recommendations
    • Consider weekly assessment of diarrhea throughout the first 2 cycles
  • Drug-Drug Interactions
    • Avoid concomitant use of PPIs
    • If H2-antagonists must be used, administer neratinib 2 hours before or 10 hours after
    • Other antacids (Tums, Maalox) should be separated by at least 3 hours
  • Verify in EMR that patient is scheduled for CMP for the first 3 months then every 3 months as clinically indicated

 

Patient Centered Activities:

  • Provide Oral Chemotherapy Education (OCE) Sheet and Oral Chemotherapy Education Supplemental Sheet
  • Express importance of diarrhea prophylaxis and enable patients to obtain anti-diarrheal medications with manufacturer voucher
  • Consider providing Neratinib (Nerlynx®) Treatment Support Kit (TSK)
  • Neratinib should be taken with food and around the same time each day
    • Dose escalation – Take three tablets (120 mg) daily for 7 days, then four tablets (160 mg) daily for 7 days, then six tablets (240 mg) daily thereafter
    • Initiation without escalation – Take six tablets (240 mg daily) with loperamide during the first 56 days, then loperamide as needed to maintain daily bowel movements
  • Maintain adequate oral hydration throughout treatment unless otherwise indicated
  • Counsel on other possible side effects
    • Diarrhea (95%)
      • Voucher for 3-months of anti-diarrheal medication from the manufacturer
      • Advise patients to call office if diarrhea is uncontrolled with anti-diarrheal
    • Nausea (43%)
    • Abdominal pain (36%)
    • Vomiting (26%)
    • Stomatitis (14%)
  • Financial Assistance:
  • 3-month voucher available for anti-diarrheal agents
  • Traditional financial assistance for high medication costs available through PumaPatientLynx

 

References:

  1. NERLYNX® [Package Insert]. Los Angeles, CA: Puma Biotechnology, Inc.
  2. Hurvitz S, Chan A, Iannotti N, et al. Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib- associated diarrhea in patients with HER2+ early-stage breast cancer: CONTROL trial. Presented at: 40th Annual San Antonio Breast Cancer Symposium; Dec 5-9, 2017; San Antonio, TX. Poster P3-14-01.
  3. Martin M, Holmes FA, Ejlertsen B, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. Dec 2017;18(12):1688-1700. https://www.ncbi.nlm.nih.gov/pubmed/29146401.
  4. Barcenas CH, Hurvitz SA, Di Palma J, et al. Effect of prophylaxis on neratinib-associated diarrhea and tolerability in patients with HER2+ early-stage breast cancer: Phase II CONTROL trial. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. May 31-June 4, 2019; Chicago, IL. J Clin Oncol. 2019;37:(suppl; abstr 548). https://bit.ly/2Xu86DO.

 

Supplemental Information:

Dosing Regimens from CONTROL study:

Loperamide4 mg TID days 1-14, then 4 mg BID days 15-56
Budesonide9 mg/day for 1 cycle + loperamide 4 mg TID days 1-14, then 4 mg BID days 15-56
Colestipol2 gm BID for 1 cycle + loperamide PRN + loperamide 4 mg TID days 1-14, then 4 mg BID days 15-28
Neratinib120 mg/day on days 1–7, then 160 mg/day on days 8–14, then 240 mg/day through day 364 or

160 mg/day on days 1–14, then 200 mg/day on days 15–28, then 240 mg/day through day 364

 

Dose Escalation Regimen:

  • 120 mg (3 tablets) daily days 1-7
  • 160 mg (4 tablets) daily days 8-14
  • 240 mg (6 tablets) daily thereafter

 

Dosage Adjustment for Diarrhea:

Grade 1 or 2 (≤ 5 days) or Grade 3 (≤ 2 days)

  • Maximize use of antidiarrheal agents and assess diet and aggravating substances
  • When diarrhea has improved to ≤ grade 1 or baseline, initiate loperamide 4 mg with each subsequent neratinib dose

Grade 2 (> 5 days) or Grade 3 (> 2 days) or any grade with complicating features of dehydration, fever, hypotension, renal failure, or grade 3/4 neutropenia):

  • Interrupt treatment. Modify diet; maintain fluid intake of ~2 L
  • If diarrhea improves to ≤ grade 1 in 1 week or less, resume neratinib at the same dose
  • If diarrhea improves to ≤ grade 1 in more than 1 week, resume neratinib at the next lower dose
  • When diarrhea has improved to ≤ grade 1 or baseline, initiate

loperamide 4 mg with each subsequent neratinib dose

Recurrent Grade 2 or more occurring at 120 mg once daily dose, or, Grade 4 diarrhea:

  • Permanently discontinue neratinib
Important notice: NCODA has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional. This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented. NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.
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Written By: Hassaan Shaikh, PharmD & Emily Brugioni, MD, University Health

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Description: The purpose of this PQI is a summary of the process for initiating and monitoring oral temozolomide therapy in patients with Glioblastoma Multiforme (GBM).

Background: GBM is the most common primary malignant brain tumor in adults and comprises 54 % of all gliomas with a median survival of 6 to 12 months.1 Temozolomide is an FDA approved medication used to treat GBM.2 Temozolomide is a prodrug that is converted into its active alkylating metabolite which causes DNA double strand breaks and apoptosis.2 Concurrent treatment with temozolomide and radiation followed by a 4 week break, then maintenance temozolomide for 5 days every 28 days for 6 cycles was found to improve 2 year survival from 10.4% (radiation alone) to 26.5% (radiation + temozolomide).3 Furthermore, patients with MGMT promoter methylated GBM were shown to have a better 18-month overall survival with concurrent temozolomide and radiation (62%) when compared with unmethylated MGMT (8%).4

PQI Process:

  • Ensure appropriate indication and dose, keeping in mind that dose modifications occurred frequently in the clinical trials
    • Temozolomide 75 mg/m2 PO daily during radiation followed by a 4 week break, then 150-200 mg/m2 PO daily x 5 every 28 days for 6 cycles2
  • Concurrent temozolomide with radiation can cause lymphocytopenia therefore ensure appropriate prophylaxis of Pneumocystis Jiroveci with oral trimethoprim-sulfamethoxazole, inhaled pentamidine, atovaquone or dapsone2
  • Ondansetron should be prescribed for prevention and treatment of nausea and vomiting; if nausea and vomiting occurs, ondansetron may be taken 30-60 minutes prior to temozolomide2
  • Monitor pregnancy, CBC (lymphopenia, thrombocytopenia), liver enzymes, pneumocystis2 

Dosing Interruption or Discontinuation during Concomitant Radiotherapy and Temozolomide2

ToxicityTherapy InterruptionTherapy Discontinuation
Absolute Neutrophil CountGreater than or equal to 0.5 and less than 1.5 x 109/LLess than 0.5 x 109/L
Platelet CountGreater than or equal to 10 and less than 100 x 109/LLess than 10 x 109/L
Common Toxicity Criteria (CTC) non-hematological Toxicity (except for alopecia, nausea, vomiting)CTC Grade 2CTC Grade 3 or 4

 

Temozolomide Dose Levels for Maintenance Treatment2

Dose levelDose (mg/m2/day)Remarks
-1100Reduction for prior toxicity
0150Dose during Cycle 1
1200Dose during Cycles 2-6 in absence of toxicity

 

Temozolomide Dose Reduction or Discontinuation during Maintenance Treatment2

ToxicityReduce Temozolomide by 1 Dose LevelDiscontinue Temozolomide
Absolute Neutrophil CountLess than 1.0 x 109/LDiscontinue if dose reduction to less than 100 mg/m2 is required or if the same Grade 3 non hematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction
Platelet CountLess than 50 x 109 /L
Common Toxicity Criteria (CTC) Non Hematological Toxicity

(except for alopecia, nausea, vomiting)

CTC Grade 3CTC Grade  4

 

Temozolomide Dose Modification Table2

Patient Centered Activities:

  • Provide Oral Chemotherapy Education (OCE) sheet
  • Provide Treatment Support Kit (TSK)
  • Counsel patient on disease state, treatment regimen, what to expect and verify patient understanding
  • Counsel patient on common side effects which include alopecia, constipation, nausea/vomiting, headache, seizure, and fatigue
  • Temozolomide is preferred to be taken one hour prior to radiation on radiation days
  • Counsel patient to swallow capsules (may be multiple) whole with a full glass of water
    • May administer on an empty stomach and/or bedtime to reduce nausea/vomiting and consistently take in this manner
    • Do not repeat dose if vomiting occurs after the dose is administered

References:

  1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers. V.2.2021, 09/08/21.
  2. Temozolomide [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.
  3. Stupp R, Mason WP, van den Bent MJ, et al: Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 352:987-96, 2005.
  4. Hegi ME, Diserens AC, Godard S, et al: Clinical trial substantiates the predictive value of O-6- methylguanine-DNA methyltransferase promoter methylation in glioblastoma patients treated with temozolomide. Clin Cancer Res 10:1871-4, 2004.
Important notice: NCODA has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional.  This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented.  NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.

 

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