2nd bout with Lymphoma - starting Bendeka, a new Bendamustine formulation

Starting Bendeka + rituximab + allopurinol tomorrow morning. Today is Sunday and I forgot to ask my oncologist if I should start the allopurinol the day before, or the day starting chemo. Does anyone have any experience with this? Thanks!

Changed title to help others interested in Bendeka find this post - Admin

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  • This advice needs to come from your doctor... I would page him.

    Bendeka is a very new version of bendamustine, you are probably one of the first clinical patients on this forum to have it...

    ~chris

  • Thanks, I will.

  • All the best Howie, please tell us how it goes, because this is uncharted water to many of us...

    ~chris

  • The med insert:

    "Treat CLL with 10-minute infusion"

    "Developed under the direction and sponsorship of Teva Pharmaceuticals USA, Inc.

    Important Safety Information Prescribing InformationBENDEKA™ (bendamustine HCI) injection

    Go with the only bendamustine HCl that has a 10-minute infusion

    Time matters BENDEKA® is indicated for the treatment of patients with

    •Chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

    Please see Important Safety Information, including contraindication in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol.

    BENDEKA offers administration efficiencies1

    10-minute infusion

    Short-time infusion

    Ready-to-dilute solution

    25 mg/mL concentration

    administered as a 50 mL admixture

    – No DMA (dimethylacetamide)

    Multiple-dose vial

    Allow vial to reach room temperature (15° to 30°C

    or 59° to 86°F) prior to use

    Store partially used vial in refrigerator in original carton

    Six dose withdrawals per vial for up to 28 days from first use

    Three diluent options

    0.9% Sodium Chloride injection, USP

    2.5% Dextrose/0.45%

    Sodium Chloride Injection, USP

    5% Dextrose Injection, USP

    Consider BENDEKA for this patient

    Patient Chart

    Recommended BENDEKA dosage for CLL iis 100 mg/m2

    •Administered intravenously over 10 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles1

    –Dose modifications for hematologic toxicity:

    for ≥Grade 3 toxicity, reduce the dose to 50 mg/m2

    on Days 1 and 2 of each cycle; if ≥Grade 3 toxicity

    recurs, reduce the dose to 25 mg/m2 on Days 1 and

    2 of each cycle

    –Dose modifications for non-hematologic toxicity:

    for clinically significant ≥Grade 3 toxicity, reduce the

    dose to 50 mg/m2 on Days 1 and 2 of each cycle

    –Dose re-escalation may be considered

    Additional dosing considerations1

    Delay treatment for Grade 4 hematologic toxicity or clinically significant ≥Grade 2 non-hematologic toxicity

    •Store BENDEKA at recommended refrigerated storage conditions (2 to 8° C or 36 to 46° F). When refrigerated the contents may partially freeze. Allow the vial to reach room temperature (15 to 30° C or 59 to 89° F) prior to use

    •Dilute BENDEKA prior to infusion

    •Concomitant CYP1A2 inducers or inhibitors have the potential to affect the exposure of bendamustine

    •Renal impairment: Do not use if CrCL is <40 mL/min. Use with caution in lesser degrees of renal impairment

    •Hepatic impairment: Do not use in moderate or severe hepatic impairment. Use with caution in mild hepatic impairment

    Important Safety Information

    Contraindication: BENDEKA® (bendamustine hydrochloride) Injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol.

    Myelosuppression: Bendamustine hydrochloride caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions. Monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle.

    Infections: Infection, including pneumonia, sepsis, septic shock, hepatitis and death has occurred. Patients with myelosuppression following treatment with BENDEKA are more susceptible to infections. Patients treated with bendamustine hydrochloride are at risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster. Patients should undergo appropriate monitoring, prophylaxis, and treatment measures prior to administration.

    Anaphylaxis and Infusion Reactions: Infusion reactions to bendamustine hydrochloride have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus, and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe (Grade 3-4) reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions.

    Tumor Lysis Syndrome: Tumor lysis syndrome associated with bendamustine hydrochloride has occurred. The onset tends to be within the first treatment cycle with bendamustine hydrochloride and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. There may be an increased risk of severe skin toxicity when bendamustine hydrochloride and allopurinol are administered concomitantly.

    Skin Reactions: Skin reactions have been reported with bendamustine hydrochloride treatment including rash, toxic skin reactions, and bullous exanthema. In a study of bendamustine hydrochloride (90 mg/m2 ) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred. TEN has been reported for rituximab. Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported when bendamustine hydrochloride was administered concomitantly with allopurinol and other medications known to cause these syndromes. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue BENDEKA.

    Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with bendamustine hydrochloride, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma. The association with BENDEKA therapy has not been determined.

    Extravasation Injury: Extravasations resulting in hospitalizations from erythema, marked swelling, and pain have been reported with bendamustine hydrochloride. Assure good venous access prior to starting drug infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of BENDEKA.

    Embryo-fetal Toxicity: Bendamustine hydrochloride can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using BENDEKA.

    Most Common Adverse Reactions:

    •Adverse reactions (frequency >5%) during infusion and within 24 hours post‑infusion are nausea and fatigue.

    •Most common non-hematologic adverse reactions for CLL (frequency ≥15%) are pyrexia, nausea, and vomiting.

    •Most common hematologic abnormalities (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.

    For more information, call 1-800-896-5855 or

    visit BENDEKAHCP.com

    Please see Full Prescribing Information for BENDEKA.

    The information presented in this email is intended for US residents only.

    Reference: 1. BENDEKA® (bendamustine hydrochloride) Injection [Prescribing Information]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2016

    Teva Pharmaceuticals USA, Inc. | 41 Moores Road | Frazer, Pennsylvania 19355

    BENDEKA® is a registered trademark of Cephalon, Inc.

    ©2017 Cephalon, Inc., a wholly-owned subsidiary of

    Teva Pharmaceutical Industries Ltd."

    Jeff

  • I was switched over to Bendeka when treated (BR) March-June, and while side effects were less, my response was not as expected. June I was started on Ibrutinib and finally my numbers are near normal range. CT soon to see if I have attained remission. Wow, a year has gone by, since diagnosis...a tough year, but looking up and up.

  • Good to hear the Ibrutinib worked for you. Completed 1st infusion of BR and Neulasta so won't know for a while. Wiped out now but hopeful. Thanks for your support and feedback.

  • I had to start it the day before...but I had Gazyva for my lymphoma.

  • Just a word of caution re. allopurinol - I became allergic to this (not that uncommon) and lost consciousness the last time I took it. Most people tolerate it OK, but a significant number do not. It seems to me that many doctors are not aware of the risks with that medicine.

    So, keep a wary eye on how you feel... we're all different, and react differently to medications.

  • Your info is appreciated.

  • Allopurinol ...watch for a rash... get to emergency care

    allopurinol...SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR OTHER SIGNS WHICH MAY INDICATE AN ALLERGIC REACTION. In some instances a skin rash may be followed by more severe hypersensitivity reactions such as exfoliative, urticarial, and purpuric lesions, as well as Stevens-Johnson syndrome (erythema multiforme exudativum), and/or generalized vasculitis, irreversible hepato-toxicity, and, on rare occasions, death.

  • I stopped Allopurinol immediately after developing allover petechiae, and terrible nausea. Within 2 weeks, petechiae and nausea disappeared, However, livedo reticularis started, and still apparent, especially when cold.

  • Thanks for the allopurinol caution. So far, no problem.

  • Thanks! I will. Sitting here with first day of rutuximab and allopurinol. My whole back and head is itching. My oncologist just came in and said response due to allergic response to rituximab. Started Benadryl and hydrocortisone IV. Itching is subsiding already. Probably will zone out on Benadryl......

  • Rule 1 - Always tell your infusion nurse if you feel anything different no matter how minor you think it is - itchy nose - ANYTHING. I'm glad your doctor got things under control quickly.

  • Thank you! Started iyesterday of 1st infusion of rituximab for relapse of lymphoma after 8 years. Guess what, my immune system still remembered to create antibodies so within an hour my head, chest, and back started itching like crazy. Immediately called infusion nurse who immediately brought in my oncologist. Hydrocortisone and Benadryl infused stat and it stopped the reaction cold! Thanks again for RULE 1. !

  • Good - well done!

    The problem with itching as a symptom on BR and allopurinol is that all three can cause it. During one infusion of rituximab, I had a different type of allergic response - became very shivery - nurse injected me with (I think) adrenaline, and I was OK again fairly soon. Although I had 4 courses of rituximab, this was the only allergic response.

    As for bendamustine - this is known to cause skin rashes - I had a fairly bad one (not as bad as some others, though) - my haematologist offered to discontinue the treatment and try something different, but I said it was tolarable and to go ahead. Treated it with antihistamine tablets and cream (E45 - may have had something stronger to begin with - I forget). Nearly 5 years later, still have a tendency to rash on the chest, especially when it's cold.

    Neither of these responses was as scary as that to allopurinol - I'd been given it during treatment - not sure if it made me ill then (had an infection and 9 days' hospital, so hard to judge!) - quite some time later, my bloods were reckoned to be slightly up on urea, so I was given allopurinol - after taking just one tablet, I began to feel 'off', and within a few hours staggered to the bathroom where I passed out for 15-20 min. Taken to A&E until I recovered.

    So - bear in mind that any one of the agents could be responsible, if you feel unwell. And don't delay seeking help from your doctor or (in emergency) your hospital.

  • Hi Scarletnoir: Thanks for comprehensive response. Hope you're doing OK. Doing well now except for Bendeka fatigue. Have a question that I haven't posed to my oncologist yet, but will. Did your allergic reaction to rituximab have any adverse effects on its immune action on B cells? Hope not. Please let me know. Thanks.

    Howie

  • Not as far as I know - and as I say, the other rituximab infusions were trouble free. I see you are staying alert and asking for help when things seem to be causing an adverse effect - good!

    Very best of luck for your treatment.

  • Hope your're starting to feel better now Howie.

    Best wishes

    Sue

  • Hi Sue: Thanks, feeling better. The Bendeka (bendamustine) fatigue sweeps in like the fog. I'm now about 8 days out from 1st infusion so expect fatigue to dissipate (hopefully before next round). Let me know how you're doing.

    Howie

  • Hi Howie--Thanks so much for sharing your experiences with BR--can you tell me how soon after your Bendeka infusion that you experienced the fatigue? Thx.

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