Newly funded drug linked to tachycardia, hep B and infection


The TGA has updated its safety advice for ibrutinib after reviewing latest research on the medicine’s risks and effects

Ibrutinib, marketed in Australia as Imbruvica, is used for the treatment of certain types of blood cancers, including mantle cell lymphoma and Waldenstrom’s macroglobulinaemia chronic lymphocytic leukaemia (CLL, which includes small lymphocytic lymphoma).

Just last month Prime Minister Malcolm Turnbull and Health Minister Greg Hunt announced $460 million in funding to go towards ibrutinib starting in December, following a PBAC recommendation.

“This listing will save lives,” said Leukemia Foundation CEO Bill Petch when the funding was announced.

“It means that Australians with CLL who have run out of treatment options can access this new oral therapy which is showing remarkable results. We are another step closer to a time when no one will die from this disease.”

However the TGA warns health professionals to be aware that cases of ventricular tachyarrhythmia have been associated with the use of ibrutinib.

For example, a 2017 study of case reports from post-marketing sources and clinical trial data identified 11 cases of ventricular tachycardia/ventricular fibrillation, and six additional cases of sudden cardiac death, in patients exposed to ibrutinib.

In 12 of the 17 total cases, the events occurred without any evidence of prior cardiac history.

Image: Science Photo Library
Image: Science Photo Library

A further 52 cases of ventricular tachyarrhythmia have been reported in post-marketing settings.

Due to the potential severity of these events, the TGA recommends that ibrutinib should be temporarily discontinued in patients who develop signs and/or symptoms of ventricular tachyarrhythmia, including palpitations, chest pain, dyspnea, dizziness or fainting.

A cumulative review of data from clinical trials and post-marketing cases has also identified eight reports of hepatitis B reactivation in ibrutinib-treated patients, where the role of ibrutinib was considered probable or possible.

One fatal outcome has been reported in a patient due to hepatitis B reactivation and concurrent metastatic melanoma.

“Given the existence of several reported cases, the PI is being updated to reflect the updated safety information,” says the TGA in its Medicines Safety Update.

“Hepatitis B virus status should be established before initiating treatment with ibrutinib.”

Additionally, infections (including sepsis, neutropenic sepsis, bacterial, viral or fungal infections) have been observed in patients treated with ibrutinib.

Some of these infections have resulted in hospitalisation and, in some cases, death.

“The role of ibrutinib in these opportunistic infections continues to be monitored,” says the TGA.

However, “given the relatively high number of fatal cases with opportunistic infection, healthcare professionals should consider prophylaxis according to standard of care for patients who are at an increased risk of opportunistic infection”.

The TGA reminds healthcare professionals and consumers to report all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, and herbal, traditional or alternative remedies.

“You don’t need to be certain, just suspicious,” it says.

The TGA particularly requests reports of:

  • all suspected reactions to new medicines;
  • all suspected medicines interactions;
  • suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.

Reports may be submitted:

For more information about reporting, visit www.tga.gov.au or contact the TGA’s Pharmacovigilance and Special Access Branch on 1800 044 114.

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3 Comments

  1. Julian Rush
    01/12/2017

    I was diagnosed with HepB 3 months ago and was devastated by the news. I have been ill and sore for over 10 years, with no one being able to figure out what was wrong with me. It was always written off as a virus or infection. Then 2 years ago the severe muscle cramps started. I had them from scalp to toes, and it was when they ran the full spectrum of tests to figure the cramps out, that they discovered the HepB along with severe Vitamin D deficiency, which I link to the HepB. I was so tired and nauseous and in constant pain. I am just sick and tired of feeling sick and tired!!nothing was really working to help my condition.I went off the Sebivo (with the doctor’s knowledge) and started on hepatitis B herbal formula i ordered from Health Herbal Clinic, my symptoms totally declined over a 5 weeks use of the hepatitis B virus natural herbal formula the disease is totally reversed!! Visit there website www. healthherbalclinic. net

  2. Steward Miles
    01/01/2018

    I do remember having lots of abdominal pain and dark urine, loss of appetite at all time.

    I started taking vaccine like Engerix B, Heplisav-B, but all to no avail.

    Then a friend of mine told me about a herbal remedy called “Furtil Herb”. At first i doubted it, later on i decided to give it a try.

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    Within 2-3 days of taking the medicine, i started noticing that all the pains i do feel before were gone.

    And after 11days, i then went for a medical test and my result came out NEGATIVE and completely free of Hepatitis B.

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  3. Marvel Sac
    04/02/2018

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    herbal medicine to cure all kind of diseases including hepatitis b virus
    (HBV), CANCER. ALS Hepatitis A,B/C, fertility spell, Herpes HIV and all
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