Prescribing information

   

 

An established safety profile

 

With over a decade of real-world clinical practice and across 5 clinical trials, REVOLADE is an established immune thrombocytopenia (ITP) treatment with a proven efficacy and safety profile in adult and paediatric patients1–5

Summary of adult safety data

In the EXTEND study, no new safety findings were observed in >300 patients treated with REVOLADE, lasting up to 8.76 years

 

Most adverse events (AEs) were mild-moderate

92% of REVOLADE patients (n=277/302) experienced at least one AE of any grade but most were mild-moderate in severity (grade 1–2)

The most frequent AEs were headache (28%, n=86/302), common cold (25%, n=74/302), and upper respiratory tract infection (23%, n=69/302)

 

Serious AEs

The most common serious AEs were cataracts (5%, n=16/302), pneumonia (3%, n=8/302), anaemia (2%, n=5/302) and alanine aminotransferase (ALT) increase (2%, n=5/302)

 

AEs occurring in >10% of patients (n=302)1

Adapted from Wong R, et al. 2017

Serious adverse events (AEs)

While most AEs in the RAISE study were grade 1 or 2 in severity, 15% (n=20/135) of REVOLADE patients experienced grade 3 or 4 AEs. This was comparable to the 11% (n=7/61) treated with placebo

 

Bleeding AEs

The rate of on-treatment serious bleeding was significantly lower in patients receiving REVOLADE (<1%, n=1/135) compared with placebo (7%, n=4/61; p=0.03)

 

Any grade of AE occurring in ≥5% of patients

 

Adapted from Cheng G, et al. 20112

On-therapy vs. off-therapy adverse events (AEs)

The frequency of on-therapy AEs (45 of 66 patients experienced 196 events) was similar to that of off-therapy AEs (41 of 65 patients experienced 122 events)

In addition to this, over successive cycles of treatment, no increase in the incidence of any specific AE was seen

 

Serious AEs

Serious AEs occurred in 1 (2%, n=66) patient on therapy and 3 (5%, n=66) patients off therapy

 

The most common AEs observed in ≥10% of patients treated with REVOLADE3

 

Any AEs

 

Adapted from Bussel J, et al. 20133

 


 

Headaches

 

Adapted from Bussel J, et al. 20133


 

Diarrhoea

 

Adapted from Bussel J, et al. 20133

 

Summary of paediatric safety data

Adverse events (AEs) during the REVOLADE-only phase

2 (3%, n=65) patients experienced increased alanine aminotransferase (ALT) concentrations that led to treatment discontinuation of treatment. Abnormalities were resolved with discontinuation of REVOLADE

An additional 3 (5%, n=65)  patients experienced  increases of ALT that were ≥3 times the upper limit of normal 

  • 2 met the liver stopping criteria and were withdrawn from the study
  • 1 patient had the event at the 2-week follow-up after the last dose of study medication

No patients had new or worsening cataracts or thromboembolic events during the study, nor were any malignancies or thromboses reported

Adverse events (AEs) during the double-blind period

5 (8%, n=63) of patients receiving REVOLADE had alanine aminotransferase (ALT)  levels ≥3 times the upper limit of normal  ULN)

  • 2 patients met liver chemistry stopping criteria and were withdrawn
  • Hepatobiliary laboratory parameters resolved in 2 of 3 remaining patients while they were still on treatment
  • Hepatobiliary laboratory parameters resolved in 1 patient after study treatment discontinuation in the open-label treatment period

 

AEs during the open-label period

of patients had grade 3 or 4 AEs

  • 1 patient had grade 4 neutropenia, which was judged to be unrelated to REVOLADE by the local investigator

of patients treated with REVOLADE were judged to have:

  • A new cataract (n=1)
  • Progression of a pre-existing cataract (n=1)

Both patients were receiving corticosteroids

of patients receiving REVOLADE had ALT concentrations ≥3 times the ULN

  • 3 patients met the protocol-defined stopping criteria
 

 

REVOLADE for a trusted treatment patients can count on

 

AE, adverse event; ALT, alanine aminotransferase; FCT, film-coated tablet; ITP, immune thrombocytopenia; PfOS, powder for oral suspension; ULN, upper limit of normal.

References:

  1. Wong R, et al.  Blood. 2017;130:2527–2536.
  2. Cheng G, et al. Lancet. 2011;377:393–402. 
  3. Bussel J, et al. Br J Haematol. 2013;160:538–546. 
  4. Bussel J, et al. Lancet. 2015:315–325. 
  5. Grainger J, et al. Lancet. 2015;386:1649–1658.
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UK | June 2021 | 125352
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]