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The treatment landscape
for polycythaemia vera

JAKAVI^® (ruxolitinib) is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea (also referred to as hydroxycarbamide in the UK).¹

BSH guidelines for high-risk patients with PV^2*

First-line treatment options:

Hydroxyurea or interferon (preferably pegylated interferon)

Not all forms of interferon therapy are licensed for use in PV.

Second-line treatment options:

In patients treated with hydroxyurea as first line, interferon as second-line treatment, or, where treated with interferon as first line, recommend hydroxyurea as second-line treatment
Consider pegylated interferon as second line in those patients who have had non-pegylated interferon first line and could not tolerate it
JAKAVI^® (ruxolitinib) second or third line in hydroxyurea-resistant or ‑intolerant patients

Third-line or further treatment options:

Busulphan, 32P or pipobroman in those with limited life expectancy
Anagrelide in combination with hydroxyurea may be helpful in those where platelet control is difficult

Pipobroman and anagrelide are not licensed for use in PV in the UK.

Not all forms of interferon therapy are licensed for use in PV. Please refer to the relevant SmPC before prescribing.

*Age ≥65 years and/or prior PV-associated arterial or venous thrombosis.

Adapted from McMullin M F et al, 2019²

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32P: phosphorus-32; BSH: British Society for Haematology

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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 online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report or alternatively email medinfo.uk@novartis.com or call 01276 698370

References

JAKAVI^® Summary of Product Characteristics. Available at: medicines.org.uk
McMullin M F, Harrison C N et al. A guideline for the diagnosis and management of polycythaemia vera. A British Society for Haematology Guideline. Br J Haematol 2019;184(2):176-191

RESPONSE was a phase III, randomised, open-label, multicentre trial to evaluate the efficacy and safety of JAKAVI^® (n=110) versus best available therapy (n=112). The primary endpoint was HCT control and ≥35% reduction in spleen volume at Week 32. The trial included venesection-dependent patients with splenomegaly, who had hydroxyurea (HU)‑resistant or -intolerant PV.²

HCT control* and ≥35% reductions in spleen volume at Week 32²	JAKAVI^®	Best available therapy
	21%	1%
	p<0.001

RESPONSE‑2 was a phase IIIb, prospective, randomised, open-label, multicentre trial to assess the efficacy and safety of JAKAVI^® (n=74) versus best available therapy (n=75). The primary endpoint was the proportion of patients who achieved HCT control at Week 28. The trial included venesection-dependent patients with PV without splenomegaly who are resistant to or intolerant of HU.³

HCT control* at Week 28⁴	JAKAVI^®	Best available therapy
	62%	19%
	p<0.0001
Total number of venesections (up to Week 80)³	JAKAVI^®	Best available therapy
Total number of venesections (up to Week 80)³	36	106

*Control was defined as no venesection eligibility (defined as HCT of >45% and ≥3% above baseline or HCT >48%).^2,3

HCT: haematocrit

References: 2. Vannucchi A M et al. N Engl J Med 2015;372:426-435; 3. Griesshammer M et al. Ann Hematol 2018;97:1591-1600; 4. Passamonti F et al. Lancet Oncol 2017;18:88-99

Prescribing information and adverse event reporting (hosted externally) ›

BSH guidelines for high-risk patients with PV2*

References

BSH guidelines for high-risk patients with PV^2*