Ropeginterferon alfa-2b injection
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Injections containing ropeginterferon alfa-2b.
These products have been produced by recombinant technology using E.coli.
Treatment of polycythemia vera
Monotherapy for the treatment of polycythaemia vera without symptomatic splenomegaly.
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
The recommended starting dose is 100 micrograms (50 micrograms in patients undergoing parallel cytoreductive therapy) which can be gradually increased by 50 micrograms every two weeks (whilst decreasing cytoreductive therapy as appropriate) until haematological parameters are stabilised. The maximum single dose recommended is 500 micrograms, administered every 2 weeks. Phlebotomy may be necessary to normalise blood hyperviscosity as a rescue treatment.
The dose at which haematological parameters are stabilised, should be maintained and administered every two weeks for a minimum of 1.5 years. Following this period, dose may be reduced or administration prolonged up to four week intervals, as appropriate for the patient.
For subcutaneous injection only.
Preferred injection site is in the abdominal skin, but not within 5cm of the naval or thigh.
Ropeinterferon alfa-2b can be administered by a physician, nurse, family member or patient following training on administration of subcutaneous injections with the pre-filled pen. See package leaflet for instructions for use.
Children under 18 years
History of autoimmune disorder
Immunosuppressed transplant recipients
End stage renal disease
Hepatic impairment - Child-Pugh score greater than 6
History of severe psychiatric disorder
Recent cerebrovascular accident
Recent myocardial infarction
Severe cardiovascular disorder
Severe psychiatric disorder
Uncontrolled diabetes mellitus
Uncontrolled thyroid disorder
Precautions and Warnings
History of cardiovascular disorder
Severe renal impairment
Reduce dose in patients with severe renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Contains benzyl alcohol
Avoid injection into broken or bruised skin
Consult local policy on the safe use of anti-cancer drugs
Record name and batch number of administered product
Treatment to be administered under the supervision of a specialist
Determine thyroid function before initiating treatment
Monitor ophthalmic function before and during long-term use
Dental check-ups advisable during long-term treatment
If visual disturbances occur, perform ophthalmic evaluation
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Monitor blood counts regularly
Monitor liver function on prolonged therapy
Monitor serum potassium regularly
Determine TSH levels if patient develops symptoms of thyroid dysfunction
Modify dose if adverse effects occur
Discontinue if hypersensitivity reactions occur
Discontinue if patient develops respiratory symptoms
Discontinue if renal function deteriorates
Discontinue if severe skin reaction occurs
Reduce dose or discontinue if a significant rise in hepatic enzymes occurs
Female: Ensure adequate contraception during treatment
Advise patient on appropriate tooth brushing during treatment
Pregnancy and Lactation
Ropeginterferon alfa-2b is contraindicated during pregnancy.
Use of ropeginterferon alfa-2b during pregnancy is contraindicated by the manufacturer. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.
Use ropeginterferon alfa-2b with caution during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking ropeginterferon alfa-2b. The presence of ropeginterferon alfa-2b in human breast milk in unknown and therefore potential risk to the infant cannot be excluded. Ropeginterferon alfa-2b should only be given to breast feeding mothers when the benefit to the mother outweighs the potential risk to the infant.
Disturbances of gastrointestinal function
Idiopathic thrombocytopenic purpura (ITP)
Increases in hepatic enzymes
Injection site reactions
Peripheral motor neuropathy
Pulmonary artery hypertension
Rise in body temperature
Thrombotic thrombocytopenic purpura
Vogt-Koyanagi- Harada (VKH) syndrome
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: September 2021
Summary of Product Characteristics: Besremi 250microgram/0.5ml solution for inj. pen. AOP Orphan Pharmaceuticals. Revised May 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 September 2021
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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