Ropeginterferon alfa-2b injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections containing ropeginterferon alfa-2b.
These products have been produced by recombinant technology using E.coli.
Drugs List
Therapeutic Indications
Uses
Treatment of polycythemia vera
Monotherapy for the treatment of polycythaemia vera without symptomatic splenomegaly.
Dosage
Adults
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Titration phase
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.
Maintenance phase
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.
Administration
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.
Contraindications
Autoimmune disease
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
Pregnancy
Recent cerebrovascular accident
Recent myocardial infarction
Severe cardiovascular disorder
Severe psychiatric disorder
Uncontrolled diabetes mellitus
Uncontrolled thyroid disorder
Precautions and Warnings
Breastfeeding
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
Pregnancy
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.
Lactation
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.
Side Effects
Abdominal pain
Aggression
Alopecia
Anaemia
Anxiety
Apathy
Arthralgia
Arthritis
Asthenia
Blindness
Bone pain
Cardiac disorders
Chills
Confusion
Constipation
Cough
Deafness
Decreased appetite
Depression
Diabetes mellitus
Diarrhoea
Disturbances of gastrointestinal function
Dizziness
Dry eyes
Dyspnoea
Dysuria
Epistaxis
Erectile dysfunction
Fatigue
Flushing
Graves' disease
Groin pain
Haematoma
Haemorrhagic cystitis
Hallucinations
Headache
Hepatic disorders
Hepatic failure
Hepatomegaly
Hepatotoxicity
Hypertension
Hyperthyroidism
Hypertriglyceridaemia
Hypoesthesia
Hypothyroidism
Idiopathic thrombocytopenic purpura (ITP)
Increases in hepatic enzymes
Infections
Influenza-like symptoms
Injection site reactions
Insomnia
Leukopenia
Microangiopathy
Migraine
Mood changes
Muscle spasm
Muscle weakness
Musculoskeletal pain
Myalgia
Nail dystrophy
Nausea
Neck pain
Neutropenia
Nightmares
Painful extremities
Pancytopenia
Paraesthesia
Peripheral motor neuropathy
Photosensitivity
Pneumonia
Pneumonitis
Polyneuropathy
Pruritus
Pulmonary artery hypertension
Pulmonary fibrosis
Pulmonary infiltrates
Pyrexia
Radiculopathy
Rash
Raynaud's phenomenon
Retinal detachment
Retinal disturbances
Rise in body temperature
Sarcoidosis
Sjogren's syndrome
Skin depigmentation
Skin exfoliation
Skin reactions
Somnolence
Suicidal ideation
Throat irritation
Thrombocytopenia
Thrombotic thrombocytopenic purpura
Thyroiditis
Tinnitus
Tremor
Urinary retention
Vertigo
Vogt-Koyanagi- Harada (VKH) syndrome
Weight loss
Overdosage
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 ).
Further Information
Last Full Review Date: September 2021
Reference Sources
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
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.