Peginterferon alfa-2a

Generic name
Peginterferon alfa-2a
Brand name
ATC Code
L03AB11
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Peginterferon alfa-2a

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Chronic hepatitis B
  • Subcutaneous
    • 3 years up to 18 years

      • BSA 0.54-0.74 m²: 65 mcg/week
        BSA 0.75-1.08 m²: 90 mcg/week
        BSA 1.09-1.51 m²: 135 mcg/week
        BSA     > 1.52 m²: 180 mcg/week

      • Dose adjustments

        Toxicity Adjust the dose Discontinue treatment
        Neutropenia neutrophils 0.5 to 0.75 x 10E9/litre: first dose reduction
        neutrophils 0.25 to 0.5 x 10E9/litre: interrupt until the neutrophils are > 1 x 10E9/litre and resume with the second dose reduction        		 neutrophils < 0.25 x 10E9/litre
        Thrombocytopenia thrombocytes 25 to 50 x 10E9/litre: adjust to the second dose reduction

        		 thrombocytes < 25 x 10E9/litre
        Elevated ALAT ALAT values 5 to 10 times the upper limit of normal: first dose reduction ALAT values > 10 times the upper limit of normal

         

        Starting dose first dose reduction second dose reduction third dose reduction
        65 mcg 45 mcg 30 mcg 20 mcg
        90 mcg 65 mcg 45 mcg 20 mcg
        135 mcg 90 mcg 65 mcg 30 mcg
        180 mcg 135 mcg 90 mcg 45 mcg
Chronic hepatitis C
  • Subcutaneous
    • 5 years up to 18 years

      • BSA 0.71-0.74 m²: 65 mcg/week
        BSA 0.75-1.08 m²: 90 mcg/week
        BSA 1.09-1.51 m²: 135 mcg/week
        BSA     > 1.52 m²: 180 mcg/week

      • Dose adjustments

        Toxicity Adjust the dose Discontinue treatment
        Neutropenia neutrophils 0.5 to 0.75 x 10E9/litre: first dose reduction
        neutrophils 0.25 to 0.5 x 10E9/litre: interrupt until the neutrophils are > 1 x 10E9/litre and resume with the second dose reduction        		 neutrophils < 0.25 x 10E9/litre
        Thrombocytopenia thrombocytes 25 to 50 x 10E9/litre: adjust to the second dose reduction

        		 thrombocytes < 25 x 10E9/litre
        Elevated ALAT ALAT values 5 to 10 times the upper limit of normal: first dose reduction ALAT values > 10 times the upper limit of normal

         

        Starting dose first dose reduction second dose reduction third dose reduction
        65 mcg 45 mcg 30 mcg 20 mcg
        90 mcg 65 mcg 45 mcg 20 mcg
        135 mcg 90 mcg 65 mcg 30 mcg
        180 mcg 135 mcg 90 mcg 45 mcg

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

(infection with HCV, combination therapy with ribavirin): Very common (> 10%): influenza-like symptoms (91%), sleeplessness, fatigue, irritability, reduced appetite. Headache (64%). Gastrointestinal disorders (56%). Pain in the skeletal muscles. Rash, itching, alopecia. Reaction at the injection site (45%). Common (1-10%): fever, influenza, infectious mononucleosis, pharyngitis or nasopharyngitis (due to Streptococcus), candidiasis, dental abscess, stye, (viral) gastroenteritis, urinary tract infection. Dizziness, disrupted attention, migraine. Abnormal behaviour, anger, aggression, ADHD, anxiety, depression, hallucination. Dyspnoea, nosebleed. (Aphthous) stomatitis, nausea, abdominal pain. Eye irritation, pain or itching in the eye, retina; exudates, reduced visual acuity, temporary blindness. Earache. Swollen face, fixed drug eruption. Dysuria, incontinence. Vaginal secretion. Back pain, pain in extremities. Anaemia. Hyperglycaemia, type 1 diabetes mellitus. Locally: haematoma at the injection site.

Also reported: growth inhibition. Reduction of haemoglobin, neutrophils and thrombocytes.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

  • children younger than 3 years (because of the risk of fatal toxic effect and anaphylactoid responses to benzyl alcohol in the liquid for injection).
  • a pre-existing severe psychiatric condition (severe depression, suicidal behaviour) or a medical history of one in children and adolescents;

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Using it in children results in weight loss and growth inhibition. In a number of patients, growth returned to their baseline growth curve (6 years after treatment). The amount of available data is not sufficient to conclude that the growth inhibition is always reversible. There is no data on the long-term effect on sexual maturation. These adverse effects before treatment are weighed against the child's disease characteristics such as evidence of disease progression (visible fibrosis), comorbidities that may affect the disease (such as HIV co-infection) and prognostic factors for a response (such as the HCV genotype and viral load). If possible, treat the child after the teenage growth spurt.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

IMMUNOSTIMULANTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Colony stimulating factors
L03AA02
L03AA14
Interferons
L03AB05
L03AB10
Other immunostimulants
L03AX13
L03AX15
L03AX16

Reference

  1. Roche Registration GmbH, SmPC Pegasys (EU/1/02/221) 26-03-2018

Changes

Therapeutic Drug Monitoring


Overdose