Drugs List

Therapeutic Indications

Uses

Treatment of relapsing-remitting multiple sclerosis

Administration

Patients should be advised to rotate sites for subcutaneous or intramuscular injections every two weeks.
Pre-filled pen
For subcutaneous injection.

Pre-filled syringe
For intramuscular injection.

Contraindications

Children under 18 years
Suicidal ideation
Severe depression

Precautions and Warnings

Cardiac arrhythmias
Congestive cardiac failure
Coronary arteriosclerosis
Epileptic disorder
History of depression
History of seizures
Myelosuppression
Pregnancy
Severe cardiac disorder
Severe hepatic impairment
Severe renal impairment
Thyroid dysfunction

Treatment to be initiated and supervised by a specialist
Advise patient to report injection site reactions where the skin breaks
Record name and batch number of administered product
Use only if the solution is clear and colourless
Monitor full blood count and differential WBC before and during therapy
Monitor hepatic function before treatment and regularly during treatment
Monitor cardiac function in patients with cardiac disease
Monitor closely patient with depression
Monitor for signs of nephrotic syndrome
Monitor renal function regularly
Monitor serum biochemistry regularly
Monitor thyroid function regularly if history of dysfunction
Monitor thyroid function where clinically indicated
Review self injection technique periodically, especially if reactions occur
Advise patient to report any new or worsening depression/suicidal ideation
Advise patient to report symptoms of thrombotic microangiopathy
Advise patient to stop therapy & contact Dr if hypersensitivity signs occur
Consider discontinuing treatment if nephrotic syndrome occurs
Discontinue if severe hypersensitivity reactions occur
Discontinue if thrombotic microangiopathy is confirmed
Female: Ensure adequate contraception during treatment

Cases of thrombotic microangiopathy (TMA) may manifest as thrombocytopenia purpura or haemolytic uraemic syndrome. Early symptoms include thrombocytopenia, new onset hypertension, fever and central nervous system symptoms. If such symptoms develop testing of blood platelet levels, serum LDH, blood films and renal function should be carried out.

Analgesics and antipyretics may be used prophylactically or concurrent to manage any flu-like symptoms.

Consider discontinuing peginterferon beta-1a following a single site of necrosis depending on the extent of necrosis.

In addition to normal laboratory tests required for monitoring patients with multiple sclerosis, complete blood chemistries, including liver function tests, blood cell and platelet counts should be performed prior to initiation of peginterferon beta-1a therapy, at regular intervals during and periodically thereafter.

Not all presentations are suitable for all routes of administration.

Pregnancy and Lactation

Pregnancy

Use peginterferon beta-1a with caution during pregnancy.

The manufacturer states that the use of interferon beta-1a during pregnancy may be considered if clinically required. Human data suggests no increased risk of major congenital abnormalities during the first trimester due to peginterferon beta-1a. Experience during the second than third trimester is very limited.

Animal studies have shown peginterferon beta may possibly increase the risk of spontaneous abortion and low birth weight when administered in the first trimester. The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot be evaluated based on the currently available data, but does not currently suggest an increase.

Lactation

Peginterferon beta-1a is considered safe for use during breastfeeding.

The manufacturer states that peginterferon beta-1a can be used during breastfeeding. It is suggested that the levels of interferon beta-1a secreted into human breast milk is negligible.

Schaefer suggests that due to the large molecular weight of peginterferon beta it is not excreted into human milk.

LactMed reported no adverse effects in partially breastfed infants when breastfeeding mothers received peginterferon beta-1a. Therefore, no special precautions appear to be necessary while using peginterferon beta-1a.

Side Effects

Alopecia
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Chills
Decrease in haemoglobin
Depression
Gamma glutamyl transferase (GGT) increased
Glomerulosclerosis
Haemolytic uraemic syndrome
Headache
Hypersensitivity reactions
Hyperthermia
Increase in ALT level
Increase in AST level
Influenza-like syndrome
Injection site reactions
Myalgia
Nausea
Necrosis (injection site)
Nephrotic syndrome
Neutropenia
Pain
Pain on injection
Pancytopenia
Pruritus
Pulmonary artery hypertension
Pyrexia
Reduced platelet count
Rise in body temperature
Seizures
Thrombocytopenia
Thrombotic microangiopathy
Thrombotic thrombocytopenic purpura
Urticaria
Vomiting
White blood cell count decreased

Presentation

Parenteral formulations of peginterferon beta-1a.

These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.

Drugs List

Therapeutic Indications

Uses

Treatment of relapsing-remitting multiple sclerosis

Dosage

Titration of the peginterferon dose may help to ease flu-like symptoms.

Adults

Additional Dosage Information

Administration

Patients should be advised to rotate sites for subcutaneous or intramuscular injections every two weeks.
Pre-filled pen
For subcutaneous injection.

Pre-filled syringe
For intramuscular injection.

Contraindications

Children under 18 years
Suicidal ideation
Severe depression

Precautions and Warnings

Cardiac arrhythmias
Congestive cardiac failure
Coronary arteriosclerosis
Epileptic disorder
History of depression
History of seizures
Myelosuppression
Pregnancy
Severe cardiac disorder
Severe hepatic impairment
Severe renal impairment
Thyroid dysfunction

Treatment to be initiated and supervised by a specialist
Advise patient to report injection site reactions where the skin breaks
Record name and batch number of administered product
Use only if the solution is clear and colourless
Monitor full blood count and differential WBC before and during therapy
Monitor hepatic function before treatment and regularly during treatment
Monitor cardiac function in patients with cardiac disease
Monitor closely patient with depression
Monitor for signs of nephrotic syndrome
Monitor renal function regularly
Monitor serum biochemistry regularly
Monitor thyroid function regularly if history of dysfunction
Monitor thyroid function where clinically indicated
Review self injection technique periodically, especially if reactions occur
Advise patient to report any new or worsening depression/suicidal ideation
Advise patient to report symptoms of thrombotic microangiopathy
Advise patient to stop therapy & contact Dr if hypersensitivity signs occur
Consider discontinuing treatment if nephrotic syndrome occurs
Discontinue if severe hypersensitivity reactions occur
Discontinue if thrombotic microangiopathy is confirmed
Female: Ensure adequate contraception during treatment

Cases of thrombotic microangiopathy (TMA) may manifest as thrombocytopenia purpura or haemolytic uraemic syndrome. Early symptoms include thrombocytopenia, new onset hypertension, fever and central nervous system symptoms. If such symptoms develop testing of blood platelet levels, serum LDH, blood films and renal function should be carried out.

Analgesics and antipyretics may be used prophylactically or concurrent to manage any flu-like symptoms.

Consider discontinuing peginterferon beta-1a following a single site of necrosis depending on the extent of necrosis.

In addition to normal laboratory tests required for monitoring patients with multiple sclerosis, complete blood chemistries, including liver function tests, blood cell and platelet counts should be performed prior to initiation of peginterferon beta-1a therapy, at regular intervals during and periodically thereafter.

Not all presentations are suitable for all routes of administration.

Pregnancy and Lactation

Pregnancy

Use peginterferon beta-1a with caution during pregnancy.

The manufacturer states that the use of interferon beta-1a during pregnancy may be considered if clinically required. Human data suggests no increased risk of major congenital abnormalities during the first trimester due to peginterferon beta-1a. Experience during the second than third trimester is very limited.

Animal studies have shown peginterferon beta may possibly increase the risk of spontaneous abortion and low birth weight when administered in the first trimester. The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot be evaluated based on the currently available data, but does not currently suggest an increase.

Lactation

Peginterferon beta-1a is considered safe for use during breastfeeding.

The manufacturer states that peginterferon beta-1a can be used during breastfeeding. It is suggested that the levels of interferon beta-1a secreted into human breast milk is negligible.

Schaefer suggests that due to the large molecular weight of peginterferon beta it is not excreted into human milk.

LactMed reported no adverse effects in partially breastfed infants when breastfeeding mothers received peginterferon beta-1a. Therefore, no special precautions appear to be necessary while using peginterferon beta-1a.

Side Effects

Alopecia
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Chills
Decrease in haemoglobin
Depression
Gamma glutamyl transferase (GGT) increased
Glomerulosclerosis
Haemolytic uraemic syndrome
Headache
Hypersensitivity reactions
Hyperthermia
Increase in ALT level
Increase in AST level
Influenza-like syndrome
Injection site reactions
Myalgia
Nausea
Necrosis (injection site)
Nephrotic syndrome
Neutropenia
Pain
Pain on injection
Pancytopenia
Pruritus
Pulmonary artery hypertension
Pyrexia
Reduced platelet count
Rise in body temperature
Seizures
Thrombocytopenia
Thrombotic microangiopathy
Thrombotic thrombocytopenic purpura
Urticaria
Vomiting
White blood cell count decreased

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: May 2019

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Summary of Product Characteristics: Plegridy 63, 94 and 125 micrograms solution for injection in pre-filled pen. Biogen Idec Ltd. Revised December 2020.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Peginterferon Beta. Last revised: 15 June 2020
Last accessed: 13 April 2021