PLEGRIDY adverse reactions1

Setting patient expectations about common side effects and equipping patients with strategies to manage these side effects can help prepare them for treatment.

The most common adverse reactions reported in year 1 of ADVANCE, in which patients with relapsing MS received PLEGRIDY or placebo by subcutaneous (SC) injection, were injection site reactions (ISRs) and flu-like symptoms (FLS).1

Adverse reactions with an incidence 2% higher for PLEGRIDY SC than for placebo in ADVANCE (year 1)

Adverse reaction

PLEGRIDY n=512
%

Placebo n=500
%

Nervous System Disorders

Headache

44

33

Gastrointestinal Disorders

Nausea

9

6

Vomiting

5

2

Musculoskeletal and Connective Tissue Disorders

Myalgia

19

6

Arthralgia

11

7

General Disorders and Administration Site Conditions

Injection site erythema

62

7

Influenza like illness

47

13

Pyrexia

45

15

Chills

17

5

Injection site pain

15

3

Asthenia

13

8

Injection site pruritis

13

1

Hyperthermia

4

1

Pain

5

3

Injection site edema

3

0

Injection site warmth

3

0

Injection site hematoma

3

1

Injection site rash

2

0

Investigations

Body temperature increased

6

3

Alanine aminotransferase increased

6

3

Aspartate aminotransferase increased

4

2

Gamma-glutamyl-transferase increased

3

1

Skin and Subcutaneous Tissue Disorder

Pruritis

4

1

Incidence and tolerability of FLS

  • In ADVANCE, the incidence of FLS was 47% in the PLEGRIDY group and 13% in the placebo group
  • Fewer than 1% of patients discontinued PLEGRIDY due to FLS

Most common adverse reactions with PLEGRIDY SC and PLEGRIDY IM in bioequivalence study1

Comparison between SC and IM administration

An open-label, crossover study analyzed findings from 130 healthy volunteers to assess the bioequivalence of single doses of 125 mcg of PLEGRIDY administered as an SC and intramuscular (IM) injection.

The pharmacokinetics of 125 mcg single dose of PLEGRIDY administered subcutaneously and intramuscularly were similar.

Safety results below, from the bioequivalence study, showed a lower frequency of ISRs with PLEGRIDY IM versus PLEGRIDY SC.

55% relative reduction in ISRs

  • Overall, ISRs (eg, injection site erythema, pain, pruritus, or edema) were reported with a lower frequency in intramuscular (14%) compared to subcutaneous (32%) administration