Section 2 Warnings and Precautions

Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Neulasta. Stop using Neulasta and seek medical attention immediately if you notice any of the symptoms described in section 4.

Section 4 Side Effects

Rare side effects (may affect up to 1 in 1000 people):

• inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
• bleeding from the lung (pulmonary haemorrhage).
• Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Neulasta if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

Date of revision of the text

November 2019

Section 4.4 Special Warnings and Precautions

Stevens-Johnson syndrome

Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.

Section 4.8 Undesirable Effects

Stevens-Johnson syndrome added as a Rare ADR in Table of ADRs

Section 10 Date of revision of the text

November 2019