Safety Information

Safety profile¹

Adverse reactions observed in clinical studies of KEYTRUDA as monotherapy or in combination with chemotherapy or other anti-tumour medicines or reported from post-marketing use of KEYTRUDA are listed in the table below and continued overleaf. Adverse reactions known to occur with KEYTRUDA or chemotherapies given alone may occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical trials with combination therapy.

These reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Adverse reactions in patients treated with KEYTRUDA^*

^*Adverse reaction frequencies presented in the table may not be fully attributable to KEYTRUDA alone but may contain contributions from the underlying disease or from other medicinal products used in a combination. †Based upon a standard query including bradyarrhythmias and tachyarrhythmias.

The following terms represent a group of related events that describe a medical condition rather than a single event.

a. infusion-related reactions (drug hypersensitivity, anaphylactic reaction, anaphylactoid reaction, hypersensitivity and cytokine release syndrome)

b. hypothyroidism (myxoedema)

c. adrenal insufficiency (Addison’s disease, adrenocortical insufficiency acute, secondary adrenocortical insufficiency)

d. hypophysitis (hypopituitarism)

e. thyroiditis (autoimmune thyroiditis and thyroid disorder)

f. type 1 diabetes mellitus (diabetic ketoacidosis)

g. Guillain-Barré syndrome (axonal neuropathy and demyelinating polyneuropathy)

h. myasthenic syndrome (myasthenia gravis, including exacerbation)

i. meningitis aseptic (meningitis, meningitis non-infective)

j. uveitis (iritis and iridocyclitis)

k. myocarditis (autoimmune myocarditis)

l. pneumonitis (interstitial lung disease)

m. abdominal pain (abdominal discomfort, abdominal pain upper and abdominal pain lower)

n. colitis (colitis microscopic, enterocolitis, and autoimmune colitis)

o. pancreatitis (autoimmune pancreatitis and pancreatitis acute)

p. hepatitis (autoimmune hepatitis and drug induced liver injury)

q. rash (rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash vesicular and genital rash)

r. pruritus (urticaria, urticaria papular, pruritus generalised and pruritus genital)

s. severe skin reactions (dermatitis bullous, dermatitis exfoliative, erythema multiforme, exfoliative rash, pemphigus, skin necrosis, toxic skin eruption and Grade ≥3 of the following: acute febrile neutropenic dermatosis, contusion, decubitus ulcer, dermatitis psoriasiform, drug eruption, jaundice, pemphigoid, pruritus, pruritus generalised, rash, rash erythematous, rash generalised, rash maculopapular, rash pruritic, rash pustular and skin lesion)

t. vitiligo (skin depigmentation, skin hypopigmentation and hypopigmentation of the eyelid)

u. lichenoid keratosis (lichen planus and lichen sclerosus)

v. musculoskeletal pain (musculoskeletal discomfort, back pain, musculoskeletal stiffness, musculoskeletal chest pain and torticollis)

w. myositis (myalgia, myopathy, polymyalgia rheumatica and rhabdomyolysis)

x. arthritis (joint swelling, polyarthritis and joint effusion)

y. tenosynovitis (tendonitis, synovitis and tendon pain)

z. nephritis (nephritis autoimmune, tubulointerstitial nephritis and renal failure, renal failure acute, or acute kidney injury with evidence of nephritis, nephrotic syndrome)

aa. oedema (oedema peripheral, generalised oedema, fluid overload, fluid retention, eyelid oedema and lip oedema, face oedema, localised oedema and periorbital oedema)