Nexavar (Sorafenib)

2. Brand name
•Nexavar
Recommended by FDA
•Yes

3. Chemical Formula
• C21H16ClF3N4O3
Metabolism
• Metabolized primarily in the liver

4. Nexavar is used to treat
Liver cancer (hepatocellular
carcinoma)
Thyroid cancer
A type of kidney cancer called
advanced renal cell carcinoma

5. Haemorrhage (incl. gastrointestinal,
respiratory tract, cerebral)
Hypertension
Diarrhoea
Nausea
Vomiting
Rash
Fatigue
pain (mouth, abdominal, bone, tumour,
headache)
Increased amylase and lipase

6.  Leucopenia
 Neutropenia
 Anaemia
 Thrombocytopenia
 Anorexia
 Hypocalcaemia
 Depression
 Congestive heart
failure
 Myocardial ischemia
and infarction
 Hoarseness
 Constipation
 Stomatitis (including
dry mouth and
glossodynia)
 Dry skin
 Acne
 Renal failure
 Fever
 Influenza like illness
 Weight decrease

7.  Hypersensitivity
reactions (including
skin reactions and
urticaria)
 Hypothyroidism
 Hyperthyroidism
 Dehydration
 Acute respiratory
distress, etc)
 Gastro oesophageal
reflux disease
 Pancreatitis
 Gastritis
 Increase in bilirubin
 Jaundice
 Eczema
 Keratoacanthoma /
squamous cell cancer
of the skin

8. Recommended Daily Dose
 Nexavar should be taken
without food or together
with a low- or moderate-fat
meal.
 Patients who intend to have
a high-fat meal should take
Nexavar at least 1 hour
before or 2 hours after the
meal.
 The tablets should be taken
with a glass of water.
 400 mg (2 x 200 mg
tablets) twice daily

9. Levels of sorafenib may be
increased in patients with
severe hepatic impairment.

10. Nexavar is not recommended for use in
 Pregnant women
 Women who are breastfeeding.
 Children and adolescents (<18 years) due to
lack of data.
 Temporary interruption of sorafenib therapy
is recommended in patients undergoing
major surgical procedures.

11. Treatment should continue as long
as clinical benefit is observed or
until unacceptable toxicity occurs.

12.  Sorafenib is a multi-kinase inhibitor
 Small molecular inhibitor of
 Raf kinase
 PDGF (platelet-derived growth factor)
 VEGF receptor 2 & 3 kinases and c Kit the
receptor for Stem cell factor
 Simultaneously targets Raf/Mek/Erk
pathway

14.  Preclinical studies suggest that sorafenib
acts on tumors and tumor vasculature
By inhibiting cellular proliferation and
angiogenesis
and/or
By inducing apoptosis
 In most tumor types, sorafenib inhibited
signaling through Raf
 As evidenced by reduced pERK levels

15. Sorafenib induces apoptosis
Primarily by down-regulation of the
anti apoptotic protein Mcl-1 by a
MEK/ERK-independent mechanism

16. In a study of 602 people
Nexavar helped slow cancer growth
and extend the lives of patients
compared with patients who did not
receive Nexavar
Nexavar extended overall survival by
44%.