Nexavar多吉美

Nexavar Adverse Reactions

sorafenib

Manufacturer:

Bayer

Distributor:

Zuellig
/
Firma Chun Cheong
Full Prescribing Info
Adverse Reactions
The most important serious adverse reactions were myocardial infarction/ischaemia, gastrointestinal perforation, drug-induced hepatitis, haemorrhage and hypertension/hypertensive crisis.
The most common adverse reactions were diarrhoea, fatigue, alopecia, infection, hand-foot skin (corresponds to palmar-plantar erythrodysaesthesia syndrome in MedDRA) and rash.
Adverse reactions reported in multiple clinical trials or through post-marketing use are listed below in Table 2 (see Table 2), by system organ class (in MedDRA) and frequency. Frequencies are defined as: Very common (≥1/10), common (≥1/100, <1/10), uncommon (>1/1,000, <1/100), rare (≥1/10,000, <1/1,000), not known (cannot be estimated from the data available).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Click on icon to see table/diagram/image

Further Information on Selected Adverse Drug Reactions: Congestive Heart Failure: In company-sponsored clinical trials, congestive heart failure was reported as an adverse event in 1.9% of patients treated with sorafenib (N=2,276). In study 11213 (RCC), adverse events consistent with congestive heart failure were reported in 1.7% of patients treated with sorafenib and 0.7% receiving placebo. In study 100554 (HCC), 0.99% of those treated with sorafenib and 1.1% receiving placebo were reported with these events.
Additional Information on Special Populations: In clinical trials, certain adverse drug reactions eg, hand-foot skin reaction, diarrhoea, alopecia, decreased weight, hypertension, hypocalcaemia and keratoacanthoma/squamous cell carcinoma of skin occurred at a substantially higher frequency in patients with differentiated thyroid compared to patients in the renal cell or hepatocellular carcinoma studies.
Laboratory Test Abnormalities in HCC (Study 3) and RCC (Study 1) Patients: Increased lipase and amylase were very commonly reported. CTCAE grade 3 or 4 lipase elevations occurred in 11% and 9% of patients in the sorafenib group in study 1 (RCC) and study 3 (HCC), respectively, compared to 7% and 9% of patients in the placebo group. CTCAE grade 3 or 4 amylase elevations were reported in 1% and 2% of patients in the sorafenib group in study 1 and 3, respectively, compared to 3% of patients in each placebo group. Clinical pancreatitis was reported in 2 of 451 sorafenib-treated patients (CTCAE grade 4) in study 1, 1 of 451 patients (CTCAE grade 2) in the placebo group in study 1.
Hypophosphataemia was a very common laboratory finding, observed in 45% and 35% of sorafenib-treated patients compared to 12% and 11% of placebo patients in study 1 and study 3, respectively. CTCAE grade 3 hypophosphataemia (1–2 mg/dL) in study 1 occurred in 13% of sorafenib-treated patients and 3% of patients in the placebo group; in study 3 in 11% of sorafenib treated patients and 2% of patients in the placebo group. There were no cases of CTCAE grade 4 hypophosphataemia (<1 mg/dL) reported in either sorafenib or placebo patients in study 1 and 1 case in the placebo group in study 3. The etiology of hypophosphataemia associated with sorafenib is not known.
CTCAE grade 3 or 4 laboratory abnormalities occurring in ≥5% of sorafenib-treated patients included lymphopenia and neutropenia.
Hypocalcaemia was reported in 12% and 26.5% of sorafenib-treated patients compared to 7.5% and 14.8% of placebo patients in study 1 and study 3, respectively. Most reports of hypocalcaemia were low grade (CTCAE grade 1 and 2). CTCAE grade 3 hypocalcaemia (6-7 mg/dL) occurred in 1.1% and 1.8% of sorafenib-treated patients, and 0.2% and 1.1% of patients in the placebo group; and CTCAE grade 4 hypocalcaemia (<6 mg/dL) occurred in 1.1% and 0.4% of sorafenib-treated patients, and 0.5% and 0% of patients in the placebo group in study 1 and 3, respectively. The etiology of hypocalcaemia associated with sorafenib is unknown.
In studies 1 and 3, decreased potassium was observed in 5.4% and 9.5% of sorafenib-treated patients compared to 0.7% and 5.9% of placebo patients, respectively. Most reports of hypokalaemia were low grade (CTCAE grade 1). In these studies, CTCAE grade 3 hypokalaemia occurred in 1.1% and 0.4% of sorafenib-treated patients, and 0.2% and 0.7% of patients in the placebo group. There were no reports of hypokalaemia CTCAE grade 4.
Laboratory Test Abnormalities in DTC Patients (Study 5): Hypocalcaemia was reported in 35.7% of sorafenib-treated patients compared to 11% of placebo patients. Most reports of hypocalcaemia were low grade. CTCAE grade 3 hypocalcaemia occurred in 6.8% of sorafenib-treated patients and 1.9% of patients in the placebo group and CTCAE grade 4 hypocalcaemia occurred in 3.4% of sorafenib-treated patients and 1% of patients in the placebo group.
Other clinically relevant laboratory abnormalities observed in the study 5 are shown in Table 3 (see Table 3).

Click on icon to see table/diagram/image
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in