SONORA Tablet 120's

INTRODUCTION ABOUT SONORA TABLET

SONORA TABLET contains Sorafenib which belongs to the group of medicines called
Multikinase inhibitors. It is used to manage liver cancer (hepatocellular
carcinoma), and kidney cancer (advanced renal cell carcinoma) at an advanced
stage when standard therapy has not helped to stop the disease or considered
unsuitable. SONORA TABLET is also used to manage differentiated thyroid cancer
that is not responding to radioactive iodine management.

SONORA TABLET is not recommended for use in patients with squamous cell lung
cancer.  SONORA TABLET should be used with caution in patients with severe liver
or kidney disease, high blood pressure, and heart diseases such as abnormal
heart rhythm disorders like prolonged QT interval, diabetes, and bleeding
problems. Consult your doctor before taking SONORA TABLET

SONORA TABLET is not recommended for use during pregnancy or if you think you
could become pregnant, use adequate contrace
medicine. SONORA TABLET is not recommended for use in breastfeeding women as it
interferes with the growth of the developing baby. Contact your doctor for
advice before taking SONORA TABLET

The safety and efficacy of SONORA TABLET in children and adolescents aged below
18 years have not yet been established. SONORA TABLET should be used with
caution in elderly patients with kidney failure. Contact your doctor before
taking SONORA TABLET. The most common side effects of taking SONORA TABLET are
nausea, diarrhoea, vomiting, constipation, weakness or tiredness, hair loss
(alopecia) or rash. Contact your physician if any of the symptoms worsen.

USES OF SONORA TABLET

• Manage liver cancer (hepatocellular carcinoma)
• Manage kidney cancer (advanced renal cell carcinoma)
• Manage thyroid cancer (differentiated thyroid carcinoma)

HOW SONORA TABLET WORKS

SONORA TABLET is an oral multi-kinase inhibitor which blocks tumour cell growth.
It targets several enzymes on the surface of cancer cells and also targets
within the cell. Several of these targets are thought to be involved in
angiogenesis (making of blood vessels). SONORA TABLET works by slowing down the
rate of growth of cancer cells and cutting off the blood supply that keeps
cancer cells growing.

DIRECTIONS FOR USE

Take SONORA TABLET as advised by your physician. Swallow the medicines with a
glass of water. Do not crush or chew the medicine. Your physician will decide
the correct dose and duration for you depending upon your age, body weight and
disease condition.

SIDE EFFECTS OF SONORA TABLET

COMMON

• nausea
• diarrhoea
• vomiting
• constipation
• abdominal pain
• weakness or tiredness
• mouth pain, pain in bones, and tumour pain
• hair loss (alopecia)
• headache
• itching or rash
• redness or painful palms and soles
• bleeding in the brain, lungs or airways, stomach and intestine
• high blood pressure
• infections
• loss of appetite
• joint pain (arthralgia)
• fever
• weight loss
• flu-like illness
• indigestion
• difficulty swallowing
• inflamed or dry mouth
• tongue pain
• hypocalcaemia (decrease in calcium levels in the blood)
• low blood sugar levels
• hypokalaemia (decrease in potassium levels)
• muscle pain
• tingling and numbness sensations in fingers and toes
• erection problems (impotence)
• change in voice
• acne
• inflamed, dry, scaly skin or shedding
• kidney failure
• decrease in white blood cells (leukopenia)
• decrease in red blood cells (anaemia)
• decrease in platelet count (thrombocytopenia)
• inflammation of hair follicles
• hypothyroidism
• hyponatremia (low sodium levels in the blood)
• change in sense of taste
• redness of the face and other areas of the skin (flushing)
• runny nose
• heartburn
• skin cancer
• thickening of the skin
• muscle spasms
• ringing in the ear

UNCOMMON

• gastritis, abdominal pain caused by pancreatitis, inflammation of the gall bladder and/or bile ducts
• yellowish discolouration of skin or white of the eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinemia)
• allergic reactions like skin reactions and hives
• dehydration
• enlargement of breasts
• breathing difficulty
• eczema
• hyperthyroidism
• multiple skin eru
• reversible posterior leukoencephalopathy (reversible swelling in the rear part of the brain that can be associated with headache, change in consciousness, fits and visual loss)

RARE

• sunburn-like rash or severe radiation recall dermatitis may occur in patients with a history of radiotherapy management
• abnormal heart rhythm (QT prolongation)
• nephrotic syndrome (damage to the kidney causing leakage of proteins)
• inflammation of the vessels in the skin causing skin rashes
• allergic reaction such as swelling of the face, tongue causing difficulty in breathing or swallowing (angioedema)
• serious reactions of the skin and/or mucous membranes include painful blisters, fever, and extensive detachment of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• breakdown of muscles (rhabdomyolysis) causing kidney problems
• inflammation of the vessels in the skin which may result in skin rash (leucocytoclastic vasculitis)

Stop taking SONORA TABLET and contact your physician immediately if you
experience any of the following side effects:

• severe allergic reactions (such as blisters, hives, skin swelling, face or tongue, difficulty breathing or swallowing, etc.)
• symptoms of Tumour lysis syndrome (TLS) such as nausea, shortness of breath, irregular heartbeat, muscular cramps, seizure, clouding of urine and tiredness
• rashes and skin reactions especially on the hands and feet
• chest pain or heart problems such as heart attack
• perforation or holes in the stomach or the intestine
• severe bleeding which may also present as bloody vomit, brownish urine, red or black coloured stool, coughing up blood or blood clots, heavy menstrual bleeding, vaginal bleeding, bleeding from the nose etc.
• severe diarrhoea
• severe high blood pressure or liver injury

HOW TO MANAGE SIDE EFFECTS

!### Constipation

Eat fibre rich foods such as fresh fruits, vegetables, and cereals. Drink more
water and exercise regularly. Contact your doctor if constipation did not
improve.

!### Diarrhea

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated.
Do not take any medicine on your own for managing diarrhoea. Contact your doctor
if diarrhoea did not improve.

Headache

Rest and relax. Drink plenty of fluids such as water or electrolytes and apply a
pain-relieving balm on the head if necessary. Contact your doctor if your
headache worsens.

!### Nausea And Vomiting

Take this medicine with, or just after meals. Stick to simple meals. Avoid
eating oily or spicy foods. Contact your doctor if nausea and vomiting did not
improve.

!### Skin Rash Or Itching

Avoid taking bath with hot water as it irritates the skin further and do not
scratch the affected area. Use sunscreen and protective clothing when going
outdoors. Contact your doctor if rashes worsen.

!### Stomach Pain

Try to rest and relax. Eat smaller meals but take them frequently. Keep a
heating pad on your stomach. Contact your doctor if stomach pain worsens.

WARNING & PRECAUTIONS

!### PREGNANCY

ContraindicatedSONORA TABLET is not recommended for use during pregnancy or if you think you
could become pregnant, use adequate contrace
medicine. Consult your doctor before taking SONORA TABLET.

!### BREASTFEEDING

ContraindicatedSONORA TABLET is not recommended for use in breastfeeding women as it interferes
with the growth of the developing baby. Consult your doctor before taking SONORA
TABLET.

!### DRIVING AND USING MACHINES

Use with CautionThere is no evidence that SONORA TABLET will affect the ability to drive or
operate machines.

!### KIDNEY

Use with CautionSONORA TABLET should be used with caution in patients with poor kidney function.
Consult your doctor before taking SONORA TABLET.

!### LIVER

Use with CautionSONORA TABLET should be used with caution in patients with severe liver disease.
Consult your doctor before taking SONORA TABLET.

!### ALLERGY

ContraindicatedDo not take SONORA TABLET if you are allergic to Sorafenib or any other
ingredients of this medicine.

!### LUNGS

ContraindicatedSONORA TABLET is not recommended for use in patients with squamous cell lung
cancer.  Consult your doctor before taking SONORA TABLET.

!### HEART DISEASE

Use with CautionSONORA TABLET should be used with caution in patients with high blood pressure
and heart diseases such as abnormal heart rhythm disorders called prolonged QT
interval. Consult your doctor before taking SONORA TABLET.

!### USE IN PEDIATRICS

Consult your doctorThe safety and efficacy of SONORA TABLET in children and adolescents (below 18
years of age) have not yet been established. Consult child’s doctor for advice

!### USE IN GERIATRICS

Use with CautionSONORA TABLET should be used with caution in elderly patients with kidney
failure. Consult your doctor before taking SONORA TABLET.

OTHERS

Before taking SONORA TABLET, inform your doctor if you have:

• aneurysm (enlargement or weakening of blood vessels) or tearing of blood vessel wall
• diabetes
• bleeding problems
• surgery, or recently had an operation
• perforation of the stomach and intestine
• low potassium, magnesium and calcium levels

INTERACTIONS

A. Drug-Drug interactions:

Before taking SONORA TABLET, inform your doctor if you are taking any of the
following medicines:

• rifampicin, rifabutin, rifampin (used to manage tuberculosis)
• neomycin or other antibiotics (used to manage bacterial infections)
• St. john’s wort (used to manage depression)
• phenytoin, carbamazepine or phenobarbital (used to manage fits)
• dexamethasone (used to manage inflammation)
• warfarin or phenprocoumon, anticoagulants such as dabigatran (used to manage blood clots)
• doxorubicin, capecitabine, docetaxel, paclitaxel, gemcitabine, cisplatin and irinotecan (used to manage cancer)
• digoxin (used to manage heart failure)
• midazolam (used to manage seizures)
• dextromethorphan (used to manage cough)
• omeprazole (used to manage gastric ulcers)

B. Drug - Food interactions:

Do not take SONORA TABLET with high fat meals, as this may make the medicine
less effective. If you intend to have a high fat meal, take SONORA TABLET at
least 1 hour before or 2 hours after the meal. Consult your doctor for advice.

Overdosage:

If you or anyone else accidentally take too much of SONORA TABLET, consult your
doctor immediately or visit the nearby hospital. Symptoms of overdosage are
severe diarrhoea and skin reactions.

SYNOPSIS

Drug	:	Sorafenib
Pharmacological Category	:	Multikinase inhibitors
Therapeutic Indication	:	Liver Cancer, Kidney Cancer, Thyroid Cancer
Dosage Forms	:	Tablet

MORE INFORMATION

• Keep SONORA TABLET out of the sight and reach of children.
• Store at room temperature

FAQs ABOUT SONORA TABLET

Q: How does SONORA TABLET work?

A: SONORA TABLET is an oral multi-kinase inhibitor which blocks tumour cell
growth. It targets several enzymes on the surface of cancer cells and also
targets within the cell. Several of these targets are thought to be involved in
angiogenesis (making of blood vessels). SONORA TABLET works by slowing down the
rate of growth of cancer cells and cutting off the blood supply that keeps
cancer cells growing.

Q: Does SONORA TABLET affects fertility?

A: Yes, SONORA TABLET reduces fertility in both men and women. Consult your
doctor before taking SONORA TABLET if you want to father a child or if you are a
woman with childbearing potential. Your doctor may recommend you to use
effective contrace

Q: What are the common side effects of taking SONORA TABLET?

A: The most common side effects of taking SONORA TABLET are nausea, diarrhoea,
vomiting, constipation, feeling weak or tiredness, and hair loss (alopecia).
Consult your physician if any of the symptoms worsen.

Q: For how long should I need to take SONORA TABLET?

A: If SONORA TABLET is well tolerated, then you should continue taking it for
the duration as suggested by the doctor. However, if you experience any unusual
reactions which bothers you talk to your doctor for advice

Q: IsSONORA TABLET safe to use in patients with heart disease?

A: SONORA TABLET should be used with caution in patients with high blood
pressure and heart diseases such as abnormal heart rhythm disorders called
prolonged QT interval. Consult your doctor before taking SONORA TABLET

REFERENCES

1. KD. Tripathi. Anticancer drugs. Essentials of medical pharmacology. Eighth
   Edition. 2019. Page – 931

2. Sorafenib. National Institute of Health. NLM. National Centre for
   Biotechnology Information. PubChem Compound Summary. 2004. [Accessed on 26th
   June 2022]

3. Ali Ben Mousa. Sorafenib in the Treatment of Advanced Hepatocellular
   Carcinoma. NIH. National Library of Medicine. National Center for Biotechnology
   Information. The Saudi Journal of Gastroenterology. January 2008. [Accessed on
   26th July 2022]

4. Remedica Ltd. Sorafenib Tosylate. Electronic Medicines Compendium (EMC).
   [Revised in April 2022] [Accessed on 26th July
   2022]

5. Bayer health care.Sorafenib Tosylate. U.S. Food & Drug Administration (FDA).
   [Revised in December 2018] [Accessed on 26th July 2022]

6. Bayer AG. Sorafenib Tosylate. European Medical Agency (EMA). [Accessed on
   26th July
   2022]

USEFUL DIAGNOSTIC TESTS

• Complete blood count
• Kidney function test
• Liver function test
• Thyroid function test