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Sorafenib

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Molecule Summary

Uses
Liver, Kidney And Thyroid Cancer
Therapy
Anti-Neoplastic
Side Effects
Hand-Foot Skin Reaction, Diarrhoea, Rash, High Blood Pressure
3 Step Quality
Assurance
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available
NPPA
Regulated

Molecule Description

Sorafenib contains sorafenib as its active ingredient. It is a prescription cancer medicine that belongs to a group called kinase inhibitors. Unlike medicines that target just one protein, sorafenib blocks multiple proteins involved in cancer cell growth and in the formation of new blood vessels that tumours need to survive and expand (a process called angiogenesis). Blocking several of these proteins at once, it helps slow the growth and spread of cancer. It comes as a round, red film-coated tablet taken by mouth. This medicine is used to treat three types of cancer in adults: liver cancer ( hepatocellular carcinoma); advanced kidney cancer (renal cell carcinoma); and thyroid cancer that has spread or come back, is getting worse, and is no longer responding to radioactive iodine treatment (locally recurrent or metastatic progressive differentiated thyroid carcinoma). It is taken on its own and not in combination with standard chemotherapy for these cancers. Sorafenib is an oral medicine taken at home, under the supervision of a specialist doctor experienced in cancer treatment. Take it at the same time each day and follow the recommended food instructions. Treatment usually continues as long as it is helping and the side effects remain manageable.

Uses

  • Liver cancer ( hepatocellular carcinoma, HCC)
  • Advanced kidney cancer (advanced renal cell carcinoma, RCC)
  • Thyroid cancer

Contraindications

When should one not use Sorafenib

  • If you are allergic to sorafenib or any other ingredient in this medicine, a serious allergic reaction may occur
  • If you have squamous cell lung cancer and are receiving or planning to receive carboplatin and paclitaxel chemotherapy, as this combination has been linked with a significant increase in the risk of death

Side effects

Common side effects of this drug are:

  • Sorafenib can cause a range of side effects. The most common ones are listed below.
  • Very common side effects (seen in more than 1 in 5 patients):
  • Diarrhoea
  • Fatigue and weakness
  • Infections
  • Hair thinning or patchy hair loss (alopecia)
  • Hand-foot skin reaction (palmar-plantar erythrodysesthesia, PPE), causing redness, pain, swelling, and blistering on the palms and soles of the feet
  • Skin rash and skin peeling
  • Weight loss
  • Reduced appetite
  • Nausea
  • Stomach and abdominal pain
  • High blood pressure (hypertension)
  • Bleeding (haemorrhage)
  • Other commonly reported side effects:
  • Vomiting and constipation
  • Mouth sores (stomatitis), dry mouth, and voice changes (dysphonia)
  • Joint pain (arthralgia) and muscle pain (myalgia)
  • Headache and changes in taste (dysgeusia)
  • Shortness of breath
  • Nosebleeds (epistaxis)
  • Dry skin and itching (pruritus)
  • Raised liver enzyme readings in blood tests
  • Low phosphate, potassium, and calcium levels in the blood
  • Depression
  • Nerve pain (sensory neuropathy)
  • Kidney problems, including protein in the urine (proteinuria)
  • Serious side effects requiring immediate medical attention:
  • Heart problems, including heart attack, reduced blood flow to the heart, or heart failure. Symptoms may include chest pain, shortness of breath, or swelling of the legs.
  • Serious bleeding, including bleeding from the stomach or intestines, lungs, or brain.
  • Dangerously high blood pressure, which may require urgent treatment.
  • Gastrointestinal perforation (a hole in the stomach or intestine), causing severe stomach pain, fever, nausea, or vomiting.
  • Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, causing blistering or peeling skin.
  • Severe liver injury, which may cause yellowing of the skin or eyes and can lead to liver failure.
  • Changes in heart rhythm (QT prolongation), which can sometimes cause dangerous irregular heartbeats.
  • Reversible posterior leukoencephalopathy syndrome (RPLS), a rare brain condition that may cause seizures, severe headache, confusion, or vision changes.
  • Severe inflammation of the pancreas (pancreatitis) or lungs (interstitial lung disease).
  • Contact your doctor immediately if you develop chest pain, unusual bleeding, severe stomach pain, severe skin reactions, yellowing of the skin or eyes, seizures, confusion, or an irregular heartbeat.

Precautions and Warnings

Pregnancy

Pregnancy

No. Sorafenib may seriously harm the unborn baby and may cause birth defects or pregnancy loss. If you are pregnant, think you may be pregnant, or plan to become pregnant, tell your doctor immediately. Women who could become pregnant should use effective contraception during treatment and as advised by their doctor after the last dose.

Breast Feeding

Breast Feeding

You should not breastfeed during treatment with Sorafenib because sorafenib may harm a nursing infant. Discuss with your doctor when breastfeeding can safely be resumed.

Driving

Driving

Sorafenib does not appear to directly affect the ability to drive or operate machinery. However, if you feel very unwell, dizzy, or fatigued due to side effects, do not drive and let your doctor know.

Alcohol

Alcohol

There is no specific established alcohol interaction with sorafenib. However, alcohol may worsen fatigue, nausea, or diarrhoea. Discuss alcohol consumption with your doctor.

Other General Warnings

Other General Warnings

Talk to your doctor if
  • Consult your doctor if-
  • You develop chest pain, shortness of breath, swelling, dizziness, or fainting, as Sorafenib can affect the heart.
  • You notice unusual bleeding or unexplained bruising.
  • You develop painful redness, swelling, blisters, or peeling on your hands or feet.
  • You develop a severe rash, blistering, or peeling skin, especially with mouth sores.
  • You have severe stomach pain, fever, nausea, or vomiting.
  • You notice yellowing of the skin or eyes, dark urine, or abdominal pain, which may indicate liver problems.
  • You experience irregular heartbeat, dizziness, or fainting, as Sorafenib can affect heart rhythm.
  • You are planning surgery, as Sorafenib may delay wound healing.
  • You have thyroid cancer, as regular TSH monitoring may be needed.
  • You take warfarin or other blood thinners, as closer blood-clotting monitoring may be required.
  • You are planning to have children, as Sorafenib may affect male fertility.
  • Take Sorafenib consistently without food or with a low- or moderate-fat meal. Avoid high-fat meals around the time of dosing.
  • Tell your doctor immediately about unusual bleeding, such as vomiting blood, blood in stools, coughing up blood, or prolonged nosebleeds.
  • Have your blood pressure checked regularly, especially during the first few weeks of treatment.
  • Report painful redness, swelling, or blisters on your hands or feet, as these may indicate hand-foot skin reaction.
  • Tell your doctor immediately if you develop chest pain, shortness of breath, or an irregular heartbeat.
  • Tell your doctor before any planned surgery, as Sorafenib may affect wound healing.
  • If you have thyroid cancer, your doctor may monitor your TSH levels regularly during treatment.
  • Women who could become pregnant should use effective contraception during treatment and as advised afterwards. Men with partners who could become pregnant should also use contraception as advised.
  • Inform all your doctors, dentists, and emergency healthcare providers that you are taking Sorafenib.
  • Keep out of reach of children and pets.

Mode of Action

How Does It Work?

Sorafenib contains sorafenib, a targeted cancer medicine that blocks several proteins called kinases involved in cancer growth. By blocking these proteins, sorafenib slows the growth and multiplication of cancer cells and reduces the formation of new blood vessels that tumours need to grow and survive. It may also promote cancer-cell death, helping to slow the progression of certain cancers.

Interactions

Interactions with other medicines

  • Rifampicin, carbamazepine, phenytoin, phenobarbital, dexamethasone, rifabutin, and St. John’s Wort: These may lower sorafenib levels and make it less effective. Tell your doctor before using them.
  • Neomycin: Taking oral neomycin may greatly reduce sorafenib levels, so it should be avoided if possible.
  • Warfarin: Sorafenib may affect blood clotting and increase the risk of bleeding. Your doctor may monitor your INR and other blood-clotting tests more closely.
  • Sorafenib may affect how some other medicines are processed in the body. Your doctor will check for possible interactions.
  • Ketoconazole and omeprazole do not appear to significantly affect sorafenib levels.
  • Tell your doctor about all medicines, vitamins, supplements, and herbal products you take.

Interactions with food items

Sorafenib can be taken without food or with a low- or moderate-fat meal. Avoid taking it with a high-fat meal, as this may reduce how much sorafenib your body absorbs. If having a high-fat meal, take the medicine at least 1 hour before or 2 hours after the meal. Drink enough fluids throughout the day, especially if you have diarrhoea.

Dosage

Overdose

Taking too much Sorafenib may cause severe diarrhoea and skin reactions, particularly hand-foot skin reactions. There is no specific antidote for sorafenib overdose. If you think you have taken too much, contact your doctor or go to the nearest emergency department immediately. Do not take any further doses unless advised by your doctor.

Missed a Dose

If you miss a dose of Sorafenib, skip the missed dose and take your next dose at the regularly scheduled time. Do not take double the dose to make up for a missed one. If you are unsure what to do, contact your doctor or pharmacist for advice.

Frequently Asked Questions (FAQs)

Sorafenib is used for the conditions listed in the Uses section of this page. Your doctor will decide whether it is suitable for your cancer type and stage.

No. Do not stop, delay or change your treatment on your own, even if you feel well. Stopping early can make the treatment less effective. Always speak to your doctor first.

Yes. Your doctor will usually advise regular blood tests and clinical check-ups during treatment to monitor how your body is responding and to pick up side effects early.

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