SORAFENIB

COMMON BRAND NAME(S): Nexavar

GENERIC NAME(S): SORAFENIB TOSYLATE

 

Description: Sorafenib is a multikinase inhibitor, that stops the growth of cancer cells by blocking the cell surface and intracellular kinases.  These kinases are essential tumor cell signaling.

Pharmacokinetics:

Absorption: Highest blood concentration is achieved 3 hr after oral admin.

Distribution: 99.5% bound to plasma protein.

Metabolism: Primarily metabolised by isoenzyme CYP3A4 and, to a smaller extent, by glucuronidation.

Excretion: About 77% in the faeces as unchanged drug and 19% in the urine as glucuronidated metabolites. Elimination half-life: 25-48 hr.

Indications:

This medication is used to treat kidney or liver cancer.

It may also be used to treat a certain type of thyroid cancer (differentiated thyroid carcinoma).

Contraindications:

This drug should not be given to patients who had allergic reactions to this drug.

It should not be combined with carboplatin and paclitaxel in patients with squamous cell carcinoma.

How to use sorafenib

Dosage: Take 400 mg of this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after a meal) as directed by your doctor, usually twice a day.

  • Do not chew or crush the tablets. Swallow tablets whole with a full glass of water (8 ounces or 240 milliliters).
  • Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Availability: This is a prescription only drug

Please see Precautions section.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Common side effects:

  • acne,
  • dry skin,
  • nausea,
  • diarrhea,
  • patchy hair loss/thinning,
  • loss of appetite,
  • dry mouth,
  • hoarseness, or
  • tiredness

Tell your doctor right away if you have any serious side effects, including:

  • bone/muscle pain,
  • depression,
  • easy bruising or bleeding,
  • headache,
  • tongue/mouth sores or pain,
  • numbness/tingling of the hands/feet,
  • shortness of breath,
  • swollen hands/ankles/feet,
  • signs of liver problems (such as stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine)

Get medical help right away if you have any very serious side effects, including:

  • chest/jaw/left arm pain,
  • severe abdominal/stomach pain,
  • bloody vomit,
  • coughing up blood,
  • bloody stools,
  • difficulty speaking,
  • loss of balance,
  • sudden vision changes,
  • seizures,
  • severe dizziness,
  • fainting

Blood pressure: This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Skin: If the patient starts manifesting with rashes, blisters, redness, swelling, pain, especially on the palms of your hands or the soles of your feet while taking this drug. Your doctor may prescribe medication for your skin or change your treatment plan.

Thyroid: Tell your doctor right away if you have signs of an underactive thyroid (such as weight gain, cold intolerance, slow heartbeat, constipation, or unusual tiredness) or signs of an overactive thyroid (such as mental/mood changes, heat intolerance, fast/pounding/irregular heartbeat, unusual weight loss).

Immunity: This medication can lower the body’s ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions:

  • Allergy: Before taking sorafenib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
  • Medical History: Before using this medication, tell your doctor or pharmacistif you had: bleeding problems, heart problems (such as heart attack, angina), high blood pressure, liver problems.
  • Risk of QT interval prolongation: The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs, such as: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
  • Risk of cardiac ischemia or infarction: Patients taking sorafenib has increased risk of heart problems. Temporary or permanent discontinuation of Sorafenib should be considered to those who develop cardiac ischemia or infarction.
  • Risk of hemorrhage: An increased risk of bleeding may occur following Sorafenib administration. If bleeding occurs, medical intervention and permanent discontinuation should be considered. To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.
  • Risk of dermatologic toxicities: Hand-foot skin reaction and rash represent the most common adverse reactions attributed to Sorafenib. There have been reports of Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN).  Discontinue drug if these occur.
  • Immunization: Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Pregnancy Risk:  Category D.  This medication is not recommended for use during pregnancy. It may harm an unborn baby. To avoid pregnancy, both males and females using sorafenib must use reliable form(s) of birth control during treatment and for at least 2 weeks after stopping this drug. Consult your doctor for more details.

Breastfeeding: It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions:

  • Some products that may interact with this drug include: other anti-cancer drugs (such as docetaxel, doxorubicin, irinotecan), “blood thinners” (anticoagulants such as warfarin, heparins), neomycin taken by mouth.
  • Other medications can affect the removal of sorafenib from your body, which may affect how sorafenib works. Examples include dexamethasone, rifamycins (such as rifampin/rifabutin), St. John’s wort, drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital), among others.

Overdose:

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as blood pressure, calcium/phosphate/potassium levels, lipase, amylase, complete blood counts, liver/thyroid function tests) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brands:

Available Brands

  • Nexavar [ Bayer ]

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