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These brands contain the same active ingredient (Sorafenib Tosylate). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Sofenib is indicated for:
Pharmacology
Sorafenib is a kinase inhibitor, and it works by reducing the growth of tumour cells. It has been shown to block several kinases inside the cell (CRAF, BRAF and mutant BRAF) as well as kinases on the cell surface (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3 and PDGFR-β). Many of these kinases are thought to take part in tumour cell signalling, angiogenesis and apoptosis.
In immunocompromised mice, sorafenib slowed tumour growth and angiogenesis in human hepatocellular carcinoma and renal cell carcinoma. It did the same in several other human tumour xenografts.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended daily dose of Sorafenib is 400 mg tablets taken twice daily without food, which means at least 1 hour before or 2 hours after a meal. Treatment should go on until the patient is no longer getting clinical benefit from the therapy or until unacceptable toxicity occurs.
Management of suspected adverse drug reactions may need a temporary interruption and/or a dose reduction of Sorafenib therapy. When the dose has to be reduced, Sorafenib may be lowered to 400 mg once daily. If a further reduction is needed, it may be lowered to a single 400 mg dose every other day.
Recommended regimens and treatment duration for Sorafenib therapy are as follows.
Grade 1: Numbness, dysesthesia, paresthesia, tingling, painless swelling, erythema or discomfort of the hands or feet which does not disrupt the patient's normal activities.
Any occurrence: Continue treatment with Sorafenib and consider topical therapy for symptomatic relief.
Grade 2: Painful erythema and swelling of the hands or feet and/or discomfort affecting the patient's normal activities.
1st occurrence: Continue treatment with Sorafenib and consider topical therapy for symptomatic relief. If there is no improvement within 7 days, see below.
No improvement within 7 days or 2nd or 3rd occurrence: Interrupt Sorafenib treatment until the toxicity resolves to Grade 0 to 1. When resuming treatment, decrease the Sorafenib dose by one dose level (400 mg daily or 400 mg every other day).
4th occurrence: Discontinue Sorafenib treatment.
Grade 3: Moist desquamation, ulceration, blistering or severe pain of the hands or feet, or severe discomfort that leaves the patient unable to work or perform activities of daily living.
1st or 2nd occurrence: Interrupt Sorafenib treatment until the toxicity resolves to Grade 0 to 1. When resuming treatment, decrease the Sorafenib dose by one dose level (400 mg daily or 400 mg every other day).
3rd occurrence: Discontinue Sorafenib treatment.
No dose adjustment is needed on the basis of the patient's age, gender or body weight.
Missed doses: If a dose of Sorafenib is missed, skip it and take the next dose at the regular time. Do not double your dose of Sorafenib.
Side Effects
Sorafenib Tosylate can cause serious side effects. These include cardiac ischemia and infarction, hemorrhage, hypertension, hand-foot skin reaction and rash, gastrointestinal perforation, and problems with wound healing.
Cautions & Contraindications
Warnings & Precautions
Cardiac ischemia, infarction: if a patient develops cardiac ischemia and/or infarction while on Sorafenib Tosylate, the doctor should consider stopping it, either temporarily or permanently. Risk of Hemorrhage: bleeding may be more likely after administration of the medicine. In the RCC Study there was one fatal hemorrhage in each treatment group. If any bleeding needs medical intervention, permanent discontinuation should be considered. Risk of Hypertension: in the HCC study, hypertension was reported in approximately 9.4% of treated patients, and in the RCC Study in approximately 16.9%. When hypertension is severe or persistent despite antihypertensive therapy, temporary or permanent discontinuation should be considered. Risk of Dermatologic Toxicities: hand-foot skin reaction and rash are the most common adverse reactions attributed to Sorafenib Tosylate. Risk of Gastrointestinal Perforation: if a gastrointestinal perforation happens, the therapy should be discontinued. Warfarin Co-Administration: patients who take warfarin at the same time should be monitored regularly for changes in prothrombin time, INR or clinical bleeding episodes. Wound Healing Complications: whether to resume therapy after a major surgical intervention should be based on clinical judgment of adequate wound healing. Use in combination with Carboplatin and Paclitaxel in Non-small Cell Lung Cancer: in patients with squamous cell carcinoma (prospectively stratified), mortality was higher when Sorafenib Tosylate was added than in those treated with carboplatin and paclitaxel alone. Interactions with UGT1A1 Substrates: the medicine can raise plasma concentrations of drugs that are substrates of UGT1A1. Interaction with Docetaxel & Doxorubicin: it can also raise plasma concentrations of Docetaxel and Doxorubicin. Hepatic Impairment: hepatic impairment may reduce plasma concentrations of Sorafenib Tosylate. Neomycin: co-administration of oral Neomycin decreases exposure to Sorafenib Tosylate.
Contraindications
Patients who have a known severe hypersensitivity to Sorafenib, or to any other component of the Sorafenib product, must not take it. Sorafenib is also contraindicated when it is given together with carboplatin and paclitaxel in patients with squamous cell lung cancer.
Pregnancy & Breastfeeding
Sorafenib may harm an unborn baby if a pregnant woman takes it. This is based on how the medicine works and on what was seen in animal studies. Women who could become pregnant should be told to avoid pregnancy while they are on Sorafenib. Nobody knows yet whether Sorafenib passes into human breast milk.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use: Sorafenib Tosylate has not been studied for safety and effectiveness in pediatric patients.
Geriatric Use: Older and younger patients showed no differences in safety or efficacy.
Renal impairment: Patients with any degree of renal impairment don't need a dose adjustment of Sorafenib Tosylate.
Hepatic impairment: In people with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, the AUC of Sorafenib Tosylate may be 23 to 65% lower than in subjects with normal liver function. In HCC patients with Child-Pugh A and B hepatic impairment, systemic exposure and safety data were comparable. Sorafenib Tosylate has not been studied in patients with Child-Pugh C hepatic impairment.
Overdose
There's no specific treatment for a Sorafenib Tosylate overdose. The highest dose studied in clinical trials was 800 mg twice daily. At that dose, the adverse reactions seen were mainly diarrhea and skin (dermatologic) reactions.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Sorafenib Tosylate at room temperature, below 30°C. Leave the desiccant in the bottle, and keep the tablets in their original bottle.
Drug Interactions
Common questions about Sofenib 200 mg
What is Sofenib 200 mg Tablet?
Sofenib 200 mg Tablet is a medicine that contains Sorafenib Tosylate. It is made by Renata PLC. It belongs to the Targeted Cancer Therapy group of medicines.
What is Sofenib used for?
Sofenib is used for: Cancer.
What are the side effects of Sofenib?
Sorafenib Tosylate can cause serious side effects. These include cardiac ischemia and infarction, hemorrhage, hypertension, hand-foot skin reaction and rash, gastrointestinal perforation, and problems with wound healing.
Can I take Sofenib during pregnancy or while breastfeeding?
Sorafenib may harm an unborn baby if a pregnant woman takes it. This is based on how the medicine works and on what was seen in animal studies. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Sofenib?
There's no specific treatment for a Sorafenib Tosylate overdose. The highest dose studied in clinical trials was 800 mg twice daily. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Sofenib?
Keep Sorafenib Tosylate at room temperature, below 30°C. Leave the desiccant in the bottle, and keep the tablets in their original bottle.
Can I take other medicines with Sofenib?
Some medicines can interact with Sorafenib Tosylate, for example: Paclitaxel, Carboplatin, Carbamazepine, Fluorouracil, Rifampicin, Dexamethasone. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Soracent by Incepta Pharmaceuticals Ltd. has the same ingredient and strength for ৳150.00 per unit, compared with ৳300.00 for Sofenib. Ask your doctor or pharmacist before switching.
Do I need a prescription for Sofenib?
Sofenib is a prescription (Rx) medicine. Take it as your doctor advises.