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Sorafenat (Sorafenib)

Brand: Natco
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SORAFENAT 200MG

Description

Sorafenat is belongs to the type of protein kinase inhibitor, Sorafenat is studied as synthetic compound targeting signal react for growth and angiogenesis.

Sorafenat also prohibits the VEGFR-2/PDGFR-beta signaling force, through blockade of tumor angiogenesis.

Sorafenat is a prescription drugs which is used under guidance of medical oncologist.

Sorafenat prescribing information

Sorafenat is indicatedfor the treatment for patients with Metastatic renal cell cancer

Sorafenat is indicated for the treatment for patients with Metastatic Hepatocellular cancer.

Sorafenat is indicated for the treatment for patients with Thyroid cancer.

Sorafenat mechanism

Sorafenib combine with multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT-3, VEGFR-2, VEGFR-3, and PDGFR-ß). Various of these kinases are thought to be including in angiogenesis, hence sorafenib decrease blood flow to the tumor. Sorafenib is specific in targeting the Raf/Mek/Erk pathway. By prohibiting these kinases, genetic transcription containing cell proliferation and angiogenesis is prohibited.

Absorption

The oral bioavailability is 38 to 49%.

The high plasma concentration time of Sorafenat is 3 hours.

Distribution

Sorafenib is largely bound to the human plasma protein at the range of 99.5%

Metabolism

Sorafenib is go through oxidative metabolism, intermediated by CYP3A4, in addition of Glucuronidation mediated by UGT1A9.

Excretion

The excretion of Sorafenat occurs via urine, feces and biliary excretion also undergone.

The unchanged form of Sorafenib is around 51% should be recovered in feces and not in urine, biliary excretion also occurred.

The half-life period of Sorafenat is relatively 25 to 48 hours.

Dosage regimens of Sorafenat tablets

In HCC, RCC or TC condition:

The usual prescribed dosage of Sorafenat is 400mg tablet (200mg×2 tablets) should be taken as two times a day.

Dose variation in HCC & RCC

The dosage should be varied in HCC & RCC, if dose reduction is required. The dosage should be decreased to 400mg as a single dose. If further reduction is required, provide 400mg as a single dose for alternative day.

Dose variation in dermatological toxicities with HCC

Grade 1 toxicity: Extend the Sorafenat therapy and provide with topical therapy for symptomatic relief.

Grade 2 toxicity: Extend the Sorafenat therapy and provide with topical therapy for symptomatic relief. If it occurs continuously, discontinue the Sorafenat therapy.

Grade 3 toxicity: Discontinue the Sorafenat therapy, if it is needed the dose should be reduced by two times a day into single dose.

Dose alteration in thyroid carcinoma

First dose reduction: 600mg of Sorafenat should be recommend

Second dose reduction: 400mg of Sorafenat should be prescribed for two times a day

Third dose reduction: 200mg of Sorafenat should be prescribed as a single dose.

Sorafenat caused side effects

Most common side effects

Hand foot skin reaction

Musculoskeletal disorders

Loss of weight

Increasing amylase & lipase

Diarrhea

Alopecia

Infection

Post marketing adverse effects

Osteonecrosis

Interstitial lung disease

Folliculitis

Leucopenia

Neutropenia

Anemia

Stevens Johnson syndrome

Angioedema

Hypothyroidism

Hypocalcemia

Hypokalemia

Hyponatremia

Depression

Peripheral sensory neuropathy

Rhabdomyolysis

Thrombocytopenia

Tinnitus

Congestive heart failure

Rhinorrhea

Dysphonia

Gastro esophageal reflux

Sorafenat Drug – Drug interaction

While co administration Sorafenat with antibiotic like neomycin causes depletion AUC of Sorafenib.

The solubility of Sorafenat is depends upon pH, if pH increases causes decreasing the solubility.

Sorafenat tablets while concomitant use with Midazolam, dextromethorphan, or Omeprazole causes no elevation of systemic exposure of these drugs.

Co administration of Sorafenat with other anti-neoplastic agents likes;

Paclitaxel or carboplatin: Causes elevation of exposure of Sorafenib

Capecitabine: Increase Capecitabine exposure.

Doxorubicin/Irinotecan: Elevation of AUC of doxorubicin and Irinotecan

Combination With neomycin: Intercede with enterohepatic recycling of Sorafenib, causes depletion of Sorafenib exposure.

Sorafenat tablets are concurrent use with strong CYP3A4 inhibitors like ketoconazole causes no variation in AUC of Sorafenib.

Contraindication of Sorafenat

In patients with squamous cell lung cancer, are contraindicated in combination of Sorafenat with carboplatin & paclitaxel.

Some anaphylactic reactions occur, if patients are contraindicated to the component of Sorafenat tablets.

Precaution

  • Some adverse reactions occur during the treatment with Sorafenat tablets;
  • Stop the therapy of Sorafenat
  • Combination of Sorafenat with warfarin causes elevation of INR level. To avoid this problem, monitor the patients bleeding (prothrombin time) frequently.
  • Sorafenat tablets should be postponed during surgical procedures, to prevent wound complications.
  • Elevation of mortality during combination of Sorafenatwith carboplatin/paclitaxel and gemcitabine/cisplatin in squamous lung cancer:
  • This combination is contraindicated for the patients with squamous cell lung cancer.
  • Sorafenat causes prolongation of QT intervals; avoid this therapy in patients who have cardiac problems.
  • During the therapy with Sorafenat, causes elevation of transaminase leads to liver injury and causes liver failure.
  • Sorafenat tablet causes fetal harm
  • TSH level should be monitored frequently and adjust thyroid replacement.
  • Monitor the blood pressure frequently and provide anti-hypertensive agents for this condition.

Pregnancy and lactation

Pregnancy

The pregnancy category of Sorafenat tablet: D

Sorafenat tablets should not be recommended in pregnancy conditions

Breast feeding should not be recommended

Storage and handling

Sorafenat tablet stored at 25oC (77oF).

Protect the container from moisture, heat and light

Missed dose

If patients missed to take the dose of Sorafenat, must consult with medical practitioner and follow the instruction. or the missed dose should be skipped and follow the regular dosing schedule.

 

  • Trade name Sorafenat
  • Substance Sorafenib 200mg
  • Manufacturer Natco Pharma Limited
  • Packaging 120 tablets
  • Country of origin India
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