Soranib (Sorafenib 200mg)

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Soranib is belongs to the type of protein kinase inhibitor, Soranib is studied as synthetic compound targeting signal react for growth and angiogenesis. Soranib also prohibits the VEGFR-2/PDGFR-beta... Read more
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  • Cipla Ltd.
  • Trade name Soranib
  • Substance Sorafenib 200mg
  • Manufacturer Cipla Limited
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SORANIB 200MG

Desscription

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

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

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

Soranib prescribing information

Soranib is indicated for the treatment for patients with Metastatic renal cell cancer

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

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

Soranib 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 Soranib 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 Soranib 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 Soranib is relatively 25 to 48 hours.

Dosage regimens of Soranib tablets

In HCC, RCC or TC condition:

The usual prescribed dosage of Soranib 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 Soranib therapy and provide with topical therapy for symptomatic relief.

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

Grade 3 toxicity: Discontinue the Soranib 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 Soranib should be recommend

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

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

Soranib 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

Soranib Drug – Drug interaction

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

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

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

Co administration of Soranib 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.

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

Contraindication of Soranib

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

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

Precaution

  • Some adverse reactions occur during the treatment with Soranib tablets;
  • Stop the therapy of Soranib
  • Combination of Soranib with warfarin causes elevation of INR level. To avoid this problem, monitor the patients bleeding (prothrombin time) frequently.
  • Soranib tablets should be postponed during surgical procedures, to prevent wound complications.
  • Elevation of mortality during combination of Soranibwith carboplatin/paclitaxel and gemcitabine/cisplatin in squamous lung cancer:
  • This combination is contraindicated for the patients with squamous cell lung cancer.
  • Soranib causes prolongation of QT intervals; avoid this therapy in patients who have cardiac problems.
  • During the therapy with Soranib, causes elevation of transaminase leads to liver injury and causes liver failure.
  • Soranib 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 Soranib tablet: D

Soranib tablets should not be recommended in pregnancy conditions

Breast feeding should not be recommended

Storage and handling

Soranib tablet stored at 25oC (77oF).

Protect the container from moisture, heat and light

Missed dose

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

  • Trade name Soranib
  • Substance Sorafenib 200mg
  • Manufacturer Cipla Limited
  • Packaging 120 tablets
  • Country of origin India
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