Sorafenat

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BRAND :  SORAFENAT PRICE :  225$ STRENGTH : 200MG ACTIVE :  SORAFENAT-SORAFENIB-200MG COMPANY NAME :  NATCO TABLETS :  120 TABLETS read more

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Drug profile;

Sorafenat is classified as multi kinase inhibitors, it is not suggested as curable medicine but Sorafenat is used to decelerate the growth rate of tumor cells by barricade the actions of an aberrant protein signal transduction helps to grow the cancer cells.

Sorafenat is treated by diminishing the blood supply to the tumor cells and block their division and production.

Sorafenat has an anti-neoplastic activity against;

ü  Renal cell carcinoma in advanced stage

ü  Hepatocellular carcinoma

ü  Thyroid carcinoma

 

Trade name: Sorafenat

Active component: Sorafenib

Mfg: Natco pharma

Pack: 120 tablets in a container

Strength: 200MG

Category: protein tyrosine inhibitor or Anti-cancer drug

 

Sorafenat prescribing information;

The prescribing information of Sorafenat is depends upon the component of the product called Sorafenib; used

In the treatment of metastatic renal cell cancer

In the treatment of Hepatocellular cancer

In the treatment of advance or long lasting characterized thyroid cancer awkward to radioactive iodine.

 

Sorafenat mechanism;

The activity of Sorafenat containing Sorafenib is developing in-vitro.

Sorafenat expels its activity by prohibiting assorted intracellular & cell surface kinase which is important for tumor cell signaling exudation, angiogenesis and apoptosis.

Due to prohibition of these multikinases is a source of cancer growth termination.

Reduction of cancer cell angiogenesis happens in HCC, RCC and elevation of cancer cell apoptosis occurs in HCC, RCC & TC

 

Absorption

The oral bioavailability of Sorafenat is occurs as 38 to 49%.

The peak plasma concentration time of Sorafenat is 3 hours.

Sorafenat tablets is administered with high fat meals, the absorption of Sorafenib is reduces to 30% when correlated to fasted state.

The steady state plasma concentration of Sorafenib occurs within 7 days.

 

Distribution

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

 

Metabolism

Sorafenat is undergoes oxidative metabolism, intermediated by CYP3A4, in addition of Glucuronidation mediated by UGT1A9.

Sorafenib consolidate compound disassociated in GI tract by bacterial glucuronidase activity granted reabsorption of the unconjugated active substance.

 

Excretion

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

Overall 96% of dose should be replaced within 14 days, in which 77% excreted in feces; 19% in urine.

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.

 

When to take the Sorafenat tablets;

Sorafenat tablets should be taken without food.

Sorafenat tablets should be taken at least 1 hour earlier or 2 hours after a meal

 

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.

 

Dosage alteration in severe conditions;

Sorafenat tablets used therapy should be postponed for short period of time in major surgical procedures.

Sorafenat tablets should be postponed or permanently discontinued for following conditions like;

Hemorrhage

Cardiac ischemia

Severe hypertension

Gastrointestinal perforation

QTc prolongation

Liver injury

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.

In concurrent use of CYP3A4 inducers;

Sorafenat tablets should be co administered with CYP3A4 inducers like anti-convulsants; st. Johns wort etc causes decreasing the systemic exposure of Sorafenib.

The efficiency of Sorafenib has not been established in pediatric patients.

The Dosage should not be adjusted in elderly patients.

In renal and hepatic impairment patients, no dosage adjustment should be recommended.

 

Sorafenat caused side effects;

A Sorafenat tablet causes some adverse effects;

Hypertension

Myocardial infarction or ischemia

Gastrointestinal perforation

Drug caused hepatitis

Hemorrhage

Most common side effects;

Diarrhea

Alopecia

Infection

Hand foot skin reaction

Musculoskeletal disorders

Loss of weight

Increasing amylase & lipase

Post marketing adverse effects;

Stevens Johnson syndrome

Angioedema

Rhabdomyolysis

Osteonecrosis

Interstitial lung disease

Folliculitis

Leucopenia

Neutropenia

Anemia

Thrombocytopenia

Hypothyroidism

Hypocalcaemia

Hypokalemia

Hyponatremia

Depression

Peripheral sensory neuropathy

Tinnitus

Congestive heart failure

Rhinorrhoea

Dysphonia

Gastro esophageal reflux

 

Sorafenat Drug – Drug interaction;

Other drugs;

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

 

Antibiotics;

While combining 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.

 

Anti-cancer drugs

Combination 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

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

CYP3A4 inducers;

Sorafenat tablets combined with strong CYP3A4 inducers like rifampin causes decrease in AUC of Sorafenib. Avoid concurrent use of Sorafenat with strong CYP3A4 inducers like anti-convulsants, anti-mycobacterials & herbal product like st. Johns wort.

This results as to cause loss of exposure to Sorafenib and leads to reduce the therapeutic effect of Sorafenat tablets.

CYP3A4 inhibitors;

 Sorafenat tablets are combined with strong CYP3A4 inhibitors like ketaconazole causes no variation in AUC of Sorafenib.

 

Sorafenat Food – Drug interaction;

Sorafenib absorption is reduced by food; it should be taken without food.

 

Possible 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.

 

Safety measures;

Some adverse reactions occur during the treatment with Sorafenat tablets;

Exposure of GI perforation:

Stop the therapy of Sorafenat tablets.

Warfarin:

Combination of Sorafenat with warfarin causes elevation of INR level. To avoid this problem monitor the patients bleeding (prothrombin time) frequently.

Wound healing complications:

Sorafenat tablets should be postponed during surgical procedures, to prevent wound complications.

Elevation of mortality during combination of Sorafenat with carboplatin/paclitaxel and gemcitabine/cisplatin in squamous lung cancer:

This combination is contraindicated for the patients with squamous cell lung cancer.

Exposure of QT extension:

Sorafenat causes prolongation of QT intervals; avoid this therapy in patients who have cardiac problems.

Therapy induced hepatitis:

During the therapy with Sorafenat, causes elevation of transaminase leads to liver injury and causes liver failure.

Embryo fetal harm:

Sorafenat tablet causes fetal harm

Thyroid stimulating hormone impairment in thyroid carcinoma:

TSH level should be monitored frequently and adjust thyroid replacement.

Exposure of cardiac ischemia or infarction:

To avoid this condition, postpone or discontinue the therapy

Exposure of hemorrhage:

Permanent discontinuation of Sorafenat therapy

Exposure of hypertension:

Monitor the blood pressure frequently and provide anti-hypertensive agents for this condition.

Exposure of dermatological toxicity:

Dosage modification is suggested and provide topical agent for symptomatic relief. In severe condition discontinue the therapy with Sorafenat.

 

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 container should be stored at 25oC (77oF).

Protect the container from moisture, heat and light

 

Missed dose;

Sorafenat tablet is a chemo drug, used only by the patients having a valid prescription

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

 

Over dosage;

The maximum dosage of Sorafenat is 800mg twice daily, the major adverse reaction occurs in this dosage condition is diarrhea, dermatological reactions.

Over dosage is rare in Sorafenat therapy, if it may occurs monitor the acute toxicity related to over dosage of Sorafenat. Supportive measures should be provided to the patients.

In suspected cases, Sorafenat tablet should be withheld and symptomatic relief should be given.

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