Votrient-400mg

Brand name: Votrient Active substance: Pazopanib hydrochloride Strength: 400Mg Mfg: GSK Pack: 30 tablets in a container Classified as: Anti-neoplastic agent read more

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Drug profile of Votrient

Votrient tablets are containing a functioning constituent like Pazopanib Hydrochloride; introduce as hydrochloride salt of Pazopanib which is a little moiety ousts restraining movement against tyrosine kinase with hostile to malignancy impact.

Votrient is FDA endorsed item which is intense and different focused on receptors like endothelial development factor receptor tyrosine kinase inhibitor causes bar of development of tumor cells and prompts angiogenesis restraint.

Brand name: Votrient

Active substance: Pazopanib hydrochloride

Strength: 400Mg

Mfg: GSK

Pack: 30 tablets in a container

Classified as: Anti-neoplastic agent

Prescribing information of Votrient

Votrient tablets are majorly indicated in the conditions such as;

  • Metastatic renal cell carcinoma
  • Advanced soft tissue sarcoma

The major drawback of Votrient tablets therapy includes as;

The potency of Votrient tablets are not evaluated for the therapy of adipocytic soft tissue sarcoma & gastrointestinal stromal tumors patients.

Mechanism of Votrient

Pazopanib hydrochloride, a second generation drug which is considered as multitargeted tyrosine kinase prohibitor which is dynamic against vascular endothelial development factor receptor I, II, and III, platelet determined development factor alpha and beta and cKit.

Pazopanib is additionally targets angiogenesis pathway; which is basic for tumor vein development and this arrangement is in charge of tumor continuance and development.

Pazopanib pharmacologically characterized as;

Tyrosine kinase prohibitor

Anti-angiogenesis

Absorption

Votrient tablets after administration, reaches maximum plasma concentration time between 2 to 4 hours.

While compared the administration of whole tablets, with crushed powder of tablet causes increased bioavailability and absorption of Pazopanib frequently.

The effect of food with Pazopanib causes elevation in systemic exposure of Pazopanib; votrient tablets should be administered at least 1 hour earlier or 2 hours after the food intake.

Distribution

The human plasma protein binding capacity of Pazopanib is very high nearly it reaches as 99%.

Metabolism

The metabolism of Pazopanib is undergoes with the help of CYP3A4 with lesser contribution of CYP1A2 & CYP2C8.

Excretion

The terminal half life period of Pazopanib is 30.9 hours.

The primary elimination of Pazopanib is occurs via feces; lesser in urine.

When to take the Votrient

The administration of Votrient tablets should be recommended as without food.

It should be taken as 1 hour earlier or 2 hours after food intake.

Dosage regimens of Votrient

The daily recommended dose of Votrient tablets are 800mg should be taken orally as a single dose.

The dose of Votrient should not be exceeded to 800mg

Votrient 400mg tablet contains 400mg of Pazopanib hydrochloride.

Dose alteration:

In renal cell cancer; the starting dose is 400mg and followed by decreasing or increasing the dose of 200mg depends upon the tolerability of the patients.

In soft tissue sarcoma, the dose should be reduced or elevates as 200mg on the basis of patients tolerability.

In liver impairment:

There is no dosage adjustment should be recommended for mild condition.

In moderated impaired patients, other than Votrient tablet should be considered; the dose of votrient should be decreased to 200mg daily.

Votrient treatment should be discontinued in case of severe hepatic impairment condition.

Concurrent use of CYP3A4 inhibitors:

This combinational therapy causes elevation of Pazopanib concentration and leads to adverse.

 To avoid this problem, this concomitant use should not be allowed.

If this combination of Pazopanib with CYP3A4 inhibitors is necessary for the patients, the dose of Pazopanib should be reduced to 400mg and monitor the adverse effects frequently.

Concurrent use of CYP3A4 inducers:

This usage may reduce the concentration of Pazopanib, to overcome the problem avoid this concomitant use.

In case of patient is necessary for using strong CYP3A4 inducers, stop the Votrient therapy

Votrient caused side effects

The major adverse effects;

Liver toxicity

Prolongation of QT intervals

Cardiac dysfunction

Hemorrhage

Venous & arterial thromboembolic

GI perforations

Interstitial lung disease

Reversible posterior leukoencephalopathy syndrome

Increased blood pressure

Infections

Increased toxicities

Thrombotic microangiopathy

The common side effects;

In renal cell:

Diarrhea

Hypertension

Hair color altered

Nausea

Anorexia

Vomiting

Fatigue

Asthenia

Abdominal pain

Headache

Lab abnormalities:

Leucopenia

Neutropenia

Thrombocytopenia

Lymphocytopenia

Elevation of AST & ALT

Hyperglycemia

Elevation of bilirubin

Depletion of phosphorus

Depletion of sodium, magnesium

In soft tissue sarcoma;

Similar to renal cell cancer but some alteration may occur;

Loss of appetite

Tumor pain

Dysgeusia

Musculoskeletal pain

Myalgia

GI pain

Exfoliative rash

Peripheral edema

Dizziness

Skin hypo pigmentation

Stomatitis

Chest pain

Lab abnormalities:

Leucopenia

Neutropenia

Thrombocytopenia

Lymphocytopenia

Elevation of AST & ALT

Hyperglycemia

Depletion of albumin

Elevation of alkaline phosphatase

Depletion of sodium

Elevation of total bilirubin, potassium

Lipase level increase

Pneumothorax

Bradycardia

Retinal detachment

Pancreatitis

Polycythemia

Drug- drug interaction

Concurrent use of votrient tablet with the drugs metabolized by CYP3A4, CYP2D6 or CYP2C8 should not be allowed, this combination may causes prohibition of metabolism of these products and leads to severe effect.

Concurrent uses of Votrient tablets with simvastatin leads to elevate the levels of ALT, to avoid this problem discontinue the therapy.

Votrient absorption should be affected by gastric regulators; co administration of this combination should be avoided. It should be administered with dosing intervals for avoid the problem like depletion of exposure of Pazopanib.

Votrient tablet combined with CYP3A4 inhibitors causes elevating the concentration of Pazopanib. In this condition the dose of votrient should be reduced to 400mg, in case of increased adverse effects, discontinue the therapy.

Votrient tablets are co administered with CYP3A4 inducers causes depletion of concentration of Pazopanib. Avoid this combination. In such exceptional conditions patient must require strong CYP3A4 inducers means, stop the Votrient tablet.

Pazopanib is a P-gp & BCRP substrates, if Votrient tablets are combined with P-gp or BCRP inhibitors may leads to increase the exposure of Pazopanib and causes severe adverse effects. Avoid this combination therapy.

Food drug interaction

Patients should not be consuming grape fruit or juice during the therapy.

This may elevates the Pazopanib levels in blood leads to increase the cardiac disorders.

While taking Votrient with food elevates its absorption and levels in the blood.

Possible contraindications

No suspected contraindications occur

Hypersensitivity reactions may occur due to patients may contraindicate to the component of Votrient tablet.

Contraindicated to pregnancy and lactation

Safety measures

  1. Hepatic toxicity:

Examine by taking hepatic function test periodically

Stop the therapy

Avoid concomitant use of simvastatin

Avoid the combination with the drugs may causes hepatic function abnormalities

  1. QT extension:

Monitor ECG of patient regularly

Provide with alternative medicines

Stop the therapy in severe condition

  1. Cardiac dysfunction:

Interrupt or discontinue the therapy, while cardiac dysfunctions like ischemic condition, myocardial infarction etc.

  1. Hemorrhagic:

Stop the treatment

Arterial thromboembolic events

GI perforation

Interstitial lung disease

Reversible posterior leukoencephalopathy syndrome

Hypertension

Wound healing

Hypothyroidism

Proteinuria

Infection

Increased toxicity

Embryo fetal toxicity

For all these above mentioned conditions, discontinue the treatment.

Pregnancy and lactation

Pregnancy category: D

Votrient should not be suggested to pregnancy and lactating women

Votrient may cause fetal damage

Storage and handling

Votrient tablet container should be stored at 20oC & 25oC.

Protect the container from moisture, heat & light.

Missed dose

Do not administered the missed dose of votrient tablet; if it is less than 12 hours for the next dose

Over dosage

Votrient over dosage should not have any antidote, if it may occurs patients should be provided with supportive measures and monitor the signs and symptoms.

Hemodialysis should not be suggested, because Pazopanib is largely bounds to human plasma protein and it founds difficult to remove by hemodialysis.

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