Pazoren 200

Pazopanib Hydrochloride is a protein kinase inhibitor used in the treatment of kidney cancer and soft tissue sarcoma. Pazopanib Hydrochloride should be taken on an empty stomach, but try to have it at the same time every day to get the most benefits. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to. Diarrhea and high blood pressure are the most common side effects of this medicine. Doctor may advise for regular monitoring of your blood pressure while on treatment. Drink plenty of fluids to overcome diarrhea or consult with your doctor if it bothers you. This medicine may reduce the number of blood cells in your blood, thereby, increasing the susceptibility to infections. Hence, inform your doctor if you experience fever, flu-like symptoms and shortness of breath. Before taking it, tell your doctor if you have heart disease, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. The use of effective contraception by both males and females during treatment is important to avoid pregnancy. Pazopanib Hydrochloride is an anti-cancer medication. It works by binding and inhibiting the enzyme receptors (tyrosine kinase) that are responsible for the proliferation of the cancerous cells. It also restricts the growth of new blood vessels within the tumor. This is how it works against cancer.

• Kidney cancer • Soft tissue sarcoma

Multikinase inhibitor (including VEGF & PDGF receptor tyrosine kinases) some of which are implicated in tumor growth, angiogenesis, & metastasis

Adult Dose: Advanced Renal Cell Carcinoma 800 mg PO qDay on empty stomach Soft Tissue Sarcomas 800 mg PO qDay on empty stomach Hepatic Impairment Billirubin ULN: No dosage adjustment required Billirubin >1.5-3 x ULN: Decreased dose to 200 mg PO qDay Billirubin >3 x ULN: Not recommended Child Dose: Safety and efficacy not established; not indicated for use in pediatric patients Renal Dose: Renal impairment: No dosage adjustment required

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Pazopanib Hydrochloride is to be taken empty stomach.

Common: • Headache • Nausea • Vomiting • Musculoskeletal (bone, muscle or joint) pain • Fatigue • Change in color of hair • Diarrhea • High blood pressure • Decreased appetite • Weight loss • Taste change • Abnormal skin pigmentation • Hair discoloration • Tumor pain • Breathlessness

[UNSAFE] Pazopanib Hydrochloride may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur. Pazopanib Hydrochloride is used for the treatment of thyroid cancer. Take it with or without food, preferably at the same time each day. Diarrhea may occur as a side effect. Drink plenty of fluids and inform your doctor if it doesn't stop or if you find blood in your stools. Use a reliable contraceptive method to prevent pregnancy while you are taking this medicine and for a month after you stop taking it. Do not take it with medication lowering the stomach acid (such as antacids, H2 blockers including ranitidine), as it may affect the working of medicine. It may affect wound healing time. Be careful while shaving, cutting fingernails or toenails, or using sharp objects. Monitor your blood pressure regularly while taking this medication. Inform your doctor if you notice symptoms of very high blood pressure such as severe headache, confusion, problems with your eyesight, nausea or vomiting. Inform your doctor about the consumption of Pazopanib Hydrochloride before going for surgical procedure. It may cause serious bleeding problem. Inform your doctor if you get headaches, stomach pain or if you notice blood in your urine or stools. Do not take this medicine if you are pregnant, planning to conceive or breastfeeding.

Hypersensitivity.

Co-administration w/ CYP3A4 (eg, itraconazole, clarithromycin, atazanavir, idinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice), P-gp & BCRP inhibitors, high-/low-fat food increases exposure & conc of pazopanib. Co-administration w/ CYP3A4 (eg, rifampicin) inducers may decrease plasma pazopanib conc. P-gp & BCRP inducers may alter exposure & distribution of pazopanib. Pazopanib may alter exposure &/or distribution of CYP3A4 substrates (eg, midazolam), CYP2C8 substrates (eg, paclitaxel) & UGT1A1 substrates (eg, irinotecan & its active metabolite SN-38). Pazopanib may increase the ratio of dextrometrophan to dextrophan conc after administration of dextrometrophan. Proton-pump inhibitors (eg, esomeprazole) & other agents that increase gastric pH may decrease bioavailability of pazopanib. Concomitant use w/ simvastatin & other statins may lead to ALT elevations.

[CONSULT YOUR DOCTOR] It is not known whether it is safe to consume alcohol with Pazopanib Hydrochloride. Please consult your doctor.

[CONSULT YOUR DOCTOR] Pazopanib Hydrochloride is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.

[UNSAFE] Pazopanib Hydrochloride is unsafe to use during breastfeeding. Data suggests that the drug may cause toxicity to the baby.

[SAFE IF PRESCRIBED] Pazopanib Hydrochloride is safe to use in patients with kidney disease. No dose adjustment of Pazopanib Hydrochloride is recommended. [CAUTION] Pazopanib Hydrochloride should be used with caution in patients with liver disease. Dose adjustment of Pazopanib Hydrochloride may be needed. Please consult your doctor. Use of Pazopanib Hydrochloride is not advised in patients with moderate to severe liver disease.

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