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Vandetanib (Caprelsa)

Trade Name : CAPRELSA

AstraZeneca Pharmaceuticals LP

TABLET

Strength 100 mg/1

VANDETANIB Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Vandetanib (Caprelsa) which is also known as CAPRELSA and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 100 mg/1 per ml. Read more

Vandetanib (Caprelsa) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions 3/2016
  • WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH
  • See full prescribing information for complete boxed warning.
  • CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration. Monitor electrolytes periodically. Avoid drugs known to prolong the QT interval. Only prescribers and pharmacies certified with the restricted distribution program are able to prescribe and dispense CAPRELSA (, ).
  • CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
  • Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.
  • CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. n
  • Use of CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. n
  • The recommended dose of CAPRELSA is 300 mg taken orally once daily until disease progression or unacceptable toxicity occurs.
  • CAPRELSA may be taken with or without food.
  • Do not take a missed dose within 12 hours of the next dose.
  • Do not crush CAPRELSA tablets. The tablets can be dispersed in 2 ounces of water by stirring for approximately 10 minutes (will not completely dissolve). Do not use other liquids for dispersion. Swallow immediately after dispersion. Mix any remaining residue with 4 additional ounces of water and swallow.
  • The dispersion can also be administered through nasogastric or gastrostomy tubes.
  • For adverse reactions
  • The 300 mg daily dose can be reduced to 200 mg (two 100 mg tablets) and then to 100 mg for Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or greater toxicities.
  • Interrupt CAPRELSA for the following:
  • For recurrent toxicities, reduce the dose of CAPRELSA to 100 mg after resolution or improvement to CTCAE Grade 1 severity, if continued treatment is warranted.
  • Because of the 19-day half-life, adverse reactions including a prolonged QT interval may not resolve quickly. Monitor appropriately [n n n n n n n n ].
  • For patients with renal impairment
  • Reduce the starting dose to 200 mg in patients with moderate (creatinine clearance u226530 to <50 mL/min) and severe (creatinine clearance <30 mL/min) renal impairment [n n n ].
  • For patients with hepatic impairment
  • CAPRELSA is not recommended for use in patients with moderate and severe hepatic impairment [n ].
  • CAPRELSA 100-mg tablets are white, round, biconvex, film-coated, and intagliated with u2018Z 100u2019 on one side and plain on the reverse side.
  • CAPRELSA 300-mg tablets are white, oval, biconvex, film-coated, and intagliated with u2018Z 300u2019 on one side and plain on the reverse side.
  • 100 mg and 300 mg tablets n
  • Do not use in patients with congenital long QT syndrome [].
  • u00a0
  • (4)
  • No data
  • 2.1n- 5.1
  • 2.1n- 5.2
  • 2.1n- 5.3
  • 2.1n- 5.4n- 5.5n- 5.6n- 5.7n- 5.8n- 5.9n- 5.10
  • 5.14n- 8.1
  • The following serious adverse reactions are discussed elsewhere in the label:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • Patients with unresectable locally advanced or metastatic medullary thyroid cancer were treated with CAPRELSA 300 mg (n=231) or Placebo (n=99). The population exposed to CAPRELSA was 58% male, 94% white, and had a median age of 50 years. The data described below reflect a median exposure to CAPRELSA for 607 days.
  • The most commonly reported adverse drug reactions which occurred in >20% of CAPRELSA-treated patients and with a between-arm difference of u22655% included, in order of decreasing frequency: diarrhea/colitis, rash, acneiform dermatitis, hypertension, nausea, headache, upper respiratory tract infection, decreased appetite, and abdominal pain.
  • Among CAPRELSA-treated patients, dose interruption occurred in 109 (47%) and dose reduction occurred in 83 (36%). Adverse reactions led to study treatment discontinuation in 28 of 231 patients (12%) receiving CAPRELSA and in 3 of 99 patients (3.0%) receiving placebo. Adverse reactions leading to permanent discontinuation in 2 or more (u22650.9%) patients treated with CAPRELSA were: asthenia (1.7%), rash (1.7%), diarrhea (0.9%), fatigue (0.9%), pyrexia (0.9%), elevated creatinine (0.9%), QT prolongation (0.9%), and hypertension (0.9%).
  • Clinically important uncommon adverse drug reactions in patients who received CAPRELSA versus patients who received placebo included pancreatitis (0.4% vs. 0%) and heart failure (0.9% vs. 0%).
  • Blurred vision was more common in patients who received CAPRELSA versus patients who received placebo for medullary thyroid cancer (9% vs. 1%, respectively). Scheduled slit lamp examinations revealed corneal opacities (vortex keratopathies) in treated patients, which can lead to halos and decreased visual acuity. Perform ophthalmologic examination, including slit lamp examination, in patients who report visual changes.
  • Class effects
  • CAPRELSA is an inhibitor of vascular endothelial growth factor receptor (VEGFR) signaling. Inhibition of VEGFR signaling can result in intestinal perforation. Intestinal perforation occurred in 0.4% of CAPRELSA treated patients versus 0% of placebo treated patients.
  • The incidence of Grade 1-2 bleeding events was 14% in patients receiving CAPRELSA compared with 7% on placebo in the randomized portion of the medullary thyroid cancer (MTC) study.
  • No patient with a Grade 3-4 ALT elevation had a concomitant increase in bilirubin in the MTC study.
  • The most common adverse drug reactions (>20%) seen with CAPRELSA and with a between-arm difference of u22655 % have been diarrhea/colitis, rash, acneiform dermatitis, hypertension, nausea, headache, upper respiratory tract infections, decreased appetite and abdominal pain.
  • To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1u2013800u2013236u20139933 or FDA at 1-800-FDA-1088 or n
  • No data
  • No data
  • In the event of an overdose, monitor patients closely for QTc prolongation. Because of the 19-day half-life, adverse reactions may not resolve quickly.
  • Vandetanib has the chemical name N-(4-bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl) methoxy]quinazolin-4-amine.
  • The structural and molecular formulas are:
  • CHBrFNOn
  • Vandetanib has a molecular weight of 475.36. Vandetanib exhibits pH-dependent solubility, with increased solubility at lower pH. Vandetanib is practically insoluble in water with a value of 0.008 mg/mL at 25u00b0C (77u00b0F).
  • CAPRELSA tablets for daily oral administration are available in two dosage strengths containing either 100 mg or 300 mg of vandetanib. The tablet cores contain the following inactive ingredients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet film-coat contains the following inactive ingredients: hypromellose 2910, macrogol 300, and titanium dioxide E171.
  • No data
  • No data
  • A double-blind, placebo-controlled study randomized patients with unresectable locally advanced or metastatic medullary thyroid cancer to CAPRELSA 300 mg (n=231) versus placebo (n=100).
  • The primary objective was demonstration of improvement in progression-free survival (PFS) with CAPRELSA compared to placebo. Other endpoints included evaluation of overall survival and overall objective response rate (ORR). Centralized, independent blinded review of the imaging data was used in the assessment of PFS and ORR. Upon objective disease progression based on the investigatoru2019s assessment, patients were discontinued from blinded study treatment and given the option to receive open-label CAPRELSA. Nineteen percent (44/231) of the patients initially randomized to CAPRELSA opted to receive open-label CAPRELSA after disease progression, and 58% (58/100) of the patients initially randomized to placebo opted to receive open-label CAPRELSA after disease progression.
  • The result of the PFS analysis, based on the central review RECIST assessment, showed a statistically significant improvement in PFS for patients randomized to CAPRELSA (Hazard Ratio (HR) = 0.35; 95% Confidence Interval (CI) = 0.24-0.53; p<0.0001). Analyses in the subgroups of patients who were symptomatic or had progressed within 6 months prior to their enrollment showed similar PFS results (HR = 0.31 95% CI: 0.19, 0.53 for symptomatic patients; HR = 0.41 95% CI: 0.25, 0.66 for patients who had progressed within 6 months prior to enrollment).
  • At the time of the primary analysis of PFS, 15% of the patients had died and there was no significant difference in overall survival between the two treatment groups. The overall objective response rate (ORR) for patients randomized to CAPRELSA was 44% compared to 1% for patients randomized to placebo. All objective responses were partial responses.
  • u201cOSHA Hazardous Drugsu201d (OSHA Technical Manual). OSHA.
  • 100 mg Tablets
  • 300 mg Tablets
  • CAPRELSA tablets should be stored at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C u2013 30u00b0C (59u00b0F u2013 86u00b0F) [See USP controlled room temperature].
  • Procedures for proper handling and disposal of anticancer drugs should be considered. A guideline on this subject has been published. Do not crush CAPRELSA tablets.
  • SEE FDA-APPROVED PATIENT LABELING (MEDICATION GUIDE)
  • CAPRELSAu00ae (kap-rel-sah)
  • (vandetanib)
  • Tablets
  • Read this Medication Guide before you start taking CAPRELSA and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
  • What is the most important information I should know about CAPRELSA?
  • CAPRELSA can cause a change in the electrical activity of your heart called QT prolongation,
  • Your healthcare provider should perform tests to check the levels of your blood potassium, calcium, magnesium, and thyroid-stimulating hormone (TSH) as well as the electrical activity of your heart with a test called an electrocardiogram (ECG). You should have these tests:
  • Your healthcare provider may stop your CAPRELSA treatment for a while and restart you at a lower dose if you have QT prolongation.
  • Call your healthcare provider right away if you feel faint, light-headed, or feel your heart beating irregularly while taking CAPRELSA. These may be symptoms related to QT prolongation.
  • What is CAPRELSA?
  • CAPRELSA is a prescription medicine used to treat medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body. It takes a long time to get rid of CAPRELSA from your body and you may be at risk for side effects related to CAPRELSA after you have stopped your treatment.
  • It is not known if CAPRELSA is safe and effective in children.
  • Who should not take CAPRELSA?
  • Do not take CAPRELSA if you have had QT prolongation.
  • What should I tell my healthcare provider before taking CAPRELSA?
  • Before you take CAPRELSA, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • Especially tell your healthcare provider if you take:
  • Ask your healthcare provider if you are not sure if your medicine is one listed above.
  • Do not take other medicines while taking CAPRELSA until you have talked with your healthcare provider or pharmacist.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
  • How should I take CAPRELSA?
  • Call your healthcare provider right away if you take too much CAPRELSA.
  • What should I avoid while taking CAPRELSA?
  • What are the possible side effects of CAPRELSA?
  • CAPRELSA may cause serious side effects, including:
  • The most common side effects of CAPRELSA include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of CAPRELSA. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store CAPRELSA?
  • Keep CAPRELSA and all medicines out of the reach of children.
  • General information about CAPRELSA.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CAPRELSA for a condition for which it was not prescribed. Do not give CAPRELSA to other people, even if they have the same symptoms you have. It may harm them.
  • This Medication Guide summarizes important information about CAPRELSA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CAPRELSA that is written for health professionals.
  • For more information, go to www.caprelsa.com or call 1-800-236-9933.
  • What are the ingredients in CAPRELSA?
  • Active ingredient: vandetanib
  • Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Distributed by:
  • AstraZeneca Pharmaceuticals LP
  • Wilmington, DE 19850
  • Issued: 03/2016
  • CAPRELSA is a registered trademark of the AstraZeneca group of companies
  • u00a9AstraZeneca 2013. All Rights Reserved.
  • NDC 0310-7820-30
  • 30 tablets
  • Caprelsau00ae
  • (vandetanib) tablets
  • 100 mg
  • Rx only
  • Dispense the accompanying
  • Medication Guide to each patient.
  • AstraZeneca
  • NDC0310-7840-30
  • 30 tablets
  • Caprelsau00ae
  • (vandetanib) tablets
  • 300 mg
  • Rx only
  • Dispense the accompanying
  • Medication Guide to each patient.
  • AstraZeneca

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