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Everolimus (Afinitor)

Trade Name : Afinitor

Novartis Pharmaceuticals Corporation

TABLET

Strength 5 mg/1

EVEROLIMUS Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE]

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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 Everolimus (Afinitor) which is also known as Afinitor and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 5 mg/1 per ml. Read more

Everolimus (Afinitor) 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

Packaging and Delivery

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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.

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About GNH

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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  • AFINITOR is a kinase inhibitor indicated for the treatment of:
  • AFINITOR and AFINITOR DISPERZ are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. ()
  • AFINITOR DISPERZ is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. ()
  • Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ()n
  • Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic.n AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors. ()n
  • Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. ()n
  • Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ()n
  • Do not combine AFINITOR and AFINITOR DISPERZ to achieve the total daily dose. ()
  • Modify the dose for patients with hepatic impairment or for patients taking drugs that inhibit or induce P-glycoprotein (P-gp) and CYP3A4. ()
  • Breast Cancer:
  • NET:
  • RCC:
  • TSC-Associated Renal Angiomyolipoma:
  • TSC-Associated SEGA:
  • TSC-Associated Partial-Onset Seizures:
  • AFINITOR
  • Tablets, white to slightly yellow and elongated with a bevelled edge:
  • AFINITOR DISPERZ
  • Tablets for oral suspension, white to slightly yellowish, round, and flat with a bevelled edge:
  • AFINITOR: 2.5 mg, 5 mg, 7.5 mg, and 10 mg tablets ()
  • AFINITOR DISPERZ: 2 mg, 3 mg, and 5 mg tablets ()
  • AFINITOR/AFINITOR DISPERZ is contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives .
  • Clinically significant hypersensitivity to everolimus or to other rapamycin derivatives. ()
  • No data
  • Non-Infectious Pneumonitis: Monitor for clinical symptoms or radiological changes. Withhold or permanently discontinue based on severity. (, )n
  • Infections: Monitor for signs and symptoms of infection. Withhold or permanently discontinue based on severity. (, )n
  • Severe Hypersensitivity Reactions: Permanently discontinue for clinically significant hypersensitivity. ()n
  • Angioedema: Patients taking concomitant angiotensin-converting-enzyme (ACE) inhibitors may be at increased risk for angioedema. Permanently discontinue for angioedema. (, )n
  • Stomatitis: Initiate dexamethasone alcohol-free mouthwash when starting treatment. (, )n
  • Renal Failure: Monitor renal function prior to treatment and periodically thereafter. ()n
  • Risk of Impaired Wound Healing: Withhold for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of treatment after resolution of wound healing complications has not been established. ()n
  • Geriatric Patients: Monitor and adjust dose for adverse reactions. ()n
  • Metabolic Disorders: Monitor serum glucose and lipids prior to treatment and periodically thereafter. Withhold or permanently discontinue based on severity. (, )n
  • Myelosuppression: Monitor hematologic parameters prior to treatment and periodically thereafter. Withhold or permanently discontinue based on severity. (, )n
  • Risk of Infection or Reduced Immune Response with Vaccination: Avoid live vaccines and close contact with those who have received live vaccines. Complete recommended childhood vaccinations prior to starting treatment. ()n
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. (, , )nttttttttt
  • The following serious adverse reactions are described elsewhere in the labeling:
  • www.fda.gov/medwatch
  • Breast cancer, NET, RCC: Most common adverse reactions (incidence u2265 30%) include stomatitis, infections, rash, fatigue, diarrhea, edema, abdominal pain, nausea, fever, asthenia, cough, headache, and decreased appetite. ()
  • TSC-Associated Renal Angiomyolipoma: Most common adverse reaction (incidence u2265 30%) is stomatitis. ()
  • TSC-Associated SEGA: Most common adverse reactions (incidence u2265 30%) are stomatitis and respiratory tract infection. ()
  • TSC-Associated Partial-Onset Seizures: Most common adverse reaction (incidence u2265 30%) is stomatitis. ()
  • No data
  • P-gp and strong CYP3A4 inhibitors: Avoid concomitant use. (, )n
  • P-gp and moderate CYP3A4 inhibitors: Reduce the dose as recommended. (, )n
  • P-gp and strong CYP3A4 inducers: Increase the dose as recommended. (, )nttttttttt
  • No data
  • For breast cancer, NET, RCC, or TSC-associated renal angiomyolipoma patients with hepatic impairment, reduce the dose. (, )n
  • For patients with TSC-associated SEGA or TSC-associated partial-onset seizures and severe hepatic impairment, reduce the starting dose and adjust dose to attain target trough concentrations. (, , )
  • AFINITOR (everolimus) and AFINITOR DISPERZ (everolimus tablets for oral suspension) are kinase inhibitors.
  • The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is:
  • AFINITOR for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.
  • AFINITOR DISPERZ for oral administration contains 2 mg, 3 mg, or 5 mg of everolimus and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, and microcrystalline cellulose.
  • No data
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  • AFINITOR
  • 2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with u201cLCLu201d on one side and u201cNVRu201d on the other; available in:
  • Blisters of 28 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0594-51
  • Each carton contains 4 blister cards of 7 tablets each
  • 5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with u201c5u201d on one side and u201cNVRu201d on the other; available in:
  • Blisters of 28 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0566-51
  • Each carton contains 4 blister cards of 7 tablets each
  • 7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with u201c7P5u201d on one side and u201cNVRu201d on the other; available in:
  • Blisters of 28 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0620-51
  • Each carton contains 4 blister cards of 7 tablets each
  • 10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with u201cUHEu201d on one side and u201cNVRu201d on the other; available in:
  • Blisters of 28 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0567-51
  • Each carton contains 4 blister cards of 7 tablets each
  • AFINITOR DISPERZ
  • 2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with u201cD2u201d on one side and u201cNVRu201d on the other; available in:
  • Blisters of 28 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0626-51
  • Each carton contains 4 blister cards of 7 tablets each
  • 3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with u201cD3u201d on one side and u201cNVRu201d on the other; available in:
  • Blisters of 28 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0627-51
  • Each carton contains 4 blister cards of 7 tablets each
  • 5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with u201cD5u201d on one side and u201cNVRu201d on the other; available in:
  • Blisters of 28 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0628-51
  • Each carton contains 4 blister cards of 7 tablets each
  • Store at 20u00b0C-25u00b0C (68u00b0F-77u00b0F); excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F). See USP Controlled Room Temperature.
  • Store in the original container, protect from light and moisture.ntttttt
  • Follow special handling and disposal procedures for anticancer pharmaceuticals.n
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Non-infectious Pneumonitis
  • Advise patients of the risk of developing non-infectious pneumonitis and to immediately report any new or worsening respiratory symptoms to their healthcare provider .
  • Infections
  • Advise patients that they are more susceptible to infections and that they should immediately report any signs or symptoms of infections to their healthcare provider .
  • Hypersensitivity Reactions
  • Advise patients of the risk of clinically significant hypersensitivity reactions and to promptly contact their healthcare provider or seek emergency care for signs of hypersensitivity reaction including rash, itching, hives, difficulty breathing or swallowing, flushing, chest pain, or dizziness .
  • Angioedema with Concomitant Use of ACE Inhibitors
  • Advise patients to avoid ACE inhibitors and to promptly contact their healthcare provider or seek emergency care for signs or symptoms of angioedema .
  • Stomatitis
  • Advise patients of the risk of stomatitis and to use alcohol-free mouthwashes during treatment .
  • Renal Impairment
  • Advise patients of the risk of developing kidney failure and the need to monitor their kidney function periodically during treatment .
  • Risk of Impaired Wound Healing
  • Advise patients that AFINITOR/AFINITOR DISPERZ may impair wound healing. Advise patients to inform their healthcare provider of any planned surgical procedure .
  • Geriatric Patients
  • Inform patients that in a study conducted in patients with breast cancer, the incidence of deaths and adverse reactions leading to permanent discontinuation was higher in patients u2265 65 years compared to patients < 65 years .
  • Metabolic Disorders
  • Advise patients of the risk of metabolic disorders and the need to monitor glucose and lipids periodically during therapy .
  • Myelosuppression
  • Advise patients of the risk of myelosuppression and the need to monitor CBCs periodically during therapy .
  • Risk of Infection or Reduced Immune Response with Vaccination
  • Advise patients to avoid the use of live vaccines and close contact with those who have received live vaccines .
  • Embryo-Fetal Toxicity
  • Advise females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 8 weeks after the last dose. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 weeks after the last dose .
  • Lactation
  • Advise women not to breastfeed during treatment with AFINITOR/AFINITOR DISPERZ and for 2 weeks after the last dose .
  • Infertility
  • Advise males and females of reproductive potential of the potential risk for impaired fertility .
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • T2020-31
  • No data
  • Instructions For Usen- AFINITOR (a-fin-it-or) DISPERZ (dis-perz)n- (everolimus tablets for oral suspension)
  • Read these Instructions for Use for AFINITOR DISPERZ before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
  • Important Information:
  • Supplies needed to prepare the suspension in an oral syringe:
  • Supplies needed to prepare the suspension in a small drinking glass:
  • Preparing a dose of AFINITOR DISPERZ suspension using an oral syringe:
  • Step 1:
  • Step 2:
  • Step 3:
  • Step 4:
  • Step 5:
  • Step 6:
  • Step 7:
  • Step 8:
  • Step 9: n- 3 minutes
  • Step 10: n- Do not shake
  • Step 11:
  • Step 12:
  • Step 13:
  • Step 14:
  • Step 15:
  • Step 16:
  • Step 17:
  • If the total prescribed dose is more than 10 mg, repeat steps 4 through 17 to finish giving the dose.
  • Step 18:
  • Step 19:
  • Preparing a dose of AFINITOR DISPERZ suspension using a small drinking glass:
  • Step 1:
  • Step 2:
  • Step 3:
  • Step 4:
  • Step 5:
  • Step 6:
  • Step 7:
  • Step 8: n- 3 minutes
  • Step 9:
  • Step 10:
  • If your total prescribed dose is more than 10 mg, repeat steps 4 through 10 to finish taking your dose.
  • Step 11:
  • Step 12:
  • Step 13:
  • How should I store AFINITOR DISPERZ?
  • Keep AFINITOR DISPERZ and all medicines out of the reach of children.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • nttttttDistributed by:nttttttNovartis Pharmaceuticals CorporationnttttttEast Hanover, New Jersey 07936
  • T2018-82June 2018
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 2.5 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0594-51
  • Afinitoru00ae (everolimus) Tablets
  • Each tablet contains
  • 2.5 mg everolimus
  • 28 Tablets
  • Carton contains 4 individual blister cards of 7 tablets.
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 5 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0566-51
  • Afinitoru00ae (everolimus) Tablets
  • Each tablet contains
  • 5 mg everolimus
  • 28 Tablets
  • Carton contains 4 individual blister cards of 7 tablets.
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 7.5 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0620-51
  • Afinitoru00ae (everolimus) Tablets
  • Each tablet contains
  • 7.5 mg everolimus
  • 28 Tablets
  • Carton contains 4 individual blister cards of 7 tablets.
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 10 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0567-51
  • Afinitoru00ae (everolimus) Tablets
  • Each tablet contains
  • 10 mg everolimus
  • 28 Tablets
  • Carton contains 4 individual blister cards of 7 tablets.
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 2 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0626-51
  • Afinitor DISPERZu00aenttttttt(everolimus tablets for oral suspension)
  • TABLETS MUST BE DISPERSED IN WATER.
  • TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.
  • 28 Tablets for Oral Suspension
  • Carton contains 4 individual blister cards of 7 tablets.
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 3 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0627-51
  • Afinitor DISPERZu00aenttttttt(everolimus tablets for oral suspension)
  • TABLETS MUST BE DISPERSED IN WATER.
  • TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.
  • 28 Tablets for Oral Suspension
  • Carton contains 4 individual blister cards of 7 tablets.
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 5 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0628-51
  • Afinitor DISPERZu00aenttttttt(everolimus tablets for oral suspension)
  • TABLETS MUST BE DISPERSED IN WATER.
  • TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.
  • 28 Tablets for Oral Suspension
  • Carton contains 4 individual blister cards of 7 tablets.

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