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Erlotinib (Erlotinib)

Trade Name : Erlotinib

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 100 mg/1

ERLOTINIB HYDROCHLORIDE Kinase Inhibitor [EPC],Protein Kinase 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 Erlotinib (Erlotinib) which is also known as Erlotinib and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 100 mg/1 per ml. Read more

Erlotinib (Erlotinib) 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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  • No data
  • Erlotinib tablets are a kinase inhibitor indicated for:
  • The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. ()
  • First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. () n
  • Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. ()
  • Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. ()
  • No data
  • NSCLC: 150 mg orally, on an empty stomach, once daily ()
  • Pancreatic cancer: 100 mg orally, on an empty stomach, once daily ()
  • 100 mg tablets
  • White film-coated tablets for daily oral administration. Round, biconvex, unscored, white film-coated, debossed on one side and on the other side.
  • 150 mg tablets
  • White film-coated tablets for daily oral administration. Round, biconvex, unscored, white film-coated, debossed on one side and on the other side.
  • Tablets: 100 mg and 150 mg ()
  • None.
  • None ()
  • No data
  • Interstitial lung disease (ILD)
  • Renal failure
  • Hepatotoxicity
  • Gastrointestinal perforations
  • Bullous and exfoliative skin disorders
  • Cerebrovascular accident (CVA)
  • Microangiopathic hemolytic anemia (MAHA)
  • Ocular disorders
  • Hemorrhage in patients taking warfarin
  • Embryo-fetal toxicity
  • The following serious adverse reactions, which may include fatalities, are discussed in greater detail in other sections of the labeling:
  • The most common adverse reactions (u2265 20%) with erlotinib from a pooled analysis in patients with NSCLC across all approved lines of therapy, with and without EGFR mutations, and in patients with pancreatic cancer were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting. ()
  • CYP3A4 Inhibitorsn- [see Clinical Pharmacology ()].
  • Avoid co-administering erlotinib with strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan,indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and CYP1A2 inhibitor (e.g., ciprofloxacin). Reduce the erlotinib dosage when co-administering with a strong CYP3A4 inhibitor or a combined CYP3A4 and CYP1A2 inhibitor if co-administration is unavoidable n
  • CYP3A4 Inducersn- [see Clinical Pharmacology ()]n- [see Dosage and Administration ()]
  • CYP1A2 Inducers and Cigarette Smokingn- [see Dosage and Administration () and Clinical Pharmacology ()]
  • Drugs that Increase Gastric pHn- [see Clinical Pharmacology ()]n- [see Dosage and Administration (2.4)]
  • Anticoagulantsn- [see Warnings and Precautions () and Adverse Reactions ()].
  • CYP3A4 inhibitors or a combined CYP3A4 and CYP1A2 inhibitor increase erlotinib plasma concentrations. Avoid concomitant use. If not possible, reduce erlotinib dose. (, )
  • CYP3A4 inducers decrease erlotinib plasma concentrations. Avoid concomitant use. If not possible, increase erlotinib dose. (,u00a0)
  • Cigarette smoking and CYP1A2 inducers decrease erlotinib plasma concentrations. Avoid concomitant use. If not possible, increase erlotinib dose. (,u00a0)
  • Drugs that increase gastric pH decrease erlotinib plasma concentrations. For proton pump inhibitors avoid concomitant use if possible. For H-2 receptor antagonists, take erlotinib 10 hours after H-2 receptor antagonist dosing. For use with antacids, separate dosing by several hours. (,u00a0)
  • Lactation: Do not breastfeed (8.2)
  • Withhold erlotinib in patients with an overdose or suspected overdose and institute symptomatic treatment.
  • Erlotinib Tablets, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. Erlotinib Tablets contain erlotinib as the hydrochloride salt that has the following structural formula:
  • CHNOu2022HCl M.W. 429.90
  • The molecule has a pK of 5.42 at 25u00b0C. Erlotinib hydrochloride is very slightly soluble in water, slightly soluble in methanol and practically insoluble in acetonitrile, acetone, ethyl acetate and hexane.
  • Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.4 mg/mL occurs at a pH of approximately 2.
  • Erlotinib Tablets for oral administration are available in two dosage strengths containing erlotinib hydrochloride (109.3 mg and 163.9 mg) equivalent to 100 mg and 150 mg erlotinib and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide, and triacetin.
  • No data
  • Two-year carcinogenicity studies were conducted in mice and rats with erlotinib at oral doses of up to 60 mg/kg/day in mice, 5 mg/kg/day in female rats, and 10 mg/kg/day in male rats. The studies were negative for carcinogenic findings. Exposure in mice at the highest dose tested was approximately 10 times the exposure in humans at the erlotinib dose of 150 mg/day. The highest dose evaluated in male rats resulted in exposures that were twice those in humans and exposures at the highest tested dose in female rats were slightly lower than those in humans.
  • Erlotinib did not cause genetic damage in a series of assays (bacterial mutation, human lymphocyte chromosome aberration and mammalian cell mutation) and in the mouse bone marrow micronucleus test.
  • Erlotinib did not impair fertility in either male or female rats.
  • No data
  • Erlotinib Tablets are available as follows:
  • 100 mg: Round, biconvex, unscored, white film-coated tablets, debossed on one side and on the other side; supplied in bottles of 30 (NDC 0093-7663-56).
  • 150 mg: Round, biconvex, unscored, white film-coated tablets, debossed on one side and on the other side; supplied in bottles of 30 (NDC 0093-7664-56).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Skin rash, bullous and exfoliative skin disorders
  • Diarrhea n n- [see Adverse Reactions (n- Array
  • Interstitial lung disease n n- [see Dosage and Administration (n- Array
  • Renal failure n n- [see Warnings and Precautions (n- Array
  • Hepatotoxicity
  • Advise patients to immediately report signs or symptoms of hepatotoxicity n n
  • Gastrointestinal perforations n n- [see Dosage and Administration (n- Array
  • Cerebrovascular accident n n- [see Dosage and Administration (n- Array
  • Ocular disorders n n- [see Dosage and Administration (n- Array
  • Hemorrhage in patients taking warfarin n n- [see Warnings and Precautions (n- Array
  • Hair and nail disorders n n- [see Adverse Reactions (n- Array
  • Embryo-fetal toxicity
  • For further information please call 1-888-838-2872.
  • Manufactured In Croatia By: n Zagreb, Croatia
  • Manufactured For:n North Wales, PA 19454
  • Rev. A 2/2019
  • No data
  • No data

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