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Ceritinib (Zykadia)

Trade Name : ZYKADIA

Novartis Pharmaceuticals Corporation

CAPSULE

Strength 150 mg/1

CERITINIB Kinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C9 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 Ceritinib (Zykadia) which is also known as ZYKADIA and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 150 mg/1 per ml. Read more

Ceritinib (Zykadia) 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
  • ntttttttZYKADIA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test .ntttttt
  • ZYKADIA is a kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC)u00a0whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.u00a0(, )
  • Recommended dosage: 450 mg orally once daily with food.u00a0()
  • Capsules: 150 mg hard gelatin capsule with opaque blue cap and opaque white body containing a white to off-white powder. The opaque blue cap is marked in black ink with u201cLDK 150MGu201du00a0and the opaque white body is marked in black ink with u201cNVRu201d.
  • Tablets: 150 mg film-coated tablet, light blue, round, biconvex with beveled edges, without score, debossed with u201cNVRu201d on one side and u201cZY1u201d on the other side.
  • Capsules: 150 mg ()ntttttttt
  • Tablets: 150 mg ()ntttttttt
  • None.
  • None ()
  • No data
  • Gastrointestinal Adverse Reactions
  • Hepatotoxicity
  • Interstitial Lung Disease/Pneumonitis
  • QT Interval Prolongation
  • Hyperglycemia
  • Bradycardia
  • Pancreatitis
  • Embryo-Fetal Toxicity
  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • 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.
  • The data in the Warnings and Precautions section reflect exposure to ZYKADIA 750 mg once daily under fasted conditions in 925 patients with ALK-positive NSCLC across seven clinical studies, including ASCEND-4 and ASCEND-1, described below, a randomized active-controlled study, two single arm studies, and two dose-escalation studies. The majority of patients enrolled in these studies had received prior treatment with chemotherapy and/or crizotinib for NSCLC. Among these 925 patients, the most common adverse reactions (u2265 25% incidence) were diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and weight loss. Approximately 45% of patients initiating treatment with ZYKADIA 750 mg under fasted conditions had an adverse reaction that required at least one dose reduction and 66% of patients had an adverse reaction that required at least one dose interruption. The median time to first dose reduction due to any reason was 7 weeks.
  • In ASCEND-8, a dose optimization study, ZYKADIA 450 mg daily with food (N = 89) was compared to 750 mg daily under fasted conditions (N = 90) in both previously treated and untreated patients with ALK-positive NSCLC. The overall safety profile of ZYKADIA 450 mg with food was consistent with ZYKADIA 750 mg fasted, except for a reduction in gastrointestinal adverse reactions, while achieving comparable steady-state exposure . The most common adverse reactions (u2265 25% incidence) in the 450 mg with food arm were diarrhea, nausea, abdominal pain, vomiting, and fatigue. The incidence and severity of gastrointestinal adverse reactions (diarrhea 56%, nausea 45%, and vomiting 35%) were reduced for patients treated with ZYKADIA 450 mg with food; the only Grade u2265 3 adverse reaction was Grade 3 diarrhea in one patient (1.1%) . In patients treated with ZYKADIA 450 mg with food, 10% of patients had an adverse reaction that required at least one dose reduction and 42% of patients had an adverse reaction that required at least one dose interruption. The median time to first dose reduction due to any reason was 8 weeks.
  • Previously Untreated ALK-Positive Metastatic NSCLC
  • The safety of ZYKADIA was evaluated in ASCEND-4, an open-label, randomized, active-controlled multicenter study of 376 previously untreated ALK-positive NSCLC patients [see Clinical Studies (14.1)]. Patients received ZYKADIA 750 mg daily (N = 189) under fasted conditions or chemotherapy and maintenance chemotherapy (N = 187). Chemotherapy regimens were pemetrexed (500 mg/m) and investigatoru2019s choice of cisplatin (75 mg/m) or carboplatin [area under the curve (AUC) of 5 - 6 mg*min/mL] administered every 21 days. Patients who completed 4 cycles of chemotherapy without progressive disease received pemetrexed (500 mg/m) as single-agent maintenance therapy every 21 days. The median duration of exposure to ZYKADIA was 18 months.
  • The demographic characteristics of the study population were 57% female, median age 54 years (range: 22 to 81 years), 22% age 65 years or older, 54% White, 42% Asian, 2% Black, and 2% other races. Patients were enrolled in Europe (53%), Asia Pacific (42%), and South America (5%) regions. The majority of patients had adenocarcinoma (97%), never smoked (61%), and 32% had brain metastases at screening.
  • The following fatal adverse reactions occurred in 4 patients treated with ZYKADIA: myocardial infarction, respiratory tract infection, pneumonitis, and unknown cause.
  • Serious adverse reactions were reported in 38% of patients treated with ZYKADIA. The most frequent serious adverse reactions were pneumonia (4%), pleural effusion (4%), vomiting (4%), nausea (3%), dyspnea (3%), hyperglycemia (3%), AST increased (2%), lung infection (2%), and pericardial effusion (2%).
  • Among patients treated with ZYKADIA, dose interruptions due to adverse reactions occurred in 77%, dose reductions were required in 66%, and adverse reactions that led to discontinuation of therapy occurred in 12% of patients. The most frequent adverse reactions, reported in at least 10% of patients treated with ZYKADIA, that led to dose interruptions or reductions were: increased ALT (48%), increased AST (34%), vomiting (15%), increased blood creatinine (14%), increased gamma-glutamyl transpeptidase (GGT) (13%), diarrhea (13%), and nausea (13%). The most frequent adverse reactions that led to discontinuation of ZYKADIA in 1% or more of patients in ASCEND-4 were increased blood creatinine (2.1%), increased amylase (1.1%), and increased lipase (1.1%).
  • Tables 3u00a0and 4u00a0summarize adverse reactions and laboratory abnormalities, respectively, in ASCEND-4.
  • Additional clinically significant adverse reactions occurring in 2% or more of patients treated with ZYKADIA 750 mg under fasted conditions included: vision disorder (4% comprised of vision impairment, blurred vision, photopsia, accommodation disorder, presbyopia, reduced visual acuity, or vitreous floaters), bradycardia (4%), ILD/pneumonitis (2%), hepatotoxicity (2%), and renal failure (2%).
  • Previously Treated ALK-Positive Metastatic NSCLC
  • The safety of ZYKADIA was evaluated in ASCEND-1, a multicenter, single-arm, open-label clinical study of 255 ALK-positive patients (246 patients with NSCLC and 9 patients with other cancers who received ZYKADIA at a dose of 750 mg daily under fasted conditions) . The median duration of exposure to ZYKADIA was 6 months.
  • The study population characteristics were: median age 53 years, age less than 65 (84%), female (53%), White (63%), Asian (34%), NSCLC adenocarcinoma histology (90%), never or former smoker (97%), ECOG PS 0 or 1 (89%), brain metastases (49%), and number of prior therapies 2 or more (67%).
  • Fatal adverse reactions in patients treated with ZYKADIA occurred in 5% of patients, consisting of: pneumonia (4 patients), respiratory failure, ILD/pneumonitis, pneumothorax, gastric hemorrhage, general physical health deterioration, pulmonary tuberculosis, cardiac tamponade, and sepsis (1 patient each).
  • Serious adverse reactions reported in 2% or more of patients in ASCEND-1 were convulsion, pneumonia, ILD/pneumonitis, dyspnea, dehydration, hyperglycemia, and nausea.
  • Dose reductions due to adverse reactions occurred in 59% of patients treated with ZYKADIA. The most frequent adverse reactions, reported in at least 10% of patients, that led to dose reductions or interruptions were: increased ALT (29%), nausea (20%), increased AST (16%), diarrhea (16%), and vomiting (16%). Discontinuation of therapy due to adverse reactions occurred in 10% of patients treated with ZYKADIA. The most frequent adverse reactions that led to discontinuation in 1% or more of patients in ASCEND-1 were pneumonia, ILD/pneumonitis, and decreased appetite.
  • Tables 5 and 6 summarize adverse reactions and laboratory abnormalities, respectively, in ASCEND-1.
  • Additional clinically significant adverse reactions occurring in 2% or more of patients treated with ZYKADIA 750 mg under fasted conditions included neuropathy (17% comprised of paresthesia, muscular weakness, gait disturbance, peripheral neuropathy, hypoesthesia, peripheral sensory neuropathy, dysesthesia, neuralgia, peripheral motor neuropathy, hypotonia, or polyneuropathy), vision disorder (9% comprised of vision impairment, blurred vision, photopsia, accommodation disorder, presbyopia, or reduced visual acuity), prolonged QT interval (4%), and bradycardia (3%).
  • The most common adverse reactions (incidence of u2265 25%) in patients treated with ZYKADIA 450 mg with food are diarrhea, nausea, abdominal pain, vomiting, and fatigue and with ZYKADIA 750 mg under fasted conditions are diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and weight loss. ()
  • No data
  • CYP3A Inhibitors and Inducers
  • CYP3A Substrates
  • CYP2C9 Substrates
  • nttu00a0u00a0u00a0u00a0u00a0nt
  • Lactation
  • Severe Hepatic Impairment
  • Ceritinib is a kinase inhibitor for oral administration. The molecular formula for ceritinib is CHNOClS. The molecular weight is 558.14 g/mol. Ceritinib is described chemically as 5-Chloro-N4-[2-[(1-methylethyl)sulfonyl]phenyl]-N2-[5-methyl-2-(1-methylethoxy)-4-(4-piperidinyl)phenyl]-2,4-pyrimidinediamine.
  • The chemical structure of ceritinib is shown below:
  • Ceritinib is a white to almost white or light yellow powder.
  • ZYKADIA is supplied as printed hard-gelatin capsules containing 150 mg of ceritinib and the following inactive ingredients: colloidal silicon dioxide, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and hard gelatin capsule shells. The capsule shell is composed of FD&C Blue # 2, gelatin, and titanium dioxide.
  • ZYKADIA is supplied as film-coated tablets containing 150 mg of ceritinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and povidone. The tablet coating contains FD&C Blue # 2 aluminum lake, hypromellose, polyethylene glycol 4000, talc, and titanium dioxide.
  • No data
  • No data
  • No data
  • ZYKADIA 150 mg capsules
  • Hard gelatin capsule with opaque blue cap and opaque white body; opaque blue cap marked in black ink with u201cLDK 150MGu201d, opaque white body marked in black ink with u201cNVRu201d. Available in:
  • Bottles of 70 capsulesu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDC 0078-0640-70
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) .
  • ZYKADIA 150 mg tablets
  • Film-coated tablet, light blue, round, biconvex with beveled edges, without score, debossed with u201cNVRu201d on one side and u201cZY1u201d on the other side. Available in:
  • Bottles of 84 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0694-84
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) .
  • Advise the patient to read the FDA-approved patient labeling (Patient Information)n
  • Gastrointestinal Adverse Reactions
  • nttttttttInform patients that diarrhea, nausea, vomiting, and abdominal pain are the most commonly reported gastrointestinal adverse reactions. Inform patients of supportive care options such as antiemetic and anti-diarrheal medications. Advise patients to contact their healthcare provider for severe or intolerable gastrointestinal symptoms. Inform patients that if vomiting occurs during the course of treatment, they should not take an additional dose, but should continue with the next scheduled dose of ZYKADIA .nttttttt
  • Hepatotoxicity
  • nttttttttInform patients of the signs and symptoms of hepatotoxicity. Advise patients to contact their healthcare provider immediately for signs or symptoms of hepatotoxicity .nttttttt
  • Interstitial Lung Disease/Pneumonitis
  • nttttttttInform patients of the risks of severe or fatal ILD/pneumonitis. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms .nttttttt
  • Arrhythmias
  • ntttttttInform patients of the risks of QTc interval prolongation and bradycardia. Advise patients to contact their healthcare provider immediately to report new chest pain or discomfort, changes in heartbeat, palpitations, dizziness, lightheadedness, fainting, and changes in or new use of heart or blood pressure medications .nttttttt
  • Hyperglycemia
  • Inform patients of the signs and symptoms of hyperglycemia. Advise patients to contact their healthcare provider immediately for signs or symptoms of hyperglycemia .nttttttt
  • Pancreatitis
  • nttttttttInform patients of the signs and symptoms of pancreatitis and the need to monitor lipase and amylase levels prior to the start of treatment and periodically thereafter as clinically indicated .nttttttt
  • Embryo-Fetal Toxicity
  • Lactation
  • nttttttttAdvise women not to breastfeed during treatment with ZYKADIA and for 2 weeks following completion of therapy n
  • Drug Interactions
  • nttttttttInform patients not to consume grapefruit and grapefruit juice during treatment with ZYKADIA .nttttttt
  • Dosing Instructions
  • nttttttttAdvise patients to take ZYKADIA with food . Advise patients to make up a missed dose of ZYKADIA unless the next dose is due within 12 hours .nttttttt
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • u00a9 Novartis
  • T2019-43
  • No data
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0640-70
  • Zykadian
  • (ceritinib) capsules
  • 150 mg
  • 70 Capsules
  • NOVARTIS
  • Rx only
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0694-84
  • Zykadian
  • (ceritinib) tablets
  • 150 mg
  • 84 Tablets
  • NOVARTIS
  • Rx only

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