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Drug overview for ENSACOVE (ensartinib hydrochloride):
Generic name: ENSARTINIB HYDROCHLORIDE (en-SAR-ti-nib)
Drug class: Antineoplastic - Protein-Tyrosine Kinase Inhibitors
Therapeutic class: Antineoplastics
Ensartinib hydrochloride, an inhibitor of multiple receptor tyrosine kinases including anaplastic kinase (ALK), is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: ENSARTINIB HYDROCHLORIDE (en-SAR-ti-nib)
Drug class: Antineoplastic - Protein-Tyrosine Kinase Inhibitors
Therapeutic class: Antineoplastics
Ensartinib hydrochloride, an inhibitor of multiple receptor tyrosine kinases including anaplastic kinase (ALK), is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ENSACOVE (ensartinib hydrochloride) have been approved by the FDA:
Indications:
Anaplastic lymphoma kinase positive non-small cell lung cancer
Professional Synonyms:
ALK positive NSCLC
Indications:
Anaplastic lymphoma kinase positive non-small cell lung cancer
Professional Synonyms:
ALK positive NSCLC
The following dosing information is available for ENSACOVE (ensartinib hydrochloride):
Dosage of ensartinib hydrochloride is expressed in terms of ensartinib.
If adverse events occur during therapy, temporary interruption, dosage reduction, and/or discontinuance of ensartinib may be necessary. If dosage reduction is necessary, an initial reduction to 200 mg once daily is recommended. If further dosage reduction is necessary, the dosage should be reduced to 150 mg once daily.
Once the dosage has been reduced for adverse reactions, do not subsequently increase the dose of ensartinib. If a dosage of 150 mg is not tolerated, ensartinib should be permanently discontinued.
If adverse events occur during therapy, temporary interruption, dosage reduction, and/or discontinuance of ensartinib may be necessary. If dosage reduction is necessary, an initial reduction to 200 mg once daily is recommended. If further dosage reduction is necessary, the dosage should be reduced to 150 mg once daily.
Once the dosage has been reduced for adverse reactions, do not subsequently increase the dose of ensartinib. If a dosage of 150 mg is not tolerated, ensartinib should be permanently discontinued.
Administer ensartinib orally once daily, at the same time each day, with or without food. The capsules should be swallowed whole and should not be crushed, chewed, or opened; the contents should not be dissolved. If a dose of ensartinib is missed, take the missed dose as soon as it is remembered, unless the next dose is due within 12 hours.
If vomiting occurs after administration of ensartinib, do not take an additional dose, and take the next dose at its scheduled time. Store capsules at 20-25degreesC (excursions permitted to 15-30degreesC). Store in the original container with dessicant to protect from moisture.
If vomiting occurs after administration of ensartinib, do not take an additional dose, and take the next dose at its scheduled time. Store capsules at 20-25degreesC (excursions permitted to 15-30degreesC). Store in the original container with dessicant to protect from moisture.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ENSACOVE 25 MG CAPSULE | Maintenance | Adults take 1 capsule (25 mg) administer with 2 - 100 mg capsules (for a total dose of 225 mg) by oral route once daily |
| ENSACOVE 100 MG CAPSULE | Maintenance | Adults take 2 capsules (200 mg) administer with 1 - 25 mg capsule (for a total dose of 225 mg) by oral route once daily |
No generic dosing information available.
The following drug interaction information is available for ENSACOVE (ensartinib hydrochloride):
There are 0 contraindications.
There are 9 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Ensartinib/Selected Strong CYP3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Strong inducers of CYP3A4 may induce the metabolism of ensartinib.(1) CLINICAL EFFECTS: Concurrent or recent use of strong CYP3A4 inducers may reduce the clinical effectiveness of ensartinib.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The US manufacturer of ensartinib states that concurrent use of strong CYP3A4 inducers should be avoided.(1) DISCUSSION: Ensartinib is predominately metabolized by CYP3A4.(1) Strong CYP3A4 inducers linked to this monograph are: apalutamide, barbiturates, carbamazepine, encorafenib, fosphenytoin, ivosidenib, mitotane, phenobarbital, phenytoin, primidone, rifampin, and rifapentine.(2,3) |
ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, BRAFTOVI, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTALBITAL, BUTALBITAL-ACETAMINOPHEN, BUTALBITAL-ACETAMINOPHEN-CAFFE, BUTALBITAL-ASPIRIN-CAFFEINE, CARBAMAZEPINE, CARBAMAZEPINE ER, CARBATROL, CEREBYX, DILANTIN, DILANTIN-125, DONNATAL, EQUETRO, ERLEADA, FIORICET, FOSPHENYTOIN SODIUM, LYSODREN, MITOTANE, MYSOLINE, PENTOBARBITAL SODIUM, PHENOBARBITAL, PHENOBARBITAL SODIUM, PHENOBARBITAL-BELLADONNA, PHENOBARBITAL-HYOSC-ATROP-SCOP, PHENOHYTRO, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED, PRIFTIN, PRIMIDONE, RIFADIN, RIFAMPIN, SEZABY, TEGRETOL, TEGRETOL XR, TENCON, TIBSOVO |
| Ensartinib/Selected Moderate CYP3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Moderate inducers of CYP3A4 may induce the metabolism of ensartinib.(1) CLINICAL EFFECTS: Concurrent or recent use of moderate CYP3A4 inducers may reduce the clinical effectiveness of ensartinib.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The US manufacturer of ensartinib states that concurrent use of moderate CYP3A4 inducers should be avoided.(1) DISCUSSION: Ensartinib is predominately metabolized by CYP3A4.(1) Moderate CYP3A4 inducers linked to this monograph are: belzutifan, bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, etravirine, lesinurad, lorlatinib, mavacamten, mitapivat, modafinil, nafcillin, pexidartinib, pacritinib, repotrectinib, rifabutin, telotristat, thioridazine, and tovorafenib.(2,3) |
AUGTYRO, BOSENTAN, CAMZYOS, EFAVIRENZ, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, ETRAVIRINE, INTELENCE, LORBRENA, MODAFINIL, NAFCILLIN, NAFCILLIN SODIUM, OJEMDA, PROVIGIL, PYRUKYND, RIFABUTIN, SYMFI, TAFINLAR, TALICIA, THIORIDAZINE HCL, THIORIDAZINE HYDROCHLORIDE, TRACLEER, TURALIO, VONJO, WELIREG, XCOPRI, XERMELO |
| Ensartinib/Selected Strong CYP3A4 Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ensartinib is primarily metabolized by CYP3A4. Ensartinib metabolism may be inhibited by strong CYP3A4 inhibitors.(1) CLINICAL EFFECTS: The concurrent administration of a strong CYP3A4 inhibitor may result in elevated levels of and toxicity from ensartinib.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of ensartinib states that concurrent use of strong CYP3A4 inhibitors should be avoided.(1) DISCUSSION: Ensartinib is predominately metabolized by CYP3A4.(1) Strong CYP3A4 inhibitors include: adagrasib, ceritinib, grapefruit, idelalisib, ribociclib, troleandomycin, and voriconazole.(2,3) |
KISQALI, KRAZATI, VFEND, VFEND IV, VORICONAZOLE, VORICONAZOLE (HPBCD), ZYDELIG, ZYKADIA |
| Ensartinib/Selected Moderate CYP3A4 Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ensartinib is primarily metabolized by CYP3A4. Ensartinib metabolism may be inhibited by moderate CYP3A4 inhibitors.(1) CLINICAL EFFECTS: The concurrent administration of a moderate CYP3A4 inhibitor may result in elevated levels of and toxicity from ensartinib.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of ensartinib states that concurrent use of moderate CYP3A4 inhibitors should be avoided.(1) DISCUSSION: Ensartinib is predominately metabolized by CYP3A4.(1) Moderate CYP3A4 inhibitors include: amprenavir, aprepitant, atazanavir, avacopan, berotralstat, clofazimine, crizotinib, darunavir, duvelisib, fedratinib, fluconazole, fosamprenavir, fosnetupitant, imatinib, oral lefamulin, lenacapavir, letermovir, netupitant, nilotinib, nirogacestat, rilzabrutinib, stiripentol, tofisopam, treosulfan, and voxelotor.(2,3) |
AKYNZEO, APONVIE, APREPITANT, ATAZANAVIR SULFATE, CINVANTI, CLOFAZIMINE, COPIKTRA, DANZITEN, DARUNAVIR, DIACOMIT, DIFLUCAN, EMEND, EVOTAZ, FLUCONAZOLE, FLUCONAZOLE-NACL, FOSAMPRENAVIR CALCIUM, GLEEVEC, GRAFAPEX, IMATINIB MESYLATE, IMKELDI, INREBIC, NILOTINIB D-TARTRATE, NILOTINIB HCL, OGSIVEO, ORLADEYO, PREVYMIS, PREZCOBIX, PREZISTA, REYATAZ, SUNLENCA, SYMTUZA, TASIGNA, TAVNEOS, WAYRILZ, XALKORI, XENLETA, YEZTUGO |
| Ensartinib/Selected P-glycoprotein (P-gp) Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ensartinib is a P-glycoprotein (P-gp) substrate. P-gp inhibitors may increase the levels of ensartinib.(1) CLINICAL EFFECTS: The concurrent administration of a P-glycoprotein (P-gp) inhibitor may result in elevated levels of and toxicity from ensartinib.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of ensartinib states that concurrent use of P-glycoprotein (P-gp) inhibitors should be avoided.(1) DISCUSSION: Ensartinib is a substrate of P-gp. Inhibitors of P-gp may increase toxicity of ensartinib.(1) Inhibitors of P-gp linked to this monograph include: abrocitinib, amiodarone, Asian ginseng (Panax ginseng), asunaprevir, azithromycin, belumosudil, capmatinib, carvedilol, cimetidine, cyclosporine, danicopan, daridorexant, diosmin, eliglustat, flibanserin, fostamatinib, ginkgo biloba, glecaprevir and pibrentasvir, hydroquinidine, ivacaftor, lapatinib, mavorixafor, milk thistle (Silybum marianum), neratinib, osimertinib, propafenone, quercetin, quinidine, ranolazine, rolapitant, silibinin, silymarin, sotagliflozin, tepotinib, tezacaftor, valbenazine, velpatasvir, vemurafenib, venetoclax, vilazodone, vimseltinib, and voclosporin.(2,3) |
ADDYI, ALYFTREK, AMIODARONE HCL, AMIODARONE HCL-D5W, ASPRUZYO SPRINKLE, AZITHROMYCIN, CARVEDILOL, CARVEDILOL ER, CERDELGA, CIBINQO, CIMETIDINE, COREG, COREG CR, CYCLOSPORINE, CYCLOSPORINE MODIFIED, EPCLUSA, FLIBANSERIN, GENGRAF, INGREZZA, INGREZZA INITIATION PK(TARDIV), INGREZZA SPRINKLE, INPEFA, KALYDECO, LAPATINIB, LUPKYNIS, MAVYRET, NEORAL, NERLYNX, NEXTERONE, NUEDEXTA, PACERONE, PROPAFENONE HCL, PROPAFENONE HCL ER, QUINIDINE GLUCONATE, QUINIDINE SULFATE, QUVIVIQ, RANOLAZINE ER, REZUROCK, ROMVIMZA, SANDIMMUNE, SOFOSBUVIR-VELPATASVIR, SYMDEKO, TABRECTA, TAGRISSO, TAVALISSE, TEPMETKO, TRIKAFTA, TYKERB, VARUBI, VENCLEXTA, VENCLEXTA STARTING PACK, VIIBRYD, VILAZODONE HCL, VOSEVI, VOYDEYA, XOLREMDI, ZELBORAF, ZITHROMAX, ZITHROMAX TRI-PAK |
| Ensartinib/Dual Strong CYP3A4 & P-gp Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ensartinib is primarily metabolized by CYP3A4 and is transported by P-glycoprotein (P-gp).(1) Inhibitors of CYP3A4 and P-gp may inhibit the absorption and metabolism of ensartinib.(1) CLINICAL EFFECTS: Concurrent use with dual inhibitors of CYP3A4 and P-gp may result in elevated systemic levels and toxicity from ensartinib.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of ensartinib states concurrent use with both P-gp and strong CYP3A4 inhibitors should be avoided.(1) DISCUSSION: Ensartinib is predominately metabolized by CYP3A4 and is a P-gp substrate.(1) Dual P-gp and strong CYP3A4 inhibitors linked to this monograph include: boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, josamycin, ketoconazole, levoketoconazole, lonafarnib, lopinavir, mibefradil, mifepristone, nefazodone, nelfinavir, nirmatrelvir, paritaprevir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, tipranavir, and tucatinib.(2,3) |
APTIVUS, CLARITHROMYCIN, CLARITHROMYCIN ER, EVOTAZ, GENVOYA, ITRACONAZOLE, ITRACONAZOLE MICRONIZED, KALETRA, KETOCONAZOLE, KORLYM, LANSOPRAZOL-AMOXICIL-CLARITHRO, LOPINAVIR-RITONAVIR, MIFEPREX, MIFEPRISTONE, NEFAZODONE HCL, NORVIR, NOXAFIL, OMECLAMOX-PAK, PAXLOVID, POSACONAZOLE, PREZCOBIX, RECORLEV, RITONAVIR, SPORANOX, STRIBILD, SYMTUZA, TOLSURA, TUKYSA, TYBOST, VIRACEPT, VOQUEZNA TRIPLE PAK, ZOKINVY |
| Ensartinib/Dual Moderate CYP3A4 & P-gp Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ensartinib is primarily metabolized by CYP3A4 and is transported by P-glycoprotein (P-gp).(1) Inhibitors of CYP3A4 and P-gp may inhibit the absorption and metabolism of ensartinib.(1) CLINICAL EFFECTS: Concurrent use with dual inhibitors of CYP3A4 and P-gp may result in elevated systemic levels and toxicity from ensartinib.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of ensartinib states concurrent use with both P-gp and moderate CYP3A4 inhibitors should be avoided.(1) DISCUSSION: Ensartinib is predominately metabolized by CYP3A4 and is a P-gp substrate.(1) Dual P-gp and moderate CYP3A4 inhibitors linked to this monograph include: conivaptan, diltiazem, dronedarone, erythromycin, fluvoxamine, isavuconazonium, Schisandra, and verapamil.(2,3) |
CARDIZEM, CARDIZEM CD, CARDIZEM LA, CARTIA XT, CONIVAPTAN-D5W, CRESEMBA, DILT-XR, DILTIAZEM 12HR ER, DILTIAZEM 24HR ER, DILTIAZEM 24HR ER (CD), DILTIAZEM 24HR ER (LA), DILTIAZEM 24HR ER (XR), DILTIAZEM HCL, DILTIAZEM HCL-0.7% NACL, DILTIAZEM HCL-0.9% NACL, DILTIAZEM HCL-NACL, DILTIAZEM-D5W, E.E.S. 200, E.E.S. 400, ERY-TAB, ERYPED 200, ERYPED 400, ERYTHROCIN LACTOBIONATE, ERYTHROCIN STEARATE, ERYTHROMYCIN, ERYTHROMYCIN ESTOLATE, ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN LACTOBIONATE, FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE ER, MATZIM LA, MULTAQ, TIADYLT ER, TIAZAC, TRANDOLAPRIL-VERAPAMIL ER, VAPRISOL-5% DEXTROSE, VERAPAMIL ER, VERAPAMIL ER PM, VERAPAMIL HCL, VERAPAMIL SR |
| Ensartinib/Dual Moderate CYP3A4 Inducers & P-gp Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ensartinib is primarily metabolized by CYP3A4 and is transported by P-glycoprotein (P-gp).(1) Inducers of CYP3A4 may induce the metabolism of ensartinib while inhibitors of P-gp may increase the absorption of ensartinib.(1) CLINICAL EFFECTS: The net effect of this interaction is unknown. Concurrent use of ensartinib with CYP3A4 inducers may result in decreased levels and effectiveness of ensartinib while concurrent use of P-gp inhibitors may result in elevated systemic levels and toxicity from ensartinib.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The manufacturer of ensartinib states concurrent use with both P-gp inhibitors and moderate CYP3A4 inducers should be avoided.(1) DISCUSSION: Ensartinib is predominately metabolized by CYP3A4 and is a P-gp substrate.(1) Dual moderate CYP3A4 inducers and P-gp inhibitors linked to this monograph include: elagolix and sotorasib.(2,3) |
LUMAKRAS, ORIAHNN, ORILISSA |
| Ensartinib/Dual Strong CYP3A4 Inducers & P-gp Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ensartinib is primarily metabolized by CYP3A4 and is transported by P-glycoprotein (P-gp).(1) Inducers of CYP3A4 may induce the metabolism of ensartinib while inhibitors of P-gp may increase the absorption of ensartinib.(1) CLINICAL EFFECTS: The net effect of this interaction is unknown. Concurrent use of ensartinib with CYP3A4 inducers may result in decreased levels and effectiveness of ensartinib while concurrent use of P-gp inhibitors may result in elevated systemic levels and toxicity from ensartinib.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The manufacturer of ensartinib states concurrent use with both P-gp inhibitors and strong CYP3A4 inducers should be avoided.(1) DISCUSSION: Ensartinib is predominately metabolized by CYP3A4 and is a P-gp substrate.(1) Dual strong CYP3A4 inducers and P-gp inhibitors linked to this monograph include: enzalutamide, lumacaftor-ivacaftor, and St. John's wort.(2,3) |
ORKAMBI, XTANDI |
There are 0 moderate interactions.
The following contraindication information is available for ENSACOVE (ensartinib hydrochloride):
Drug contraindication overview.
*Hypersensitivity reaction to ensartinib hydrochloride, FD&C Yellow No. 5 (tartrazine), or to any of its components.
*Hypersensitivity reaction to ensartinib hydrochloride, FD&C Yellow No. 5 (tartrazine), or to any of its components.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Pregnancy |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Bradycardia |
| Diabetes mellitus |
| Hyperuricemia |
| Interstitial lung disease |
The following adverse reaction information is available for ENSACOVE (ensartinib hydrochloride):
Adverse reaction overview.
The most common adverse reactions (incidence >=20%) reported with ensartinib in clinical studies were rash, musculoskeletal pain, constipation, pruritus, cough, nausea, edema, vomiting, fatigue, and pyrexia.
The most common adverse reactions (incidence >=20%) reported with ensartinib in clinical studies were rash, musculoskeletal pain, constipation, pruritus, cough, nausea, edema, vomiting, fatigue, and pyrexia.
There are 5 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Hemorrhage Pneumonia |
| Rare/Very Rare |
|---|
|
Cellulitis DRESS syndrome Drug-induced hepatitis |
There are 36 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal hepatic function tests Anemia Constipation Cough Edema Elevated serum amylase Fatigue Fever Gamma-glutamyl transferase raised Hyperbilirubinemia Hyperglycemia Hypermagnesemia Hyperuricemia Hypoalbuminemia Hypocalcemia Hypokalemia Hyponatremia Hypophosphatemia Increased creatine kinase level Kidney disease with reduction in glomerular filtration rate (GFr) Lymphopenia Musculoskeletal pain Nausea Pruritus of skin Skin rash Vomiting |
Alopecia Anorexia Bradycardia Dizziness Dry skin Dysgeusia Interstitial pneumonitis Skin photosensitivity Upper respiratory infection Visual changes |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ENSACOVE (ensartinib hydrochloride):
Safety and efficacy of ensartinib have not been established in pediatric patients <18 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no available human data on ensartinib use in pregnant women. However, based on animal studies, ensartinib can cause fetal harm when administered during pregnancy. When administered to pregnant rats, embryo-fetal mortality, alterations to growth, and structural abnormalities occurred at maternal exposures approximately equivalent to the human exposure at the recommended dose of 225 mg per day.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating ensartinib. Females of reproductive potential and males with female partners of reproductive potential should use effective contraception during treatment with ensartinib and for 1 week after the last dose.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating ensartinib. Females of reproductive potential and males with female partners of reproductive potential should use effective contraception during treatment with ensartinib and for 1 week after the last dose.
It is not known whether ensartinib is distributed into human milk. Effects of the drug on breastfed infants or milk production are also not known. However, because of the potential for adverse effects in breastfed children, advise women not to breastfeed during treatment with ensartinib and for 1 week after the last dose.
In clinical studies, 16% of 458 patients were >=65 years of age. Exploratory analysis suggests that geriatric patients (>=65 years of age) experience a higher incidence of serious adverse events (43% vs 27%), more frequent adverse events leading to treatment discontinuations (18% vs 10%), and dose modifications (34% vs 16%) when compared to patients <65 years of age.
The following prioritized warning is available for ENSACOVE (ensartinib hydrochloride):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ENSACOVE (ensartinib hydrochloride)'s list of indications:
| ALK positive non-small cell lung cancer | |
| C34 | Malignant neoplasm of bronchus and lung |
| C34.0 | Malignant neoplasm of main bronchus |
| C34.00 | Malignant neoplasm of unspecified main bronchus |
| C34.01 | Malignant neoplasm of right main bronchus |
| C34.02 | Malignant neoplasm of left main bronchus |
| C34.1 | Malignant neoplasm of upper lobe, bronchus or lung |
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.31 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of lower lobe, left bronchus or lung |
| C34.8 | Malignant neoplasm of overlapping sites of bronchus and lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of overlapping sites of right bronchus and lung |
| C34.82 | Malignant neoplasm of overlapping sites of left bronchus and lung |
| C34.9 | Malignant neoplasm of unspecified part of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of unspecified part of right bronchus or lung |
| C34.92 | Malignant neoplasm of unspecified part of left bronchus or lung |
| C39.9 | Malignant neoplasm of lower respiratory tract, part unspecified |
Formulary Reference Tool