you financial [0.001:<0.001 OTHER PRESPECIFIED ENDPOINTS Complete Response Acute phase Delayed phase 89 75 78 56> <0.001> <0.001 83 68 68 47> <0.001> <0.001 Complete Protection Overall Acute phase Delayed phase 63 85 66 49 75 52 0.001 NS > <0.001 56 80 61 41 65 44> <0.001> <0.001> <0.001 No Emesis Overall Acute phase Delayed phase 78 90 81 55 79 59> <0.001 0.001> <0.001 66 84 72 44 69 48> <0.001> <0.001> <0.001 No Nausea Overall Delayed phase 48 51 44 48 NS # NS # 49 53 39 40 NS NS No Significant Nausea Overall Delayed phase 73 75 66 69 NS # NS # 71 73 64 65 NS # NS # Visual analogue scale (VAS) score range: 0 mm=no nausea; 100 mm=nausea as bad as it could be. * N: Number of patients (older than 18 years of age) who received cisplatin, study drug, and had at least one post-treatment efficacy evaluation. Overall: 0 to 120 hours post-cisplatin treatment. Acute phase: 0 to 24 hours post-cisplatin treatment. Delayed phase: 25 to 120 hours post-cisplatin treatment. Not statistically significant when adjusted for multiple comparisons. # Not statistically significant. In both studies, the estimated time to first emesis after initiation of cisplatin treatment was longer with the Aprepitant regimen, and the incidence of first emesis was reduced in the Aprepitant regimen group compared with standard therapy group as depicted in the Kaplan-Meier curves in Figure 1. Figure 1: Percent of Patients Receiving HEC Who Remain Emesis Free Over Time Cycle 1 p-Value> <0.001 based on a log rank test for Study 1 and Study 2; nominal p-values not adjusted for multiplicity. Additional Patient-Reported Outcomes: The impact of nausea- and vomiting on patients' daily lives was assessed in Cycle 1 of both studies using the Functional Living Index Emesis (FLIE), a validated nausea-and vomiting-specific patient-reported outcome measure. Minimal or no impact of nausea and vomiting on patients' daily lives is defined as a FLIE total score greater than 108. In each of the 2 studies, a higher proportion of patients receiving the Aprepitant regimen reported minimal or no impact of nausea and vomiting on daily life (Study 1: 74% versus 64%; Study 2: 75% versus 64%). Multiple-Cycle Extension: In the same 2 clinical studies, patients continued into the Multiple-Cycle extension for up to 5 additional cycles of chemotherapy. The proportion of patients with no emesis and no significant nausea by treatment group at each cycle is depicted in Figure 2. Antiemetic effectiveness for the patients receiving the Aprepitant regimen was maintained throughout repeat cycles for those patients continuing in each of the multiple cycles. Figure 2: Proportion of Patients Receiving HEC with No Emesis and No Significant Nausea by Treatment Group and Cycle Prevention of Nausea and Vomiting Associated with MEC in Adults Aprepitant was studied in two randomized, double-blind, parallel-group studies (Studies 3 and 4) in adult patients receiving MEC. In Study 3, in breast cancer patients, Aprepitant in combination with ondansetron and dexamethasone was compared with standard therapy (ondansetron and dexamethasone) in patients receiving a MEC regimen that included cyclophosphamide 750 to 1500 mg/m 2 ; or cyclophosphamide 500 to 1500 mg/m 2 and doxorubicin (less than or equal to 60 mg/m 2 ) or epirubicin (less than or equal to 100 mg/m 2 ). See Table 15. In this study, the most common combinations were cyclophosphamide + doxorubicin (61%); and cyclophosphamide + epirubicin + fluorouracil (22%). Of the 438 patients who were randomized to receive the Aprepitant regimen, 99.5% were women. Of these, approximately 80% were White, 8% Black, 8% Asian, 4% Hispanic, and less than 1% Other. The Aprepitant-treated patients in this clinical study ranged from 25 to 78 years of age, with a mean age of 53 years; 70 patients were 65 years or older, with 12 patients being over 74 years. Table 15: MEC Treatment Regimens Studies 3 and 4 * Day 1 Day 2 Day 3 CINV Aprepitant Regimen Oral Aprepitant 125 mg 80 mg 80 mg Oral Dexamethasone 12 mg none none Oral Ondansetron 8 mg 2 doses none none CINV Standard Therapy Oral Dexamethasone 20 mg none none Oral Ondansetron 8 mg 2 doses 8 mg twice daily 8 mg twice daily * Aprepitant placebo and dexamethasone placebo were used to maintain blinding. Aprepitant was administered 1 hour prior to chemotherapy treatment on Day 1 and in the mornings on Days 2 and 3. Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1. The 12 mg dose of dexamethasone on Day 1 reflects a dosage adjustment to account for a drug interaction with the Aprepitant regimen [see Clinical Pharmacology ( 12.3 )] . The first ondansetron dose was administered 30 to 60 minutes prior to chemotherapy treatment on Day 1 and the second dose was administered 8 hours after first ondansetron dose. The antiemetic activity of Aprepitant was evaluated based on the following endpoints in which emetic episodes included vomiting, retching, or dry heaves: Primary endpoint: complete response (defined as no emetic episodes and no use of rescue therapy as recorded in patient diaries) in the overall phase (0 to 120 hours post-chemotherapy) Other prespecified endpoints: no emesis (defined as no emetic episodes regardless of use of rescue therapy) no nausea (maximum VAS less than 5 mm on a 0 to 100 mm scale) no significant nausea (maximum VAS less than 25 mm on a 0 to 100 mm scale) complete protection (defined as no emetic episodes, no use of rescue therapy, and a maximum nausea visual analogue scale [VAS] score less than 25 mm on a 0 to 100 mm scale) complete response during the acute and delayed phases. A summary of the key results from Study 3 is shown in Table 16. In Study 3, a statistically significantly (p=0.015) higher proportion of patients receiving the Aprepitant regimen (51%) in Cycle 1 had a complete response (primary endpoint) during the overall phase compared with patients receiving standard therapy (42%). The difference between treatment groups was primarily driven by the "No Emesis Endpoint", a principal component of this composite primary endpoint. In addition, a higher proportion of patients receiving the Aprepitant regimen in Cycle 1 had a complete response during the acute (0 to 24 hours) and delayed (25 to 120 hours) phases compared with patients receiving standard therapy; however, the treatment group differences failed to reach statistical significance, after multiplicity adjustments. Table 16: Percent of Patients Receiving MEC Responding by Treatment Group and Phase Cycle 1 of Study 3 ENDPOINTS Aprepitant Regimen (N=433) * % Standard Therapy (N=424) * % p-Value PRIMARY ENDPOINT Complete Response 51 42 0.015 OTHER PRESPECIFIED ENDPOINTS No Emesis 76 59 NS No Nausea 33 33 NS No Significant Nausea 61 56 NS No Rescue Therapy 59 56 NS Complete Protection 43 37 NS * N: Number of patients included in the primary analysis of complete response. Overall: 0 to 120 hours post-chemotherapy treatment. NS when adjusted for prespecified multiple comparisons rule; unadjusted p-value> <0.001. Additional Patient-Reported Outcomes: In Study 3, in patients receiving MEC, the impact of nausea and vomiting on patients' daily lives was assessed in Cycle 1 using the FLIE. A higher proportion of patients receiving the Aprepitant regimen reported minimal or no impact on daily life (64% versus 56%). This difference between treatment groups was primarily driven by the "No Vomiting Domain" of this composite endpoint. Multiple-Cycle Extension: In Study 3, patients receiving MEC were permitted to continue into the Multiple-Cycle extension of the study for up to 3 additional cycles of chemotherapy. The antiemetic effect for patients receiving the Aprepitant regimen was maintained during all cycles. In Study 4, Aprepitant in combination with ondansetron and dexamethasone was compared with a standard therapy (ondansetron and dexamethasone alone) in patients receiving a MEC regimen that included any intravenous dose of oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin; cyclophosphamide intravenous (less than 1500 mg/m 2 ); or cytarabine intravenous (greater than 1 g/m 2 ). See Table 15. Patients receiving the Aprepitant regimen were receiving chemotherapy for a variety of tumor types including 50% with breast cancer, 21% with gastrointestinal cancers including colorectal cancer, 13% with lung cancer and 6% with gynecological cancers. Of the 430 patients who were randomized to receive the Aprepitant regimen, 76% were women and 24% were men. The distribution by race was 67% White, 6% Black or African American, 11% Asian, and 12% multiracial. Classified by ethnicity, 36% were Hispanic and 64% were non-Hispanic. The Aprepitant-treated patients in this clinical study ranged from 22 to 85 years of age, with a mean age of 57 years; approximately 59% of the patients were 55 years or older with 32 patients being over 74 years. The antiemetic activity of Aprepitant was evaluated based on no vomiting (with or without rescue therapy) in the overall period (0 to 120 hours post-chemotherapy) and complete response (defined as no vomiting and no use of rescue therapy) in the overall period. A summary of the key results from Study 4 is shown in Table 17. In Study 4, a statistically significantly higher proportion of patients receiving the Aprepitant regimen (76%) in Cycle 1 had no vomiting during the overall phase compared with patients receiving standard therapy (62%). In addition, a higher proportion of patients receiving the Aprepitant regimen (69%) in Cycle 1 had a complete response in the overall phase (0 to 120 hours) compared with patients receiving standard therapy (56%). In the acute phase (0 to 24 hours following initiation of chemotherapy), a higher proportion of patients receiving Aprepitant compared to patients receiving standard therapy were observed to have no vomiting (92% and 84%, respectively) and complete response (89% and 80%, respectively). In the delayed phase (25 to 120 hours following initiation of chemotherapy), a higher proportion of patients receiving Aprepitant compared to patients receiving standard therapy were observed to have no vomiting (78% and 67%, respectively) and complete response (71% and 61%, respectively). In a subgroup analysis by tumor type, a numerically higher proportion of patients receiving Aprepitant were observed to have no vomiting and complete response compared to patients receiving standard therapy. For sex, the difference in complete response rates between the Aprepitant and standard regimen groups was 14% in females (64.5% and 50.3%, respectively) and 4% in males (82.2% and 78.2%, respectively) during the overall phase. A similar difference for sex was observed for the no vomiting endpoint. Table 17: Percent of Patients Receiving MEC Responding by Treatment Group Cycle 1 of Study 4 ENDPOINTS Aprepitant Regimen (N=430) * % Standard Therapy (N=418) * % p-Value No Vomiting Overall 76 62> <0.0001 Complete Response Overall 69 56 0.0003 * N = Number of patients who received chemotherapy treatment, study drug, and had at least one post-treatment efficacy evaluation. Pediatric use information is approved for Merck Sharp & Dohme Corp.'s EMEND (Aprepitant) capsules. However, due to Merck Sharp & Dohme Corp.'s marketing exclusivity rights, this drug product is not labeled with that information. Prevention of PONV in Adults In two multicenter, randomized, double-blind, active comparator-controlled, parallel-group clinical studies (Studies 7 and 8), Aprepitant was compared with ondansetron for the prevention of postoperative nausea and vomiting in 1658 patients undergoing open abdominal surgery. These two studies were of similar design; however, they differed in terms of study hypothesis, efficacy analyses and geographic location. Study 7 was a multinational study including the U.S., whereas, Study 8 was conducted entirely in the U.S. In the two studies, patients were randomized to receive 40-mg Aprepitant, 125-mg Aprepitant, or 4-mg ondansetron as a single dose. Aprepitant was given orally with 50 mL of water 1 to 3 hours before anesthesia. Ondansetron was given intravenously immediately before induction of anesthesia. A comparison between the Aprepitant 125-mg dose did not demonstrate any additional clinical benefit over the 40-mg dose and is not a recommended dosage regimen [see Dosage and Administration ( 2.2 )] . Of the 564 patients who received 40-mg Aprepitant, 92% were women and 8% were men; of these, 58% were White, 13% Hispanic American, 7% Multi-Racial, 14% Black, 6% Asian, and 2% Other. The age of patients treated with 40-mg Aprepitant ranged from 19 to 84 years, with a mean age of 46.1 years. 46 patients were 65 years or older, with 13 patients being 75 years or older. The antiemetic activity of Aprepitant was evaluated during the 0 to 48 hour period following the end of surgery. Efficacy measures in Study 7 included: no emesis (defined as no emetic episodes regardless of use of rescue therapy) in the 0 to 24 hours following the end of surgery (primary) complete response (defined as no emetic episodes and no use of rescue therapy) in the 0 to 24 hours following the end of surgery (primary) no emesis (defined as no emetic episodes regardless of use of rescue therapy) in the 0 to 48 hours following the end of surgery (secondary) time to first use of rescue medication in the 0 to 24 hours following the end of surgery (exploratory) time to first emesis in the 0 to 48 hours following the end of surgery (exploratory). A closed testing procedure was applied to control the type I error for the primary endpoints. The results of the primary and secondary endpoints for 40-mg Aprepitant and 4-mg ondansetron are described in Table 20: Table 20: Response Rates for Select Efficacy Endpoints (Modified-Intention-to-Treat Population) Study 7 n/m = Number of responders/number of patients in analysis. Δ Difference (%): Aprepitant 40 mg minus Ondansetron. Treatment n/m (%) Aprepitant vs. Ondansetron Δ Odds ratio * Analysis PRIMARY ENDPOINTS No Vomiting 0 to 24 hours (Superiority) (no emetic episodes) Aprepitant 40 mg 246/293 (84.0) 12.6% 2.1 P> <0.001 Ondansetron 200/280 (71.4) Complete Response (Non-inferiority: If LB > 0.65) (no emesis and no rescue therapy, 0 to 24 hours) Aprepitant 40 mg 187/293 (63.8) 8.8% 1.4 LB=1.02 Ondansetron 154/280 (55.0) Complete Response (Superiority: If LB >1.0) (no emesis and no rescue therapy, 0 to 24 hours) Aprepitant 40 mg 187/293 (63.8) 8.8% 1.4 LB=1.02 Ondansetron 154/280 (55.0) SECONDARY ENDPOINT No Vomiting 0 to 48 hours (Superiority) (no emetic episodes) Aprepitant 40 mg 238/292 (81.5) 15.2% 2.3 P <0.001 Ondansetron 185/279 (66.3) * Estimated odds ratio for Aprepitant versus Ondansetron. A value of> 1 favors Aprepitant over Ondansetron. P-value of two-sided test <0.05. LB = lower bound of 1-sided 97.5% confidence interval for the odds ratio. Based on the prespecified fixed sequence multiplicity strategy, Aprepitant 40 mg was not superior to Ondansetron. In Study 7, the use of Aprepitant did not affect the time to first use of rescue medication when compared to ondansetron. However, compared to the ondansetron group, use of Aprepitant delayed the time to first vomiting, as depicted in Figure 3. Figure 3: Percent of Patients Who Remain Emesis Free During the 48 Hours Following End of Surgery Study 7 Efficacy measures in Study 8 included: complete response (defined as no emetic episodes and no use of rescue therapy) in the 0 to 24 hours following the end of surgery (primary) no emesis (defined as no emetic episodes regardless of use of rescue therapy) in the 0 to 24 hours following the end of surgery (secondary) no use of rescue therapy in the 0 to 24 hours following the end of surgery (secondary) no emesis (defined as no emetic episodes regardless of use of rescue therapy) in the 0 to 48 hours following the end of surgery (secondary). Study 8 failed to satisfy its primary hypothesis that Aprepitant is superior to ondansetron in the prevention of PONV as measured by the proportion of patients with complete response in the 24 hours following end of surgery. The study demonstrated that 40-mg Aprepitant had a clinically meaningful effect with respect to the secondary endpoint "no vomiting" during the first 24 hours after surgery and was associated with a 16% improvement over ondansetron for the no vomiting endpoint. Table 21: Response Rates for Select Efficacy Endpoints (Modified-Intention-to-Treat Population) Study 8 Treatment n/m (%) Aprepitant vs. Ondansetron Δ Odds ratio * Analysis PRIMARY ENDPOINT Complete Response (no emesis and no rescue therapy, 0 to 24 hours) Aprepitant 40 mg 111/248 (44.8) 2.5% 1.1 0.61 Ondansetron 104/246 (42.3) SECONDARY ENDPOINTS No Vomiting (no emetic episodes, 0 to 24 hours) Aprepitant 40 mg 223/248 (89.9) 16.3% 3.2> <0.001 Ondansetron 181/246 (73.6) No Use of Rescue Medication (for established emesis or nausea, 0 to 24 hours) Aprepitant 40 mg 112/248 (45.2) -0.7% 1.0 0.83 Ondansetron 113/246 (45.9) No Vomiting 0 to 48 hours (Superiority) (no emetic episodes, 0 to 48 hours) Aprepitant 40 mg 209/247 (84.6) 17.7% 2.7> <0.001 * Ondansetron 164/245 (66.9) n/m = Number of responders/number of patients in analysis. Δ Difference (%): Aprepitant 40 mg minus Ondansetron. * Estimated odds ratio: Aprepitant 40 mg versus Ondansetron. Not statistically significant after pre-specified multiplicity adjustment. How Supplied/Storage and Handling Aprepitant Capsules, USP, 125 mg: hard gelatin capsules with a pink opaque colored cap imprinted with Glenmark logo 'G' in black ink and a white opaque colored body imprinted with '585' in black ink. They are supplied as follows: NDC 68462-585-76 Carton of 6 capsules (containing 1 x 6 unit-dose blisters) Aprepitant Capsules, USP, 80 mg: hard gelatin capsules with a white opaque colored cap imprinted with Glenmark logo 'G' in black ink and a white opaque colored body imprinted with '584' in black ink. They are supplied as follows: NDC 68462-584-76 Carton of 6 capsules (containing 1 x 6 unit-dose blisters) NDC 68462-584-58 Blister card of 2 capsules (2-day pack containing two 80 mg capsules) Aprepitant Capsules, USP, 3-day pack (125-mg/80-mg/80-mg): NDC 68462-112-33 Blister card of 3 capsules (3-day pack containing one 125 mg capsule and two 80 mg capsules) Aprepitant Capsules, USP, 40 mg: hard gelatin capsules with a mustard yellow colored cap imprinted with Glenmark logo 'G' in black ink and a white opaque colored body imprinted with '583' in black ink. They are supplied as follows: NDC 68462-583-11 Carton of 10 capsules (containing 1 x 10 unit-dose blisters) NDC 68462-583-85 Carton of 5 capsules (containing 5 x 1 unit-dose blisters) Storage and Handling Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature]. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Advise patients that hypersensitivity reactions, including anaphylaxis, have been reported in patients taking Aprepitant. Advise patients to stop taking Aprepitant and seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, or difficulty in breathing or swallowing. Drug Interactions Advise patients to discuss all medications they are taking, including other prescription, non-prescription medication or herbal products [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. Warfarin: Instruct patients on chronic warfarin therapy to follow instructions from their healthcare provider regarding blood draws to monitor their INR during the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day regimen of Aprepitant with each chemotherapy cycle, or following administration of a single 40-mg dose of Aprepitant for the prevention of postoperative nausea and vomiting [see Warnings and Precautions ( 5.2 )] . Hormonal Contraceptives: Advise patients that administration of Aprepitant may reduce the efficacy of hormonal contraceptives. Instruct patients to use effective alternative or back-up methods of contraception (such as condoms and spermicides) during treatment with Aprepitant and for 1 month following the last dose of Aprepitant [see Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.3 )] . Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ Pithampur, Dist.-Dhar Madhya Pradesh 454 775, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa June 2017 Patient Information Aprepitant (a-PRE-pi-tant) Capsules Read this Patient Information before you start taking Aprepitant capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. What are Aprepitant capsules? Aprepitant capsules are a prescription medicine used: In adults to prevent nausea and vomiting caused by certain anti-cancer (chemotherapy) medicines. When used for this purpose, Aprepitant capsules are always used with other medicines that treat nausea and vomiting. In adults to prevent nausea and vomiting after surgery Aprepitant capsules are not used to treat nausea and vomiting that you already have. Aprepitant capsules should not be used continuously for a long time (chronic use). Who should not take Aprepitant capsules? Do not take Aprepitant capsules if you: are allergic to Aprepitant or any of the ingredients in Aprepitant capsules. See the end of this leaflet for a complete list of ingredients in Aprepitant capsules. are taking pimozide (ORAP ) What should I tell my doctor before taking Aprepitant capsules? Before you take Aprepitant capsules, tell your doctor if you: have liver problems are pregnant or plan to become pregnant. It is not known if Aprepitant capsules can harm your unborn baby. Women who use birth control medicines containing hormones to prevent pregnancy (birth control pills, skin patches, implants, and certain IUDs) should also use a back-up method of birth control during treatment with Aprepitant capsules and for 1 month after your last dose of Aprepitant capsules. are breastfeeding or plan to breastfeed. It is not known if Aprepitant passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Aprepitant capsules. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Aprepitant capsules may affect the way other medicines work, and other medicines may affect how Aprepitant capsules work causing serious side effects. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. How should I take Aprepitant capsules? Take Aprepitant capsules exactly as prescribed. Swallow Aprepitant capsules whole. If you are receiving chemotherapy, Aprepitant capsules may be taken with or without food. If you take too much Aprepitant, call your doctor, or go to the nearest hospital emergency room. If you are receiving cancer chemotherapy , Aprepitant capsules are taken as 3 doses over 3 days - starting on the day you have chemotherapy, and for the following 2 days. In adults who are receiving chemotherapy, there are 2 ways your doctor may prescribe Aprepitant capsules for you: Capsules of Aprepitant by mouth for all 3 doses: You should get a package that has 3 capsules of Aprepitant. Day 1 (Day of chemotherapy): Take one 125 mg capsule of Aprepitant (white and pink) by mouth 1 hour before you start your chemotherapy treatment. Day 2 and Day 3: Take one 80 mg capsule of Aprepitant (white) by mouth 1 hour before you start your chemotherapy treatment. If no chemotherapy treatment is given on Days 2 and 3, Aprepitant capsules should be taken in the morning. Intravenous (IV) injection into a vein on day 1 of chemotherapy, then capsules by mouth on the 2 days after chemotherapy: Day 1 (Day of chemotherapy): Aprepitant will be given to you by intravenous (IV) injection in your vein 30 minutes before you start your chemotherapy treatment. You should get a package that has 2 capsules of Aprepitant. Day 2 and Day 3: Take one 80 mg capsule of Aprepitant (white) by mouth 1 hour before you start your chemotherapy treatment. If no chemotherapy treatment is given on Days 2 and 3, Aprepitant capsules should be taken in the morning. If you are an adult and are having surgery: Your doctor will prescribe a 40 mg capsule of Aprepitant for you before surgery. Take Aprepitant within 3 hours before surgery. Follow your doctor's instructions about restrictions on eating and drinking before surgery. If you take the blood thinner medicine warfarin sodium (COUMADIN , JANTOVEN ), your doctor may do blood tests after you take Aprepitant to check your blood clotting. What are the possible side effects of Aprepitant capsules? In adults taking Aprepitant capsules to prevent nausea and vomiting caused by chemotherapy, the most common side effects include tiredness, diarrhea, weakness, indigestion, stomach (abdominal) pain, hiccups, decrease in white blood cell count, dehydration, and changes in liver function tests. In adults taking Aprepitant capsules to prevent nausea and vomiting after surgery, the most common side effects include constipation and low blood pressure (hypotension). Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Aprepitant capsules. For more information ask your doctor 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 Aprepitant capsules? Store at room temperature, between 68 F to 77 F (20 C to 25 C). Keep Aprepitant capsules and all medicines out of the reach of children. General information about the safe and effective use of Aprepitant capsules Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Aprepitant capsules for a condition for which they were not prescribed. Do not give Aprepitant capsules to other people, even if they have the same symptoms you have. They may harm them. You can ask your doctor or pharmacist for information about Aprepitant capsules that is written for health professionals. For more information about Aprepitant capsules call 1-888-721-7115. What are the ingredients in Aprepitant capsules? Active ingredient: Aprepitant Inactive ingredients: colloidal silicon dioxide, hydroxyethyl cellulose, microcrystalline cellulose, mannitol, poloxamer, povidone, sodium stearyl fumarate, vitamin E polyethylene glycol succinate, and purified water. The capsule shell excipients are gelatin, sodium lauryl sulphate and titanium dioxide. The 40-mg capsule shell also contains iron oxide yellow, and the 125-mg capsule also contains FD&C Red #3. Non-volatile solvents in the imprinting ink are shellac, iron oxide black and potassium hydroxide. Pediatric use information is approved for Merck Sharp & Dohme Corp.'s EMEND (Aprepitant) capsules. However, due to Merck Sharp & Dohme Corp's marketing exclusivity rights, this drug product is not labeled with that information. The brands listed in the above sections "Who should not take Aprepitant capsules?" and "How should I take Aprepitant capsules?" are the registered trademarks of their respective owners and are not trademarks of Glenmark Pharmaceuticals Inc., USA. Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ Pithampur, Dist.-Dhar Madhya Pradesh 454 775, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: June 2017 Package/Label Display Panel Package/Label Display Panel Package/Label Display Panel Package/Label Display Panel Package/Label Display Panel Package/Label Display Panel Aprepitant Aprepitant capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68462-583 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aprepitant (Aprepitant) Aprepitant 40 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) MICROCRYSTALLINE CELLULOSE MANNITOL POLOXAMER 407 POVIDONE, UNSPECIFIED SODIUM STEARYL FUMARATE TOCOPHERSOLAN WATER GELATIN, UNSPECIFIED SODIUM LAURYL SULFATE TITANIUM DIOXIDE FERRIC OXIDE YELLOW SHELLAC FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE Product Characteristics Color YELLOW (mustard [cap]) , WHITE (opaque [body]) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code G;583 Contains Packaging # Item Code Package Description 1 NDC:68462-583-11 1 BLISTER PACK in 1 CARTON 1 10 CAPSULE in 1 BLISTER PACK 2 NDC:68462-583-85 5 BLISTER PACK in 1 CARTON 2 1 CAPSULE in 1 BLISTER PACK 3 NDC:68462-583-40 1 BLISTER PACK in 1 CARTON 3 1 CAPSULE in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207777 10/12/2017 Aprepitant Aprepitant capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68462-584 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aprepitant (Aprepitant) Aprepitant 80 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) MICROCRYSTALLINE CELLULOSE MANNITOL POLOXAMER 407 POVIDONE, UNSPECIFIED SODIUM STEARYL FUMARATE TOCOPHERSOLAN WATER GELATIN, UNSPECIFIED SODIUM LAURYL SULFATE TITANIUM DIOXIDE SHELLAC FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE Product Characteristics Color WHITE (opaque [cap]) , WHITE (opaque [body]) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code G;584 Contains Packaging # Item Code Package Description 1 NDC:68462-584-58 2 CAPSULE in 1 DOSE PACK 2 NDC:68462-584-76 1 BLISTER PACK in 1 CARTON 2 6 CAPSULE in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207777 10/12/2017 Aprepitant Aprepitant capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68462-585 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aprepitant (Aprepitant) Aprepitant 125 mg Inactive Ingredients Ingredient Name Strength HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) TOCOPHERSOLAN POLOXAMER 407 POVIDONE, UNSPECIFIED MANNITOL WATER SODIUM STEARYL FUMARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE GELATIN, UNSPECIFIED SODIUM LAURYL SULFATE TITANIUM DIOXIDE FD&C RED NO. 3 SHELLAC FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE Product Characteristics Color PINK (opaque [cap]) , WHITE (opaque [body]) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code G;585 Contains Packaging # Item Code Package Description 1 NDC:68462-585-76 1 BLISTER PACK in 1 CARTON 1 6 CAPSULE in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207777 10/12/2017 Aprepitant Aprepitant kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68462-112 Packaging # Item Code Package Description 1 NDC:68462-112-33 1 KIT in 1 DOSE PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 Part 2 1 Part 1 of 2 Aprepitant Aprepitant capsule Product Information Route of Administration ORAL DEA Schedul attempt to
crack of dawn Aprepitant outcome
EmoticonEmoticon