Aprepitant

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Recommended Dosage for Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) ( 2.1 )
• Aprepitant capsules in
• adults and pediatric patients 12 years of age and older:
• is 125 mg on Day 1 and 80 mg on Days 2 and 3.
• Administer aprepitant capsules 1 hour prior to chemotherapy on Days 1, 2, and 3. If no chemotherapy is given on Days 2 and 3, administer aprepitant capsules in morning.
• See Full Prescribing Information for recommended dosages of concomitant dexamethasone and 5-HT3 antagonist for HEC and MEC. Recommended Dosage for PONV ( 2.2 )
• Adults:
• 40 mg aprepitant capsules within 3 hours prior to induction of anesthesia. Preparation and Administration ( 2.3 )
• Aprepitant capsules can be administered with or without food.
• Swallow aprepitant capsules whole.
• For details on preparation see Full Prescribing Information. 2.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)
• Adults and Pediatric Patients 12 Years of Age and Older The recommended oral dosage of aprepitant capsules, dexamethasone, and a 5-HT 3 antagonist in
• adults and pediatric patients 12 years of age and older who can swallow oral capsules, for the prevention of nausea and vomiting associated with administration of HEC or MEC is shown in Table 1 or Table 2 , respectively. Table 1:
• Recommended Dosing for the Prevention of Nausea and Vomiting Associated with HEC Population Day1 Day 2 Day 3 Day 4 Aprepitant capsules Administer aprepitant capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3. If no chemotherapy is given on Days 2 and 3, administer aprepitant capsules in the morning.
• Adults and Pediatric Patients 12 years and Older 125 mg orally 80 mg orally 80 mg orally none Dexamethasone
• Adults 12 mg orally 8 mg orally 8 mg orally 8 mg orally Pediatric Patients 12 years and Older If a corticosteroid, such as dexamethasone, is coadministered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies ( 14.3 )] . Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with aprepitant capsules [see Clinical Pharmacology ( 12.3 )] . 5-HT 3 antagonist
• Adults and Pediatric Patients 12 years and Older See selected 5-HT 3 antagonist prescribing information for the recommended dosage none none none Table 2:
• Recommended Dosing for the Prevention of Nausea and Vomiting Associated with MEC Population Day1 Day 2 Day 3 Aprepitant capsules Administer aprepitant capsules 1 hour prior to chemotherapy treatment on Days 1, 2 and 3. If no chemotherapy is given on Days 2 and 3, administer aprepitant capsules in the morning.
• Adults and Pediatric Patients 12 years and Older 125 mg orally 80 mg orally 80 mg orally Dexamethasone
• Adults 12 mg orally none none Pediatric Patients 12 years and Older If a corticosteroid, such as dexamethasone, is coadministered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies ( 14.3 )] . Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1. A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with aprepitant capsules [see Clinical Pharmacology ( 12.3 )] . 5-HT 3 antagonist
• Adults and Pediatric Patients 12 years and Older See the selected 5-HT 3 antagonist prescribing information for recommended dosage none none 2.2 Prevention of Postoperative Nausea and Vomiting (PONV) The recommended oral dosage of aprepitant capsules in
• adults is 40 mg within 3 hours prior to induction of anesthesia. 2.3 Administration Instructions Aprepitant capsules can be administered with or without food. Aprepitant capsules
• Swallow capsules whole.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• Prevention of Nausea and Vomiting Associated with HEC or MEC The safety and effectiveness of aprepitant capsules in pediatric patients 12 years of age and older for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC, including high-dose cisplatin, and MEC.
• Use of aprepitant in these age groups is supported by evidence from 302 pediatric patients in a randomized, double-blind, active comparator controlled clinical study (n=207 patients aged 6 months to less than 12 years, n=95 patients aged 12 through 17 years).
• Aprepitant was studied in combination with ondansetron with or without dexamethasone (at the discretion of the physician) [see Clinical Studies ( 14.3 )] .
• Adverse reactions were similar to those reported in adult patients [see Adverse Reactions ( 6.1 )] .
• The safety and effectiveness of aprepitant for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months.
• Prevention of Postoperative Nausea and Vomiting (PONV) The safety and effectiveness of aprepitant has not been established for the prevention of postoperative nausea and vomiting in pediatric patients.
• Juvenile Animal Study A study was conducted in young rats to evaluate the effects of aprepitant on growth and on neurobehavioral and sexual development.
• Rats were treated at oral doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended pediatric human dose and exposure in female rats equivalent to the pediatric human exposure) from the early postnatal period (Postnatal Day 10) through Postnatal Day 58.
• Slight changes in the onset of sexual maturation were observed in female and male rats; however, there were no effects on mating, fertility, embryonic-fetal survival, or histomorphology of the reproductive organs.
• There were no effects in neurobehavioral tests of sensory function, motor function, and learning and memory.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Of the 544 adult cancer patients treated with aprepitant in CINV clinical studies, 31% were aged 65 and over, while 5% were aged 75 and over.
• Of the 1120 adult cancer patients treated with aprepitant in PONV clinical studies, 7% were aged 65 and over, while 2% were aged 75 and over.
• Other reported clinical experience with aprepitant has not identified differences in responses between elderly and younger patients.
• In general, use caution when dosing elderly patients as they have a greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy [see Clinical Pharmacology ( 12.3 )].

Quoted from the official label, section “Geriatric Use”.

Side effects

• Most common adverse reactions (≥3%) are ( 6.1 ):
• Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)
• Adults:
• fatigue, diarrhea, asthenia, dyspepsia, abdominal pain, hiccups, white blood cell count decreased, dehydration, and alanine aminotransferase increased
• Pediatrics:
• neutropenia, headache, diarrhea, decreased appetite, cough, fatigue, hemoglobin decreased, dizziness and hiccups PONV
• Adults:
• constipation and hypotension To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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 clinical practice. The overall safety of aprepitant was evaluated in approximately 6,800 individuals. Adverse Reactions in
• Adults in the Prevention of Nausea and Vomiting Associated with HEC and MEC In 2 active-controlled, double-blind clinical trials in patients receiving highly emetogenic chemotherapy (HEC) (Studies 1 and 2), aprepitant in combination with ondansetron and dexamethasone (aprepitant regimen) was compared to ondansetron and dexamethasone alone (standard therapy) [see Clinical Studies ( 14.1 )] . In 2 active-controlled clinical trials in patients receiving moderately emetogenic chemotherapy (MEC) (Studies 3 and 4), aprepitant in combination with ondansetron and dexamethasone (aprepitant regimen) was compared to ondansetron and dexamethasone alone (standard therapy) [see Clinical Studies ( 14.2 )] . The most common adverse reaction reported in patients who received MEC in pooled Studies 3 and 4 was dyspepsia (6% versus 4%). Across these 4 studies there were 1412 patients treated with the aprepitant regimen during Cycle 1 of chemotherapy and 1099 of these patients continued into the Multiple-Cycle extension for up to 6 cycles of chemotherapy. The most common adverse reactions reported in patients who received HEC and MEC in pooled Studies 1, 2, 3 and 4 are listed in Table 5. Table 5:
• Most Common Adverse Reactions in Patients Receiving HEC and MEC from a Pooled Analysis of HEC and MEC Studies Reported in ≥3% of patients treated with the aprepitant regimen and at a greater incidence than standard therapy. Aprepitant, ondansetron and dexamethasone Aprepitant regimen (N=1412) Ondansetron and dexamethasone Standard therapy (N=1396) fatigue 13% 12% diarrhea 9% 8% asthenia 7% 6% dyspepsia 7% 5% abdominal pain 6% 5% hiccups 5% 3% white blood cell count decreased 4% 3% dehydration 3% 2% alanine aminotransferase increased 3% 2% In a pooled analysis of the HEC and MEC studies, less common adverse reactions reported in patients treated with the aprepitant regimen are listed in Table 6 . Table 6:
• Less Common Adverse Reactions in Aprepitant-Treated Patients from a Pooled Analysis of HEC and MEC Studies Reported in >0.5% of patients treated with the aprepitant regimen, at a greater incidence than standard therapy and not previously described in Table 5 . Infection and Infestations oral candidiasis, pharyngitis Blood and the Lymphatic System Disorders anemia, febrile neutropenia, neutropenia, thrombocytopenia Metabolism and Nutrition Disorders decreased appetite, hypokalemia Psychiatric Disorders anxiety Nervous System Disorders dizziness, dysgeusia, peripheral neuropathy Cardiac Disorders palpitations Vascular Disorders flushing, hot flush Respiratory, Thoracic and Mediastinal Disorders cough, dyspnea, oropharyngeal pain Gastrointestinal Disorders dry mouth, eructation, flatulence, gastritis, gastroesophageal reflux disease, nausea, vomiting Skin and Subcutaneous Tissue Disorders alopecia, hyperhidrosis, rash Musculoskeletal and Connective Tissue Disorders musculoskeletal pain General Disorders and Administration Site Condition edema peripheral, malaise Investigations aspartate aminotransferase increased, blood alkaline phosphatase increased, blood sodium decreased, blood urea increased, proteinuria, weight decreased In an additional active-controlled clinical study in 1169 patients receiving aprepitant and HEC, the adverse reactions were generally similar to that seen in the other HEC studies with aprepitant. In another CINV study, Stevens-Johnson syndrome was reported as a serious adverse reaction in a patient receiving the aprepitant regimen with cancer chemotherapy. Adverse reactions in the Multiple-Cycle extensions of HEC and MEC studies for up to 6 cycles of chemotherapy were generally similar to that observed in Cycle 1. Adverse Reactions in Pediatric Patients 6 Months to 17 Years of Age in the Prevention of Nausea and Vomiting Associated with HEC or MEC In a pooled analysis of 2 active-controlled, clinical trials in pediatric patients aged 6 months to 17 years who received highly or moderately emetogenic cancer chemotherapy (Study 5 and a safety study, Study 6), aprepitant in combination with ondansetron with or without dexamethasone (aprepitant regimen) was compared to ondansetron with or without dexamethasone (control regimen). There were 184 patients treated with the aprepitant regimen during Cycle 1 and 215 patients received open-label aprepitant for up to 9 additional cycles of chemotherapy. In Cycle 1, the most common adverse reactions reported in pediatric patients treated with the aprepitant regimen in pooled Studies 5 and 6 are listed in Table 7 . Table 7:
• Most Common Adverse Reactions in Aprepitant-Treated Pediatric Patients in HEC and MEC Pooled Studies 5 and 6 Reported in ≥3% of patients treated with the aprepitant regimen and at a greater incidence than control regimen. Aprepitant and Ondansetron Aprepitant regimen (N=184) Ondansetron Control regimen (N=168) neutropenia 13% 11% headache 9% 5% diarrhea 6% 5% decreased appetite 5% 4% cough 5% 3% fatigue 5% 2% hemoglobin decreased 5% 4% dizziness 5% 1% hiccups 4% 1% Forty-nine patients were treated with ifosfamide chemotherapy in each arm. Two of the patients treated with ifosfamide in the aprepitant arm developed behavioral changes (agitation=1; abnormal behavior=1), whereas no patient treated with ifosfamide in the control arm developed behavioral changes. Aprepitant has the potential for increasing ifosfamide-mediated neurotoxicity through induction of CYP3A4 [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] . Adverse Reactions in Adult Patients in the Prevention of PONV In 2 active-controlled, double-blind clinical studies in patients receiving general anesthesia (Studies 7 and 8), 40 mg oral aprepitant was compared to 4 mg intravenous ondansetron [see Clinical Studies ( 14.4 )] . There were 564 patients treated with aprepitant and 538 patients treated with ondansetron. The most common adverse reactions reported in patients treated with aprepitant for PONV in pooled Studies 7 and 8 are listed in Table 8 . Table 8:
• Most Common Adverse Reactions in Aprepitant-Treated Patients in a Pooled Analysis of PONV Studies Reported in ≥3% of patients treated with the Aprepitant 40 mg and at a greater incidence than ondansetron. Aprepitant 40 mg (N = 564) Ondansetron (N = 538) constipation 9% 8% hypotension 6% 5% In a pooled analysis of PONV studies, less common adverse reactions reported in patients treated with aprepitant are listed in Table 9 . Table 9:
• Less Common Adverse Reactions in Aprepitant-Treated Patients in a Pooled Analysis of PONV Studies Reported in >0.5% of patients treated with aprepitant and at a greater incidence than ondansetron. Infections and Infestations postoperative infection Metabolism and Nutrition Disorders hypokalemia, hypovolemia Nervous System Disorders dizziness, hypoesthesia, syncope Cardiac Disorders bradycardia Vascular Disorders hematoma Respiratory, Thoracic and Mediastinal Disorders dyspnea, hypoxia, respiratory depression Gastrointestinal Disorders abdominal pain, dry mouth, dyspepsia Skin and Subcutaneous Tissue Disorders urticaria General Disorders and Administration Site Conditions hypothermia Investigations blood albumin decreased, bilirubin increased, blood glucose increased, blood potassium decreased Injury, Poisoning and Procedural Complications operative hemorrhage, wound dehiscence 1. Reported in >0.5% of patients treated with aprepitant and at a greater incidence than ondansetron. In addition, two serious adverse reactions were reported in PONV clinical studies in patients taking a higher than recommended dose of aprepitant:
• one case of constipation, and one case of sub-ileus. Other Studies Angioedema and urticaria were reported as serious adverse reactions in a patient receiving aprepitant in a non-CINV/non-PONV study. (Aprepitant is only approved in the CINV and PONV populations). 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of aprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissue disorders:
• pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermal necrolysis. Immune system disorders:
• hypersensitivity reactions including anaphylactic reactions [see Contraindications ( 4 )] . Nervous system disorders:
• i fosfamide-induced neurotoxicity reported after aprepitant and ifosfamide coadministration.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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 )] .
• Finished Drug Product Manufactured by Novartis d.o.o. 1000 Ljubljana, Slovenia for Sandoz Inc., Princeton, NJ 08540

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Aprepitant Capsules, USP :
• 40 mg:
• hard gelatin capsules with opaque white cap and opaque white body containing white to off white colored pellets. The cap is imprinted with ‘SZ’ and the body is imprinted with ‘525’ in black ink.
• 80 mg:
• hard gelatin capsules with opaque white cap and clear transparent body containing white to off white colored pellets. The cap is imprinted with ‘SZ’ and the body is imprinted with ‘528’ in black ink.
• 125 mg:
• hard gelatin capsules with opaque light blue cap and opaque white body containing white to off white colored pellets. The cap is imprinted with ‘SZ’ and the body is imprinted with ‘529’ in black ink. Aprepitant Capsules, USP:
• 40 mg; 80 mg; 125 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Aprepitant capsules, USP 40 mg, are hard gelatin capsules with opaque white cap and opaque white body containing white to off white colored pellets.
• The cap is imprinted with ‘SZ’ and the body is imprinted with ‘525’ in black ink.
• NDC 0781-2321-06, unit-dose package of 1 NDC 0781-2321-51, unit-dose package of 5 Aprepitant capsules, USP 80 mg, are hard gelatin capsules with opaque white cap and clear transparent body containing white to off white colored pellets.
• The cap is imprinted with ‘SZ’ and the body is imprinted with ‘528’ in black ink.
• NDC 0781-2322-68, unit-dose package of 6 NDC 0781-2322-46, unit of use bi-fold package of 2 Aprepitant capsules, USP 125 mg, are hard gelatin capsules with opaque light blue cap and opaque white body containing white to off white colored pellets.
• The cap is imprinted with ‘SZ’ and the body is imprinted with ‘529’ in black ink.
• NDC 0781-2323-68, unit-dose package of 6 NDC 0781-4063-36, unit of use tri-fold pack containing one 125 mg capsule and two 80 mg capsules.
• Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

• Aprepitant capsules, USP contain the active ingredient, aprepitant.
• Aprepitant is a substance P/neurokinin 1 (NK 1 ) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R ,3 S )-2-[(1 R )-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H -1,2,4-triazol-3-one.
• Its empirical formula is C 23 H 21 F 7 N 4 O 3 , and its structural formula is:
• Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43.
• It is practically insoluble in water.
• Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile.
• Each aprepitant capsule, USP for oral administration contains either 40 mg, 80 mg or 125 mg of aprepitant and the following inactive ingredients:
• hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate and sucrose.
• The aprepitant capsule shell for 40 mg and 80 mg consists of gelatin and titanium dioxide.
• The aprepitant capsule shell for 125 mg consists of FD&C Blue #1, gelatin and titanium dioxide.
• The capsule is printed with edible black pharmaceutical ink.
• The printing ink contains black iron oxide, propylene glycol and shellac.
• This product meets USP dissolution test 2. structural_formula

Quoted from the official label, section “Description”.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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