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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 21.04.2022
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Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)
Aprepitant Sandoz® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of:
- acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
- nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Aprepitant Sandoz® capsules, in combination with other antiemetic agents, is indicated in patients 12 years of age and older for the prevention of:
- acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
- nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Prevention of Postoperative Nausea and Vomiting (PONV)
Aprepitant Sandoz capsules are indicated in adults for the prevention of postoperative nausea and vomiting.
Limitations of Use
- Aprepitant Sandoz has not been studied for the treatment of established nausea and vomiting.
- Chronic continuous administration of Aprepitant Sandoz is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.
Aprepitant Sandoz (Aprepitant Sandoz) blocks the actions of chemicals in the body that trigger nausea and vomiting.
Aprepitant Sandoz is used in adults and children to prevent nausea and vomiting caused by cancer chemotherapy. Aprepitant Sandoz is also used (only in adults) to prevent nausea and vomiting that may be caused by surgery.
Aprepitant Sandoz is given ahead of time and will not treat nausea or vomiting that you already have.
Aprepitant Sandoz capsules are for use in adults and children who are at least 12 years old. The oral suspension (liquid) can be given to adults and children as young as 6 months old.
Prevention of Nausea and Vomiting Associated with HEC and MEC
The recommended dosages in adults of Aprepitant Sandoz, dexamethasone, and a 5-HT3 antagonist for the prevention of nausea and vomiting associated with administration of HEC or MEC are shown in Table 1 and Table 2, respectively.
Preparation of Aprepitant Sandoz for
Intravenous Infusion
Table 3 includes preparation instructions for Aprepitant Sandoz for HEC as a 130 mg single-dose regimen and for MEC as a 100 mg single dose followed by 2 days of oral Aprepitant Sandoz as a 3-day regimen. Differences in preparation for each dose are displayed as bolded text.
Caution: Do not mix Aprepitant Sandoz with solutions for which physical and chemical compatibility have not been established. Aprepitant Sandoz is incompatible with any solutions containing divalent cations (e.g. calcium, magnesium), including Lactated Ringer’s Solution and Hartmann's Solution.
Storage
The diluted Aprepitant Sandoz solution is stable at ambient room temperature for 6 hours in 0.9% Sodium Chloride Injection, USP or 12 hours in 5% Dextrose Injection, USP.
See also:
What is the most important information I should know about Aprepitant Sandoz?
Aprepitant Sandoz is contraindicated in patients:
- who are hypersensitive to any component of the product. Hypersensitivity reactions including anaphylactic reactions have been reported with fosaprepitant and oral Aprepitant Sandoz.
- taking pimozide. Inhibition of CYP3A4 by Aprepitant Sandoz could result in elevated plasma concentrations of pimozide, which is a CYP3A4 substrate, potentially causing serious or life-threatening reactions, such as QT prolongation, a known adverse reaction of pimozide.
Use Aprepitant Sandoz as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Aprepitant Sandoz. Talk to your pharmacist if you have questions about this information.
- Take Aprepitant Sandoz by mouth with or without food.
- Do not start Aprepitant Sandoz if you already have nausea or vomiting before you take it. Tell your doctor.
- It is important to follow your doctor's instructions for the timing of each dose and for the length of treatment. If you are not sure how or when to take Aprepitant Sandoz, check with your doctor.
- If you miss a dose of Aprepitant Sandoz, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Aprepitant Sandoz.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
IV (Aprepitant Sandoz):
Prevention of chemotherapy-induced nausea and vomiting:
Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy, including high-dose cisplatin, as single-dose Aprepitant Sandoz regimen (in combination with other antiemetics) in adults.
Prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy as a single-dose Aprepitant Sandoz regimen (in combination with other antiemetics) in adults.
Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy as a 3-day Aprepitant Sandoz regimen (in combination with other antiemetics) in adults.
Oral (Aprepitant Sandoz oral):
Prevention of chemotherapy-induced nausea and vomiting:
Prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy (initial and repeat courses; in combination with other antiemetics) in patients ≥12 years (capsules) and in patients ≥6 months (oral suspension).
Prevention of nausea and vomiting associated with moderately emetogenic chemotherapy (initial and repeat courses; in combination with other antiemetics) in patients ≥12 years (capsules) and in patients ≥6 months (oral suspension).
Note: Generic Aprepitant Sandoz capsules are only approved for use in adults.
Postoperative nausea and vomiting (generic capsules): Prevention of postoperative nausea and vomiting (PONV) in adults. Note: The PONV indication was removed from the Aprepitant Sandoz capsule US prescribing information (in September 2019); however, it remains in the labeling for generic Aprepitant Sandoz capsules.
Limitations of use: Aprepitant Sandoz has not been studied for the management of existing nausea and vomiting. Chronic, continuous administration is not recommended (has not been studied and chronic use may alter Aprepitant Sandoz's drug interaction profile).
See also:
What other drugs will affect Aprepitant Sandoz?
Aprepitant Sandoz is a substrate, a moderate inhibitor and an inducer of CYP3A4. Aprepitant Sandoz is also an inducer of CYP2C9.
Effect of Aprepitant Sandoz on the Pharmacokinetics of Other Agents: As a moderate inhibitor of CYP3A4, Aprepitant Sandoz can increase plasma concentrations of co-administered medicinal products that are metabolized through CYP3A4.
Aprepitant Sandoz should not be used concurrently with pimozide, terfenadine, astemizole or cisapride. Inhibition of CYP3A4 by Aprepitant Sandoz could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions.
Aprepitant Sandoz has been shown to induce the metabolism of S(-) warfarin and tolbutamide, which are metabolized through CYP2C9. Co-administration of Aprepitant Sandoz with these drugs or other drugs that are known to be metabolized by CYP2C9 eg, phenytoin, may result in lower plasma concentrations of these drugs.
Aprepitant Sandoz is unlikely to interact with drugs that are substrates for the P-glycoprotein transporter, as demonstrated by the lack of interaction of Aprepitant Sandoz with digoxin in a clinical drug interaction study.
5-HT3 Antagonists: In clinical drug interaction studies, Aprepitant Sandoz did not have clinically important effects on the pharmacokinetics of ondansetron or granisetron. No clinical or drug interaction study was conducted with dolasetron.
Corticosteroids: Dexamethasone: Aprepitant Sandoz, when given as a regimen of 125 mg with dexamethasone co-administered orally as 20 mg on Day 1, and Aprepitant Sandoz when given as 80 mg/day with dexamethasone co-administered orally as 8 mg on Days 2 through 5, increased the AUC of dexamethasone, a CYP3A4 substrate by 2.2-fold, on Days 1 and 5. The usual oral dexamethasone doses should be reduced by approximately 50% when co-administered with Aprepitant Sandoz, to achieve exposures of dexamethasone similar to those obtained when it is given without Aprepitant Sandoz. The daily dose of dexamethasone administered in clinical studies with Aprepitant Sandoz reflects an approximate 50% reduction of the dose of dexamethasone.
Methylprednisolone: Aprepitant Sandoz, when given as a regimen of 125 mg on Day 1 and 80 mg/day on Days 2 and 3, increased the AUC of methylprednisolone, a CYP3A4 substrate, by 1.3-fold on Day 1 and by 2.5-fold on Day 3, when methylprednisolone was co-administered IV as 125 mg on Day 1 and orally as 40 mg on Days 2 and 3. The usual IV methylprednisolone dose should be reduced by approximately 25%, and the usual oral methylprednisolone dose should be reduced by approximately 50% when co-administered with Aprepitant Sandoz, to achieve exposures of methylprednisolone similar to those obtained when it is given without Aprepitant Sandoz.
Caution is advised and additional monitoring may be appropriate in patients receiving Aprepitant Sandoz and co-administered with the following chemotherapeutic agents metabolized primarily or in part by CYP3A4: Etoposide, vinorelbine, docetaxel, paclitaxel, irinotecan, ifosfamide, imatinib, vinblastine and vincristine.
Warfarin: A single 125-mg dose of Aprepitant Sandoz was administered on Day 1 and 80 mg/day on Days 2 and 3 to healthy subjects who were stabilized on chronic warfarin therapy. Although there was no effect of Aprepitant Sandoz on the plasma AUC of R(+) or S(-) warfarin determined on Day 3, there was a 34% decrease in S(-) warfarin (a CYP2C9 substrate) trough concentration accompanied by a 14% decrease in the prothrombin time (reported as International Normalized Ratio or INR) 5 days after completion of dosing with Aprepitant Sandoz. In patients on chronic warfarin therapy, the prothrombin time (INR) should be closely monitored in the 2-week period, particularly at 7-10 days following initiation of the 3-day regimen of Aprepitant Sandoz with each chemotherapy cycle.
Tolbutamide: Aprepitant Sandoz, when given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, decreased the AUC of tolbutamide (a CYP2C9 substrate) by 23% on Day 4, 28% on Day 8 and 15% on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of the 3-day regimen of Aprepitant Sandoz and on Days 4, 8 and 15.
Oral Contraceptives:
Midazolam: Aprepitant Sandoz increased the AUC of midazolam, a sensitive CYP3A4 substrate, by 2.3-fold on Day 1 and 3.3-fold on Day 5, when a single oral dose of midazolam 2 mg was co-administered on Day 1 and Day 5 of a regimen of Aprepitant Sandoz 125 mg on Day 1 and 80 mg/day on Days 2 through 5. The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these agents with Aprepitant Sandoz.
In another study with IV administration of midazolam, Aprepitant Sandoz was given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, and midazolam 2 mg IV was given prior to the administration of the 3-day regimen of Aprepitant Sandoz and on Days 4, 8 and 15. Aprepitant Sandoz increased the AUC of midazolam by 25% on Day 4 and decreased the AUC of midazolam by 19% on Day 8 relative to the dosing of Aprepitant Sandoz on Days 1 through 3. These effects were not considered clinically important. The AUC of midazolam on Day 15 was similar to that observed at baseline.
Effect of Other Agents on the Pharmacokinetics of Aprepitant Sandoz: Aprepitant Sandoz is a substrate for CYP3A4; therefore, co-administration of Aprepitant Sandoz with drugs that inhibit CYP3A4 activity may result in increased plasma concentrations of Aprepitant Sandoz. Consequently, concomitant administration of Aprepitant Sandoz with strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir) should be approached cautiously; but concomitant administration of Aprepitant Sandoz with moderate CYP3A4 inhibitors (eg, diltiazem) does not result in clinically meaningful changes in plasma concentrations of Aprepitant Sandoz.
Aprepitant Sandoz is a substrate for CYP3A4; therefore, co-administration of Aprepitant Sandoz with drugs that strongly induce CYP3A4 activity (eg, rifampin, carbamazepine, phenytoin) may result in reduced plasma concentrations of Aprepitant Sandoz that may result in decreased efficacy of Aprepitant Sandoz. Concomitant administration of Aprepitant Sandoz with St. John's wort is not recommended.
Ketoconazole: When a single 125-mg dose of Aprepitant Sandoz was administered on Day 5 of a 10-day regimen of 400 mg/day of ketoconazole, a strong CYP3A4 inhibitor, the AUC of Aprepitant Sandoz increased approximately 5-fold and the mean terminal half-life of Aprepitant Sandoz increased approximately 3-fold. Concomitant administration of Aprepitant Sandoz with strong CYP3A4 inhibitors should be approached cautiously.
Rifampin: When a single 375-mg dose of Aprepitant Sandoz was administered on Day 9 of a 14-day regimen of 600 mg/day of rifampin, a strong CYP3A4 inducer, the AUC of Aprepitant Sandoz decreased approximately 11-fold and the mean terminal half-life decreased approximately 3-fold. Co-administration of Aprepitant Sandoz with drugs that induce CYP3A4 activity may result in reduced plasma concentrations and decreased efficacy of Aprepitant Sandoz.
Additional Interactions: Diltiazem: In patients with mild to moderate hypertension, administration of Aprepitant Sandoz once daily, as a tablet formulation comparable to 230 mg of the capsule formulation, with diltiazem 120 mg 3 times daily for 5 days, resulted in a 2-fold increase of Aprepitant Sandoz AUC and a simultaneous 1.7-fold increase of diltiazem AUC. These pharmacokinetic effects did not result in clinically meaningful changes in ECG, heart rate, or blood pressure beyond those changes induced by diltiazem alone.
Paroxetine: Co-administration of once daily doses of Aprepitant Sandoz, as a tablet formulation comparable to 85 mg or 170 mg of the capsule formulation, with paroxetine 20 mg once daily, resulted in a decrease in AUC by approximately 25% and Cmax by approximately 20% of both Aprepitant Sandoz and paroxetine.
See also:
What are the possible side effects of Aprepitant Sandoz?
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 Sandoz for injection was evaluated in approximately 1600 individuals.
Adverse Reactions for the Prevention of Nausea and Vomiting Associated with MEC
In an active-controlled clinical trial in patients receiving MEC, safety was evaluated in 504 patients receiving a single dose of Aprepitant Sandoz for injection in combination with ondansetron and dexamethasone (Aprepitant Sandoz regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (standard therapy). The most common adverse reactions are listed in Table 4.
Table 4 : Most Common Adverse Reactions in Patients Receiving MEC*
| Aprepitant Sandoz for injection, ondansetron, and dexamethasone† (N=504) | Ondansetron and dexamethasone‡ (N=497) | |
| fatigue | 15% | 13% |
| diarrhea | 13% | 11% |
| neutropenia | 8% | 7% |
| asthenia | 4% | 3% |
| anemia | 3% | 2% |
| peripheral neuropathy | 3% | 2% |
| leukopenia | 2% | 1% |
| dyspepsia | 2% | 1% |
| urinary tract infection | 2% | 1% |
| pain in extremity | 2% | 1% |
| *Reported in ≥ 2% of patients treated with the Aprepitant Sandoz regimen and at a greater incidence than standard therapy. †Aprepitant Sandoz regimen ‡Standard therapy |
Infusion-site reactions were reported in 2.2% of patients treated with the Aprepitant Sandoz regimen compared to 0.6% of patients treated with standard therapy. The infusion-site reactions included: infusion-site pain (1.2%, 0.4%), injection-site irritation (0.2%, 0.0%), vessel puncture-site pain (0.2%, 0.0%), and infusion-site thrombophlebitis (0.6%, 0.0%), reported in the Aprepitant Sandoz regimen compared to standard therapy, respectively.
Adverse Reactions for the Prevention of Nausea and Vomiting Associated with HEC
In an active-controlled clinical study in patients receiving HEC, safety was evaluated for 1143 patients receiving a single dose of Aprepitant Sandoz for injection compared to 1169 patients receiving the 3-day regimen of oral Aprepitant Sandoz (Aprepitant Sandoz). The safety profile was generally similar to that seen in the MEC study with fosaprepitant and prior HEC studies with Aprepitant Sandoz. However, infusion-site reactions occurred at a higher incidence in patients in the fosaprepitant group (3.0%) compared to those in the Aprepitant Sandoz group (0.5%). The following additional infusion-site reactions occurred in HEC study and were not reported in the MEC study described above: infusion-site erythema (0.5%, 0.1%), infusion-site pruritus (0.3%, 0.0%), and infusion-site induration (0.2%, 0.1%), reported in the fosaprepitant group compared to the Aprepitant Sandoz group, respectively.
Since fosaprepitant is converted to Aprepitant Sandoz, those adverse reactions associated with Aprepitant Sandoz might also be expected to occur with Aprepitant Sandoz for injection. See the full prescribing information for Aprepitant Sandoz capsules for complete safety information regarding studies performed with oral Aprepitant Sandoz.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Aprepitant Sandoz. 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.
Nervous system disorders: ifosfamide-induced neurotoxicity reported after Aprepitant Sandoz and ifosfamide coadministration.
Aprepitant Sandoz, an antiemetic, is a substance P/neurokinin 1 (NK1) receptor antagonist which, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Aprepitant Sandoz is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors. Aprepitant Sandoz has little or no affinity for serotonin (5-HT3), dopamine, and corticosteroid receptors, the targets of existing therapies for chemotherapy-induced nausea and vomiting (CI NV).
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