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Cinvanti

  • Generic Name: aprepitant injectable emulsion
  • Brand Name: Cinvanti

Cinvanti (Aprepitant Injectable Emulsion) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Cinvanti Side Effects Center

What Is Cinvanti?

Cinvanti (aprepitant) is a substance P/neurokinin-1 (NK 1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, 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; and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

What Are Side Effects of Cinvanti?

Common side effects of Cinvanti include:

Dosage for Cinvanti

Single Dose Regimen: The recommended dosage of Cinvanti in adults is 130mg on Day 1 as an intravenous infusion over30 minutes approximately 30 minutes prior to chemotherapy. 3-Day Regimen: The recommended dosage of Cinvanti in adults is 100 mg administered on Day 1 as an intravenous infusion over 30 minutes, approximately 30 minutes prior to chemotherapy. Aprepitant capsules (80mg) are given orally on Days 2 and 3. Cinvanti is part of a regimen that includes a corticosteroid and a 5-HT3 antagonist.

What Drugs, Substances, or Supplements Interact with Cinvanti?

Cinvanti may interact with:

Tell your doctor all medications and supplements you use.

Cinvanti During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Cinvanti. Cinvanti is not recommended for use in pregnant women due to the alcohol content. It is unknown if Cinvanti passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Cinvanti (aprepitant) Injectable Emulsion, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Cinvanti Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, itching, difficult breathing, dizziness, trouble swallowing, fast heartbeat, wheezing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • pain or burning when you urinate;
  • sores or white patches in your mouth or throat, sore throat;
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Common side effects may include:

  • stomach pain, indigestion, burping, loss of appetite;
  • low blood cell counts;
  • diarrhea, constipation;
  • hiccups;
  • abnormal liver function tests;
  • headache, dizziness;
  • dehydration;
  • pain in your arms or legs;
  • pain, hardening, redness, swelling, or itching where the medicine was injected;
  • cough; or
  • feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cinvanti (Aprepitant Injectable Emulsion)

 

Cinvanti Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]

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 safety of CINVANTI was evaluated as a single-dose in healthy subjects and established from adequate and well-controlled studies of intravenous fosaprepitant and/or oral aprepitant [see Clinical Studies]. Adverse reactions observed in these adequate and well-controlled studies are described below.

Safety Of CINVANTI

A total of 200 healthy subjects received a single 130 mg dose of CINVANTI as a 30-minute infusion. Adverse reactions reported in at least 2% of subjects were headache (3%) and fatigue (2%). The safety profile of CINVANTI in 50 healthy subjects who received a single 2-minute injection was similar to that seen with a 30-minute infusion.

Single-Dose Intravenous Fosaprepitant --HEC

In an active-controlled clinical study in patients receiving HEC, safety was evaluated for 1143 patients receiving a single intravenous dose of fosaprepitant, a prodrug of aprepitant, compared to 1169 patients receiving a 3-day regimen of oral aprepitant [see Clinical Studies]. When administered intravenously, fosaprepitant is converted to aprepitant within 30 minutes. The safety profile was generally similar to that seen in prior HEC studies with a 3-day regimen of oral aprepitant. However, infusion-site reactions occurred at a higher incidence in patients in the intravenous fosaprepitant group (3%) compared to those in the oral aprepitant group (0.5%). The reported infusion-site reactions included: infusion-site erythema, infusion-site pruritus, infusion-site pain, infusion-site induration and infusion-site thrombophlebitis.

Adverse reactions associated with oral aprepitant may also be expected to occur with CINVANTI. See the full prescribing information for oral aprepitant for complete safety information.

Single-Dose Intravenous Fosaprepitant --MEC

In an active-controlled clinical trial in patients receiving MEC, safety was evaluated in 504 patients receiving a single dose of intravenous fosaprepitant in combination with ondansetron and dexamethasone (intravenous fosaprepitant regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (standard therapy). The most common adverse reactions are listed in Table 5.

Table 5: Most Common Adverse Reactions in Patients Receiving MEC*

Intravenous fosaprepitant, 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 intravenous fosaprepitant regimen and at a greater incidence than standard therapy.
†Intravenous fosaprepitant regimen
‡Standard therapy

Infusion-site reactions were reported in 2.2% of patients treated with the intravenous fosaprepitant 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 8 infusion-site thrombophlebitis (0.6%, 0.0%), reported in the intravenous fosaprepitant regimen compared to standard therapy, respectively.

3-Day Oral Aprepitant --MEC

In 2 active-controlled clinical trials in patients receiving MEC, 868 patients were treated with a 3-day oral aprepitant regimen during Cycle 1 of chemotherapy and 686 of these patients continued into extensions for up to 4 cycles of chemotherapy. In both studies, oral aprepitant was given in combination with ondansetron and dexamethasone (oral aprepitant regimen) and was compared to ondansetron and dexamethasone alone (standard therapy) [see Clinical Studies].

In the combined analysis of Cycle 1 data for these 2 studies, adverse reactions were reported in approximately 14% of patients treated with the aprepitant regimen compared with approximately 15% of patients treated with standard therapy. Treatment was discontinued due to adverse reactions in 0.7% of patients treated with the aprepitant regimen compared with 0.2% of patients treated with standard therapy.

The most common adverse reactions reported in patients treated with the oral aprepitant regimen with an incidence of at least 1% and greater than standard therapy are listed in Table 6.

Table 6: Adverse Reactions (≥ 1%) in Patients Receiving MEC with a Greater Incidence in the Oral 3-Day Aprepitant Regimen Relative to Standard Therapy

Oral Aprepitant Regimen
(N = 868)		 Standard Therapy
(N = 846)
Fatigue 1.4 0.9
Eructation 1.0 0.1

A listing of adverse reactions reported in less than 1% in patients treated with the oral aprepitant regimen that occurred at an incidence greater than in patients treated with standard therapy are presented in the Less Common Adverse Reactions subsection below.

Less Common Adverse Reactions

Adverse reactions reported in studies in patients treated with the 3-day oral aprepitant regimen with an incidence < 1% and greater than standard therapy are listed in Table 7.

Table 7: Adverse Reactions (incidence < 1%) in Patients Observed in Studies with a Greater Incidence in the Oral Aprepitant Regimen Relative to Standard Therapy

Infection and infestations candidiasis, staphylococcal infection
Blood and the lymphatic system disorders anemia, febrile neutropenia
Metabolism and nutrition disorders weight gain, polydipsia
Psychiatric disorders disorientation, euphoria, anxiety
Nervous system disorders dizziness, dream abnormality, cognitive disorder, lethargy, somnolence
Eye disorders conjunctivitis
Ear and labyrinth disorders tinnitus
Cardiac disorders bradycardia, cardiovascular disorder, palpitations
Vascular disorders hot flush, flushing
Respiratory, thoracic and mediastinal disorders pharyngitis, sneezing, cough, postnasal drip, throat irritation
Gastrointestinal disorders nausea, acid reflux, dysgeusia, epigastric discomfort, obstipation, gastroesophageal reflux disease, perforating duodenal ulcer, vomiting, abdominal pain, dry mouth, abdominal distension, feces hard, neutropenic colitis, flatulence, stomatitis
Skin and subcutaneous tissue disorders rash, acne, photosensitivity, hyperhidrosis, oily skin, pruritus, skin lesion
Musculoskeletal and connective tissue disorders muscle cramp, myalgia, muscular weakness
Renal and urinary disorders polyuria, dysuria, pollakiuria
General disorders and administration site condition edema, chest discomfort, malaise, thirst, chills, gait disturbance
Investigations alkaline phosphatase increased, hyperglycemia, microscopic hematuria, hyponatremia, weight decreased, neutrophil count decreased

In another chemotherapy-induced nausea and vomiting study, Stevens-Johnson syndrome was reported as a serious adverse reaction in a patient receiving aprepitant with cancer chemotherapy.

The adverse experience profiles in the Multiple-Cycle extensions of HEC and MEC studies for up to 6 cycles of chemotherapy were similar to that observed in Cycle 1.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of intravenous fosaprepitant and/or intravenous or oral 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 [see WARNINGS AND PRECAUTIONS].

Immune system disorders: hypersensitivity reactions including anaphylaxis and anaphylactic shock [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].

Nervous system disorders: ifosfamide-induced neurotoxicity reported after aprepitant and ifosfamide coadministration.

DRUG INTERACTIONS

Effect Of Aprepitant On The Pharmacokinetics Of Other Drugs

Aprepitant is a substrate, weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4. Aprepitant is also an inducer of CYP2C9 [see CLINICAL PHARMACOLOGY].

Some substrates of CYP3A4 are contraindicated with CINVANTI [see CONTRAINDICATIONS]. Dosage adjustment of some CYP3A4 and CYP2C9 substrates may be warranted, as shown in Table 8.

Table 8: Effects of Aprepitant on the Pharmacokinetics of Other Drugs

CYP3A4 Substrates
Pimozide
Clinical Impact Increased pimozide exposure.
Intervention CINVANTI is contraindicated [see CONTRAINDICATIONS].
Benzodiazepines
Clinical Impact Increased exposure to midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) may increase the risk of adverse reactions [see CLINICAL PHARMACOLOGY].
Intervention Monitor for benzodiazepine-related adverse reactions.
Dexamethasone
Clinical Impact Increased dexamethasone exposure [see CLINICAL PHARMACOLOGY].
Intervention Reduce the dose of oral dexamethasone by approximately 50% [see DOSAGE AND ADMINISTRATION].
Methylprednisolone
Clinical Impact Increased methylprednisolone exposure [see CLINICAL PHARMACOLOGY].
Intervention Reduce the dose of oral methylprednisolone by approximately 50% on Days 1 and 2 for patients receiving HEC and on Day 1 for patients receiving MEC.
Reduce the dose of intravenous methylprednisolone by 25% on Days 1 and 2 for patients receiving HEC and on Day 1 for patients receiving MEC.
Chemotherapeutic Agents that are Metabolized by CYP3A4
Clinical Impact Increased exposure of the chemotherapeutic agent may increase the risk of adverse reactions [see CLINICAL PHARMACOLOGY].
Intervention Vinblastine, vincristine, or ifosfamide or other chemotherapeutic asents
Monitor for chemotherapeutic-related adverse reactions.
Etoposide, vinorelbine, paclitaxel, and docetaxel
No dosage adjustment needed.
Hormonal Contraceptives
Clinical Impact Decreased hormonal exposure during administration of and for 28 days after administration of the last dose of aprepitant [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].
Intervention Effective alternative or back-up methods of contraception (such as condoms or spermicides) should be used during treatment with CINVANTI and for 1 month following administration of CINVANTI or oral aprepitant, whichever is administered last.
Examples birth control pills, skin patches, implants, and certain IUDs
CYP2C9 Substrates
Warfarin
Clinical Impact Decreased warfarin exposure and decreased prothrombin time (INR) [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].
Intervention In patients on chronic warfarin therapy, monitor the prothrombin time (INR) in the 2-week period, particularly at 7 to 10 days, following administration of CINVANTI with each chemotherapy cycle.
Other Antiemetic Agents
5-HT3 Antagonists
Clinical Impact No change in the exposure of the 5-HT3 antagonist [see CLINICAL PHARMACOLOGY].
Intervention No dosage adjustment needed.
Examples ondansetron, granisetron, dolasetron

Effect Of Other Drugs On The Pharmacokinetics Of Aprepitant

Aprepitant is a CYP3A4 substrate [see CLINICAL PHARMACOLOGY]. Co-administration of CINVANTI with drugs that are inhibitors or inducers of CYP3A4 may result in increased or decreased plasma concentrations of aprepitant, respectively, as shown in Table 9.

Table 9: Effects of Other Drugs on Pharmacokinetics of Aprepitant

Moderate to Strong CYP3A4 Inhibitors
Clinical Impact Significantly increased exposure of aprepitant may increase the risk of adverse reactions associated with CINVANTI [see ADVERSE REACTION and CLINICAL PHARMACOLOGY].
Intervention Avoid concomitant use of CINVANTI.
Examples Moderate inhibitor: diltiazem Strons inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir
Strong CYP3A4 Inducers
Clinical Impact Substantially decreased exposure of aprepitant in patients chronically taking a strong CYP3A4 inducer may decrease the efficacy of CINVANTI [see CLINICAL PHARMACOLOGY].
Intervention Avoid concomitant use of CINVANTI.
Examples rifampin, carbamazepine, phenytoin

Read the entire FDA prescribing information for Cinvanti (Aprepitant Injectable Emulsion)

&Copy; Cinvanti Patient Information is supplied by Cerner Multum, Inc. and Cinvanti Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.