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Nepafenac: Drug information

Nepafenac: Drug information
(For additional information see "Nepafenac: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Ilevro;
  • Nevanac
Brand Names: Canada
  • Ilevro;
  • Nevanac
Pharmacologic Category
  • Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic
Dosing: Adult
Ocular pain and inflammation associated with cataract surgery

Ocular pain and inflammation associated with cataract surgery: Ophthalmic:

0.1% suspension: Instill 1 drop into affected eye(s) 3 times daily, beginning 1 day prior to surgery, the day of surgery, and through the first 2 weeks of the postoperative period.

0.3% suspension: Instill 1 drop into affected eye(s) once daily, beginning 1 day prior to surgery, the day of surgery, and through the first 2 weeks of the postoperative period. Instill 1 additional drop 30 to 120 minutes prior to surgery.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Ocular pain and inflammation associated with cataract surgery

Ocular pain and inflammation associated with cataract surgery: Ophthalmic: Children ≥10 years and Adolescents: Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Cardiovascular: Hypertension (≤4%)

Central nervous system: Foreign body sensation of eye (≤10%), headache (≤4%)

Gastrointestinal: Nausea (≤4%), vomiting (≤4%)

Ophthalmic: Decreased visual acuity (≤10%), increased intraocular pressure (≤10%), sticky sensation of eye (≤10%), conjunctival edema (≤5%), corneal edema (≤5%), crusting of eyelid (≤5%), eye discomfort (≤5%), eye pain (≤5%), eye pruritus (≤5%), lacrimation (≤5%), ocular hyperemia (≤5%), photophobia (≤5%), vitreous detachment (≤5%), xerophthalmia (≤5%)

Respiratory: Sinusitis (≤4%)

Contraindications

Hypersensitivity to nepafenac, other NSAIDs, or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Asthma, urticarial, or acute rhinitis precipitated by acetylsalicylic acid or other NSAIDs.

Warnings/Precautions

Concerns related to adverse effects:

• Aspirin/NSAID sensitivity: Use with caution in patients with previous sensitivity to acetylsalicylic acid and phenylacetic acid derivatives, including patients who experience bronchospasm, asthma, rhinitis, or urticaria following NSAID or aspirin.

• Keratitis: May cause keratitis; continued use in a patient with keratitis may cause severe corneal adverse reactions, potentially resulting in loss of vision. Immediately discontinue use in patients with evidence of corneal epithelial damage.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a predisposition to bleeding (bleeding tendencies or medications which interfere with coagulation).

• Diabetes: Use with caution in patients with diabetes mellitus; may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Ocular disease: Use with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, ocular surface disease, or repeat ocular surgeries (within a short timeframe); may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may be at risk of corneal adverse events, potentially resulting in loss of vision.

Special populations:

• Surgery patients: May slow/delay healing or prolong bleeding time following surgery. Increased intraocular bleeding (including hyphema) has been reported. To minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.

Other warnings/precautions:

• Contact lenses: May contain benzalkonium chloride which may be absorbed by soft contact lenses; contact lenses should not be worn during treatment.

• Duration of therapy: Use for more than 1 day prior to surgery or for 14 days beyond surgery may increase risk and severity of corneal adverse events.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Ophthalmic:

Ilevro: 0.3% (1.7 mL [DSC], 3 mL) [contains benzalkonium chloride, edetate (edta) disodium, propylene glycol]

Nevanac: 0.1% (3 mL) [contains benzalkonium chloride, edetate (edta) disodium]

Generic Equivalent Available: US

No

Pricing: US

Suspension (Ilevro Ophthalmic)

0.3% (per mL): $152.08

Suspension (Nevanac Ophthalmic)

0.1% (per mL): $131.65

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Ophthalmic:

Ilevro: 0.3% (3 mL) [contains benzalkonium chloride, edetate (edta) disodium, propylene glycol]

Nevanac: 0.1% (5 mL) [contains benzalkonium chloride, edetate (edta) disodium]

Administration: Adult

Ophthalmic: For topical ophthalmic use only; shake well prior to use. Remove contact lenses prior to using solutions containing benzalkonium chloride. To avoid contamination, do not touch tip of container to any surface. May be administered with other eye drops; wait at least 5 minutes before administering other eye drops. To minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; do not use the same bottle for both eyes.

Administration: Pediatric

Ophthalmic: For topical ophthalmic use only; shake well prior to use. Remove contact lenses prior to using solutions containing benzalkonium chloride. To avoid contamination, do not touch tip of container to any surface. May be administered with other eye drops; wait at least 5 minutes before administering other eye drops. To minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; do not use the same bottle for both eyes.

Use: Labeled Indications

Ocular pain and inflammation associated with cataract surgery: Treatment of pain and inflammation associated with cataract surgery

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Anticoagulants: Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Corticosteroids (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy

Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Pregnancy Considerations

Teratogenic events were not observed in animal reproduction studies. Exposure to nonsteroidal anti-inflammatory drugs late in pregnancy may lead to premature closure of the ductus arteriosus.

Breastfeeding Considerations

It is not known if nepafenac is excreted in breast milk; the manufacturer recommends that caution be exercised when administering to nursing women.

Mechanism of Action

Nepafenac is a prodrug which once converted to amfenac inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Low levels (0.2 to 0.5 ng/mL [Nevanac]; 0.6 to 1.6 ng/mL [Ilevro]) of nepafenac and amfenac are detected in the plasma following ophthalmic administration

Metabolism: Hydrolyzed in ocular tissue to amfenac (active)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Nevanac;
  • (AR) Argentina: Ilevro;
  • (AT) Austria: Nevanac;
  • (AU) Australia: Ilevro;
  • (BD) Bangladesh: Nep ts | Nepafix | Nepagen | Nepagen ts | Neparact ts | Nevan | Nevan ts | Olivan ts | Opanac | Optafenac | Optafenac ts;
  • (BE) Belgium: Nevanac;
  • (BG) Bulgaria: Apfecto | Nevanac;
  • (BR) Brazil: Nevanac;
  • (CO) Colombia: Nepaoftal | Nevanac;
  • (CZ) Czech Republic: Nevanac;
  • (DE) Germany: Nevanac;
  • (DO) Dominican Republic: Nevanac | Oksana;
  • (EC) Ecuador: Nefadol | Nepaoftal;
  • (EE) Estonia: Nevanac;
  • (EG) Egypt: Elinepafen | Nevanac | Nevxal | Ramedafenac;
  • (ES) Spain: Nevanac;
  • (FI) Finland: Nevanac;
  • (FR) France: Nevanac;
  • (GB) United Kingdom: Nevanac;
  • (GR) Greece: Nevanac;
  • (HK) Hong Kong: Nevanac;
  • (HU) Hungary: Nevanac;
  • (ID) Indonesia: Nevanac;
  • (IE) Ireland: Nevanac;
  • (IN) India: Amplinak | Avanep | Ilevro | Klarnep | Micronac | Nepablu bf | Nepacure | Nepalact | Nepapix | Neypac | Nypa | Oxiflam | Xinep;
  • (IT) Italy: Nevanac;
  • (JO) Jordan: Nevanac;
  • (JP) Japan: Nevanac;
  • (KE) Kenya: Nepaz | Nevanac;
  • (KW) Kuwait: Nevanac;
  • (LB) Lebanon: Nevanac;
  • (LT) Lithuania: Nevanac;
  • (LU) Luxembourg: Nevanac;
  • (LV) Latvia: Nevanac;
  • (MX) Mexico: Nevanac | Pranayam;
  • (NG) Nigeria: Nevan;
  • (NL) Netherlands: Nevanac;
  • (NO) Norway: Nevanac;
  • (PE) Peru: Nepafen | Nevanac;
  • (PH) Philippines: Nevanac;
  • (PK) Pakistan: Acukat | Avanep | Barinep | Barinep ophthalmic suspension | Curanep | Ilevro | Nafen | Nepac | Nepafen | Nepanac | Nepasol | Neplo | Nevanac | Nuvanac | Pafnac;
  • (PL) Poland: Nevanac;
  • (PR) Puerto Rico: Ilevro;
  • (PT) Portugal: Nevanac;
  • (PY) Paraguay: Nevanac;
  • (QA) Qatar: Nevanac;
  • (RU) Russian Federation: Nevanac;
  • (SA) Saudi Arabia: Nevanac;
  • (SE) Sweden: Nevanac;
  • (SG) Singapore: Nevanac;
  • (SK) Slovakia: Nevanac;
  • (TR) Turkey: Apfecto | Nevanac;
  • (TW) Taiwan: Ilevro | Nevanac;
  • (UA) Ukraine: Nevanac;
  • (UY) Uruguay: Nevanac;
  • (ZA) South Africa: Nevanac
  1. Ilevro (nepafenac) topical ophthalmic suspension [prescribing information]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; March 2020.
  2. Ilevro (nepafenac) [product monograph]. Dorval, Quebec, Canada; Novartis Pharmaceuticals Canada; April 2018.
  3. Nevanac (nepafenac) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; September 2021.
  4. Nevanac (nepafenac) [product monograph]. Dorval, Quebec, Canada; Novartis Pharmaceuticals Canada; January 2018.
Topic 9468 Version 178.0

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