Pegaptanib: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->{{RB}}  
|authorTag=<!--Overview-->{{RB}}
|genericName=Pegaptanib sodium
|genericName=Pegaptanib sodium
|aOrAn=a
|aOrAn=a
|drugClass= Ophthalmologic Agent
|drugClass=Ophthalmologic Agent
|indicationType=treatment
|indicationType=treatment
|indication=neovascular (wet) age-related macular degeneration
|indication=neovascular (wet) age-related macular degeneration
|adverseReactions=
|adverseReactions=<!--Black Box Warning-->
 
 
<!--Black Box Warning-->
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|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* Ocular or Periocular Infections
Macugen is contraindicated in patients with ocular or periocular infections.
 
=====Hypersensitivity=====
Macugen is contraindicated in patients with known hypersensitivity to pegaptanib sodium or any other excipient in this product.


<!--Warnings-->
<!--Warnings-->
|warnings=* Description
|warnings=* Endophthalmitis
Intravitreous injections, including those with Macugen, have been associated with endophthalmitis. Proper aseptic injection technique should always be utilized when administering Macugen. In addition, patients should be monitored during the week following the injection to permit early treatment, should an infection occur [see Dosage and Administration (2.4)].


====Precautions====
5.2 Increases in Intraocular Pressure
Increases in intraocular pressure have been seen within 30 minutes of injection with Macugen. Therefore, intraocular pressure as well as the perfusion of the optic nerve head should be monitored and managed appropriately [see Dosage and Administration (2.4)].


* Description
5.3 Anaphylaxis
Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in the post-marketing experience following the Macugen intravitreal administration procedure


<!--Adverse Reactions-->
<!--Adverse Reactions-->


<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials= Injection Procedure
 
Serious adverse events related to the injection procedure occurring in < 1% of intravitreous injections included endophthalmitis [see Warnings and Precautions (5.1)], retinal detachment, and iatrogenic traumatic cataract.
=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 


6.2 Clinical Studies Experience
The most frequently reported adverse events in patients treated with Macugen 0.3 mg for up to two years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased intraocular pressure (IOP), ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10-40% of patients.


=====Miscellaneous=====
The following events were reported in 6-10% of patients receiving Macugen 0.3 mg therapy:


Ocular: blepharitis, conjunctivitis, photopsia, vitreous disorder.
Non-Ocular: bronchitis, diarrhea, dizziness, headache, nausea, urinary tract infection.


The following events were reported in 1-5% of patients receiving Macugen 0.3 mg therapy:


<!--Drug Interactions-->
Ocular: allergic conjunctivitis, conjunctival edema, corneal abrasion, corneal deposits, corneal epithelium disorder, endophthalmitis, eye inflammation, eye swelling, eyelid irritation, meibomianitis, mydriasis, periorbital hematoma, retinal edema, vitreous hemorrhage.
Non-Ocular: arthritis, bone spur, carotid artery occlusion, cerebrovascular accident, chest pain, contact dermatitis, contusion, diabetes mellitus, dyspepsia, hearing loss, pleural effusion, transient ischemic attack, urinary retention, vertigo, vomiting.
|postmarketing=Anaphylaxis/anaphylactoid reactions, including angioedema, have been identified during postapproval use of Macugen. 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
|drugInteractions=* Drug
|drugInteractions=* Drug
:* Description
:* Description

Revision as of 21:38, 13 February 2015

Pegaptanib
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Pegaptanib is a Ophthalmologic Agent that is FDA approved for the treatment of neovascular (wet) age-related macular degeneration. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration.

Dosage

  • Single-use glass syringe pre-filled with 0.3 mg of Macugen® in a nominal 90 μL solution for intravitreal injection.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pegaptanib in adult patients.

Non–Guideline-Supported Use

  • Diabetic macular edema[1]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Pegaptanib in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pegaptanib in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pegaptanib in pediatric patients.

Contraindications

  • Ocular or Periocular Infections

Macugen is contraindicated in patients with ocular or periocular infections.

Hypersensitivity

Macugen is contraindicated in patients with known hypersensitivity to pegaptanib sodium or any other excipient in this product.

Warnings

  • Endophthalmitis

Intravitreous injections, including those with Macugen, have been associated with endophthalmitis. Proper aseptic injection technique should always be utilized when administering Macugen. In addition, patients should be monitored during the week following the injection to permit early treatment, should an infection occur [see Dosage and Administration (2.4)].

5.2 Increases in Intraocular Pressure Increases in intraocular pressure have been seen within 30 minutes of injection with Macugen. Therefore, intraocular pressure as well as the perfusion of the optic nerve head should be monitored and managed appropriately [see Dosage and Administration (2.4)].

5.3 Anaphylaxis Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in the post-marketing experience following the Macugen intravitreal administration procedure

Adverse Reactions

Clinical Trials Experience

Injection Procedure Serious adverse events related to the injection procedure occurring in < 1% of intravitreous injections included endophthalmitis [see Warnings and Precautions (5.1)], retinal detachment, and iatrogenic traumatic cataract.

6.2 Clinical Studies Experience The most frequently reported adverse events in patients treated with Macugen 0.3 mg for up to two years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased intraocular pressure (IOP), ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10-40% of patients.

The following events were reported in 6-10% of patients receiving Macugen 0.3 mg therapy:

Ocular: blepharitis, conjunctivitis, photopsia, vitreous disorder. Non-Ocular: bronchitis, diarrhea, dizziness, headache, nausea, urinary tract infection.

The following events were reported in 1-5% of patients receiving Macugen 0.3 mg therapy:

Ocular: allergic conjunctivitis, conjunctival edema, corneal abrasion, corneal deposits, corneal epithelium disorder, endophthalmitis, eye inflammation, eye swelling, eyelid irritation, meibomianitis, mydriasis, periorbital hematoma, retinal edema, vitreous hemorrhage. Non-Ocular: arthritis, bone spur, carotid artery occlusion, cerebrovascular accident, chest pain, contact dermatitis, contusion, diabetes mellitus, dyspepsia, hearing loss, pleural effusion, transient ischemic attack, urinary retention, vertigo, vomiting.

Postmarketing Experience

Anaphylaxis/anaphylactoid reactions, including angioedema, have been identified during postapproval use of Macugen. 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

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pegaptanib in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Pegaptanib during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pegaptanib with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Pegaptanib with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Pegaptanib with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Pegaptanib with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pegaptanib with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pegaptanib in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pegaptanib in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pegaptanib in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pegaptanib in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Pegaptanib in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Pegaptanib in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Pegaptanib in the drug label.

Pharmacology

There is limited information regarding Pegaptanib Pharmacology in the drug label.

Mechanism of Action

Structure

File:Pegaptanib01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Pegaptanib in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Pegaptanib in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Pegaptanib in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Pegaptanib in the drug label.

How Supplied

Storage

There is limited information regarding Pegaptanib Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Pegaptanib |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Pegaptanib |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Pegaptanib in the drug label.

Precautions with Alcohol

  • Alcohol-Pegaptanib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Cunningham ET, Adamis AP, Altaweel M, Aiello LP, Bressler NM, D'Amico DJ; et al. (2005). "A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema". Ophthalmology. 112 (10): 1747–57. doi:10.1016/j.ophtha.2005.06.007. PMID 16154196.
  2. ↑ Empty citation (help)
  3. ↑ "http://www.ismp.org". External link in |title= (help)

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