Pegaptaninb sodium - @ - Opthalmic Injection - Selective vascular Endothelial Growth Factor Antagonist- (Feb 2006)
Drug Interaction:
Not known
Indication:
LIST OF DRUGS DURING 2006
Sr.No- 10
Name of the Drug- Pegaptinib Sodium Injection (0.3mg) Pharmacological Classification- For nerovascular (wet) age related macular
degeneration
Date of Approval- 06-02-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Pegaptinib Sodium Injection 06-02-2006
0.03mg Macular degeneration
For Neovascular (Wet) age related
Neovascular age-related macular degeneration ( AMD )
Adverse Reaction:
Serious adverse reactions related to the injection procedure ocuring is less than 1%
which ncluded endophthalmitus, retinal detachment, and intragoenic traumatic cataract
Most frequently reported adverse reactions- in approx ( 10 to 30% )
anterior chamber inflamation, blurred vision, cataract, conjuntival hemorrhage, corneal edema,
eye discharge, eye irritation, eye pain, hypertension, increased intraocular pressure,
ocular discomfort, reduced visual acuity, visual disturbances., visual floaters, and vitreous
opacites.
Contra-Indications:
Ocular or periocularinfections , known hypersensitivity to pegaptanib or other component
Special Precautions/Warnings-
Renal function impairment - dosage adjustment for patients with renal failure is not required when administering 0.3mg dose
Endophthalmitis - intravenous injections including those with pegaptanib have been associated with endophthalmitis . Use proper asceptic injection technique when administering pegaptanib. In addition monitor patients during the week following injection to permit early treatment if required
Increased intraocular pressure- icrease in intraocular pressure have been seen within 30 minutes of injection with pegaptanib. Monitor and manage intraocular pressure.
Administration - for ophthalmic intravitreal injection only.
Pregnancy - use of pragaptanib during pregnancy only if the potential benefit to mother justifies the potential risk to the fetus.
Lactation- excercise caution when peganaptib is administered to a breast feeding woman
Children- safety and efficacy of use in children have not been established
Monitoring- following injection, monitor patient for elevation of intraocular pressure and for
endophthalmitis. Insruct patients to report sysptoms suggestive of endophthmitis
Dosages/ Overdosage Etc:
Indication-
Neovascular age-related macular degeneration ( AMD )
Dosage-
The injection procedure should be carried out under controlled aspectic conditions which include the use of sterile gloves, a sterile drape, and a sterile eyellid speculum
The patients medical history of hypersensitivity reactions should be evaluated prior to
performing intravitreal procedure. Adequate anesthesia and a broad spectrum microcide
should be given prior to injection
Patient Information:
1. In the days following pagaptanib administration patients are at risk for the development of
endophthalmitis .
2. If eye becomes red, sensitive to light , painful, or develops a change of vision, the patient should seek immediate attention of an ophthalmologist
Pregnancy and lactation:
Pregnancy -
Use of pragaptinib during pregnancy only if the potential benefit to mother justifies
the potential risk to the fetus.
Lactation-
Excercise cautionwhen peganaptib is administered to a breast feeding woman
Children-
Safety and efficacy of use in children have not been established