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Contraindications/Warnings/Precautions/Adverse effects

7 evidence topics · 1 source

Warnings and precautions

Contraindications

“LYTENAVA is contraindicated in patients with ocular or periocular infections.” (opens the prescribing information at this quote)
“LYTENAVA is contraindicated in patients with active intraocular inflammation.” (opens the prescribing information at this quote)
“LYTENAVA is contraindicated in patients with known hypersensitivity to bevacizumab products or any of the ingredients in LYTENAVA. Hypersensitivity reactions may manifest as severe intraocular inflammation.” (opens the prescribing information at this quote)

Warning: endophthalmitis and retinal detachments

“Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering LYTENAVA. In addition, patients should be monitored following the injection to permit early treatment should an infection occur [see Dosage and Administration (2.3) and Patient Counseling Information (17)].” (opens the prescribing information at this quote)

Warning: increases in intraocular pressure

“Increases in intraocular pressure have been noted post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure prior to and following intravitreal injection with LYTENAVA and manage appropriately [see Dosage and Administration (2.4)].” (opens the prescribing information at this quote)

Warning: thromboembolic events

“Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).” (opens the prescribing information at this quote)

Adverse reactions: clinical trial exposure and most common reaction

“The data described below reflect exposure to LYTENAVA in 601 patients, in five clinical trials [see Clinical Studies (14)].” (opens the prescribing information at this quote)
“Most common adverse reaction (≥ 4%) reported in patients receiving LYTENAVA was conjunctival hemorrhage (4%) (6.1).” (opens the prescribing information at this quote)

Adverse reactions: common ocular events versus ranibizumab

Adverse Reactions	LYTENAVA 1.25 mg (N = 601)	Ranibizumab 0.5 mg (N = 345)
Conjunctival hemorrhage	“4%”	“3%”
Eye pain	“2%”	“1%”
Vitreous floaters	“2%”	“1%”

Adverse reactions: less common ocular events

“Less common ocular adverse reactions reported in the study eye in <1% of patients treated with LYTENAVA were corneal abrasion, dry eye, eye irritation, and intraocular pressure increased.” (opens the prescribing information at this quote)