LUCENTIS (ranibizumab)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Ocular infection

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Cerebrovascular accident
Ocular inflammation
Pregnancy

There are 5 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Endophthalmitis
Ocular hypertension
Retinal detachment
Retinal vasculitis
Thromboembolic disorder

There are 19 severe adverse reactions.

More Frequent	Less Frequent
Cataracts Conjunctival hemorrhage Conjunctival hyperemia Ocular hypertension Ocular pain	Blepharitis Bronchitis Impaired wound healing Maculopathy Visual changes

Rare/Very Rare
Acute myocardial infarction Arterial thrombosis Cerebrovascular accident Endophthalmitis Influenza Retinal detachment Retinal vascular occlusion Tear of retinal pigment epithelium Thromboembolic disorder

There are 16 less severe adverse reactions.

More Frequent	Less Frequent
Foreign body sensation of eye Ocular irritation Vitreous floater	Arthralgia Cough Dry eye Eye tearing Headache disorder Nausea Ocular discomfort Ocular itching Ocular redness Pharyngitis Posterior capsule opacification Upper respiratory infection

Rare/Very Rare
Retinal vasculitis

Category C. (See Users Guide.) Studies have not been conducted with ranibizumab in pregnant women; it is not known whether the drug can cause fetal harm when administered during pregnancy. In embryofetal studies in animals, fetal skeletal abnormalities were observed when pregnant animals were exposed to serum ranibizumab concentrations higher than those produced with single eye treatments in humans.

Based on its mechanism as a VEGF antagonist, it is possible that ranibizumab may adversely affect embryofetal development or reproductive capacity. The drug should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.

It is not known whether ranibizumab is distributed in human milk. Because many drugs are excreted in human milk, caution is advised if the drug is administered in nursing women.

In clinical studies, approximately 79% of patients randomized to receive ranibizumab were 65 years of age or older and 54% were 75 years of age or older. No substantial differences in efficacy or systemic exposure (after correcting for creatinine clearance) relative to younger adults were observed.