The Zydus Partnership

What Important Safety Information should I know about NUFYMCO?

• You should not receive NUFYMCO if you have an infection in or around the eye or are allergic to NUFYMCO or any of its ingredients. NUFYMCO is a prescription medication given by injection into the eye, and it has side effects. NUFYMCO is not for everyone. Some patients receiving ranibizumab products have had detached retinas and serious eye infections. If your eye becomes red, sensitive to light, or painful, or if you have a change in vision, call or visit your eye doctor right away.
• Some patients have had increased eye pressure before and within 1 hour of an injection. Your eye doctor should check your eye pressure and eye health before and after your NUFYMCO injection.
• Uncommonly, patients receiving ranibizumab products have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes. Fatal events were seen more often in patients with DME and DR with ranibizumab products compared with patients who did not receive ranibizumab products. Although there were only few fatal events which included causes of death typical of patients with advanced diabetic complications, these events may be caused by ranibizumab products.
• Severe inflammation of the veins in the retina, with or without blockage, usually with preexisting inflammation in the eye or after other treatments in the eye, have been reported with the use of ranibizumab products. Call your eye doctor immediately if you experience a change in vision. Your eye doctor may stop your treatment.
• Some patients receiving ranibizumab products have serious side effects related to the injection. These include serious infections inside the eye, detached retinas, and cataracts. The most common eye-related side effects are increased redness in the white of the eye, eye pain, small specks in vision, and increased eye pressure. The most common non-eye-related side effects are nose and throat infections, anemia, nausea, and cough.
• Reports of a tear in the outermost layer of the retina in patients with wAMD have been reported after treatment with ranibizumab products.
• NUFYMCO is for prescription use only.

For additional Safety Information, please talk to your doctor and see the NUFYMCO full Prescribing Information.

These are not all the possible side effects of NUFYMCO. Call your eye doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.