Side Effects of Susvimo (ranibizumab)

Susvimo (ranibizumab injection) for intravitreal use via Susvimo ocular implant is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor.

Common side effects of Susvimo include a red spot on the eye caused by broken blood vessels (conjunctival hemorrhage), eye redness, inflammation of the colored part of the eye (iritis), eye pain, eye “floaters,” feeling something is in the eye, and headache.

Serious side effects of Susvimo include infection inside the eye (endophthalmitis, a medical emergency), retinal detachments, implant dislocation, bleeding inside the eye (vitreous hemorrhages) that may result in temporary vision loss, opening or gaping in the layer that covers the white part of the eye that may cause the implant to be exposed (conjunctival erosions or retractions), blister-like collection of fluid on the layer that covers the white part of the eye (conjunctival bleb), postoperative decrease in visual clarity, air bubbles causing improper filling of the implant, and deflection of the implant and subsequent injury.

There are no listed drug interactions of Susvimo.

There are no adequate and well-controlled studies of Susvimo administration in pregnant women. Based on the anti-VEGF mechanism of action for ranibizumab treatment with Susvimo may pose a risk to human embryofetal development. Females of reproductive potential should use effective contraception during treatment with Susvimo and for at least 12 months after the last dose of Susvimo.

There are no data available on the presence of ranibizumab in human milk, the effects of ranibizumab on the breastfed infant or the effects of ranibizumab on milk production/excretion. Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when Susvimo is administered to a nursing woman.
 

WARNING

ENDOPHTHALMITIS

The Susvimo implant has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. In clinical trials, 2.0% of patients receiving a ranibizumab implant experienced at least one episode of endophthalmitis.

What are the serious side effects of Susvimo?

Susvimo may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• severe eye pain,
• redness in the white of the eye,
• extreme sensitivity to bright light,
• decreased vision,
• swelling of the eyelid,
• floaters in the eye,
• sudden flashes of light,
• shadows in the vision field,
• implant dislocation,
• cloudy vision,
• lines or dark dots in your vision,
• dry or irritated eyes,
• feeling like something is in your eye,
• difficulty closing your eye,
• postoperative decrease in visual acuity,
• air bubbles causing improper filling of the implant, and
• deflection of the implant

Get medical help right away, if you have any of the symptoms listed above.

What are the common side effects of Susvimo?

The most common side effects of Susvimo include:

• redness of the eye,
• itching,
• feeling like something is in your eye,
• tearing of the eye,
• eye pain,
• reduced vision,
• headache,
• abnormally shaped pupils,
• sensitivity to light,
• vision loss, and
• eye pain

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Susvimo. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The following adverse reactions are discussed in greater detail in other sections of the label:

• Endophthalmitis
• Rhegmatogenous Retinal Detachment 
• Implant Dislocation 
• Vitreous Hemorrhage 
• Conjunctival Erosion or Retraction 
• Conjunctival Bleb 
• Postoperative Decrease in Visual Acuity

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.

The data below (Table 2) reflect exposure of 248 patients with nAMD in the Archway study following the Susvimo initial fill and implant insertion, refill, and implant removal (if necessary) procedures up to Week 40. In this patient population the most common (≤ 10%) adverse reactions up to Week 40 were conjunctival hemorrhage (72%), conjunctival hyperemia (26%), iritis (23%), and eye pain (10%).

Table 2 : Adverse Reactions in nAMD patients occurring in ≤ 4% of patients in the SUSVIMO arm

Immunogenicity

• As with all therapeutic proteins, there is potential for immune response in patients treated with ranibizumab including Susvimo. The detection of an immune response is highly dependent on the sensitivity, specificity, and drug tolerance level of the assay.
• Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.
• For these reasons, comparison of the incidence of antibodies in the study described below with the incidence of antibodies in other studies or to other products may be misleading.
• In previously treated nAMD patients, anti-ranibizumab antibodies were detected in 2.1% (5 of 243) of patients prior to insertion of the Susvimo implant. After the Susvimo implant insertion and treatment, anti-ranibizumab antibodies developed in 12% (29 of 247) patients.
• No clinically meaningful differences in the pharmacokinetics, efficacy, or safety in patients with treatment-emergent anti-ranibizumab antibodies were observed.